What happened

Shares of Aimmune Therapeutics (NASDAQ: AIMT) fell 23.3% in February, according to data provided by S&P Global Market Intelligence, as the launch of its new peanut allergy treatment took time to unfold.

Aimmune rose 40% last year as investors anticipated Palforzia, the firsttreatment approved by the Food and Drug Administration for peanut allergy in children. The regulatory agency approved the treatment on Jan. 31, and now investors are waiting to see how the first weeks of sales progress. The process is taking time because of the risk management procedure involved in the launch.

Image source: Getty Images.

Palforzia, an orally administered powder made of peanut protein, works by desensitizing patients to the allergen. In order to lower risk in case a new patient suffers a reaction to the therapy, the FDA has set up the Risk Evaluation and Mitigation Strategy (REMS) program. Physicians and patients must enroll in REMS and follow guidelines before treatment can begin. This process, along with the FDA's standard procedure of examining and releasing the first batches of biologic product, lengthened the timeline from approval to sales. Aimmune said during its recent earnings call that it expects to record the first Palforzia sales this month.

Getting physicians and patients on board in the next few months will be crucial for Aimmune. DBVTechnologies (NASDAQ: DBVT) is close behind, with an FDA decision on its peanut allergy drug expected in August. Aimmune now has the advantage of being first to market, before rivals enter with competing products. Aimmune is also expecting a decision on Palforzia from the Europeanregulatory agency in the fourth quarter, and said a decision in Switzerland could come in mid-2021.

All of these elements represent catalysts for the shares over the next year or so. If Aimmune can assure its position as market leader, the shares of this biotech company will benefit in the long term.

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Why Aimmune Therapeutics Shares Fell 23.3% in February - Nasdaq

Bone Marrow Stem Cells Comments Off on Why Aimmune Therapeutics Shares Fell 23.3% in February – Nasdaq | March 5th, 2020

Why is it that when a woman runs for an office or does something remarkable so very often the first thing people say is look at her hair or WHAT is she wearing! Well, there is a woman whose photos adorn the halls of the volunteer organization where I volunteer. And because she is the founder of the organization there are lots of photos in the office and in books about the history of the organization. The organization is Hadassah, The Womens Zionist Organization of America. The woman, the founder, is Henrietta Szold (1860-1945).

When I look at her photos, I dont focus on her hair, which changed little over the decades of her work. I dont look at the black pocketbook she often carried which seems not to have changed over the decades of her work. I dont think about her shoes, which were sturdy and usually black. Nope when I look at Miss Henrietta Szolds photo the first thing I think of look at how strong she is, look at the determination and purpose in her eyes, look at what those eyes have seen and those hands have touched. The rest unimportant and anecdotal.

As we are commemorating Womens History and Womens Empowerment Month in March, its very appropriate to tell you that even before Henrietta started Hadassah in a New York City synagogue in 1912 with a study group, she had, in her young life, already broken gender barriers and established institutions. Henrietta started the first night school for immigrants in the US and she studied at the Jewish Theological Seminary in an era when the idea of a female rabbi was unthinkable. An empowered woman look no further absolutely.

When Henriettas eyes first saw the disease and living conditions of the Jews in pre-state Israel on a trip with her mother in 1911, her mission of practical Zionism and her purpose were born. When you read her letters looking for funding or in subsequent years, letters between her and the nurses she sent over to provide pasteurized milk to babies and new moms, and to set up public health stations in Jerusalem to fight off the flies on the eyes of children suffering from trachoma, her words are full of determination and, excuse the old fashioned word gumption. This woman had moxie, this woman had chutzpah, this woman had guts. And thank G-d she did. Because she and her womens organization built the State of Israel. Hadassah created the medical infrastructure of Palestine and continues to do so today in Israel, a mere 108 years later. When there is purpose to what you are committed to and that purpose is accompanied by action there can be longevity. How about an organization that looks forward to the next 100 years? How about volunteers that are active for decades?

They say the proof is in the pudding, that you can judge something only once you have used or experienced it. So: Been there. Done that. Doing it.

Ive been a life member of Hadassah for 54 years, worked in just about every capacity and position at every possible level of the organization. I have gone to Israel so many times but when I juxtapose the memories of my first visit in 1966 with my most recent visit in 2018, WOW, the differences are staggering. Close to the top of the list are the ongoing changes at Hadassah Hospitals and Youth Villages. In the early years, beginning in 1913 when Henrietta sent over the first two nurses, Hadassah Hospitals and Clinics covered the map and over the years. Hadassah and the Hadassah Medical Organization (HMO) created many firsts the first medical school, dental school, nursing school, cancer institute, childrens hospice, ambulatory surgery center, ER unit for premature babies, and trauma treatment center in Israel.

Today the two hills of healing stand at opposite ends of Jerusalem Mt. Scopus (opened in 1939, closed in 1948, reopened in 1975) and the Ein Kerem campus, a tertiary care facility, built in 1961 as Ben Gurion told Hadassah to build in the southwest outskirts of Jerusalem and the city would grow out to it. Which is just what happened. Today, a light rail and bus bring people from all over the area to the hospital. In 2012, the Sarah Wetsman Davidson Hospital Tower opened adding 500 beds and 20 operating theaters. In 2020, Hadassah is re-imagining and re-energizing the campus with its 360 Degrees of Healing Campaign.

Hadassah Hospitals were first in Israel with heart, liver, lung and bone marrow transplants, computer-guided hip replacement (first in the world), macular degeneration clinical trial using embryonic stem cells to repair vision (second in the world) and bone marrow registry for Arabs (only one in the world). Hadassah Medical Organization (HMO) triage procedures and surgical techniques developed by Hadassah doctors were used following the Boston Marathon bombing. HMO doctors and nurses have been first responders in the Philippines, Haiti, Indonesia and Thailand in the wake of natural disasters. Hadassah doctors recently brought humanitarian spinal surgery to Ethiopia.

No rest for this woman she found more purpose and then, more purpose, as time went on.

As a 70-year-old woman, Henrietta was a member of the Palestine Zionist Executive, the Jewish Agency Executive and the Vaad Leumi. Photos show her as often being the only woman in the room. In these capacities she directed the health/educational development and social services of the population. And then, Henrietta took over the daily operations of Youth Aliyah in Palestine. Youth Aliyah was created to bring Jewish children out of Nazi Germany and bring them to Palestine.

In 1943, Henrietta waited in the cold at the Atlit Detention Camp as 750 children from Iran disembarked a train (120 followed a few months later), saved from the atrocities of Nazi Germany. Hadassah joined the life-saving work of Youth Aliyah and continues to be a major supporter to this day. Today, Hadassah-supported youth villages, Meir Shfeyah, Ramat Hadassah Szold and Hadassah Neurim, set at-risk children in Israel on the road to success and since its beginning, more than 300,000 young people from 80 lands have graduated from Youth Aliyah.

Always with an eye to the future, Henrietta Szolds connection to Young Judaea, began in 1909, when she prompted the Federation of American Zionists to call for a junior Zionist convention of delegates from Zionist youth societies. Young Judaea was formally established as a national Zionist youth organization at that New York convention. And then, under the leadership of Henrietta Szold, the department of education was formed by the Zionist Organization of America (ZOA), which briefly sponsored Young Judaea from 1918 to 1921. Over the years, there were many different connections between Henrietta, Hadassah and Young Judaea. Today, Hadassah and Young Judaea continue their connection through their shared mission to forge a strong commitment to Jewish life, instill a love of Israel and Zionism, connect American kids to Israel through education and programs, develop leaders for the Jewish community, and advocacy. Henrietta Szold and Hadassah in the room!

Today Hadassah has 300,000 members, Associates and supporters. It is the largest Jewish womens membership organization in the United States. With members in every Congressional district, Hadassahs advocacy work in spear-heading important legislation, most recently, the Never Again Education Act working to ensure Holocaust education in public schools, is a direct modern-day application of Henriettas legacy and an illustration of purpose with action. Hadassah women are in the room!

So, I think you can see that Henrietta started a run a run of practical Zionism that stretches across decades and centuries. A run I am proud to be part of since it has enabled me to work for Israel while living here in New York. It has allowed me to make differences around the world through medical research and protocols that are shared. Four generations of life members in my family. Three generations of Hadassah Presidents in my family. Once I make our new grandson an Associate, five generations of men affiliated with Hadassah. For me, personally, Hadassah is a family affair.

Today Hadassah strives to empower women of all ages to make a difference and to become leaders in the Jewish community by continuing Henriettas legacy of Practical Zionism through our work in Israel, our advocacy here in the US, on issues that affect Israel, the Jewishcommunity and health. Henrietta asked the artist of her sculpture to make my eyes look to the future. A most meaningful and purposeful statement.

Boy, I would love to know what Henrietta carried in that black bag of hers, or better yet, what her bag would hold today. I can only imagine that shewasthe one with the tissues to wipe the eyes of the young children as they disembarked the train. Shewould bethe one with the cell phone to reach out to anyone who would listen to her pleas for assistance and for funding to facilitate medical research and care of youth. Shewould bethe one with the small flashlight to bring a big light unto the nations. Over the years I have implored our members to release their inner Henrietta. A woman of purpose and perseverance to emulate for sure.

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A Woman of Purpose and Perseverance - Thrive Global

Bone Marrow Stem Cells Comments Off on A Woman of Purpose and Perseverance – Thrive Global | March 5th, 2020

The success of approved stem cell therapies has caused a surge in interest of biopharma developers in this field; many innovator companies are currently progressing proprietary leads across different phases of clinical development, with cautious optimism

LONDON, March 4, 2020 /PRNewswire/ -- Roots Analysishas announced the addition of "Global Stem Cells Market: Focus on Clinical Therapies, 20202030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent))" report to its list of offerings.

There is a growing body of evidence supporting the vast applicability and superiority of treatment outcomes of stem cell therapies, compared to conventional treatment options. In fact, the unmet needs within this domain have spurred the establishment of many start-ups in recent years.

To order this 500+ page report, which features 185+ figures and 220+ tables, please visit this link

Key Market Insights

Over 280 stem cell therapies are under development, most of which are allogeneic products

More than 50% of the pipeline candidates are in the mid to late phase trials (phase II and above), and allogenic therapies (majority of which are derived from the bone marrow) make up 65% of the pipeline.

70% of pipeline candidates are based on mesenchymal stem cells

It is worth highlighting that the abovementioned therapies are designed to treat musculoskeletal (22%), neurological (21%) and cardiovascular (15%) disorders. On the other hand, hematopoietic stem cell-based products are mostly being evaluated for the treatment of oncological disorders, primarily hematological malignancies.

Close to 85% stem cell therapy developers are based in North America and Asia-Pacific regions

Within these regions, the US, China, South Korea and Japan, have emerged as key R&D hubs for stem cell therapies. It is worth noting that majority of the initiatives in this domain are driven by small / mid-sized companies

Over 1,500 grants were awarded for stem cell research, since 2015

More than 45% of the total amount was awarded under the R01 mechanism (which supports research projects). The NCI, NHLBI, NICHD, NIDDK, NIGMS and OD emerged as key organizations that have offered financial support for time periods exceeding 25 years as well.

Outsourcing has become indispensable to R&D and manufacturing activity in this domain

Presently, more than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing services to cater to the unmet needs of therapy developers. Examples include (in alphabetical order) Bio Elpida, Cell and Gene Therapy Catapult, Cell Tech Pharmed, GenCure, KBI Biopharma, Lonza, MEDINET, Nikon CeLL innovation, Roslin Cell Therapies, WuXi Advanced Therapies and YposKesi.

