Myles Glass has spent the past several years living life on the sidelines in a wheelchair, wishing for a better day. That day came in November 2020.

INDIANAPOLIS A 13-year-old boy living with sickle cell disease has been given a second chance at life, thanks to his mother.

Myles Glass has been through more in his young life than most adults. For the past few years, Glass has spent his days in and out of Riley Hospital for Children.

"[I] kind of have to look on the bright side of things. Being in the hospital, I meet new nurses and kids who go through what I go through. It's kind of hard to go through that at my age," Glass said.

He was diagnosed with sickle cell disease as a newborn. According to the Centers for Disease Control and Prevention, African Americans make up the largest number of people with the disease in the U.S.

Sickle cell disease is an inherited condition that impacts red blood cells and causes pain, infections and extreme fatigue. These symptoms keep Glass from doing things he loves.

"For him, it's kind of like we have to have him in a bubble," said his mother, Melissa Sanders.

Glass has spent the past several years living life on the sidelines in a wheelchair, wishing for a better day.

"[I would] hope that one day, I can do what kids do, like playing football and basketball," Glass said.

That day came in November 2020 when his mother donated bone marrow for a stem cell transplant, curing him of sickle cell disease.

"I was able to give him a second life with being a donor so that he can somewhat be a normal kid," Sanders said.

Riley Hospital for Children Dr. Seethal Jacob, who has been working with Glass and his family, said one baby every two minutes is born with sickle cell disease. She also said studies show there is a clear disparity for funding for this disease.

"There's been a lot of neglect when it comes to the disease itself. I think it's important to pay attention to the population it affects. I think that likely tells the story why sickle cell disease has been a neglected disease for so long," Jacob said.

Despite his challenges, Glass is staying positive and making strides in his physical therapy at Riley Hospital for Children.

"He's already been through harder things than most people will ever go through. I think anything else in life is going to be a piece of cake," said his physical therapist, Sarah Johnson.

"This gives me a glimpse of hope that even though you may have been diagnosed with this disease, it's not the end of the world," Sanders said.

For Glass, this is just the beginning. He hopes his story encourages other people living with sickle cell disease to keep moving forward.

"I know it's hard now, but you'll get through it. You'll be able to do what kids do your own age," Glass said.

Click here for more information on sickle cell disease and treatment options.

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SYDNEY, Oct. 5, 2021 /PRNewswire/ -- Clinical stage drug development company Pharmaxis Ltd (ASX: PXS) today announced further positive results of data analysis from a phase 1c clinical trial (MF-101) studying its drug PXS-5505 in patients with the bone marrow cancer myelofibrosis for 28 days at three dosage levels.

Assessment with Pharmaxis' proprietary assays of the highest dose has shown inhibition of the target enzymes, LOX and LOXL2, at greater than 90% over a 24-hour period at day 7 and day 28. The trial safety committee has reviewed the results and having identified no safety signals, has cleared the study to progress to the phase 2 dose expansion phase where 24 patients will be treated at the highest dose twice a day for 6 months.

Pharmaxis CEO Gary Phillips said, "We are very pleased to have completed the dose escalation phase of this study with such clear and positive findings.We will now immediately progress to the phase 2 dose expansion study where we aim to show PXS-5505 is safe to be taken longer term with the disease modifying effects that we have seen in the pre-clinical models. The trial infrastructure and funding is in place and we are on track to complete the study by the end of 2022."

Independent, peer-reviewed research has demonstrated the upregulation of several lysyl oxidase family members in myelofibrosis.The level of inhibition of LOX achieved in the current study at all three doses significantly exceeds levels that caused disease modifying effects with PXS-5505 in pre-clinical models of myelofibrosis with improvements in blood cell count, diminished spleen size and reduced bone marrow fibrosis. LOXL2 was inhibited to a similar degree and based on pre-clinical work such high inhibition is likely replicated for other LOX family members (LOXL1, 3 and 4).[1] Study data can be viewed in the full announcement.

Commenting on the results of the trial, Dr Gabriela Hobbs, Assistant Professor, Medicine, Harvard Medical School & Clinical Director, Leukaemia, Massachusetts General Hospital said, "Despite improvements in the treatment of myelofibrosis, the only curative therapy remains an allogeneic stem cell transplantation, a therapy that many patients are not eligible for due to its morbidity and mortality. None of the drugs approved to date consistently or meaningfully alter the fibrosis that defines this disease. PXS-5505 has a novel mechanism of action by fully inhibiting all LOX enzymes. An attractive aspect of this drug is that so far in healthy controls and in this phase 1c study in myelofibrosis patients, the drug appears to be very well tolerated. This is meaningful as approved drugs and those that are undergoing study, are associated with abnormal low blood cell counts. Preliminary data thus far, demonstrate that PXS-5505 leads to a dramatic, >90% inhibition of LOX and LOXL2 at one week and 28 days. This confirms what's been shown in healthy controls as well as mouse models, that this drug can inhibit the LOX enzymes in patients. Inhibiting these enzymes is a novel approach to the treatment of myelofibrosis by preventing the deposition of fibrosis and ultimately reversing the fibrosis that characterizes this disease."

The phase 1c/2a trial MF-101 cleared by the FDA under the Investigational New Drug (IND) scheme aims to demonstrate that PXS-5505, the lead asset in Pharmaxis' drug discovery pipeline, is safe and effective as a monotherapy in myelofibrosis patients who are intolerant, unresponsive or ineligible for treatment with approved JAK inhibitor drugs. Trial sites will now open to recruit myelofibrosis patients into the 6-month phase 2 study in Australia, South Korea, Taiwan and the USA.

An effective pan-LOX inhibitor for myelofibrosis would open a market that is conservatively estimated at US$1 billion per annum.

While Pharmaxis' primary focus is the development of PXS-5505 for myelofibrosis, the drug also has potential in several other cancers including liver and pancreatic cancer where it aims to breakdown the fibrotic tissue in the tumour and enhance the effect of chemotherapy treatment.

Trial Design

Name of trial

PXS5505-MF-101: A phase 1/2a study to evaluate safety, pharmacokinetic and pharmacodynamic dose escalation and expansion study of PXS-5505 in patients with primary, post-polycythaemia vera or post-essential thrombocythemia myelofibrosis

Trial number

NCT04676529

Primary endpoint

To determine the safety of PXS-5505 in patients with myelofibrosis

Secondary endpoints

Blinding status

Open label

Placebo controlled

No

Trial design

Randomised, multicentre, 4 week duration phase 1 (dose escalation) followed by 6 month phase 2 (dose expansion)

Treatment route

Oral

Treatment frequency

Twice daily

Dose level

Dose escalation: three escalating doses

Dose expansion: one dose

Number of subjects

Dose escalation: minimum of three patients to maximum of 18 patients

Dose expansion: 24 patients

Subject selection criteria

Patients with primary or secondary myelofibrosis who are intolerant, unresponsive or ineligible for treatment with approved JAK inhibitor drugs

Trial locations

Dose escalation: Australia (2 sites) and South Korea (4 sites)

Dose expansion: Australia, Korea, Taiwan, USA

Commercial partners involved

No commercial partner

Reference: (1) doi.org/10.1002/ajh.23409

AUTHORISED FOR RELEASE TO ASX BY:

Pharmaxis Ltd Disclosure Committee. Contact: David McGarvey, Chief Financial Officer and Company Secretary: T +61 2 9454 7203, E [emailprotected]

Join the Pharmaxis mailing listhere

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About Pharmaxis

Pharmaxis Ltd is an Australian clinical stage drug development company developing drugs for inflammatory and fibrotic diseases, with a focus on myelofibrosis. The company has a highly productive drug discovery engine built on its expertise in the chemistry of amine oxidase inhibitors, with drug candidates in clinical trials. Pharmaxis has also developed two respiratory products which are approved and supplied in global markets, generating ongoing revenue.

Pharmaxis is developing its drug PXS-5505 for the bone marrow cancer myelofibrosis which causes a build up of scar tissue that leads to loss of production of red and white blood cells and platelets. The US Food and Drug Administration has granted Orphan Drug Designation to PXS-5055 for the treatment of myelofibrosis and permission under an Investigational Drug Application (IND) to progress a phase 1c/2 clinical trial that began recruitment in Q1 2021. PXS5505 is also being investigated as a potential treatment for other cancers such as liver and pancreatic cancer.

Other drug candidates being developed from Pharmaxis' amine oxidase chemistry platform are targeting fibrotic diseases such as kidney fibrosis, NASH, pulmonary fibrosis and cardiac fibrosis; fibrotic scarring from burns and other trauma; and inflammatory diseases such as Duchenne Muscular Dystrophy.

Pharmaxis has developed two products from its proprietary spray drying technology that are manufactured and exported from its Sydney facility; Bronchitol for cystic fibrosis, which is approved and marketed in the United States, Europe, Russia and Australia; and Aridol for the assessment of asthma, which is approved and marketed in the United States, Europe, Australia and Asia.

Pharmaxis is listed on the Australian Securities Exchange (PXS). Its head office, manufacturing and research facilities are in Sydney, Australia. http://www.pharmaxis.com.au

About PXS-5505

PXS-5505 is an orally taken drug that inhibits the lysyl oxidase family of enzymes, two members LOX and LOXL2 are strongly upregulated in human myelofibrosis. In pre-clinical models of myelofibrosis PXS-5505 reversed the bone marrow fibrosis that drives morbidity and mortality in myelofibrosis and reduced many of the abnormalities associated with this disease. It has already received IND approval and Orphan Drug Designation from the FDA.