North America and Asia-Pacific markets are anticipated to capture over 80% share by 2030

The stem cell therapies market is anticipated to witness an annualized growth rate of over 30% during the next decade. Interestingly, the market in China / broader Asia-Pacific region is anticipated to grow at a relatively faster rate.

To request a sample copy / brochure of this report, please visit this link

Key Questions Answered

The USD 8.5 billion (by 2030) financial opportunity within the stem cell therapies market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom stem cell therapies are currently considered to be a promising alternatives for the treatment of a myriad of disease indications, with the potential to overcome challenges associated with conventional treatment options. The report includes detailed transcripts of discussions held with the following experts:

The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), stem cell therapy portfolio and an informed future outlook.

For additional details, please visit

https://www.rootsanalysis.com/reports/view_document/stem-cells-market/296.htmlor email sales@rootsanalysis.com

You may also be interested in the following titles:

Contact:Gaurav Chaudhary+1(415)800-3415+44(122)391-1091Gaurav.Chaudhary@rootsanalysis.com

Logo: https://mma.prnewswire.com/media/742223/Roots_Analysis_Logo.jpg

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With Over 280 Therapies Under Evaluation, the Stem Cell Therapy Market is Estimated to be Worth USD 8.5 Billion by 2030, Claims Roots Analysis - P&T...

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Newswise Launching no earlier than March 6 at 11:50 PM EST, the Johns Hopkins University will send heart muscle tissues, contained in a specially-designed tissue chip the size of a small cellphone, up to the microgravity environment of the International Space Station (ISS) for one month of observation.

The project, led by Deok-Ho Kim, an Associate Professor of Biomedical Engineering and Medicine at The Johns Hopkins University and the projects principal investigator, will hopefully shed light on the aging process and adult heart health, and facilitate the development of treatments for heart muscle diseases.

Scientists already know that humans exposed to space experience changes similar to accelerated aging, so we hope the results can help us better understand and someday counteract the aging process, says Kim.

The researchers also hope the study will demystify why astronauts in space have reduced heart function and are more prone to serious irregular heartbeat; these results could help protect astronauts hearts on long missions in the future, as well as provide information on how to combat heart disease.

Kim and his team used human induced pluripotent stem cells to grow cardiomyocytes, or heart muscle cells, in a bioengineered, miniaturized tissue chip that mimics the function of the adult human heart. While other researchers have studied stem cell-derived heart muscle cells in space before, these studies relied on cells cultured on 2D surfaces, or flat planes, that arent representative of how cells exist and behave in the body, and are therefore underdeveloped compared to their counterparts in adult humans.

The teams tissue platform gives the advantage of the cells residing in a 3D environment, which will allow for better imitation of how cell signals and actions develop as they would in the human body. This 3D environment is possible thanks to a new scaffold biomaterial, or support structure which holds the tissues together, that accelerates development of the heart muscle cells within. This will allow the scientists to collect data useful for understanding the adult human body. Scientists could someday use this data and platform to develop new drugs, among many other applications.

Using a motion sensor magnet setup, the team will receive real-time measurements of how the tissues on the ISS beat. After about one month in space, the tissues will return to Earth and will be analyzed for any differences in gene expression and contraction caused by the extended stay in microgravity. Some of these tissues will be cultured for an additional week on Earth for the researchers to examine any recovery effects. The team will also have identical heart tissues on Earth at the University of Washington to serve as controls.

We hope that this project will give us meaningful data that we can use to understand the hearts structure and how it functions, so that we can improve the health of both astronauts and those down here on Earth, says Kim.

"The entire team is excited to see the results we get from this experiment. If successful, we will embark on the second phase of the study where tissues will be sent up to the ISS once again in two years, but this time, we will be able to test a variety of drugs to see which ones will best ameliorate the potentially harmful effects of microgravity on cardiac function," says Jonathan Tsui, a postdoctoral fellow in the Department of Biomedical Engineering at The Johns Hopkins University and a member of Kims lab.

This project is funded by the National Center for Advancing Translational Sciences (NCATS) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) as part of the Tissue Chips in Space initiative in collaboration with the ISS U.S. National Laboratory.

Collaborators on this project include Eun Hyun Ahn of The Johns Hopkins University; Nathan Sniadecki and Alec Smith of The University of Washington; Peter Lee of Ohio State University; and Stefanie Countryman of Bioserve Space Technologies at the University of Colorado Boulder. For space flight the team has worked with BioServe Space Technologies to translate the ground platform into a space flight certified system.

Link:
Little Tissue, Big Mission: Beating Heart Tissues to Ride Aboard The ISS - Newswise

Cardiac Stem Cells Comments Off on Little Tissue, Big Mission: Beating Heart Tissues to Ride Aboard The ISS – Newswise | March 5th, 2020

Regenerative Medicine Market: Snapshot

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

Get Sample Copy of the Report @https://www.tmrresearch.com/sample/sample?flag=B&rep_id=1889

Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

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Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe areVericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc.A large number of players are anticipated to enter the global market throughout the forecast period.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Regenerative Medicine Market Analysis Growth Demand, Key Players, Share Size, and Forecast To 2025 - Monroe Scoop

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4-Mar-2020

Ingredients | Skin Care

inspira: cosmetics produces and markets high-quality, contemporary cosmetic products for individual skin care worldwide

The German company is based in Aachen and was founded in 2000. The development of outstanding and highly effective products with excellent compatibility is a matter of course for inspira: cosmetics.

The products visibly improve the appearance of the skin and let the user look in the best possible way for his/her respective age.

Now Volker Kloubert, Managing Partner of inspira: cosmetics proudly announced: "We are more than happy and feel very honoured that 3 of our entries are finalists in the Pure Beauty Global Awards and we are looking forward to the award ceremony in May in Amsterdam. Lets keep fingers crossed!

The finalist products from inspira: cosmetics reflect the broad scope of cosmetics the brand is covering.

The male scent 4MEN ONLY is nominated in the category Best Male Fragrance. A masculine composition of oriental notes, combined with woods and musk. Adventurous and very sexy! For men only. The sophisticated fragrance was created by master perfumers in Grasse/France.

Finalist in the category Best Lip Product is the Volumizing Lip Remedy, a lip care stick in stylish silver metal packaging with high quality active ingredients like hyaluronic acid, shea butter, coconut oil, spearmint oil for a fresh taste and the Peptide Complex VOLULIP than can increase the lip volume by up to 82% in 4 weeks as it stimulates the production of hyaluronic acid in the lips.

Very important: NO burning sensation, the product is smooth as silk.

Age Reboot Serum is the new holistic anti aging serum in the inspira: med range using state of the art active ingredients to protect and rejuvenate the skin.

Phyto stem cells help the skin to adapt to changing environmental conditions like heat or cold and protect the cells whereas three different hyaluronic acids smooth the skin, even out wrinkles and EGF (Epidermal Growth Factor) stimulates cell renewal.

In clinical studies the skin was rejuvenated by up to 10 years in four weeks of regular use.

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Three of inspira: cosmetics entries are finalists in the Pure Beauty Global Awards 2020 - Cosmetics Business

Skin Stem Cells Comments Off on Three of inspira: cosmetics entries are finalists in the Pure Beauty Global Awards 2020 – Cosmetics Business | March 4th, 2020

FORMS of blood cancer, such as leukaemia or lymphoma, are the fifth most common cancer, and the third biggest cause of cancer deaths.

Yet warning signs can be so unlike those of other cancers, that its often diagnosed at a very late stage.

Research by UK blood cancer charity Bloodwise (bloodwise.org.uk) found more than a third of sufferers had to visit their GP three or more times with symptoms before being a hospital referral. This makes it the worst performing cancer in terms of early diagnosis.

Why is it so difficult to spot? Blood cancers, which stop blood stem cells from working normally and can make you weak and prone to infections, have three main types with many different variations. These variations have numerous diverse symptoms, which can often be mistaken for other less serious conditions.

Not all signs of blood cancer are easily identifiable, or are associated with typical symptoms of cancer, such as a lump or abnormal mole, says haematologist Dr Manos Nikolousis, a medical consultant with UK blood cancer charity DKMS.

Blood cancer often presents in ways which are most commonly associated with unrelated and less serious illnesses, like a cold or flu. In other circumstances, patients notice a change in their body which they cant quite put their finger on.

One of the treatments for blood cancer is a stem cell transplant that restores blood-forming stem cells in patients whove had theirs destroyed by very high doses of chemotherapy and/or radiotherapy. But Nikolousis points out that only one in three blood cancer patients who need a transplant find a matching blood stem cell donor in their family. The remaining two-thirds have to rely on an unrelated donor, which significantly reduces their chance of finding a crucial match.

Here, Nikolousis outlines some blood cancer symptoms and warning signs...

Musculoskeletal pain in muscles, joints, tendons, bones or structures that support the limbs, neck or back.

One of the most common symptoms associated with blood cancer. The frequency and lasting impact of bruising can be a key warning sign, so its important to book an appointment with your GP if this develops.

Unexplained and persistent tiredness is one of the biggest tell-tale signs of blood cancer. People who have cancer-related fatigue find it incredibly challenging to complete simple tasks that we tend to take for granted.

The lymph nodes are small lumps of tissue that contain white blood cells. When inflamed, they can be felt as lumps under the skin; most commonly in the neck, armpit or groin area.

There may be new headaches that feel different. Theyre likely to occur frequently and be severe and long-lasting.

Persistent abdominal discomfort, presenting as a sharp pain or a sense of feeling full.

This can be described as a feeling of pins and needles/numbness that moves up to the legs, or from fingers to the arms.

This can feel like a fluttering, a sudden thump or a fast pounding sensation in the chest. It can also be felt in the neck or ear when lying down.

People may describe this as feeling mentally drained or dizzy.

Blood cancer patients may have continuous trouble falling asleep or staying asleep.

Persistent and irritable, this may be experienced all over the body, or in isolated spots.

These symptoms are common and dont automatically mean you have cancer. But if you notice any unusual or ongoing changes, its always best to see your doctor and get checked.

Original post:
Eleven symptoms of blood cancer that everybody needs to know about... - Echo Live

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A wave of new targeted therapies expands the options in acute myeloid leukemia.

As a mother of three, I dont focus on myself a lot, says Hibbard, who lives in Yorba Linda, California, and was then 37. I was having a lot of bone pain in Vegas, but I have scoliosis, so I always have some pain. Everything just multiplied when I got back home.

She rushed to schedule a same-day appointment with her doctor. As someone in the medical field she works as an ultrasound technician Hibbard had no hesitation about learning what could be wrong. Her doctor appeared alarmed about how sick she looked and immediately ordered bloodwork.

Her platelet count was astoundingly low. A normal count ranges from 150,000 to 450,000 platelets per microliter of blood; Hibbards hovered around 20,000. She initially assumed something had gone wrong with her intrauterine device, because she had recently experienced heavy vaginal bleeding abnormal uterine bleeding can be a symptom of certain hematologic cancers.

I thought I was anemic because I had lost a lot of blood. Cancer didnt even cross my mind until the doctor came in and told me I had leukemia, she says.

A week and half after returning from her vacation, Hibbard received a diagnosis of acute myeloid leukemia (AML). This cancer of the blood and bone marrow affects more than 20,000 people each year in the United States.

For years, prognosis remained poor for patients with the disease, which has a 24% five-year survival rate for people ages 20 and older and 67% for those younger than 20, with limited treatment options. But the past two years brought an explosion of new medications approved by the Food and Drug Administration (FDA) to treat AML, particularly therapies targeting specific genomic mutations that may confer a worse prognosis.

For more than 45 years, the treatment for AML only involved intensive chemotherapy, and that was the only chance at a cure, says Amer Zeidan, an associate professor of internal medicine at Yale Cancer Center in New Haven, Connecticut. But since 2017, weve had a revolution in the treatment of AML after many years of no approved agents. I give an analogy in (terms) of before Christ and after Christ because the landscape has changed so much.

WHAT DOES AN AML DIAGNOSIS MEAN?

Historically, chemotherapy for the treatment of AML involves two phases: induction therapy followed by consolidation therapy. Shortly after diagnosis, a patient will undergo induction therapy to rid the body of any signs of the disease.

Most often, patients receive the combination of cytarabine and an anthracycline drug such as Cerubidine (daunorubicin) or Idamycin (idarubicin). Approximately 75% of younger adults with AML and 50% of patients older than 60 achieve complete remission, or disappearance of overt leukemia in the bone marrow, after induction treatment. Once a patient has recovered, consolidation therapy, chemotherapy or a stem cell transplant kills any remaining leukemia cells.

Early signs of AML, which is typically associated with older age (more than 65 years), history of tobacco smoking and certain inherited genetic disorders, include weight loss, fatigue, fever, night sweats, bruising and excessive bleeding. Because AML is generally widespread throughout the bone marrow and possibly other organs, it is not staged like other cancers. About half of patients who achieve remission after initial treatment will relapse.

Genomic testing revealed that Hibbard had a FLT3 mutation. The most common mutation in AML, FLT3 is found in 30% of all cases and associated with a particularly aggressive form of the disease and a higher risk of relapse. My oncologist told me, Bad news you have the FLT3 mutation. But the good news is that they just developed an inhibitor you can take, recalls Hibbard. He said it with a big smile on his face.

In April 2017, the FDA approved Rydapt (midostaurin), the first targeted therapy for AML, combined with chemotherapy to treat adults with a new diagnosis and a FLT3 mutation. The oral medication belongs to a group of drugs called FLT3 inhibitors, which block several enzymes that promote cell growth.

During Hibbards month in the hospital to receive induction chemotherapy, she experienced several life-threatening complications, including a blood clotting disorder, two strokes and a bout of sepsis. Believing she was on her deathbed; she made a video saying goodbye to her children.

Hibbard recovered, returned home and began treatment with Rydapt, which made her nauseated. The drugs other common side effects include low levels of white blood cells with fever (febrile neutropenia), inflammation of the mucous membranes and vomiting.

Hibbard achieved remission following more chemotherapy and a stem cell transplant and remains free of cancer. I was extremely excited about taking Rydapt because I felt truly blessed that there was an inhibitor for my mutation, since it was so aggressive, says Hibbard, who is now 39.

It smells horrible, and its a large pill, but I took it willingly because I knew it would improve my chances of survival.

RIGHT ON TARGET

Rydapt is one of eight drugs for AML that have gained FDA approval since 2017. Xospata (gilteritinib), another type of targeted therapy that inhibits FLT3, was approved in May2019 for adults who stopped responding to treatment or whose disease had relapsed.

The IDH inhibitors Idhifa (enasidenib) and Tibsovo (ivosidenib) target mutations in the IDH1 and IDH2 genes. Daurismo (glasdegib), Venclexta (venetoclax) and Vyxeos (CPX-351) expand the options for older patients who cant be treated with intensive chemotherapy because of its toxicities. Mylotarg (gemtuzumab ozogamicin) can be given to patients who express the CD33 antigen.

We now have a better understanding of the biology behind AML, especially the molecular mutations that drive this disease, and we have developed treatment that targets these mutations, says Dr. Kevin Kelly, an associate professor of clinical medicine at the University of Southern California in Los Angeles. One of the most important mutations is FLT3, targeted by midostaurin and gilteritinib. These drugs specifically target the leukemia cells while being less toxic on the normal tissue of the body.In a large clinical trial, patients with new diagnoses who took Rydapt along with chemotherapy lived longer than those who received chemotherapy alone. After four years, 51.4% in the Rydapt group were still alive compared with 44.3% in the chemotherapy group.

Findings from the ADMIRAL trial showed that Xospata similarly extended survival. Patients who took the FLT3 inhibitor alone had a median overall survival of 9.3 months compared with 5.6 months for those given chemotherapy alone. Though encouraging, these are early findings from new files, and long-term follow-up could bring significantly different results, cautioned experts.

Side effects of Xospata include nausea, vomiting, diarrhea, constipation, pain or sores in the mouth or throat, shortness of breath, muscle or joint pain and dizziness. The drug can also cause differentiation syndrome, a potentially fatal complication believedto be caused by release of cytokines from leukemia cells. It can be treated with steroids, but prompt recognition is key. Symptoms include fever, cough, trouble breathing, bone pain, rapid weight gain and swelling in the arms, legs, underarm, groin or neck.Differentiation syndrome is also a concern for patients treated with Idhifa and Tibsovo. Based on clinical trial results showing that 19% of patients had complete remission for a median of 8.2 months, Idhifa was approved in August 2017 for patients who relapsed or became resistant to treatment for AML. The targeted therapy homes in on mutations in the IDH2 gene, which are found in 8%-19% of patients with AML.

In July 2018, Tibsovo, which targets IDH1 mutations found in 7%-14% of patients with AML, was approved. Roughly two years later, the FDA allowed the drugs use as a first-line treatment for patients who arent eligible for intensive chemotherapy.Another type of targeted therapy, Mylotarg aims at AML cells expressing the CD33 antigen, found in more than 80% of patients. Reapproved by the FDA in September 2017 to treat patients with new diagnoses and those who relapsed or became resistant to therapy, the agent combines the unique targeting of a monoclonal antibody with the cancer-killing ability of a chemotherapy drug.

What is happening now in AML is similar to what already happened with multiple myeloma. Today, proteasome inhibitors and other biological drugs have almost completely replaced chemotherapy for almost all ages and subsets of myeloma, says Dr. Naval Daver, an associate professor in the department of leukemia at The University of Texas MD Anderson Cancer Center in Houston. With these new targeted therapies, we can improve outcome and survival in AML while reducing the need for chemotherapy and even stem cell transplants.

OPTIONS FOR OLDER PATIENTS

The lack of treatment options for older patients with AML only about half of patients older than 60 receive intensive induction chemotherapy; the rest get either gentler chemotherapy that doesnt aim to cure or supportive care without any chemotherapy has meant that many are undertreated, with poorer clinical outcomes.

Fortunately, the approvals of Venclexta and Daurismo for patients aged 75 and older bring new options. Venclexta, which blocks BCL-2 proteins, was granted accelerated approved by the FDA based on promising results from early-phase clinical trials, but two larger, ongoing studies are examining its effectiveness and safety. The rate of complete remission was up to 54% for Venclexta plus decitabine but varied depending on which chemotherapy drug was given.

There has been dramatic progress in the treatment of AML in recent years, with one of the most important drugs being venetoclax for older AML populations, who have been one of the most difficult populations to treat, Daver says. It works synergistically with low-dose chemotherapy drugs already being used, which is a major breakthrough in the treatment of older patients with AML.

Daurismo targets the smoothened, or SMO, protein that fuels the growth and spread of AML. In a clinical trial, the median overall survival in older patients who received Daurismo along with chemotherapy was 8.3 months compared with 4.3 months for those who got chemotherapy alone.

Vyxeos (CPX-351) can also be used in older patients. It's August 2017 approval was for patients with two types of prognoses: newly diagnosed therapy-related AML, which occurs as a complication of cancer treatment in 8%-10% of patients within five years after chemotherapy or radiation, and AML with myelodysplasia-related changes, characterized by a history of certain blood disorders and other significant mutations within cancer cells. Patients with these types of AML tend to be older and have additional medical issues.

A study that compared Vyxeos with traditional chemotherapy showed that patients with new diagnoses who took Vyxeos lived longer, with a median overall survival of 9.56 months compared with 5.95 months, respectively.

In addition, an investigational oral therapy, CC-486, has shown a survival benefit in patients with newly diagnosed AML in the maintenance setting. In a phase 3 trial, researchers saw that the drug extended overall survival by 9.9 months compared with placebo.

We have new drugs available for subsets of the disease, which is why the management of AML is becoming more like personalized medicine, Zeidan says. I think we are going in the direction of more targeted therapy, lower toxicity agents, combinations of different oral agents and, hopefully, incremental improvement in outcomes. Im very optimistic about where the field is going.

The wealth of drug approvals certainly gives more hope to patients with AML, especially those with a previously poor prognosis and lack of treatment options. Rapid genetic testing is leading to the early classification of disease subtypes, pushing AML treatment into the realm of precision medicine. Several clinical trials in progress aim to test combinations of the newer agents, such as Venclexta with an IDH inhibitor.

Hibbard remains thankful for the targeted therapy she received. She believes that the trust she had in the newly approved Rydapt and the entire treatment process helped save her life.

I remember being terrified, with people praying over my bedside. But Im very pragmatic, so I was very much like, OK, now what do we do? Whats the next step? Hibbard says. That was my entire battle. Today I am more than a year post-transplant and grateful to kiss my kids goodnight every night.

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Extending the Options for Patients with AML by Making It Personal - Curetoday.com

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Results Surpass FDA-Agreed Efficacy Threshold

Omeros Corporation (Nasdaq: OMER) today reports an update on clinical data from its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly exceeding the FDA-agreed threshold for the primary efficacy endpoint. While an overview of preliminary data submitted to FDA was made public on December 4, 2019 in a press release from the company, all patients have now completed treatment and trial enrollment has been closed. Narsoplimab is Omeros human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (MASP-2).

In recent meetings with FDA focused on clinical as well as chemistry, manufacturing and controls (CMC) data, FDA confirmed important aspects of Omeros rolling Biologics License Application (BLA) for narsoplimab in HSCT-TMA. The BLA continues on its clear path to completion.

The efficacy threshold agreed with FDA, the updated results from the 28-patient trial, and highlights of the recent FDA meetings are the following:

Primary Endpoint

15% is the FDA-agreed efficacy threshold for the primary endpoint (i.e., the complete response rate [CRR]) in the clinical trial

The CRR for the study population, and the lower limit of the 95 percent confidence interval (95% CI), significantly exceed the efficacy threshold:

54 percent CRR (95% CI = 34 percent to 72 percent, p-value < 0.0001) in patients who received at least one dose of narsoplimab

65 percent CRR (95% CI = 43 percent to 84, p-value < 0.0001) in patients who received the protocol-specified narsoplimab treatment of at least 4 weeks of dosing

As described in the December 4, 2019 press release, the FDA-agreed primary endpoint (the CRR) is the proportion of patients who fully achieve a rigorous set of response criteria, requiring both improvement in HSCT-TMA laboratory markers (platelet count and lactate dehydrogenase [LDH] levels) and improvement in clinical status comprised of organ (renal, pulmonary, gastrointestinal and neurological) function and transfusions (platelet and red blood cells). The full response criteria are provided below.

Secondary Endpoints

Story continues

The 100-day survival (defined as survival from the day of HSCT-TMA diagnosis) is 68 percent in all treated patients, 83 percent in patients who received at least 4 weeks of narsoplimab treatment as specified by the protocol, and 93 percent in patients who responded to narsoplimab treatment. Experts familiar with the pivotal trial data would expect a 100-day survival rate of less than 20 percent in the trial population.

Preliminary results of the laboratory secondary efficacy endpoints (change from pre-treatment baseline for each laboratory value) continue to demonstrate meaningful improvement and meet statistical significance in platelet count, LDH and haptoglobin (p < 0.01 in all treated patients).

Safety

The most commonly reported adverse events in the trial were diarrhea, nausea, vomiting, hypokalemia, neutropenia and fever all common in stem-cell transplant patients.

Six deaths occurred during the trial. These were due to sepsis, progression of the underlying disease, and graft-versus-host disease, all common causes of death in this patient population.