About Myelofibrosis

Myelofibrosis is a disorder in which normal bone marrow tissue is gradually replaced with a fibrous scar-like material. Over time, this leads to progressive bone marrow failure. Under normal conditions, the bone marrow provides a fine network of fibres on which the stem cells can divide and grow. Specialised cells in the bone marrow known as fibroblasts make these fibres.

In myelofibrosis, chemicals released by high numbers of platelets and abnormal megakaryocytes (platelet forming cells) over-stimulate the fibroblasts. This results in the overgrowth of thick coarse fibres in the bone marrow, which gradually replace normal bone marrow tissue. Over time this destroys the normal bone marrow environment, preventing the production of adequate numbers of red cells, white cells and platelets. This results in anaemia, low platelet counts and the production of blood cells in areas outside the bone marrow for example in the spleen and liver, which become enlarged as a result.

Myelofibrosis can occur at any age but is usually diagnosed later in life, between the ages of 60 and 70 years. The cause of myelofibrosis remains largely unknown. It can be classified as either JAK2 mutation positive (having the JAK2 mutation) or negative (not having the JAK2 mutation).

Source: Australian Leukemia Foundation: https://www.leukaemia.org.au/disease-information/myeloproliferative-disorders/types-of-mpn/primary-myelofibrosis/

Forward-looking statements

Forwardlooking statements in this media release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the potential of products and drug candidates. All forward-looking statements included in this media release are based upon information available to us as of the date hereof. Actual results, performance or achievements could be significantly different from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are not guarantees or predictions of future results, levels of performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results to differ materially from those expressed in the statements contained in this document. For example, despite our efforts there is no certainty that we will be successful in developing or partnering any of the products in our pipeline on commercially acceptable terms, in a timely fashion or at all. Except as required by law we undertake no obligation to update these forward-looking statements as a result of new information, future events or otherwise.

CONTACT:

Media: Felicity Moffatt: T +61 418 677 701, E [emailprotected]

Investor relations:Rudi Michelson (Monsoon Communications) T +61 411 402 737, E [emailprotected]

SOURCE Pharmaxis Limited

http://www.pharmaxis.com.au

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Pharmaxis Cleared To Progress To Phase 2 Bone Marrow Cancer Trial - PRNewswire

Bone Marrow Stem Cells Comments Off on Pharmaxis Cleared To Progress To Phase 2 Bone Marrow Cancer Trial – PRNewswire | October 5th, 2021

TUCSON, Ariz., Oct. 5, 2021 /PRNewswire/ --On November 15th, 2021, healthcare professionals and the general public are invited to participate in World Cord Blood Day 2021 (www.WorldCordBloodDay.org) via a free online conference and live educational events being held around the globe. Registration is now open (free, public welcome).

Cord blood is the blood left in the umbilical cord and placenta following the birth of a child. It is rich in life-saving stem cells. While cord blood has been used for over 30 years, Covid-19 has renewed interest in this medical resource given its unique regenerative qualities and the fact that most cord blood currently stored was collected prior to the pandemic. These units are naturally Covid-free, an advantage over many other stem cell sources. Yet, cord blood is still thrown away as medical waste in the majority of births worldwide. Education is key to changing this practice and World Cord Blood Day 2021 will provide the perfect opportunity for OBGYNs, midwives, transplant doctors, nurses, parents and students to learn about this vital medical resource.

During World Cord Blood Day 2021, participants will learn how cord blood is used to treat over 80 life-threatening diseases such as leukemia and lymphoma, bone marrow failure, immune deficiency diseases and inherited blood disorders such as thalassemia and sickle cell disease. Leading transplant doctors and researchers will also highlight cord blood's role in the emerging fields of gene therapy and regenerative medicine to potentially treat cerebral palsy, autism, stroke and more.

Organized by Save the Cord Foundation, a 501c3 non-profit, World Cord Blood Day 2021 is officially sponsored by QuickSTAT Global Life Science Logistics, recognized leader in medical shipping and healthcare logistics. Inspiring Partners include Be the Match (NMDP), World Marrow Donor Association (WMDA-Netcord), AABB Center for Cellular Therapies, Cord Blood Association, and the Foundation for the Accreditation of Cellular Therapy (FACT).

"QuickSTAT, part of Kuehne+Nagel, is proud to sponsor the 5th annual World Cord Blood Day to help support and educate the healthcare community and expectant parents about the life-saving value of cord blood stem cells. We're excited to play a role in the research and development of cord blood derivative therapies by providing logistics supply chain solutions to cord blood, biotech and pharmaceutical companies worldwide," said Monroe Burgess, VP Life Science Commercial Marketing, QuickSTAT.

Visit http://www.WorldCordBloodDay.org to learn how you can participate. Show your support on social media: @CordBloodDay, #WorldCordBloodDay, #WCBD21

About Save the Cord FoundationSave the Cord Foundation (a 501c3 non-profit) was established to advance cord blood education providing non-commercial information to health professionals and the public regarding methods for saving cord blood, as well as current applications and the latest research. http://www.SaveTheCordFoundation.org.

About QuickSTAT Global Life Science LogisticsEvery day, QuickSTAT, a part of Kuehne+Nagel, safely and reliably moves thousands of critical shipments around the world. For over forty years, QuickSTAT has been entrusted with transporting human organs and tissue for transplant or research, blood, blood products, cord blood, bone marrow, medical devices, and personalized medicine, 24/7/365. QuickSTAT's specially trained experts work with hospitals, laboratories, blood banks and medical processing centers, and utilize the safest routes to ensure integrity, temperature control and chain of custody throughout the transportation process. Learn more at http://www.quickstat.aero.

Contact:Charis Ober(520) 419-0269[emailprotected]

SOURCE Save the Cord Foundation

http://www.SaveTheCordFoundation.org

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Ready to Treat Over 80 Life-Threatening Diseases, Discover the Potential of Cord Blood during World Cord Blood Day 2021 - PRNewswire

Bone Marrow Stem Cells Comments Off on Ready to Treat Over 80 Life-Threatening Diseases, Discover the Potential of Cord Blood during World Cord Blood Day 2021 – PRNewswire | October 5th, 2021

A student has completed the London Marathon alongside the stem cell donor who saved her life.

icky Lawrence, 21, from Moseley, Birmingham, was diagnosed with severe aplastic anaemia in 2008, when she was eight years old, a condition in which the bone marrow does not produce an adequate number of new blood cells.

Thanks to Elliott Brock, a physiotherapist from Mersea Island, Essex, Ms Lawrence received a transplant that same year.

Ms Lawrence sent Mr Brock a letter in 2015 and the pair met for the first time.

Fast forward to 2021 and they have just completed the London Marathon in support of Anthony Nolan.

Ms Lawrence, who is in her fourth year of a medical degree at Newcastle University, told the PA news agency that completing the marathon was absolutely amazing.

She said: Crossing the finish line was so emotional, not just because wed run 26 miles, but running 26 miles alongside the man who saved your life is a pretty big feat.

Ms Lawrence added: A big slogan of Anthony Nolan is without your support, there is no cure.

Without Elliott donating his stem cells to a stranger, I would not be here. I wouldnt have made it to Christmas. I would never have had the opportunities Ive had to go to university, to study abroad, to play hockey.

Him donating his stem cells gave me a second life and there are still so many people that need a transplant that are not finding the matches they need, especially among the ethnic minority community.

Unfortunately if you are of ethnic minority background, you only have a 37% chance of finding a match.

Mr Brock, 42, who wore a mask and cape during the race, said: That was a tongue of check nod [to the fact that the] easiest way to be called a hero is to donate your bone marrow.

I cannot emphasise to people enough that it is pain-free.

He added: It was just a day of celebration for London to celebrate having their marathon back.

The crowds were amazing and obviously to be side-by-side with the girl whose life, through the amazing work of Anthony Nolan, I managed to save sort of 13 years ago was just surreal really.

Its a lovely story of how my simple act made such a massive difference and we are able to celebrate it so many years after.

Anthony Nolan chief executive Henny Braund said: We are so grateful to Vicky and Elliott for running to raise funds and awareness of Anthony Nolan and the lifesaving work that we do.

Every day five Vickys, patients with blood cancer or a blood disorder, start their search for an Elliott.

If youre aged 16-30 and in good health, please consider joining the Anthony Nolan stem cell register. You could potentially save a life.

More information on how to join the stem cell register can be found at: http://www.anthonynolan.org/help-save-a-life/join-stem-cell-register

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Student completes London Marathon with the man who saved her life - Independent.ie

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StemExpress to use utilize the Thermo Fisher Accula rapid PCR testing system to provide event attendees with accurate results in 30 minutes.

Published: Oct. 5, 2021 at 2:33 PM CDT|Updated: 4 hours ago

SACRAMENTO, Calif., Oct. 5, 2021 /PRNewswire/ --StemExpress is proud to announce that they will be the official COVID-19 testing provider for 2021's Meeting on the Mesa, a hybrid event bringing together great minds in the cell and gene biotech sphere. It has partnered with Alliance for Regenerative Medicine to comply with the newly implemented California state COVID-19 vaccination and testing policy regarding gatherings with 1,000 or more attendees. This partnership will allow the vital in-person networking aspect of the event to commence while protecting the health and safety of participants and attendees.

In-person networking commences at the 2021 Cell and Gene Meeting on the Mesa with COVID-19 testing options provided by StemExpress.

As a leading global provider of human biospecimen products, StemExpress understands the incredible impact that Meeting on the Mesa has on the industry and has been a proud participant for many years. For over a decade, StemExpress has provided the cell and gene industry with vital research products and holds valued partnerships with many of this year's participants. As such, it understands the immense value that in-person networking provides and is excited to help bring this element back to the meeting safely and responsibly.

StemExpress has been a trusted provider of widescale COVID-19 testing solutions since early 2020 - providing testing for government agencies, public health departments, private sector organizations, and the public nationwide. For Meeting on the Mesa, StemExpress is offering convenient testing options for unvaccinated attendees and those traveling from outside of the country. Options will include take-home RT-PCR COVID Self-Testing Kits and on-site, rapid PCR testing for the duration of the event. The self-testing kit option allows attendees to test for COVID in the days leading up to the event for a seamless admission and the days following the event to confirm they haven't been exposed. The on-site rapid testing option utilizes the new Thermo Fisher Accula, offering in-person testing at the event with results in around 30 minutes. StemExpress is excited to bring these state-of-the-art COVID testing solutions to the frontlines of the Cell & Gene industry to allow for safe in-person connections.

The StemExpress partnership with Alliance for Regenerative Medicine seeks to empower the entire cell and gene industry with a long-awaited opportunity to return to traditional networking practices. It is well known that innovation doesn't exist in a vacuum - allowing great minds to come together is a sure way to spur scientific growth and advance cutting-edge research, giving hope for future cures.

Cell and Gene Meeting on the Mesa will take place October 12th, 2021, through October 14th, 2021, at Park Hyatt Aviara,7100 Aviara Resort Drive Carlsbad, CA 92011. To learn more about the event, please visit MeetingOnTheMesa.com.

For more information about COVID testing solutions for businesses and events, visit https://www.stemexpress.com/covid-19-testing/.

About StemExpress:

Founded in 2010 and headquartered in Sacramento, California, StemExpress is a leading global biospecimen provider of human primary cells, stem cells, bone marrow, cord blood, peripheral blood, and disease-state products. Its products are used for research and development, clinical trials, and commercial production of cell and gene therapies by academic, biotech, diagnostic, pharmaceutical, and contract research organizations (CRO's).

StemExpress has over a dozen global distribution partners and seven (7) brick-and-mortar cellular clinics in the United States, outfitted with GMP certified laboratories. StemExpress runs its own non-profit supporting STEM initiatives, college and high school internships, and women-led organizations. It is registered with the U.S. Food and Drug Administration (FDA) and is continuously expanding its network of healthcare partnerships, which currently includes over 50 hospitals in Europe and 3 US healthcare systems - encompassing 31 hospitals, 35 outpatient facilities, and over 200 individual practices and clinics.

StemExpress has been ranked by Inc. 500 as one of the fastest-growing companies in the U.S.

About the Alliance for Regenerative Medicine:

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 12-year history, ARM has become the voice of the sector, representing the interests of 400+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

Media Contact: Anthony Tucker, atucker@stemexpress.com

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StemExpress Partners with the Alliance for Regenerative Medicine to Provide COVID-19 Testing for the Cell and Gene Meeting on the Mesa - WSAW

Bone Marrow Stem Cells Comments Off on StemExpress Partners with the Alliance for Regenerative Medicine to Provide COVID-19 Testing for the Cell and Gene Meeting on the Mesa – WSAW | October 5th, 2021

Published: Oct. 4, 2021 at 6:00 AM EDT

NEW YORK, Oct. 4, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the2021 Cell & Gene Meeting on the Mesa, being held as a hybrid conferenceOctober 12-14, and October 19-20, 2021.

Dr. Lindborg's presentation highlights the expansion of Brainstorm's technology portfolio to include autologous and allogeneic product candidates, covering multiple neurological diseases. The most progressed clinical development program, which includes a completed phase 3 trial of NurOwn in ALS patients, remains the highest priority for Brainstorm. Brainstorm is committed to pursuing the best and most expeditious path forward to enable patients to access NurOwn.

Dr. Lindborg's presentation will be in the form of an on-demand webinar that will be available beginning October 12. Those who wish to listen to the presentation are required to registerhere. At the conclusion of the 2021 Cell & Gene Meeting on the Mesa, a copy of the presentation will also be available in the "Investors and Media" section of the BrainStorm website underEvents and Presentations.

About the 2021 Cell & Gene Meeting on the Mesa

The meeting will feature sessions and workshops covering a mix of commercialization topics related to the cell and gene therapy sector including the latest updates on market access and reimbursement schemes, international regulation harmonization, manufacturing and CMC challenges, investment opportunities for the sector, among others. There will be over 135 presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.

The conference will be delivered in a hybrid format to allow for an in-person experience as well as a virtual participation option. The in-person conference will take place October 12-14 in Carlsbad, CA. Virtual registrants will have access to all content via livestream during program dates. Additionally, all content will be available on-demand within 24 hours of the live program time. Virtual partnering meetings will take place October 19-20 via Zoom.

About NurOwn

The NurOwntechnology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwntechnology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website atwww.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwnmanufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect,""likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwntreatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwntreatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwntreatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

ContactsInvestor Relations:Eric GoldsteinLifeSci Advisors, LLCPhone: +1 646.791.9729egoldstein@lifesciadvisors.com

Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com

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BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa - WWNY

Bone Marrow Stem Cells Comments Off on BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa – WWNY | October 5th, 2021

DBMR has added a new report titled Bone Marrow-Derived Stem Cells (BMSCS) Market with analysis provides the insights which bring marketplace clearly into the focus and thus help organizations make better decisions. With a devotion and commitment of supreme level of resilience and integrated approaches, Bone Marrow-Derived Stem Cells (BMSCS) Market research report has been structured. The report also puts a light on growth opportunity assessment (GOA), customer insights (CI), competitive business intelligence (CBI), and distribution channel assessment (DCA). This world class market report analyses and evaluates the important industry trends, market size, market share estimates, and sales volume with which industry can speculate the strategies to increase return on investment (ROI). The statistics have been represented in the graphical format for an unambiguous understanding of facts and figures.

An influential Bone Marrow-Derived Stem Cells (BMSCS) Market report brings into focus plentiful of factors such as the general market conditions, trends, inclinations, key players, opportunities, and geographical analysis which all aids to take business towards the growth and success. This report provides the broader perspective of the market place with its comprehensive market insights and analysis which eases surviving and succeeding in the market. Moreover, this market report explains better market perspective in terms of product trends, marketing strategy, future products, new geographical markets, future events, sales strategies, customer actions or behaviors. Hence, the credible report brings into the focus, the more important aspects of the market or industry.

Bone marrow-derivedstem cells(BMSCS) market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to growing at a CAGR of 10.4% in the above-mentioned forecast period. Increasing awareness regarding the benefits associates with the preservation of bone marrow derived stem cells will boost the growth of the market.

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The major players covered in the bone marrow-derived stem cells (BMSCS) market report are CBR Systems, Inc, Cordlife Sciences India Pvt. Ltd., Cryo-Cell International, Inc.ESPERITE N.V., LifeCell International Pvt. Ltd., StemCyte India Therapeutics Pvt. Ltd, PerkinElmer Inc, Global Cord Blood Corporation., Smart Cells International Ltd., Vita 34 among other domestic and global players. Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Some of the factors such as introduction of novel technologies for the preservation of stem cells and their storage, surging investment that will help in research activities leading to stem cells benefits, adoption of hemotopoietic stem cell transplantation system will accelerate the growth of the bone marrow-derived stem cells (BMSCS) market in the forecast period of 2020-2027. Various factors that will create opportunities in the bone marrow-derived stem cells (BMSCS) market are increasing occurrences of various diseases along with rising applications in emerging economies.

Large cost of operation and strict regulatory framework will restrict the growth of bone marrow-derived stem cells (BMSCS) market in the above mentioned forecast period. Ethical concern leading to stem cells will become the biggest challenge in the market growth.

Global Bone Marrow-Derived Stem Cells (BMSCS) Market By Service Type (Sample Preservation and Storage, Sample Analysis, Sample Processing, Sample Collection and Transportation), Application (Personalized Banking Applications, Research Applications, Clinical Applications), Country (U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa), Market Trends and Forecast to 2027

Global Bone Marrow-Derived Stem Cells (BMSCS) Market Scope and Market Size

Bone marrow-derivedstem cells(BMSCS) market is segmented on the basis of service type and application. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Thisbonemarrow-derived stem cells (BMSCS) market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on bone marrow-derived stem cells (BMSCS) market contactData Bridge Market Researchfor anAnalyst Brief, our team will help you take an informed market decision to achieve market growth.

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Healthcare Infrastructure Growth Installed Base and New Technology Penetration

Bone marrow-derived stem cells (BMSCS) market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for bone marrow-derived stem cells (BMSCS) market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the bone marrow-derived stem cells (BMSCS) market. The data is available for historic period 2010 to 2018.