The treated population had multiple high-risk features that portend a poor outcome, including the persistence of HSCT-TMA despite modification of immunosuppression (which was a criterion for entry into the trial), graft-versus-host disease, significant infections, non-infectious pulmonary complications and neurological findings. Patients in the trial had a high expected mortality rate, with 93% of them having multiple risk factors.

"The efficacy and safety data from the pivotal trial with narsoplimab are encouraging," said Miguel-Angel Perales, M.D., Deputy Chief of the Adult Bone Marrow Transplantation Service and Director of the Adult Stem Cell Transplantation Fellowship at Memorial Sloan Kettering Cancer Center. "Given the trials stringent response criteria across laboratory markers and organ function, the complete response rate seen with narsoplimab is remarkable, as is the 100-day survival. There currently is no approved treatment for HSCT-TMA. Current therapy is generally limited to supportive care and withdrawal of drugs critical for GVHD prophylaxis. Not only could narsoplimab become central to the treatment of HSCT-TMA, it might well allow us to maintain that needed GVHD prophylaxis."

Complete clinical trial data will be presented by Dr. Perales later this month at the Annual Meeting of the European Society for Blood and Marrow Transplantation in Madrid.

Recent FDA Meeting Highlights and CMC Updates

FDA confirmed that the number of HSCT-TMA patients enrolled is sufficient for the BLAs filing and review for approval. FDA agreed to stopping enrollment.

FDA requested near-term manufacturing dates for narsoplimab so that FDAs pre-approval inspections could be scheduled.

FDA and Omeros reached agreement on CMC requirements for stability data and release assays.

Omeros elected to accelerate the manufacturing schedule for a one-time set of five narsoplimab process validation and commercial lots. These lots were successfully manufactured by Omeros manufacturing partner Lonza, satisfy the BLA requirements and can be used for commercial sale following approval.

"The non clinical sections of our BLA have been submitted, our CMC campaign is progressing well with process validation and commercial lots already manufactured, and our pivotal trial is complete," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "The efficacy threshold agreed with FDA reflects both the primary endpoints stringent response criteria and the poor outcomes expected in the patients enrolled in our trial. Of course, were very pleased that the response rates and confidence intervals seen with narsoplimab are well above that efficacy threshold. We look forward to continuing to work closely with regulators to make the drug commercially available to transplanters and their patients in the U.S. and internationally as quickly as possible."

In addition to its HSCT-TMA program, Omeros is enrolling its narsoplimab Phase 3 clinical trials for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). Narsoplimab has been granted, for both HSCT-TMA and IgA nephropathy, FDAs breakthrough therapy designation as well as orphan drug designations from FDA and the European Medicines Agency. The drug also holds FDAs fast-track designation for aHUS.

Primary Efficacy Endpoint

To be considered a responder, a patient must achieve the primary endpoint of complete HSCT-TMA response defined by improvement in laboratory markers and improvement in clinical status.

Laboratory Markers

Criteria for improvement in laboratory markers are LDH less than 1.5 x upper limit of normal AND improvement of platelet count measures:

For patients with baseline platelet count 20,000/L, response requires tripling over baseline platelet count, a post-baseline platelet count >30,000/L, and freedom from platelet transfusion

For patients with baseline platelet count >20,000/ L, response requires: an increase in platelet count by 50%, a post-baseline platelet count >75,000 /L, and freedom from platelet transfusion

Clinical Status

Criteria for improvement in clinical status requires at least one of the following:

Renal response requires >40% reduction in creatinine, or normalization of creatinine and >20% reduction in creatinine, or discontinuation of renal replacement therapy

Pulmonary response requires extubation and discontinuation of ventilator support, or discontinuation of non-invasive mechanical ventilation (continuous positive pressure ventilation)

Gastrointestinal response applicable only to patients with biopsy-proven gastrointestinal HSCT-TMA and requires improvement in gastrointestinal function as determined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria

Neurological response requires improvement in reversible neurological conditions (e.g., cessation of seizures), or stabilization of irreversible neurological conditions (e.g., stability of neurological deficits following stroke without further deterioration or subsequent strokes)

Freedom from transfusion only applicable if patient was undergoing transfusion at baseline

About Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. In addition, the company has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

About HSCT-TMA

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplants. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, GvHD, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an HSCT-TMA incidence of approximately 40 percent, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae are common. There is no approved therapy or standard of care for HSCT-TMA.

About Narsoplimab

Narsoplimab, also known as "OMS721," is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

Phase 3 clinical programs are in progress for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), in immunoglobulin A (IgA) nephropathy, and in atypical hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "can," "could," "estimate," "expect," "goal," "intend," "likely", "look forward to," "may," "on track," "plan," "potential," "predict," "project," "prospects," "scheduled," "should," "slated," "targeting," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated regulatory submissions, expectations regarding regulatory exclusivities, the timing and results of ongoing or anticipated clinical trials, and the therapeutic application of Omeros investigational product, are based on managements beliefs and assumptions and on information available to management only as of the date of this press release. Omeros actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, availability and timing of data from clinical trials and the results of such trials, unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the companys Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on March 2, 2020. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of any new information, future events or otherwise, except as required by applicable law.

Dr. Miguel-Angel Perales has received compensation from Omeros for advisory services.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200302005938/en/

Contacts

Jennifer Cook WilliamsCook Williams Communications, Inc.Investor and Media Relations360.668.3701jennifer@cwcomm.org

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Omeros Corporation Reports Updated Results from Narsoplimab HSCT-TMA Clinical Trial and Highlights from Recent Clinical and CMC Meetings with FDA -...

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2020 is already promising to be a fantastic year for space exploration. The next generation of Artemis explorers can begin applying for the program that will be journeying to the Moon, Mars and beyond; the James Webb Space Telescope is ready to test key deployments made in space, and even the Orion spacecraft that will blast off to the Moon during Artemis missions has successfully passed its final tests. Furthermore, NASA and commercial space companies prepare for the colonization of orbit, rockets are taking payloads to the International Space Station (ISS) very often and 3D bioprinting is becoming an attractive and useful method to carry out experiments. The next one up is SpaceX mission CRS-20. Scheduled to launch at 11:50 PM Eastern Time (EST) on March 6 from Floridas Cape Canaveral Air Force Station, the unpiloted cargo spacecraft is expected to arrive at the orbiting laboratory two days later with three Techshot-managed research campaigns.

The Indiana-based commercial research company is sending equipment and samples supporting plant, heart and cartilage research for NASA, Emory University and the Uniformed Services University of the Health Sciences (USU) to the ISS. According to the company, astronauts onboard the station will use Techshots 3D BioFabrication Facility (BFF) mounted inside the ISS U.S. National Laboratory (ISS National Lab) since last summer to manufacture human knee menisci for the 4-Dimensional Bioprinting, Biofabrication, and Biomanufacturing, or 4D Bio3program. Based at USU, 4D Bio3 is a collaboration between the USU and The Geneva Foundation, a non-profit organization that advances military medical research.

Funded by the U.S. Defense Health Program and managed by the Geneva Foundation, 4D Bio3promotes the development and application of advanced bioprinting, biofabrication, and biomanufacturing technologies for research pursuant to U.S. Department of Defense priorities and ultimately for translation to clinical medical defense care and training solutions.

This is our most diverse manifest to date, said Techshot President and CEO, John Vellinger. Throughout March well be conducting three major investigations in space for three customers using three very different Techshot-built research devices. Its going to be a busy month, but were excited to see the results.

Techshot owns BFF and the company built it at a cost of approximately seven million dollars. The starting point was an nScrypt printer, which now is highly modified by Techshot for use inside the ISS. In that relationship, Techshot handles all the space bioprinting, while nScrypt handles all the Earth-based bioprinting.

This first experiment for 4D Bio3 next month will be used as a test of the materials and the processes required to print a meniscus in space. Techshot engineers will upload a design file to BFF from the companys Payload Operations Control Center in Greenville, Indiana, and evaluate its success via real-time video from inside the unit. A second meniscus print will take place in BFF early next year and the item will then be returned to Earth for extensive testing and comparison to the nScrypt Earth-printed items. Last year nScrypt printed the same thing at a U.S. military base in Africa with their own printer.

Vincent B.Ho, Director of 4D Bio3 and professor and chair of radiology at USU said that meniscal injuries are one of the most commonly treated orthopedic injuries, and have a much higher incidence in military service membersreported to be almost 10 times that of the civilian population. We successfully biofabricated 3D human medial and lateral menisci in a pilot study performed in Africa last summer and anticipate learning valuable lessons on the challenges and benefits of biofabrication in microgravity by performing a similar experiment on the space station.

Besides BFF, there are four other Techshot owned and operated research machines inside the ISS today. Only the BFF is a bioprinter. The others are an X-ray machine for mice, two identical units called the Techshot Multi-use Variable-gravity Platform (MVP), and one called the ADvanced Space Experiment Processor (ADSEP), which is where cells printed in the BFF go to become conditioned and cultured into the tissue. The company has agreements with NASA and the ISS National Lab that permit Techshot to operate a commercial business in space. This is part of NASAs objective to make orbit more commercial, providing access to space for nearly anyone.

Another complex Techshot-managed experiment launching onboard SpaceX CRS-20 will test whether a heart-specific stem cell, called a cardiac progenitor, multiplies better in space and if more of them become heart muscle cells known as cardiomyocytes. This is part of Chunhui Xu, an associate professor in the department of pediatrics at the Emory University School of Medicine who studies heart cells, research that aims to improve treatments for congenital heart disorders and better the hearts ability to regenerate after injuries.

Preparing the experiments: under the vent hood, Biomedical Engineer Jordan Fite adds media to bags and fluid loops that will be used in the experiment in space (Image: Techshot)

Techshot explained that human cardiac tissues cant repair themselves once damaged from disease, due to this, repairing a failing heart by cell therapy requires a large number of cardiomyocytes, which can be converted from stem cells cultured in two dimensions in Earth-based laboratories. Without the pull of gravity, it is expected that culturing in three dimensions in space, inside specialized Techshot cell culture experiment modules, will increase the yield of high-quality heart muscle cells. The company expects that learning more about why this happens could lead to new strategies for reproducing the same results on a much larger scale on Earth, lowering costs and enabling more patients to receive needed cardiac cell therapies.

Astronaut handling Techshots BFF (Image: Techshot/NASA)

It is expected that once the cargo spacecraft reaches the station, the 12 Techshot experiment modules will be removed from the spacecraft and inserted by the crew into the companys Multi-use Variable-gravity Platform (MVP) unit number two mounted in the Japanese space laboratory known as Kibo.

We are thankful for Techshots engineers who designed the Multi-use Variable-gravity Platform hardware and will help us maintain constant communication with the astronauts during the flight operation. Their professionalism and collaboration with our team have contributed tremendously toward our overall research efforts, said Ho.

Besides the materials for the BFF meniscus print, SpaceX CRS-20 will also carry 12 Passive Orbital Nutrient Delivery System, or PONDS, plant growth devices that Techshot co-developed with Tupperware Brands, and that was first prototyped by NASA Kennedy Space Center. According to company officials, they will be growing red romaine lettuce inthe devices, installed inside two of the space stations identical plant growth chambers each called Veggie. The PONDS units are being tested in two different configurations, each representing approaches refined from two previous flight tests. For this demonstration, lettuce is expected to grow in space for 21 days. Besides the hardware built and own, Techshot also manages the space stations most complex greenhouse, called the Advanced Plant Habitat, and it manages two on-orbit research furnaces called PFMI and SUBSA.

Techshot has been working hard to get samples ready in a lab at the Space Station Processing Facility at NASAs Kennedy Space Center.

Product assurance associate Keri Roeder, program manager Nathan Thomas and mechanical engineer Grant Vellinger prepared samples for Techshot customer Emory University (Image: Techshot)

Founded more than 30 years ago, Techshot operates its own commercial research equipment in space and serves as the manager of three NASA-owned ISS payloads. The company is also working on other space 3D printing technologies. Last fall they tested a laser-based 3D metal printer in zero gravity inside an aircraft performing parabolic arcs over the Gulf of Mexico (sometimes unofficially nicknamed the vomit comet). However, officials suggest that this technology is still at least a couple of years from Techshot launching it to the space station.

NASA and dozens of companies continue to work together to develop the means for astronauts and space explorers to endure life in orbit, the Moon and other planets. This vision is enthralling for anyone who ever dreamed of going to space, even hopeful of the next generations that will be able to experience space travel and conduct research work in microgravity. Perhaps we are too hopeful of the future, but with so much going on, its difficult not to be.

The launch on Friday will be the last SpaceX launch under the current NASA CRS-1 contract, yet SpaceX will continue performing resupply missions under a new CRS-2 contract beginning with the next scheduled resupply mission in August this year. To watch the launch, which is scheduled to take place at 11:50 p.m. EST on Friday, March 6, and capture of the spacecrafts arrival at the ISS, you can tune into NASA TV using the video below:

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Techshots New Projects Will be on the Next SpaceX Mission Launch - 3DPrint.com

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A synopsis of the global canine stem cell therapy market with reference to the global healthcare pharmaceutical industry

Despite the economic and political uncertainty in the recent past, the global healthcare industry has been receiving positive nudges from reformative and technological disruptions in medical devices, pharmaceuticals and biotech, in-vitro diagnostics, and medical imaging. Key markets across the world are facing a massive rise in demand for critical care services that are pushing global healthcare spending levels to unimaginable limits.

A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry. Proactive measures such as healthcare cost containment, primary care delivery, innovation in medical procedures (3-D printing, blockchain, and robotic surgery to name a few), safe and effective drug delivery, and well-defined healthcare regulatory compliance models are targeted at placing the sector on a high growth trajectory across key regional markets.

Parent Indicators Healthcare Current expenditure on health, % of gross domestic product Current expenditure on health, per capita, US$ purchasing power parities (current prices, current PPPs) Annual growth rate of current expenditure on health, per capita, in real terms Out-of-pocket expenditure, % of current expenditure on health Out-of-pocket expenditure, per capita, US$ purchasing power parity (current prices, current PPPs) Physicians, Density per 1000 population (head counts) Nurses, Density per 1000 population (head counts) Total hospital beds, per 1000 population Curative (acute) care beds, per 1000 population Medical technology, Magnetic Resonance Imaging units, total, per million population Medical technology, Computed Tomography scanners, total, per million population

Research Methodology

Get Sample Copy of this report at https://www.xploremr.com/connectus/sample/2360

XploreMR utilizes a triangulation methodology that is primarily based on experimental techniques such as patient-level data, to obtain precise market estimations and insights on Molecule and Drug Classes, API Formulations and preferred modes of administration. Bottom-up approach is always used to obtain insightful data for the specific country/regions. The country specific data is again analysed to derive data at a global level. This methodology ensures high quality and accuracy of information.

Secondary research is used at the initial phase to identify the age specific disease epidemiology, diagnosis rate and treatment pattern, as per disease indications. Each piece of information is eventually analysed during the entire research project which builds a strong base for the primary research information.

Primary research participants include demand-side users such as key opinion leaders, physicians, surgeons, nursing managers, clinical specialists who provide valuable insights on trends and clinical application of the drugs, key treatment patterns, adoption rate, and compliance rate.

Quantitative and qualitative assessment of basic factors driving demand, economic factors/cycles and growth rates and strategies utilized by key players in the market is analysed in detail while forecasting, in order to project Year-on-Year growth rates. These Y-o-Y growth projections are checked and aligned as per industry/product lifecycle and further utilized to develop market numbers at a holistic level.

On the other hand, we also analyse various companies annual reports, investor presentations, SEC filings, 10k reports and press release operating in this market segment to fetch substantial information about the market size, trends, opportunity, drivers, restraints and to analyse key players and their market shares. Key companies are segmented at Tier level based on their revenues, product portfolio and presence.

Please note that these are the partial steps that are being followed while developing the market size. Besides this, forecasting will be done based on our internal proprietary model which also uses different macro-economic factors such as per capita healthcare expenditure, disposable income, industry based demand driving factors impacting the market and its forecast trends apart from disease related factors.

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Standard Report Structure Executive Summary Market Definition Macro-economic analysis Parent Market Analysis Market Overview Forecast Factors Segmental Analysis and Forecast Regional Analysis Competition Analysis

Target Audience Production Companies Suppliers Channel Partners Marketing Authorities Subject Matter Experts Research Institutions Financial Institutions Market Consultants Government Authorities

Market Taxonomy

The global canine stem cell therapy market has been segmented into:

Product Type: Allogeneic Stem Cells Autologous Stem cells

Application: Arthritis Dysplasia Tendonitis Lameness Others

End User: Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

Region: North America Latin America Europe Asia Pacific Japan Middle East & Africa

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Canine Stem Cell Therapy Market Will Make a Huge Impact in Near Future - News Times

Cardiac Stem Cells Comments Off on Canine Stem Cell Therapy Market Will Make a Huge Impact in Near Future – News Times | March 4th, 2020

10 things to know about stem cell therapy

New Delhi, March 3 (IANSlife) The usage of stem cells to cure or treat a disease or repair the injured tissue is defined as stem cell therapy. The best example of the stem cell treatment is seen in patients suffering from restoring the vision of the damaged eyes, grafting of the skin in severe burnt conditions. Stem cell treatments for brain or neural diseases like Parkinson''s and Alzheimer''s disease, multiple sclerosis, preventing heart strokes, curing diabetes, kidney disorders, autism, and spinal cord injuries are progressively making their way. Vipul Jain, CEO of Advancells and also a Serial entrepreneur, explains in detail the treatment, its uses, cost and effectiveness.

Q: What are stem cells?

Undifferentiated cells that are able to differentiate and transform into any type of cells of the body when and where needed. They have an enormous potential to repair, heal and regenerate. Stem cells come from blood, bone marrow, umbilical cord blood and adipose tissue.

Types of stem cell therapy

Autologous stem cell therapy: Patient receives stem cells from his/her own body

Allogeneic stem cell therapy: Patient receives the stem cells donated by another individual

Autologous stem cell therapy is better than allogeneic stem cell therapy as chances of mismatching are not there and they pose the minimum risk of immune rejection. Also, no side effects or adverse effects are seen as a person''s own blood cells are used. They start the healing process immediately in a natural way.

What is stem cell therapy?

The usage of stem cells to cure or treat a disease or repair the injured tissue is defined as stem cell therapy. Stem cells can be obtained from the bone marrow, adipose tissues etc. Due to their tremendous potential to prevent and to treat various health conditions and to repair the injured tissues global research investigation is continuously being done as to explore the maximum advantage of these cell lines.

The best example of the stem cell treatment is seen in patients suffering from restoring the vision of the damaged eyes, grafting of the skin in severe burnt conditions. Stem cell treatments for brain or neural diseases like Parkinson''s and Alzheimer''s disease, multiple sclerosis, preventing heart strokes, curing diabetes, kidney disorders, autism, and spinal cord injuries are progressively making their way.

What are the sources of stem cell?

Depending upon the disease, different stem cell source can be used in a specific condition. The procedure may involve the extraction of stem cells from adipose tissue-derived stem cells with the combination of PRP (Platelet-rich plasma) or can be obtained from bone marrow that can differentiate into progenitor cells that differentiate into various other tissues which can help in the therapy.

Procedure of stem cell therapy

The stem cells are isolated from the bone marrow or adipose tissues followed by their processing and enrichment under sterile conditions. These activated stem cells are placed back into the patient''s body at the target site for repairing the damaged tissue. It is necessary that the stem cells are injected in the specific area of injury as only then the desired results will be achieved.

Adipose stem cells are preferred over bone marrow stem cells as they are easy to isolate and contain a higher number of stem cells.

Stem cells injection

The stem cells injections are gaining much interest because it is devoid of the painful procedure, takes less time in comparison to a surgery, there are no host and recipient rejections as stem cells are harvested from the patient''s body itself and a targeted delivery system is available.

The stem cells obtained are processed in a sophisticated stem cell lab and after activation are inserted back into the host with the help of intravenous, intramuscular, intra-arterial, intradermal and intrathecal injections as per the requirement of the treatment process.

What is the use of anesthetics and why? Usually, local anesthetics are used during a stem cell procedure to numb the area but sometimes general anesthesia is also given while extracting the stem cells from bone marrow. But it is necessary to find out what anesthetic your doctor uses during orthopedic stem cell treatments.

A number of anesthetics have been found to kill the stem cells thus; the treatment''s end result will greatly depend on the use of anesthetics. Some anesthetics very well sync with the stem cell and hence, aid in the treatment.

How good are the processing techniques in the onsite labs?

Stem cells are to be extracted and processed in a clean room, under aseptic conditions maintaining a controlled environment. The doctor should explain the entire process and the number of viable stem cells infused into the patient during the process. Also, the precision of the injections to provide good quality of stem cells at the site of injury will help in better and faster recovery of the patient''s damaged area.

Duration and cost of the therapy

Cost of the treatment and its duration varies from one patient to another. The disease which needs to be cured, the severity, age factor, health condition, etc, define the duration of the therapy. One may respond during the treatment phase itself while the other may show results after a few sessions or weeks. Depending upon the disease diagnosed, the stem cells extracted, duration of the therapy, other adjuvants used in the process, the cost of the stem cell therapy can vary.

Follow-up visits

It is essential that after the stem cell therapy the patient should visit the stem cell doctor for recuperation therapies. The primary goals of such therapy is the prevention of secondary complications, analysis of recovery of motor, sensory and all the bodily functioning, psychological support/counseling for depression, mood swings or anxiety etc. and reintegration into the community.

There can be different sets of precautions which need to be followed at various steps for the recovery of the damaged tissues. The treatment and post treatment conditions may vary from person to person depending upon the disease and the severity.

Success rate of stem cell therapy

Stem cell therapy has shown results in treating serious ailments like leukemia, grafting tissues, autism, orthopedic conditions and skin problems etc. Stem Cell Therapy has been successfully used in the treatment of around 80 serious disorders.

Survival rates among patients who received stem cell treatment are significantly high, whether the cell donors are related or unrelated to them. With the ongoing research around the world, scientists are exploring new possibilities in which a number of life threatening diseases can be prevented and cured hence, the stem cells have proved to be promising in the near future as many aspects are yet to be revealed.

--IANS

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Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: IANS

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10 things to know about stem cell therapy - Outlook India

Spinal Cord Stem Cells Comments Off on 10 things to know about stem cell therapy – Outlook India | March 4th, 2020

Pune, March 03, 2020 (GLOBE NEWSWIRE) -- The global Spinal Muscular Atrophy Treatment Market size is expected to reach USD 14.49 billion by 2026, exhibiting a CAGR of 28.9% during the forecast period. The rising prevalence of rare diseases around the world will fuel demand for SMA treatment in the forthcoming years, which in turn will aid the growth of the market. As per the National Policy for the treatment of rare diseases, globally, around 6000 to 8000 rare diseases are estimated to exist with new rare diseases reported on a regular basis. Furthermore, 80% of all the rare diseases are genetically originated and therefore impact children inexplicably. The survey also revealed that 50% of new cases are in children and are responsible for 35% of deaths before the age of 1 year, 10% between the ages of 1 and 5 years and 12% between 5 and 15 years. Nonetheless, "the growing initiatives by government authorities for pre-diagnosis will impact the Spinal Muscular Atrophy Treatment Market share positively during the forecast period", predicts our lead analysts at Fortune Business Insights.