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Competitive Landscape and Bone Marrow-Derived Stem Cells (BMSCS) Market Share Analysis

Bone marrow-derived stem cells (BMSCS) market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to bone marrow-derived stem cells (BMSCS) market.

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Bone Marrow-Derived Stem Cells (BMSCS) Market : Size & Trends Shows a Rapid Growth by 2028 UNLV The Rebel Yell - UNLV The Rebel Yell

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Bone marrow transplantation, also referred to as hematopoieticular somatic cell transplantation, may be a sort of major surgery . It involves the transplantation of multidimensional, immature, and constantly dividing stem-cells from bone marrow, duct , or other sources. It are often autologous, polyglobulogenic or maybe syngenetic. This treatment are often wont to treat a good range of great diseases, like MS , red blood cell disease, paralysis agitans , disease , bone marrow cancer, leukemia, bone infection, myeloma , age related degeneration and more.

The PDF for the study can be requested using the following link: https://www.coherentmarketinsights.com/insight/request-pdf/232

Market Dynamics

High prevalence of cancer is predicted to propel growth of the worldwide bone marrow transplant market. as an example , consistent with Leukemia and Lymphoma Society, 176,200 people within the US are expected to be diagnosed with leukemia, lymphoma or myeloma in 2019. Moreover, increasing adoption of bone marrow transplant is additionally expected to assist in growth of the market. as an example , in August 2020, CytoDyn Inc., a late-stage biotechnology company, announced its efforts to duplicate Berlin and London patients HIV cure by using leronlimab during bone marrow transplant for five HIV patients who even have cancer.

Availability of effective therapies for the treatment of acute graft versus host disease is predicted to supply lucrative growth opportunities for players within the global bone marrow transplant market. as an example , in September 2020, Avalon GloboCare Corp., a clinical-stage developer of cell-based technologies and therapeutics, launched its new allogeneic mesenchymal stromal cell therapeutic platform a possible therapy for COVID-19 and for bone marrow transplant related complications of acute graft versus host disease.

However, bone marrow transplant may cause various complications like acute graft versus host disease, which is predicted to hinder growth of the worldwide bone marrow transplant market.

Among regions, the center East is predicted to witness significant growth within the global bone marrow transplant market, due to increasing adoption of bone marrow transplant within the region. as an example , in July 2020, Abu Dhabi Stem Cells Centre (ADSCC) and Sheikh Khalifa Medical City announced the primary ever successful bone marrow transplant administered within the UAE.

Competitive Analysis

Major players operating within the global bone marrow transplant market include, Lonza Group Ltd., Merck Millipore Corporation, Sanofi-Aventis LLC, AllCells LLC, STEMCELL Technologies, and American Type Culture Collection (ATCC) Inc.

Key players within the global bone marrow transplant market are focused on adopting collaboration and partnership strategies to expand their product portfolio. as an example , in November 2019, Lonza Group Ltd. partnered with Cryoport, Inc. within the cell and gene therapy field and across Lonzas vein-to-vein delivery network.

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Bone Marrow Transplant Market: North America to Dominate Market through 2027; Europe to Witness Steady Growth Over 2021-2027 UNLV The Rebel Yell -...

Bone Marrow Stem Cells Comments Off on Bone Marrow Transplant Market: North America to Dominate Market through 2027; Europe to Witness Steady Growth Over 2021-2027 UNLV The Rebel Yell -… | September 1st, 2021

Medical science is starting to license and use drugs and procedures that change the genetic code inside the bodys cells, and to correct the bad code that can give rise to conditions such as cancer and the auto-immune diseases. Since HIV is a disease that results from a virus inserting such a piece of bad code into our genes, such therapies could be used to snip out that code and effect a cure.

This was what attendees at last months International AIDS Society Conference on HIV Science (IAS 2021) heard at the workshop on curing HIV. The workshop opened with two introductory talks by Professor Hans-Peter Kiem, the chair of gene therapy at the Fred Hutchinson Cancer Research Center in Seattle in the US (the Fred Hutch) and, in a joint presentation, by the Fred Hutchs Dr Jennifer Adair and Dr Cissy Kityo of the Joint Clinical Research Centre (JCRC) in Kampala, Uganda.

The latter talk was a sign of acknowledgement that, while the prospects for genetic medicine are brighter than ever before, their expense and sophistication do not fit well with the global epidemiology of HIV, which mainly affects the worlds poorest and most disadvantaged communities. Despite this, Fred Hutch and JCRC have embarked upon a joint research programme to develop within the next few years a genetic therapy treatment for HIV that could be realistically scaled up for use in lower-income settings.

A unit of heredity, that determines a specific feature of the shape of a living organism. This genetic element is a sequence of DNA (or RNA, for viruses), located in a very specific place (locus) of a chromosome.

A type of experimental treatment in which foreign genetic material (DNA or RNA) is inserted into a person's cells to prevent or fight disease.

To eliminate a disease or a condition in an individual, or to fully restore health. A cure for HIV infection is one of the ultimate long-term goals of research today. It refers to a strategy or strategies that would eliminate HIV from a persons body, or permanently control the virus and render it unable to cause disease. A sterilising cure would completely eliminate the virus. A functional cure would suppress HIV viral load, keeping it below the level of detection without the use of ART. The virus would not be eliminated from the body but would be effectively controlled and prevented from causing any illness.

The body's mechanisms for fighting infections and eradicating dysfunctional cells.

In cell biology, a structure on the surface of a cell (or inside a cell) that selectively receives and binds to a specific substance. There are many receptors. CD4 T cells are called that way because they have a protein called CD4 on their surface. Before entering (infecting) a CD4 T cell (that will become a host cell), HIV binds to the CD4 receptor and its coreceptor.

HIV cure research pioneer Dr Paula Cannon of the University of Southern California, chairing the session, said: After several decades of effort and false starts, gene therapies now hold out promise for diseases that were previously untreatable.

Hans-Peter Kiem acknowledged the pivotal role of community advocacy in supporting cure research, noting that his project, defeatHIV, was one of the first beneficiaries of a grant from the Martin Delaney Collaboratories, named after the celebrated US treatment activist who died in 2009.

The other factor that gave impetus to HIV cure research was, of course, the announcement that someone had been cured: Timothy Ray Brown, whose HIV elimination was first announced in 2008 and who came forward publicly in 2010. He died in 2019 from the leukaemia whose treatment led to his HIV cure but by then had had 13 years of post-HIV life. He had survived long enough to talk with Adam Castillejo, the second person cured of HIV, and encourage him to come forward too.

Timothy and Adams stories showed that HIV could be cured, and with a crude form of gene therapy too: cancer patients, they were both given bone marrow transplants from donors whose T-cells lacked the gene for the CCR5 receptor, which is necessary for nearly all HIV infection.

But there have only been two cures for two reasons: firstly, bone marrow transplant is itself a very risky procedure involving deleting and replacing the entire immune system of already sick patients. In 2014 Browns doctor, Gero Hutter, reported that Timothy Ray Brown was only one of out of eight patients on whom the procedure had been tried, but that all the others had died.

Secondly, compatible bone marrow donors are hard to come by as it is, and restricting them to the 1% or so of people who lack the CCR5 receptor, all of them of northern European ancestry, means very few people could benefit from this approach. Attempting transplant with T-cells that do not lack CCR5, in the hope that replacing the immune system with cells from a person without cancer will also get rid of their HIV anyway, has produced temporary periods of undetectable HIV off therapy, but the virus has always come back.

(People like Brown and Castillejo, whose HIV infection was cured by medical intervention, need to be distinguished from people who seem to have spontaneously cured themselves, such as Loreen Willenberg: such people are of course of great interest to cure researchers, but the trick is to make it happen consistently in other people.)

Brown and Castillejos cures, as transplants, were so-called allogenic, meaning that the HIV-resistant cells came from another person. Better would be autogenic transplants, in which immune system cells are taken from a person with HIV, genetically altered in the lab dish to make them resistant to HIV, and then re-introduced. This type of procedure written about for aidsmap as long ago as 2011 by treatment advocate Matt Sharp, who underwent one.

The repertoire of gene therapies is not restricted to CCR5 deletion. Gene therapy is immensely versatile, and could be used in a number of ways.

Instead of using gene therapy to make cells resistant to HIV, it could directly repair defective genes in cells by means of cut-and-paste technology such as CRISPR/Cas9. This is already being used in trials for some genetic conditions such as cystic fibrosis and sickle-cell anaemia. Given that HIV-infected cells are also defective in the sense that they contain lengths of foreign DNA that shouldnt be there, they are amenable to the same molecular editing. Early trials have produced promising results but the challenge, as it has been in a lot of gene therapy, is to ensure that the cells containing DNA are almost entirely eliminated.

One way of doing this is not to delete the HIV DNA from infected cells but to preferentially kill off the cells themselves by creating so-called chimeric antigen receptor (CAR) T-cells. These are T-lymphocytes whose genes have been modified so that their usual receptors such as CD4 or CD8 have been replaced with receptors attuned very specifically to antigens (foreign or unusual proteins) displayed by infected cells and cancer cells. A couple of CAR cell therapies are already licensed for cancers; the problem with HIV is that the reservoir cells do not display immune-stimulating antigens on their surfaces. This means that CAR T-cells would have to be used alongside drugs such as PD-1 inhibitors that stop the cells retreating into their quiescent reservoir phase, an approach demonstrated at IAS 2021.