For more information in the analysis of this report, visit: https://www.fortunebusinessinsights.com/industry-reports/spinal-muscular-atrophy-treatment-market-100576

According to the report, published by Fortune Business Insights, titled "Spinal Muscular Atrophy Treatment Market Size, Share and Global Trend By Product (Nusinersen and Onasemnogen Abeparvovec), By Disease Type (Type 1 SMA, Type 2 SMA and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies and Others), and Geography Forecast till 2026" the market size stood at USD 1.72 billion. The SMA Treatment Market report executes a PESTEL study and SWOT analysis to reveal the stability, restrictions, openings, and threats in the smart building market. Combined with the market analysis capabilities and knowledge integration with the relevant findings, the report has foretold the robust future growth of the SMA treatment market, and all articulated with geographical and merchandise segments. Moreover, it also shows different procedures and strategies, benefactors and dealers working in the market, explores components convincing market development, generation patterns, and following systems. Additionally, the figures and topics covered in this report are both all-inclusive and reliable for the readers.

Market Driver:

R&D Initiatives by Key Players to Spur Sales Opportunities

The surge in research and development activities for the improvement of therapies and treatment options by key players will aid the Spinal Muscular Atrophy Treatment Market growth during the forecast period. Various drug pipeline for advanced stages of clinical trials by major pharmaceutical companies will augment the healthy growth of the market. For instance, Genentech/Roche's pipeline candidate of Risdiplam, which recently received a priority review from the FDA and is expected to receive a decision on approval from the FDA by May 2020. Furthermore, the growing initiatives for pre-diagnosis and positive reimbursement policies will boost the Spinal Muscular Atrophy Treatment Market trends in the foreseeable future. Moreover, the growing awareness regarding pivotal treatment options will create new opportunities for the market.

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Market Restraint:

High Cost of Products to Impede Market Expansion

The cost-intensive products and high prices associated with the rare disease therapies will subsequently obstruct the growth of the market. For instance, spinraza is expected to cost US$ 750,000 for the first year and will be repriced at US$ 375,000 after that. Apart from that, Novartis rare gene therapy, Zolgensma will come at a price of US$ 2.1 million for a one-time treatment. The expensive cost of therapies will restrict the adoption of treatment for many patients, which in turn will act as a restraint for the Spinal Muscular Atrophy Treatment Market revenue.

Regional Insight:

Presence of Major Players to Influence Growth in North America

The market in North America stood at USD 854 million in 2018 and is likely to remain dominant during the forecast period. The growth in the region is attributed to the presence of prominent players in the region. The growing awareness regarding the prevalence of rare disease and pre-treatment initiatives will bolster accelerate the Spinal Muscular Atrophy Treatment Market growth in North America.

List of the Major Players Operating in the Global SMA Treatment Market Include:

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Spinal Muscular Atrophy Treatment Market to Exhibit a Spectacular CAGR of 28.9%; Growing Initiatives by Government Authorities for Pre-Diagnosis to...

Spinal Cord Stem Cells Comments Off on Spinal Muscular Atrophy Treatment Market to Exhibit a Spectacular CAGR of 28.9%; Growing Initiatives by Government Authorities for Pre-Diagnosis to… | March 4th, 2020

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Most of you reading this would have probably never heard of such a disease. My hope is, after taking time to read this, that you will know what myeloma is and have a better understanding of bone marrow cancer in general.

So, lets get started!

Your bone marrow is the factory where all your blood cells are made. This includes red blood cells (they carry the oxygen in your blood), white blood cells (your bodys defence against infections) and platelets (small fragments that prevent and stop bleeding).

The production of these cells by the bone marrow is very well controlled by your body, both in terms of the amount and the type of cells produced. If you have an infection, for instance, your body tells the stem cells in your bone marrow to make more white blood cells to help fight the infection. In such instances, an immature, baby cell gets produced in your bone marrow which then needs to go through various stages of growth and development to become a mature white blood cell. It is then released from the bone marrow into your bloodstream to go and do the job it was destined for, to fight the infection.

This process usually runs quite smoothly, but things can, unfortunately go horribly wrong. Sometimes your body makes a mistake in the production of a white blood cell, almost like a programming error which occurs in the DNA (blueprint) of the cell. It often recognizes its mistake and corrects it, but occasionally this abnormal cell has the ability to hide from your bodys defences, doesnt listen to your bodys commands anymore and can start to increase in number without anything controlling it. This causes a variety of problems and is then called cancer.

Depending on the type of white blood cell and where in its development the programming error occurs, a person can either develop a type of bone marrow cancer (usually leukaemia or myeloma) or lymphoma (glandular cancer), which is also a type of cancer that develops from an abnormal white blood cell.

That brings us to myeloma (also called multiple myeloma or plasma cell myeloma). Myeloma is a type of bone marrow cancer that develops when a programming error occurs in the development of a specific type of white blood cell, called a plasma cell. To understand myeloma better, it is important to understand what role a plasma cell plays under normal circumstances.

They are indeed an integral part of your bodys immune system. Any infection that you may develop gets recognized by your plasma cells. They respond by rapidly producing small proteins called antibodies, which are almost like homing missiles, programmed to go and destroy only that specific virus or bacteria that is making you ill.

After an infection, some of the antibodies remain in your bloodstream and if you are exposed to that exact virus or bacteria again, they are ready to attack immediately, thereby limiting the infection. This is the rationale behind childhood vaccination; to stimulate the production of antibodies which patrol your bloodstream and protect you when you get exposed to infections like measles, polio and many others.

If these plasma cells become cancerous however, they rapidly increase in number, taking over the bone marrow and producing a massive amount of an abnormal antibody which can cause a whole array of problems. This increase in antibody levels in the bloodstream can be measured with a blood test and is also used to monitor the response to treatment.. What are thesymptoms of myeloma?

The abnormal plasma cells in the bone marrow overwhelms the normal bone marrow which most commonly leads to an inability to produce enough red blood cells. This is called anaemia. Symptoms of anaemia are related to the bodys inability to carry sufficient oxygen to your organs and include worsening fatigue, shortness of breath and dizziness.

The abnormal plasma cells also have the ability to weaken your bones. This can either be a generalized loss of bone strength (called osteoporosis), or it can lead to numerous holes being eaten in your bones. This can be seen on an X-Ray or other types of scans. It often results in significant bone pain or even worse, severe fractures with minimal- or even no trauma at all.

Bones are rich in calcium, and if they are being eaten away, their calcium content is released into the bloodstream causing an elevated blood calcium level. This can lead to dehydration, kidney failure and numerous other symptoms.

As mentioned before, the plasma cells in the bone marrow releases a massive amount of abnormal antibodies into the bloodstream. They can clog up your kidneys and cause significant- and often irreversible kidney failure. This can seriously complicate the management of the disease.

These are by far the most common features of myeloma:

Anaemia, bone lesions or fractures, hypercalcaemia and kidney failure.There are numerous other symptoms which can occur, albeit less common.

Is myeloma treatable?

Myeloma is indeed a treatable condition, but there are a couple of important treatment principles to understand.

For most people, myeloma is not a curable disease. It can, however, be carefully managed and the aim of treatment is to provide a good quality of life for as many years as possible. No patients disease is the same and where we sometimes have patients with myeloma living in excess of ten years after being diagnosed, other patients are unfortunately less fortunate and have a form of the disease that is resistant to treatment which can take its toll after only a couple of months.

We perform DNA-tests on the cancer cells and look at various other blood results in an attempt to identify those patients with high-risk disease, who potentially need more intense treatment than others.

The goal of treatment is to destroy as many abnormal plasma cells in the bone marrow as possible. This leads to recovery of the normal bone marrow and minimises the risk of any further complications, giving the body a chance to recover from any complications caused prior to treatment.

For many decades, the backbone of the treatment for myeloma was a combination of two different type of drugs: Chemotherapy and high dosages of cortisone. This is usually quite well tolerated.

The last couple of years, however, have seen an explosion of newer therapies for the treatment of myeloma. This started years ago with the discovery that Thalidomide, was extremely effective for the treatment of myeloma. Soon, more of these so-called novel therapies were developed, leading to a significant increase in the survival of patients who have access to these drugs.

The latest and most impressive of these treatments are certainly the development of monoclonal antibodies and CAR-T cells, both of which are extremely effective even in high risk or resistant myeloma. There is so much excitement about all the newer therapies, but access remains a challenge in theSouth African market.

A strong collaborative effort is required amongst pharmaceutical companies, government and medical schemes, to improve the current access of newer drugs. Nevertheless, some of these drugs have been around for many years and the costs have come down considerably, making it accessible to more people.

The initial treatment of myeloma generally consists of varying combinations of these drugs depending on the patients age, physical condition and of course, the available funding.

We usually use 3 different drugs in combination (a so-called triplet regimen) which has been proven to be very effective. Once the treatment is started, we take blood regularly to monitor the abnormal antibody levels in the blood which, as mentioned earlier, is a surrogate indicator of the number of cancer cells remaining in the bone marrow.

If we dont see a significant downward trend, the disease is likely resistant to that specific treatment combination and treatment should be adjusted accordingly. However, if the antibody levels come down significantly, we are on the right track and can continue with the same treatment until an optimal response is obtained or the development of side-effects forces us to make an adjustment.

After 4-6 months of treatment, the hope is to see no sign of any abnormal antibodies or cancer cells anymore (we call this a remission), or at least a dramatic reduction. We do however know that although we sometimes dont pick up any sign of residual disease, it is merely because the available tests are not sensitive enough. There will always be some cancer cells that remain.

As a general principle, however, the less residual disease, the longer it usually takes before it causes problems again. Because of this, we usually treat younger patients more aggressively in an attempt to obtain a deeper remission. The biggest difference in younger patients is the use of an autologous stem cell transplant as a 2nd phase of treatment to try and obtain or deepen a remission.

We harvest the patients bone marrow stem cells and keep them frozen until needed. We then administer a single high dose chemotherapy which destroys many of the remaining cancer cells, but in the process, it also destroys the normal bone marrow, without which you cannot survive. The patients stem cells are then thawed and given back to them like a blood transfusion.

After about two weeks of close monitoring in the hospital, the stem cells start to function and the patient subsequently has his/her own bone marrow back, hopefully with significantly less myeloma. The age cut-off for such a procedure is arbitrary because it largely depends on the physical condition of the patient. Most people in South Africa, however, use the age of 70 as a cut off, sometimes a bit older if the patient is in exceptional condition for his/her age.

The median age of people diagnosed with myeloma worldwide is about 70 years. The available data, however, suggests that the median age in South Africa is considerably younger, somewhere around the age of 60 years. Due to this, as well as the problems with drug availability in South Africa, we often rely quite heavily on stem cell transplantation as an important part of treatment. If enough stem cells are harvested and cryopreserved, such a transplant can be repeated on numerous occasions to improve disease control.

After a transplant, as well as for those patients who are not candidates for a transplant, a form of low-intensity maintenance therapy is often started as the next phase of treatment in an attempt to keep the disease under control for as long as possible. This duration varies considerably. We hope for a couple of years, but it is unfortunately sometimes just a couple of months before the disease worsens, after which more intense treatment needs to be restarted again and the above cycle repeats itself. The remission duration gives us a good indication regarding the nature and prognosis of the disease.

There is so much more detail about myeloma to share, but the bottom line is this: Although myeloma is not a curable cancer and can lead to devastating complications, there is good treatment available which can help many patients enjoy a good quality of life for many years.

It is important to diagnose myeloma early, so if you have some of the symptoms mentioned earlier, please contact your General Practitioner for further investigation. If any abnormalities are detected, your GP can refer you to aClinical Haematologist, who specialises in bone marrow cancers and are best equipped to treat your myeloma.

We are all very excited about the future of myeloma treatment and hope that the treating physicians, pharmaceutical companies and government can take hands to ensure proper treatment for all the people in South Africa who suffer from this disease.

This article was compiled by Dr. Hannes Koornhof (Chairman of SACHAS)MBChB, FCP (SA), Dip HIV Man (SA), Cert Clin Haematology (SA) PhysSponsored by JANSSEN PHARMACEUTICA(PTY) LTD/(EDMS) BPK. (Reg. No./Regnr. 1980/011122/07); No 2, Medical Road, Halfway House, Midrand, 1685.www.janssen.com.

Medical Info Line: 0860 11 11 17. EM-27036

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Everything you need to know about Myeloma - IOL

Bone Marrow Stem Cells Comments Off on Everything you need to know about Myeloma – IOL | March 2nd, 2020

VANCOUVER, Washington, March 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today continued positive data for its mTNBC and MBC patients.

Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. An integral part of CytoDyn's mission and purpose is to provide effective therapeutic solutions to these patients. Results of the first five patients are as follows:

Patient #1: Enrolled in mTNBC Phase 1b/2 - Injected on 9/27/2019. CTC (circulating tumor cells) dropped to zero in two weeks on 10/11/2019. Total CTC and EMT (Epithelial Mesenchymal Transition in Tumor Metastasis) dropped to zero after about one month of treatment with leronlimab (once-a-week 350 mg dose). Results from the patient's earlier CT scan indicated a more than 25% tumor shrinkage within the first few weeks of treatment with leronlimab. Most importantly, after more than five months of treatment with leronlimab and Carboplatin, the patient not only has zero CTC and zero EMT, but also zero detectible CAML (cancer-associated microphages like cells).

Patient #2: Enrolled in single IND. Patient is MBC with HER2+ stage 4 metastasis to lung, liver, and brain. Patient's radiologist cancelled 2nd round of treatment due to leronlimab's effect on shrinking the largest tumor in the brain by 56% and other lesions being stable. Leronlimab has and continues to be the only treatment in place for brain metastasis after radiation was administered to this patient in July 2019. Four and one-half months after successful radiation treatment, the patient received her first dose of leronlimab (700 mg) and no other drugs to treat the brain metastasis. The 56% shrinkage in the brain lesions occurred after only two once-weekly injections of leronlimab. After 10 weeks of treatment with leronlimab, this patient's CTC and EMT results were all zeros (results reported on 2/12/2020). The patient's CT scan in mid-February was reported as stable.

Patient #3: Enrolled on 1/3/2020. This patient's CAML counts decreased from 45 to 30. CTC+EMT are stable and there has been no change in the total number. Despite positive results, this patient stopped treatment due to complications with her implanted port, which was unrelated to leronlimab.

Patient #4: Enrolled on 1/7/2020. This patient's total CTC dropped by 75% in the first two weeks of treatment with leronlimab. After almost five weeks of treatment, the CTC remained at zero.

Patient #5: Enrolled on 2/4/2020. This patient has traveled from England to receive leronlimab. Initial response from treatment indicated tumor shrinkage and, importantly, CTC dropped to zero after three weeks of leronlimab treatment.

Patients #6 and #7: Enrolled and waiting for the first results post-baseline results.

Patients #8 through #10: Will be injected in early March.

Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, "Patients continue to be actively enrolled in this trial based on the expression of CCR5 on lymphocytes and macrophages in the tumor microenvironment. The proposed mechanism of action (MOA) consisting of inhibition of Tregs and repolarization of macrophages has demonstrated a predictable, sustained response that has reduced the size of primary and metastatic tumors and reduced circulating tumor cells in all patients tested so far."

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added, "These findings are solidifying our belief of the four mechanism of actions (MOA) for leronlimab in the treatment of cancer, as previously verified through preclinical animal studies and in published papers. These MOAs indicate that leronlimab may potentially stop metastasis in many types of solid tumor cancers, trigger the body's immune response system to destroy the cancer tumor and perhaps more. This could represent the beginning of the transformation of CytoDyn from a potential leader in HIV therapy to providing potentially a new innovative treatment opportunity to patients with various forms of cancer and potentially NASH, GvHD, MS, and perhaps many more indications. With the possibility of our first approval in HIV late this year, we could have over 30 label expansion opportunities post-HIV approval."

About Triple-Negative Breast CancerTriple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growthestrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene. TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur. Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.

About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) have granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH. Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is therefore conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additionalclinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Company's cash position, (ii)the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv)the Company's ability to enter into partnership or licensing arrangements with third parties, (v)the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Company's ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Company's clinical trials, (viii)the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTS

Investors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn Reports Remarkable Outcomes for Additional Cancer Patients in mTNBC Trial; Following an Overwhelming Community Response, CytoDyn Expects to...

Bone Marrow Stem Cells Comments Off on CytoDyn Reports Remarkable Outcomes for Additional Cancer Patients in mTNBC Trial; Following an Overwhelming Community Response, CytoDyn Expects to… | March 2nd, 2020

Pennsylvania state trooper Matt Uram was talking with his wife at a July Fourth party in 2009 when a misjudged spray of gasoline burst through a nearby bonfire and set him alight. Flames covered the entire right side of his body, and after he fell to the ground to smother them, his wife beat his head with her bare hands to put out his burning hair. It was only on the way to the ER, as the shock and adrenaline began to wear off, that the pain set in. "It was intense," he says. "If you can imagine what pins and needles feel like, then replace those needles with matches."

From the hospital, Uram was transferred to the Mercy Burn Center in Pittsburgh, where doctors removed all of the burned skin and dressed his wounds. It was on the border between a second- and third-degree burn, and he was told to prepare for months of pain and permanent disfigurement. Not long after this assessment, however, a doctor asked Uram if he would be willing to take part in an experimental trial of a new device.

The treatment, developed by German researcher Dr. Jrg Gerlach, was the world's first to use a patient's stem cells to directly heal the skin. If successful, the device would mend Uram's wounds using his body's ability to regenerate fully functioning skin. Uram agreed to the procedure without hesitation.

Five days after the accident, surgeons removed a small section of undamaged skin from Uram's right thighabout the size of a postage stampand used it to create a liquid suspension of his stem cells that was sprayed in a fine mist onto the damaged skin. Three days later, when it was time to remove the bandages and re-dress the wounds, his doctor was amazed by what he saw. The burns were almost completely healed, and any risk of infection or scarring was gone.

A study subsequently published in the scientific journal Burns described how the spray was able to regrow the skin across the burn by spreading thousands of tiny regenerative islands, rather than forcing the wound to heal from its edge to the inside. The technique meant "reducing the healing time" and "minimizing complications," with "aesthetically and functionally satisfying outcomes," the paper stated.

Dozens more burn victims in Germany and the U.S. were successfully treated with the spray following Uram's procedure, and in 2014 Gerlach sold the technology to RenovaCare. The medical technology startup has now transformed the proof-of-concept device from a complicated prototype into a user-friendly product called a SkinGun, which it hopes clinicians will be able to use outside of an experimental setting. For that to happen, RenovaCare is preparing clinical studies for later this year, with the aim of Food and Drug Administration approval for the SkinGun.

Once these obstacles are overcome, RenovaCare CEO Thomas Bold believes, the SkinGun can compete with, or even replace, today's standard of care.

Current treatment of severe burns involves transplanting healthy skin from one area of the body and stitching it to another in a process called skin grafting or mesh skin grafting. It is a painful procedure that creates an additional wound at the donor site and can cause restricted joint movement because the transplanted skin is unable to grow with the patient. It is able to cover an area only two to three times as large as the harvested patch. "The current standard of care is just horrible," says Bold. "We are part of regenerative medicineit is the medicine of the future and will be life-changing for patients."

Beyond regulatory matters, there are also limitations to the technology that make it unsuitable for competing with treatments of third-degree burns, which involve damage to muscle and other tissue below the skin. Still, stem cell researcher Sarthak Sinha believes that while the SkinGun may not be that advanced yet, it shows the vast potential of this form of regenerative medicine. "What I see as the future of burn treatment is not skin repair but rather functional regeneration of skin and its appendagessuch as hair follicles, glands and fat," says Sinha. "This could be achieved by engaging deeper layers of skin and its resident stem cells to partake in tissue regeneration."

Research is already underway at RenovaCare to enable treatment of third-degree burns, which Bold describes as "definitely within the range of possibility." Bold claims the adaptations to the SkinGun would allow it to treat other damaged organs using a patient's stem cells, but for now the company is focusing solely on burns and wounds to skinthe largest organ of the human body.

Uram's burns are now completely unnoticeable. There is no scar tissue or even pigment discoloration, and the regenerated skin even tans. "If I show someone where I was burnt, I bet $100,000 they couldn't tell," he says. "There's no scars, no residual pain; it's like the burn never happened. It's a miracle."

Uram is frustrated that the treatment is not available to other burn victims, particularly children. "I want to see the FDA get off their butts and approve this," he says. "A grown man like me to be scarred is OK, but think about the kids that have to live the rest of their lives with pain and scarring. That's not OK."

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At several labs across the US, researchers use fetal tissue from humans to investigate everything from viral infections to the developing brain. Such studies have been ongoing for decades, as have politically fraught debates about this research, because it primarily relies on tissue donated after terminated pregnancies.

Last summer, President Donald Trumps administration announced that it would be placing restrictions on experiments involving fetal tissue obtained from elective abortions, which included banning government scientists from using this material for research and applying increased scrutiny for National Institutes of Health (NIH) grant proposals from nongovernmental scientists.

Researchers say that the new restrictions on fetal tissue research have required them to change their plans for future work or to search for alternative sources of funding. Its impacted almost all of the facets of the lab, says Carolyn Coyne, a microbiologist at the University of Pittsburgh who uses fetal tissue to study how viruses penetrate the placenta.

Its affected pretty much every grant application that that weve written.

Mana Parast, University of California, San Deigo

One of the main concerns, according to several researchers who spoke to The Scientist,is the lack of clarity regarding what the NIH will require in grant applications for this work. The Department of Health and Human Services (HHS), which oversees the NIH, has stated that it would put together a new ethics advisory board to review such proposals. Last week (February 20), HHS posted a notice indicating its intent to convene the NIHs fetal tissue ethics advisory board in 2020. In a written statement to The Scientist,the NIH states that it is in the process of setting up the Ethics Advisory Board for the purpose of evaluating research proposing the use of human fetal tissue from elective abortion.

Scientists are waiting to find out who will be appointed to the board and how it will evaluate proposals once it convenes. [Well] see whether the administration is going to act in good faith and appoint a decent ethics review committee, or if theyre going to ignore the value of the scientific and medical research that needs to be done in this area and let ideology weigh out over logic, says Lawrence Goldstein, a stem cell scientist at the University of California, San Diego, whose lab has worked with fetal cells in the past. The fetal tissue that were talking aboutif we dont use it for research, it will be discarded. Thats the choice. Discard the fetal tissue in the in the trash, or use it for valuable research.

This is not the first time such a ban has been put in place. In 1988, former US President Ronald Reagan placed similar restrictions on federal funding for fetal tissue studies, which stayed in place until President Bill Clinton overturned them during the first year of his term in 1993.