A couple of other approaches could be used to produce either vaccines or cures. One is to engineer B-cells so they produce broadly neutralising antibodies. A way of tweaking them to do this, called germline targeting, is covered was also discussed at IAS 2021, but if we manage to generate B-cells that can do this, we could then in theory directly edit their genes to make them do the same thing.

"Timothy Ray Brown and Adam Castillejo were both given bone marrow transplants from donors whose T-cells lacked the gene for the CCR5 receptor."

The other way is to induce cells to make viral antigens or virus-like particles that the immune system then reacts to. Scientists have been working on this technique for 20 years and it triumphed last year when the Pfizer and Moderna vaccines against the SARS-CoV-2 virus had over 90% success in suppressing symptomatic COVID-19. These vaccines are not genetic engineering in the sense of altering the genome of cells; rather, they introduce a product of the genetic activation in cells, the messenger RNA that is produced when genes are read and which is sent out into the rest of the cell to tell it to make proteins.

However because HIV is more variable and less immunogenic than SARS-CoV-2, the vaccine induced by the RNA would have to be something that looked much more like a whole virus than just the bare spike protein induced by the Pfizer and Moderna vaccines. If there was such a vaccine could be used both therapeutically as well as in prevention, by stimulating an immune reaction to activated HIV-infected cells. Moderna have announced they will now resume the HIV vaccine research they were working on when COVID-19 hit.

The problem with all these more gentle procedures is that it has proved difficult to replace all the HIV-susceptible cells with the HIV-resistant or HIV-sensitised ones: although engraftment takes place, meaning that the autologous cells are not rejected by the body and are able to establish a population for some time (in some animal experiments, replacing as much as 90% of the native immune cells), eventually the unaltered immune cells tend to win out because the introduced cells lack the deep reservoir of replenishing cells.

Kiem said that the way scientists have been trying to get round this is to only select and alter so-called haematopoeic stem cells (HSCs). These rare and long-lived cells, found in the bone marrow, are the replenishing reservoir of the immune system. They differentiate when they reproduce and give rise to all the immune cells that do different things: CD4 and CD8 T-lymphocytes, B-cells that make antibodies, macrophages that engulf pathogens, dendritic cells, monocytes, natural killer cells, and others.

Altering HSCs genetically so that they are able to fight HIV in one way or another could in theory give rise to a persistent, HIV-resistant immune system. They could in theory lie in wait and be ready to produce effector cells of various types. They would be ready when a new HIV infection comes along (if used as a vaccine) or when HIV viral rebound happens and there is detectable virus in the body (if used as part of a cure). If a person with CAR-engineered stem cells could have repeated cycles of treatment interruption, their HIV reservoir could in theory slowly be deleted.

"Gene therapies are astonishingly expensive."

As mentioned above, although genetic medicine shows enormous promise, the complexity and expense of its techniques means that at present it is unlikely to benefit most people who really need it.

Hans-Peter Kiem said that currently about 60 million people have conditions that could benefit from gene therapy. The vast majority of these either have HIV (37 million) or haemoglobinopathies blood-malformation diseases such as sickle-cell anaemia and thalassaemia that are also concentrated in the lower-income world (20 million).

Dr Jennifer Adair, one of the first researchers to have proposed collaboration on gene therapies for HIV with African institutes, said that gene therapies have already been licensed for conditions such as thalassaemia, spinal muscular atrophy, T-cell lymphoma and a form of early-onset blindness.

But they are astonishingly expensive. The worlds most expensive drug tag goes, depending on which source you read, either to Zynteglo, a genetic medicine correcting malformed beta-haemoglobin and licensed in the US for thalassaemia, or Zolgensma, a drug licensed in Europe and given to children to correct the defective gene that results in spinal muscular atrophy.

Both cost about 1.8 million for a single dose. The price is not just due to the cost of the complex engineering used to make them, but because they are used to treat rare diseases and so have a small market.

At present the technology need to engineer autogenic genetically engineered cells is, if anything, even more expensive and complex than that needed to introduce allogenic cells. It can involve in the region of ten staff and a workspace of 50 square metres per patient. Recently a so-called gene therapy in a box has been made available that can reduce the area needed to produce autogenic genetically-engineered cells from 50 to less than one square metre, and the staff need to one or two, But what is really needed is genetic engineering in a shot; a therapy similar to a vector or RNA vaccine that can be introduced as an injection and produces the genetic changes needed within the body.

Undaunted by the challenges, the US National Institutes of Health are collaborating with the Bill and Melinda Gates foundation to work on a combined programme of HIV and sickle-cell-anaemia genetic therapy (given that something that works for one could be adapted to work with the other).

And the Fred Hutchinson Center has teamed up with the Joint Clinical Research Centre in Uganda with the very ambitious goal of making a genetic therapy that would be at least ready for human testing within two years in an African setting, and that could be scaled up to be economical for Africa if successful.

Dr Cissy Kityo of JCRC in Uganda told the conference that as of 2020, there were 373 trials of gene therapy products registered, of which 35 were in phase III efficacy trials. The global budget for regenerative medicine, which includes genetic therapy and related techniques, was $19.9 billion, having jumped by 30% since the previous year. The US Food and Drug Administration projects that based on the current rate of progress and the development pipeline, they may be licensing around 100 gene-therapy products a year by 2025.

This branch of medicine is no longer exotic, she said. Now steps have to be taken to trial gene therapies in the people who needed them most, and to turn the exotic into the affordable, she added.

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Could gene therapies be used to cure more people with HIV? - aidsmap

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DetailsCategory: DNA RNA and CellsPublished on Tuesday, 31 August 2021 18:23Hits: 284

Encouraging data confirming activity in a solid tumor indication presented on first nine patients at low dose cohorts in ongoing autologous CAR-T trial in metastatic castrate-resistant prostate cancer

Three patients showed a greater than 50% decline in prostate-specific antigen (PSA) and concordant PSMA-PET imaging results, including one patient at lowest dose with evidence of complete tumor elimination

Favorable safety profile with modest overall rates of CRS and no neurotoxicity observed

SAN DIEGO, CA, USA I August 31, 2021 I Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced preliminary results from its Phase 1 clinical trial of P-PSMA-101, the Company's solid tumor autologous CAR-T product candidate to treat patients with metastatic castrate-resistant prostate cancer (mCRPC). These data will be presented at the 6th Annual CAR-TCR Summit virtual meeting at 10:00am ET today in a presentation entitled, "P-PSMA-101 is a High-Tscm Autologous CAR-T Targeting PSMA Producing Exceptionally Deep and Durable Responses in Castration-Resistant Metastatic Prostate Cancer."

"We are excited about the preliminary data from our Phase 1 trial of P-PSMA-101, which provides further evidence of the effectiveness of our CAR-T platform for solid tumor cancers," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida, who will present at the CAR-TCR Summit. "To date, other CAR-T therapeutics have not had much success outside of hematologic malignancies. The deep and durable responses in our trial demonstrate that CAR-T products have the potential to work well against solid tumors, even at low doses, when using the appropriate technology platform."

Efficacy:

As of the cutoff date, the study had enrolled a total of nine patients with mCRPC: five patients at Dose A who each received a single treatment of 0.25X10E6 cells/kg (an average of about 20M cells), and four patients at Dose B, who each received a single treatment of 0.75X10E6 cells/kg (an average of about 60M cells). All patients received a lymphodepletion regimen consisting of 30 mg/m2 fludarabine + 300 mg/m2 cyclophosphamide. Patients were heavily pre-treated, having received an average of six prior lines of therapy with a median time since diagnosis of 6.4 years.

Key findings included:

-Five patients dosed showed measurable declines in PSA levels-Three patients treated showed a greater than 50% decline in PSA levels and had concordant improvements in PSMA-PET imaging-One patient demonstrated evidence of complete tumor elimination and remains in a durable response of greater than five months at the time of this presentation

"This innovative Poseida PSMA-directed CAR T cell platform has demonstrated a robust anti-tumor response in patients with metastatic castration resistant prostate cancer," commented Susan F. Slovin, M.D., Ph.D., Associate Vice Chair of Academic Administration at Memorial Sloan Kettering Cancer Center and investigator on the trial. "This is the first time that I have seen such impressive responses with an immunotherapy product. The responses of my patients in the trial are far beyond my expectations."

Safety and Tolerability:

P-PSMA-101 demonstrated a favorable safety and tolerability profile. After a previously reported case of Macrophage Activation Syndrome (MAS) exacerbated by patient non-compliance, only three cases of possible Cytokine Release Syndrome (CRS) were observed, which were all low grade (1/2) and were managed well with early treatment. No cases of neurotoxicity (CRES/ICANS) were observed as of the cutoff date.

The Phase 1 trial is an open label, multi-center, 3+3 dose-escalating study designed to assess the safety of P-PSMA-101 in up to 40 adult subjects with mCRPC. The primary objectives of this study are to determine the safety, efficacy, and maximum tolerated dose of P-PSMA-101. Additional information about the study is available at http://www.clinicaltrials.gov using identifier: NCT04249947.