Fetal tissue used for research is primarily obtained from elective abortions, which women can consent to donate after deciding to terminate a pregnancy. This is because there are some major limitations to tissue obtained through other means, such as miscarriages, according to Anita Bhattacharyya, a stem cell scientist at the University of Wisconsin-Madisons Waisman Center. Supply is limited and the underlying factors that lead to pregnancy loss can complicate experiments. On top of that, such events often happen unexpectedly, meaning that the collected tissue is not always intact. We would worry about using poor quality tissue as a foundation for the work we do, says Bhattacharyya, who uses donated fetal brain tissue to study brain development and disorders such as Down syndrome and fragile X syndrome.

Bhattacharyya says that although her lab currently has the tissue it needs to complete experiments from a prior grant, shes not comfortable submitting proposals for studies that require obtaining new fetal tissue. Its because I dont know whats going to happen. If I spend hours writing a grant that I think is really good science, and I send it to NIH . . . its going to get stuck there, Bhattacharyya explains. Were so busy as scientists that to just write a grant that isnt going to go anywhere is a waste of our time.

As such, her projects may suffer. According to Bhattacharyya, not only is brain development difficult to study in model organisms such as rodents, but fragile X and Down syndrome in particular are difficult, if not impossible, to model in animals. Induced pluripotent stem cells (iPSCs), which can be generated by reprogramming cells from skin or blood in adults, have offered an alternative means of studying the development and disorders of the brain, yet researchers still need to validate the results they obtain, Bhattacharyya says. Really, the only way to do that is using fetal tissue.

In addition to cells and tissue from the fetus itself, the restrictions on NIH funding were also applied to other biological materials obtained in the process of abortions, such as umbilical cord, placenta, and amniotic fluid. While some of these can be useful to scientists when collected after birth, placental tissue obtained in this way has limitations. Full term placentas are actually aged tissues, explains Coyne. If were studying a full-term placenta post-delivery, the gnawing question is: Has that placenta changed from the placenta that exists in the first or second trimester?

Mana Parast, a stem cell and placental biologist at the University of California, San Diego, who studies placental development and disorders, tells The Scientist that while the policy change has left ongoing projects unscathed, its affected pretty much every grant application that that weve written since then. While Parasts team has used fetal tissue in the past, they are now focusing on using iPSC-based models. However, like Bhattacharyya, she notes that this isnt the perfect solutionas these models are fairly new and not yet broadly accepted, it is still necessary to validate them with cells from human placentas.

Coyne says that in addition to limiting access to grants for her research, the restrictions have also made it more difficult to procure tissue. A lot of major medical schools have federally funded tissue banks, Coyne explains. Our institutional tissue bank has been affected by this such that we cant obtain tissue from elective terminations anymore.

For researchers who have been able to obtain funding from alternative sources, such as philanthropists or private foundations, the effects of the restrictions have been minimal. Thomas Reh, a biologist at the University of Washington whose team uses fetal tissue to study the developing retina, says that his groups work is currently supported by a grant from the Open Philanthropy Project, a nonprofit organization. When the political climate gets more restrictive, private donors will often step in, Reh says. I wont say that works for everybody, or that it works all the time. At least in my own case, this is whats allowed me to sort of fill these gaps when [restrictions on fetal tissue] happen.

Its the next generation of trainees that are going to be most impacted, not just because they cant get funding, but if I were one of them, I would think to myself, is this really an area that I want to specialize in?

Carolyn Coyne, University of Pittsburgh

Andrew McMahon, a stem cell scientist at the University of Southern California, still has about a year left before he needs to apply for more funding, and hes started looking into potential alternatives to NIH. My understanding is that its not entirely clear at the moment what that process is going to be, McMahon says. Ive been using the time to obtain non-NIH funding to support aspects of the research that I would have tried to get NIH funding [for] in the future.

Private funds are not available to everyone, and can be more difficult for researchers in some fields to obtain than others. For some of the disorders that I work on, the major private funding foundation does not allow fetal tissue research, Bhattacharyya says. And sometimes the foundation funding can be quite a bit less than NIH funding.

For researchers in some states, nonprofits are not the only option. In California, the states stem cell agency, the California Institute for Regenerative Medicine (CIRM) has provided funding for stem cell studies using fetal tissue since it was founded in 2004. That fund is about to run out, but a bill that would provide $5.5 billion in funding to CIRM will come before voters in November.

That will hopefully provide funding for areas of fetal tissue research that involves stem cells, Goldstein says. But . . . its ridiculous to rely on one or two states to self-fund, because we dont have all of the best and brightest [scientists], and it means lots of students and postdocs will train in areas where federal training support will be unavailable to them.

Goldstein isnt the only one concerned that the most profound effect of the governments restrictions will be on early-career investigators and trainees. While established researchers may be able to circumvent the effects of the restrictions in the short term, the ramifications for trainees in this field will likely be much longer-lasting, Coyne says. Its the next generation of trainees that are going to be most impacted, not just because they cant get funding, but if I were one of them, I would think to myself, is this really an area that I want to specialize in and get into?

One scientist, who asked to remain anonymous for fear of being harassed by anti-abortion activists, tells The Scientist that the restrictions have been a source of huge stress and anxiety for his lab, which he only established a few years ago. He adds that while his team has pivoted to using animal models and organoids generated from iPSCs, these are imperfect models of the developing human brain, which is the focus of his work.

It makes no sense to limit this research, given that the tissue from abortions will get discarded now that donation is not an option, Parast says. Were not talking about encouraging this procedurewere trying to use the material from patients who have already decided to undergo this procedure in order to be able to help other women.

Diana Kwon is a Berlin-based freelance journalist. Follow her on Twitter@DianaMKwon.

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Made from the leaves of a shrub called Camellia sinensis, black tea is known for its high content of antioxidants and compounds that have several health and beauty benefits. Most of them can be reaped by drinking a cup or two per day. You could, alternatively also apply it topically on your hair and skin.

Heres how it helps and how you can make it a daily part of your diet:

Black tea is mainly rich in antioxidants known as polyphenols that help combat free radicals.

Free radicals are unstable molecules in the body that result from both natural and environmental factors, and over time, their build-up can damage or change cells in the body.

A cup of Darjeeling black tea has many bioactive compounds that reduce the risk of some cancers, heart diseases, lowers cholesterol and reduces blood sugar.

Most of our illnesses today stem from unregulated stress, courtesy of our fast-paced lifestyle. A cup of lavender bloom tea in the evening, will ensure that your stress levels are in check.

The handpicked tea leaves infused with lavender flowers, and rose petals work as a de-stressor and help you sleep better. The tea also builds immunity and improves digestion.

The massive antioxidants and caffeine content in black tea is beneficial in preventing hair fall, stimulating hair growth and adding shine and lustre to your mane.

For the most part, drinking a cup regularly is all you need to do to see the difference in your hair health.

However, you can also apply black tea extract (room temperature) to your scalp and hair as a conditioner after shampooing every once a week to reap its benefits.

The polyphenols and tannins in black tea are responsible for preventing skin infections, premature ageing, and reducing sunburns or blemishes.

Black tea is also known to reduce inflammation and flush out toxins; hence it also works to reduce under-eye puffiness and accelerate skin regeneration.

Just place a cotton ball soaked in cold black tea on the desired area of your face or body for a few minutes for a healthy glow, and drink a cup or two for overall skin health.

Along with a few lifestyle changes, consuming a cup of black tea regularly is known to aid in weight loss.

A prolonged period of inflammation in the body can induce obesity. Black tea helps prevent visceral fat and lowers the triglyceride levels by decreasing inflammation-inducing genes.

While other beverages such as coffee and green tea are great too if consumed in the right manner, this beverage takes it a notch higher with its incredible health benefits.

Also Read: Dark Chocolate Is Healthy! 5 Reasons to Make It a Part of Your Daily Diet

(Edited by Gayatri Mishra)

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5 Reasons Science Says Your Health, Skin and Hair Needs Black Tea - The Better India

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FLORIDA TODAY's Rob Landers brings you some of today's top stories on the News in 90 Seconds. Florida Today

Get ready to rumble Friday night. And that's not just because it's Friday and it's time to party.

SpaceX is poised to launch its Falcon 9 rocket and cargo Dragon capsule from Cape Canaveral Air Force Station Launch Complex 40 no earlier than 11:50 p.m. Friday.

From there it will head on a three-day journey to the International Space Station where Dragon will deliver science experiments, cargo and supplies to the crew onboard.

This will mark the aerospace company's 20th flight under NASA's Commercial Resupply Services contract as well as the last time SpaceX uses its Dragon 1 capsule before retiring it to make way to its newer, more advanced spacecraft: Dragon 2.

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The newer spacecraft is not only equipped to carry supplies to and from the space station, but it is also certified to refly up to five times (Dragon 1 for instance, was only certified for three re-flights) and can also carry humans, which could happen as soon as May for NASA's Commercial Crew Program.

"Some of the accomplishments of SpaceX under the CRS One program includesthe first U.S. Commercial provider toberth the ISS ... With that we're looking forward to SpaceX continuing on the CRS Two contract with SpaceX-21," said Jennifer Buchli, deputy chief scientist for NASA's International Space Station Program Science Office during a media teleconference.

SpaceX launched a Falcon 9 rocket with cargo for the International Space Station on Thursday, Dec. 5, 2019. Cape Canaveral hosted the liftoff. Florida Today

For this mission, Dragon 1 will deliver several science experiments including:

ACE-T-Ellipsoids: Researchers from the New Jersey Institute of Technology will examine colloids small particles suspended within a fluid in microgravity to not only understand fluid physics more but to advance space-based additive manufacturing, an area of great interest to NASA and other agencies in the U.S.

MVP Cell-03: Emory University School of Medicine will study whether microgravity increases the production of heart cells from specific stem cells, called "human-induced pluripotent stem cells." Those specific cells have the potential to be used toreplenish cells that are damaged or lost due to cardiac diseases.

Flow Chemistry in Microgravity: Researchers from Boston University will study the effects of microgravity on chemical reactions as a step toward on-demand production of chemicals and materials in space.

Droplet Formation Study: Delta Faucet Company will study water droplet formation and water flow in microgravity to gain a better understanding on how to improve its showerhead technology in an effort to create better performance while also conserving water and energy.

Dragon will also deliver the European external payload hosting facility called Bartolomeo that will be an enhancement to the space station's European Columbus Module.

Contact Jaramillo at321-242-3668or antoniaj@floridatoday.com. Follow her onTwitterat@AntoniaJ_11.

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TMRR, in its recent market report, suggests that the Stem Cell Therapy market report is set to exceed US$ xx Mn/Bn by 2029. The report finds that the Stem Cell Therapy market registered ~US$ xx Mn/Bn in 2018 and is spectated to grow at a healthy CAGR over the foreseeable period.

The Stem Cell Therapy market research focuses on the market structure and various factors (positive and negative) affecting the growth of the market. The study encloses a precise evaluation of the Stem Cell Therapy market, including growth rate, current scenario, and volume inflation prospects, on the basis of DROT and Porters Five Forces analyses. In addition, the Stem Cell Therapy market study provides reliable and authentic projections regarding the technical jargon.

In this Stem Cell Therapy market study, the following years are considered to project the market footprint:

The content of the Stem Cell Therapy market report includes the following insights:

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On the basis of solution, the global Stem Cell Therapy market report covers the following solutions:

Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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The Stem Cell Therapy market study answers critical questions including:

All the players running in the global Stem Cell Therapy market are elaborated thoroughly in the Stem Cell Therapy market report on the basis of R&D developments, distribution channels, industrial penetration, manufacturing processes, and revenue. In addition, the report examines, legal policies, and comparative analysis between the leading and emerging Stem Cell Therapy market players.

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Stem Cell Therapy Market Opportunity Analysis and Industry Forecast up to 2017 2025 - Jewish Life News

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