"We believe the key to success in solid tumors is a product with a high percentage of desirable stem cell memory T cells (Tscm)," said Matthew Spear, M.D., Chief Medical Officer of Poseida. "In this study, we have demonstrated that a high-percentage Tscm CAR-T product can home to the bone marrow and, in at least one case, completely eliminate tumor. This bone marrow homing property may be particularly important for bone avid diseases such as prostate adenocarcinoma. Importantly, the favorable tolerability associated with our Tscm CAR-T products has carried over to prostate cancer where we have so far seen manageable cytokine release syndrome and no neurotoxicity."

Company-Hosted Conference Call and Webcast Information

Poseida's management team will host a conference call and webcast today, August 31, 2021 at 11:00am ET. The dial-in conference call numbers for domestic and international callers are (866) 939-3921 and (678) 302-3550, respectively. The conference ID number for the call is 50220147. Participants may access the live webcast and the accompanying presentation materials on Poseida's website at http://www.poseida.com in the Investors section under Events and Presentations. An archived replay of the webcast will be available for 30 days following the event.

Additional CAR-TCR Summit Highlights

Presentation: "Developing CAR-T Cells for Multiple Myeloma: From Autologous to Allogeneic"Session Date/Time: Wednesday, September 1, 2021, 4:00pm ETPresenter: Matthew Spear, M.D., CMO, Poseida Therapeutics

This presentation will outline Phase 1 and 2 development of the Company's lead autologous P-BCMA-101 CAR-T therapy and insights that were used to develop a fully allogeneic version, P-BCMA-ALLO1 that is expected to enter the clinic soon. The presentation will be part of the afternoon session on the Clinical Management Track.

Presentation: "Advancing Nonviral Manufacturing for Multi-Product Allogeneic T-Cell Therapies"Session Date/Time: Wednesday, September 1, 2021, 4:30pm ETPresenter: Devon Shedlock, Ph.D., SVP Research & Development, Poseida Therapeutics

This presentation will discuss how Poseida's piggyBac DNA Delivery System, Cas-CLOVER Site-specific Gene Editing System and Booster Molecule are used to manufacture multi-product, fully allogeneic T-cell therapies. The Company will also discuss how efficient multiplexed Cas-CLOVER gene editing exhibits low to no off-target editing or translocations as determined by next-generation sequencing, and how the Company's Booster Molecule helps to protect against the "allo tax," maintaining a favorable high-stem cell memory T cell (Tscm) product and enabling up to hundreds of doses in a single manufacturing run. This presentation will be part of the afternoon session on the Manufacturing Track.

Presentation: "Developing 'Off-the-Shelf' CAR-T Cells for Bone Marrow Transplant Conditioning"Session Date/Time: Thursday, September 2, 2021, 9:00am ETPresenter: Nina Timberlake, Ph.D., Associate Director, Research (Gene Therapy), Poseida Therapeutics

This presentation will discuss leveraging the piggyBac DNA Delivery System and Cas-CLOVER Site-specific Gene Editing System to generate off-the-shelf fully allogeneic CAR-T cells to specifically target hematopoietic cells in the bone marrow. This potential therapeutic could be used as a non-myeloablative conditioning regimen for hematopoietic stem cell transplant or as a therapeutic for the treatment of acute myeloid leukemia (AML). The presentation will occur as part of the conference's Focus Day, "CAR-TCR Beyond Oncology: Fundamental Biology & Mechanisms of Action Beyond Oncology."

The full presentations at the CAR-TCR Summit will be made available on Poseida's website at their respective session times.

About Poseida Therapeutics, Inc.

Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary genetic engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac DNA Delivery System, Cas-CLOVER Site-specific Gene Editing System and nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our wholly-owned portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics. To learn more, visit http://www.poseida.com to connect with us on Twitter and LinkedIn.

SOURCE: Poseida Therapeutics

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Poseida Therapeutics Presents Preliminary Results from Phase 1 Trial of P-PSMA-101 at the 6th Annual CAR-TCR Summit | DNA RNA and Cells | News...

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A WOMAN blamed stress for her three-month long period until doctors found out the true cause was devastating.

Bansri Dhokia, 30, from Ealing, West London, is now urging others to see their GP as soon as they are unwell.

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She thought at worst, her odd periods, fatigue and breathlessness would be down to anaemia or low thyroid function that could be treated with medication.

But the truth was far worse, and Bansri was diagnosed with a blood cancer.

Bansri was taken into hospital that night where she stayed for 12 weeks having intense treatment to save her life.

Speaking of her symptoms, which started in May 2020, Bansri said: I blamed it on being overworked.

With blood cancer, the symptoms are often quite vague and hard to diagnose.

I really noticed the fatigue first. I could sleep for 12 hours a night and still feel exhausted.

Then I started to get breathless all the time. There were activities like climbing stairs or walking down the road that I used to find easy but was suddenly finding more difficult.

Bansris heavy period, which had been ongoing for three months, was particularly unusual for her.

She made repeated trips to the doctor to find out what was wrong but kept being pushed back.

I just knew something wasn't right and repeatedly asked for blood tests, Banrsri said.

The first four blood tests between May and July came back clear and by the time she had a fifth on 21 July, she was starting to get fed up.

Busy with work, Bansri almost missed the appointment but luckily, her husband Amrit Sagoo encouraged her to go.

She said: I went for the blood test in the afternoon and that evening, I was brushing my teeth when I got a call to say the ambulance was coming to collect me.

They explained I needed to go to hospital right away. I thought it was just for a night and packed an overnight bag.

"I didnt know what was wrong and that I would end up staying in hospital for 12 weeks.

Tests at the Royal London hospital revealed Bansri had acute lymphoblastic leukaemia (ALL), a rare cancer affecting just 790 people in the UK each year, mostly children and young people.

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A problem in the bone marrow leads to insufficient important blood cells, causing symptoms of unusual bleeding, tiredness and muscle aches.

Almost seven in 10 will survive ALL for five years or longer after diagnosis, and four in ten in those aged 25 to 64.

Bansri said: I didn't know much about leukaemia. I was really scared for my life. I had no idea what the prognosis was. I just cried and I kept questioning why this was happening to me."

With lockdown restrictions still in place, Bansri had to tell her friends and family about her diagnosis over Zoom.

She said: It was the hardest thing I have ever had to do. I asked my sister to gather my family in the living room. We are very close and I could not look at her because I just couldn't deal with seeing the sadness in her face."

Bansri started chemotherapy straight away, because ALL is very aggressive and develops quickly.

She said: "It was so upsetting seeing pieces of my hair fall out on my pillow. I was growing it as we were planning to have Hindu and Sikh religious wedding ceremonies in 2020, after our civil wedding the year before.

"One day I just asked the nurse to shave my head, and in that moment, I felt really empowered."

But one of the hardest parts of the treatment - which she now needs therapy to recover from - is that she couldnt have visitors for the first eight weeks due to Covid.

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Bansri then needed a stem cell transplant to improve the chances that she would go into remission.

During the procedure, the patient has stem cells of a donor, sometimes a complete stranger, injected into their blood. The cells find their way to the bone marrow, helping it to start making normal cells again.

Most people who are white Europeans find a match from a related or unrelated donor on a large registry, but 400 UK patients don't find a suitable donor each year.

Bansri said: I knew immediately that being from an Indian background, there was a very low chance that I would find a match.

According to charities, donors are more likely to be white, and people from minority ethnic backgrounds are more likely to have rarer tissue types, making it harder to find patients from these backgrounds a matching donor.

That was quite scary because I knew how important it was to have a donor to save my life, Bansri said.

Luckily one of Bansris two siblings was a match, and the transplant took place in February 2021.

Bansri said: My recovery is going well so far but a stem cell transplant comes with many side effects, which are lifelong.

I have a long road to go but I take it day by day. Each month I get through is a success."

Bansri is vulnerable to infections because the transplant made her immune system weaker, and so she and her husband are still having to shield.

Bansri is urging people to join the stem cell donor register, particularly those in Asian communities.

HOW YOU CAN HELP SAVE A LIFE

REGISTERING to be a blood stem cell donor is easy.

Even if you can't donate to your relative, you might be ableto become a donor for someone else. You can do this by contacting one of the UK registers.

There are different donor registersin the UK.These work with each otherand with international registersto match donors with people who need stem cells.

You can sign up with:

8

8

She said: People often have a misconception that, when you join the donor registry, you're giving something up, for example, in a kidney transplant, you do give up your kidney, and it's a longer recovery time.

My sibling was in hospital for a few hours on the day and didn't have any side effects afterwards.

In my community, cancer is a bit of a taboo subject and people dont speak about it so I think there is a lack of awareness of the importance of signing up to be on the register.

Bansri is also taking part in the Leukaemia Cares Spot Leukaemia campaign, which urges the general public to understand and recognise the signs.

She said: I want to see more Asian people talking about it because its not the fault of the person - its just bad luck.

If youre experiencing any of the symptoms, contact your GP and ask for a blood test. Early diagnosis saves lives.

Symptoms of acute lymphoblastic leukaemia

The NHS says most of the symptoms of ALL are caused by a lack of healthy blood cells. They include:

In some cases, the affected cells can spread from your bloodstream into your central nervous system. This can cause neurological symptoms (related to the brain and nervous system), including:

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I blamed stress for my three-month period but it turned out to be much more sinister... - The Sun

Bone Marrow Stem Cells Comments Off on I blamed stress for my three-month period but it turned out to be much more sinister… – The Sun | September 1st, 2021

REGULATED INFORMATION

No statistically significant difference in knee pain reduction between JTA-004, placebo and active comparator, 3months after treatment; favorable JTA-004 safety profile similar to placebo and comparator

Prime focus on the continued development and expansion of its mesenchymal stromal cell based allogeneic cell and gene therapy platform

Management to host conference call today at 4pm CEST / 10am EST - details provided below

Gosselies, Belgium, 30August 2021, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces that the Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004 did not meet the primary and consequently the key secondary endpoints.

The primary objective of the JTA-004 Phase III study was to demonstrate the efficacy of JTA-004 in reducing osteoarthritic knee pain compared to placebo as measured by the WOMAC pain subscale three months after treatment. A key secondary objective was the comparison between JTA-004 and comparator Hylan G-F 20 in knee pain relief at month 3. Despite JTA-004s favorable safety profile, the study did not achieve its main objectives as no statistically significant difference in pain reduction could be observed between any of the treatment, placebo and comparator groups, with all treatment arms showing similar efficacy.

A statistically significant difference in favor of JTA-004 and the active comparator versus placebo was seen in a post-hoc analysis in a subset of patients with higher pain scores at entry.

The Company, in collaboration with existing and potential partners, will consider the options for the future of JTA-004 development.

The execution of the study was flawless and a good safety profile was observed in line with previous results. These JTA-004 efficacy results are disappointing. Knee osteoarthritis studies are recognized across the industry to be challenging to evaluate. They are also frequently complicated by a high placebo effect. We will continue to analyze the data and will consider potential next steps, said Miguel Forte, Chief Executive Officer of Bone Therapeutics. We are now fully committed to the clinical development of our advanced MSC allogeneic cell and gene therapy platform. Bone Therapeutics is concentrating on the development of this platform for the large market of orthopedic indications, with ALLOB. The progress with this platform has enabled us to expand it to other indications, including immunomodulation.

Bone Therapeutics is focused on the development of its core assets, the allogeneic cell therapy platform, including ALLOB. ALLOB is currently being evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in 178patients with fresh tibial fractures at risk of delayed or non-union. 5% to 10% of complicated long bone fractures evolve to delayed union and non-union. This study will assess the potential for a single percutaneous injection of ALLOB to accelerate fracture healing and prevent late-stage complications in these patients. Recruitment is expected to be completed in the first half of 2022 and topline results by the end of 2022. Should the pandemic continue, Bone Therapeutics may have to re-evaluate these timelines and, in that eventuality, will communicate again to the market.

Bone Therapeutics is intensifying its efforts to expand its preclinical and clinical pipeline with additional indications by enhancing and professionalizing the therapeutic capacity of its cell and gene therapy platform. This includes the development of a next generation of genetically engineered mesenchymal stromal cells (MSC) and the use of highly scalable and versatile cell sources such as induced pluripotent stem cells (iPSC).

Conference call

The management of Bone Therapeutics will host a conference call today at 4:00 pm CEST / 10:00 am EST. To participate in the conference call, please select your dial-in number from the list below quoting the conference ID 825 1002 3115#:

Belgium: +32 2 290 9360France: +33 1 7095 0103United Kingdom: +44 208 080 6592United States: +1 646 876 9923

About JTA-004 and Phase III knee osteoarthritis study

JTA-004 is Bone Therapeutics next generation of intra-articular injectable for the treatment of osteoarthritic pain in the knee. It consists of a unique mix of hyaluronic acid - a natural component of knee synovial fluid, plasma proteins, and a fast-acting analgesic. JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain.

The JTA-004 Phase III study is a controlled, randomized, double-blind trial. It evaluates the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee, compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study is being conducted in 22 centers across six European countries as well as Hong Kong. More than 700 patients with mild to moderate symptomatic knee osteoarthritis were treated in this study.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250 million cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA leads to highly invasive surgical interventions such as total knee replacement.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a diversified portfolio of cell therapies at different stages ranging from pre-clinical programs in immunomodulation to mid stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell and gene therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics announces topline results from Phase III knee osteoarthritis study with its enhanced viscosupplement JTA - GlobeNewswire

Bone Marrow Stem Cells Comments Off on Bone Therapeutics announces topline results from Phase III knee osteoarthritis study with its enhanced viscosupplement JTA – GlobeNewswire | September 1st, 2021

NEW YORK, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational highlights and financial results for the fourth quarter and full-year ended June 30, 2021 (FY2021).

During this calendar year we made significant progress in both regulatory and clinical outcomes for our lead product candidate, remestemcel-L, after experiencing a disappointing set-back last year said Silviu Itescu, Chief Executive of Mesoblast. We are pleased with recent recommendations by FDAs CBER to meet with the review team and address remaining CMC items for remestemcel-L in the treatment of steroid-refractory acute graft versus host disease in children. Additionally, our most recent meeting with the FDA has provided clarity on the pathway towards an emergency use authorization for remestemcel-L in the treatment of COVID ARDS.

Operational Highlights

Remestemcel-L Outcome of recent meeting with FDA on regulatory pathway for emergency use authorization in the treatment of COVID-19 ARDS:

Remestemcel-L in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children:

Rexlemestrocel-L in the treatment of chronic heart failure and chronic low back pain:

Manufacturing

Financial Highlights

DETAILED CLINICAL ACTIVITIES FOR THE FISCAL YEAR FY2021

Remestemcel-L

Acute Respiratory Distress Syndrome due to COVID-19

Mesoblast recently presented results from the randomized controlled trial of remestemcel-L in 222 ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) at the biennial Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases conference hosted by the University of Vermont, Burlington, VT, and at the International Society for Cell & Gene Therapy (ISCT) Scientific Signatures Series event on Cell and Gene-Based Therapies in Lung Diseases and Critical Illnesses.

The presented data included improved respiratory function in patients treated with remestemcel-L, as well as 90-day survival outcomes showing remestemcel-L significantly reduced mortality by 48% at 90 days compared to controls in a pre-specified exploratory analysis of 123 treated patients under 65 years old. The trial had been halted after the third interim analysis since the 30-day primary endpoint would not be attained.

Key presentation findings were:

Mesoblast plans to move forward with an additional Phase 3 trial in COVID-19 ARDS with the next step being to agree with the FDA the final protocol and potency assay.

Inflammatory Bowel Disease Crohns Disease and Ulcerative Colitis

A randomized, controlled study of remestemcel-L delivered by an endoscope directly to areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohns disease and ulcerative colitis commenced at Cleveland Clinic in October 2020. The investigator-initiated study is the first in humans using local cell delivery in the gut and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients with biologic-refractory Crohns disease where remestemcel-L was administered intravenously.

Rexlemestrocel-L

Chronic Heart Failure

The results from the landmark DREAM-HF randomized controlled trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L (REVASCOR) or control sham, demonstrated that a single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes, and cardiac deaths. The trials primary endpoint of reduction in volume overload related hospitalizations was not achieved. The results of this trial identify New York Heart Association (NYHA) class II HFrEF patients as the optimal target population for greatest rexlemestrocel-L treatment effect, and therefore a focus for developing rexlemestrocel-L in the largest market in heart failure.

The incidence of heart attacks and strokes were reduced by 60% over a median follow-up period of 30 months following a single dose of rexlemestrocel-L in the entire population of 537 treated patients. The incidence of death from cardiovascular causes was reduced by 60% in the 206 patients with NYHA class II disease, a significant reduction which was evident in both ischemic and non-ischemic subgroups as well as diabetic and nondiabetic patients.

The results also show that the NYHA class II patients in the control group, following an initial period of approximately 20 months of disease stability, progressed to cardiac death rates in-line with NYHA class III patients. NYHA class II patients treated with a single dose of rexlemestrocel-L did not show such cardiac death progression.

The combination of the three pre-specified outcomes of cardiac death, heart attack or stroke into a single composite outcome - called the three-point major adverse cardiovascular events (MACE) is a well-established endpoint used by the FDA to determine cardiovascular risk. Rexlemestrocel-L reduced this three-point MACE by 30% compared to controls across the entire population of 537 treated patients. In the NYHA class II subgroup of 206 patients, rexlemestrocel-L reduced the three-point MACE by 55% compared to controls.

Mesoblast expects feedback from the FDA in the next quarter on the potential pathway to US regulatory approval for rexlemestrocel-L in patients with chronic heart failure.

Chronic Low Back Pain due to Degenerative Disc Disease

The results from the randomized controlled trial of its allogeneic mesenchymal precursor cell (MPC) therapy rexlemestrocel-L in 404 enrolled patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional treatments indicate that a single injection of rexlemestrocel-L+hyaluronic acid (HA) carrier may provide a safe, durable, and effective opioid-sparing therapy for patients with chronic inflammatory back pain due to degenerative disc disease, and that greatest benefits are seen when administered earlier in the disease process before irreversible fibrosis of the intervertebral disc has occurred. The trial's composite outcomes of pain reduction together with functional responses to treatment were not met by either MPC group.

The rexlemestrocel-L+HA treatment group achieved substantial and durable reductions in CLBP compared to control through 24 months across the entire evaluable study population (n=391) compared with saline controls. Greatest pain reduction was observed in the pre-specified population with CLBP of shorter duration than the study median of 68 months (n=194) and subjects using opioids at baseline (n=168) with the rexlemestrocel-L+HA group having substantially greater reduction at all time points (1, 3, 6, 12, 18 and 24 months) compared with saline controls. There was no appreciable difference in the safety of MPC groups compared to saline control over the 24-month period of follow-up in the entire study population. In subjects using opioids at baseline, the MPC+HA demonstrated a reduction in the average opioid dose over 24 months, while saline control subjects had essentially no change.

There is a significant need for a safe, efficacious, and durable opioid-sparing treatment in patients with chronic low back pain due to severely inflamed degenerative disc disease. Mesoblast has filed a request and expects to receive feedback from the FDA on the pathway to US regulatory approval in patients with chronic low back pain due to degenerative disc disease.

Intellectual Property

Mesoblast has an extensive patent portfolio with over 1,000 patents and patent applications across 77 patent families, and patent terms extending through 2041. These patents cover composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells, and provide strong commercial protection for our products in all major markets, including the United States, Europe, Japan and China. During the fiscal year Mesoblast has significantly expanded its patent portfolio, focusing on areas of its strategic commercial interests.

Licensing agreements with JCR, Grnenthal, Tasly and Takeda highlight the strength of Mesoblast's extensive intellectual property portfolio covering mesenchymal lineage cells. Mesoblast will continue to use its patents to prosecute its commercial rights as they relate to its core strategic product portfolio. When consistent with the Companys strategic objectives, it may consider providing third parties with commercial access to its patent portfolio.

DETAILED FINANCIAL RESULTS

Financial Results for the Year Ended June 30, 2021 (FY2021)

In August we entered into a contractual amendment to extend the interest-only period of its current senior debt facility to at least January 2022 and as a result no loan repayments will be required prior to January 2022. Mesoblast is in active discussions to refinance the facility.

We expect to recognize the existing US$21.9 million of remestemcel-L pre-launch inventory on the balance sheet if we receive FDA approval.

As a result of the above and other remeasurements on revaluation of assets and liabilities, the loss after tax for FY2021 was US$98.8 million compared to US$77.9 million for FY2020. The net loss attributable to ordinary shareholders was 16.33 US cents per share for FY2021, compared with 14.74 US cents per share for FY2020.

Conference Call

There will be a webcast today, beginning at 7.00pm EDT (Monday, August 30, 2021); 9.00am AEST (Tuesday, August 31). It can be accessed via:https://webcast.boardroom.media/mesoblast-limited/20210826/NaN61036c41df5665001c97fc67

The archived webcast will be available on the Investor page of the Companys website: http://www.mesoblast.com

About Mesoblast

Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

Forward-Looking Statements

This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:

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Operational Highlights and Financial Results for the Year Ended June 30, 2021 - GlobeNewswire

Cardiac Stem Cells Comments Off on Operational Highlights and Financial Results for the Year Ended June 30, 2021 – GlobeNewswire | September 1st, 2021

Hematopoietic somatic cell Transplantation (HSCT) may be a specialized sort of blood somatic cell transplant therapy. The term hematopoietic refers to the function of the stem cells in citizenry . Stem cell refers to specialized somatic cell types which are capable of developing into specific cells like bone, muscle, blood, and nerve cells.

The PDF for the study can be requested using the following link: https://www.coherentmarketinsights.com/insight/request-pdf/1250

Hematopoietic somatic cell transplantation are often utilized in the treatment of certain cancers of the blood or bone marrow, like myeloma or leukemia. High prevalence of such diseases is predicted to assist in growth of the hematopoietic somatic cell transplantation (HSCT) market. consistent with Leukemia and Lymphoma Society, 176,200 people within the US are expected to be diagnosed with leukemia, lymphoma or myeloma in 2019.

The hematopoietic somatic cell transplantation (HSCT) market in North America is witnessing high growth, due to high adoption of allogeneic hematopoietic somatic cell transplant. Around 30,000 patients undergo allogeneic hematopoietic somatic cell transplant annually within the us .

Hematopoietic cell transplantation is that the transplantation of stem cells, generally derived from bone marrow, duct , or peripheral blood. It also can be allogenic, autologous or syngeneic. the foremost common sort of somatic cell transplant is that the allogenic transplant, which is actually the method of harvesting such stem cells that have the power to become many various specialized cell types, like bone, kidney, heart, liver, lungs, pancreas, nervous, and immune cells. However, approximately 20% to 85% of the patients develop acute Graft Versus Host Disease that affects the skin, gut, or liver. Such scenario hinders the expansion of hematopoietic somatic cell transplantation (HSCT) market.

There are different methods of transplant. just in case of a basic transplant, the stem cells are directly transplanted into an individuals veins, while a minimal invasive procedure also referred to as a micro-implantation requires the injection of the cells into the patients veins. supported the precise needs of the patient, the precise sort of transplant is completed . for instance , a toddler who has undergone bone marrow transplantation can continue to possess other somatic cell types utilized for an equivalent purpose. this is often one among the foremost commonly performed sorts of transplants.

High prevalence of red blood cell anemia is additionally expected to assist in growth of the hematopoietic somatic cell transplantation (HSCT) market. Specially created somatic cell therapies are often utilized in the treatment of red blood cell anemia. These cells are basically taken from the bone marrow of the person then induced to make a thick, jelly like substance. The patient will got to take medicine for a couple of days after the procedure to assist his bodily process the cells.

Hematopoietic cell transplantation has its own set of complications, which limit the expansion of the hematopoietic somatic cell transplantation (HSCT) market. a number of these include infection, allergies , bleeding, and scarring. Infection can occur if theres a severe immune deficiency. The patient also will need to take antibiotics to clear up the infections. If the stem cells are used, they need to be grown under very strict conditions to avoid rejection. Most surgeons attempt to perform this transplant first on those people that suffer from serious diseases like leukemia or cancer as these are the people that stand the simplest chance to achieve success .

Competitive Landscape

Key players operating in the Hematopoietic Stem Cell Transplantation (HSCT) Market are Pluristem Therapeutics Inc., CellGenix GmbH, Regen Biopharma Inc., Lonza Group, Kiadis Pharma, Taiga Biotechnologies, Inc., Takeda Pharmaceutical Company Limited, Escape Therapeutics, Inc., Bluebird Bio, Talaris Therapeutics, Inc., Marker Therapeutics Inc., and Stempeutics Research Pvt Ltd.

We also offer 15% FREE Report customization.Get This premium report with Instant US$ 2000 discount @ https://www.coherentmarketinsights.com/promo/buynow/1250

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Hematopoietic Stem Cell Transplantation (HSCT) Market by Sales, Revenue, Price and Gross Margin (2021-2027) UNLV The Rebel Yell - UNLV The Rebel Yell

Skin Stem Cells Comments Off on Hematopoietic Stem Cell Transplantation (HSCT) Market by Sales, Revenue, Price and Gross Margin (2021-2027) UNLV The Rebel Yell – UNLV The Rebel Yell | September 1st, 2021

GOLDEN, CO / ACCESSWIRE / August 31, 2021 / Vitro Biopharma, Inc. (Vitro) announced the acquisition of Fitore Nutrition (Fitore) and Infinivive MD (Infinivive). Fitore, a private company headquartered in Denver, Colorado creates clinically validated supplements and sells them direct to consumers (D2C) via their unique digital marketing platform and SEO expertise.

Infinivive, located in Cherry Creek, Colorado developed the worlds first topical cosmetic stem cell serum and is a nationally recognized company led by one of the top industry pioneers in the area of cosmetic surgery, Dr. Jack Zamora M.D.

These two acquisitions will drive significant new revenues to Vitro, funding its therapeutic pipeline and expanding Vitros overall stem cell regenerative capabilities. Vitro acquired Fitore Nutrition for $2,300,000 in a combination of notes and stock and Infinivive MD for $5,750,000 in an all-stock deal.

The acquisition of Fitore & Infinivive gives us the opportunity to leverage the revenues of both companies, increase market awareness for Vitro, and cross sell the regenerative therapies of AlloRx Stem Cells said Jack Zamora C.E.O. of Vitro Biopharma.

Vitros acquisition of Fitore and Infinivive brands makes strategic sense for Vitro as it helps to (1) leverage synergies across therapeutic outcomes and bio-supplements, (2) is consistent with managements M&A growth strategy of high growth and high margin acquisitions with a focus on ecommerce capabilities, (3) provides Vitro with a significant online presence thereby expanding Vitros branding footprint.

The integration of Fitores direct to consumer (D2C) technology platform will accelerate Vitros product penetration and brand recognition into the marketplace for all its products. To date we have had an incredibly successful partnership with Vitro with the joint development of Stemulife formerly known as STEMulize, and Spectrum +. Partnering with Vitro Biopharma only accelerates our mission as we continue to develop more life-changing products based on Vitros scientific capabilities and the expanding market demands for natural health products. said Tanner Haas C.E.O. of Fitore Inc.

Fitore and Infinivive will allow Vitro deeper access into the direct-to-consumer market channels and complement Vitros existing revenue drivers. The consolidated results of all operations are expected to drive $3-$5M in revenue over the next 12 to 18 months, a 300% plus increase in our pre-pandemic revenues. said John Evans C.F.O. and Chairman of the Board of Vitro Biopharma.

ABOUT VITRO BIOPHARMA

Vitro Biopharma is a clinical-stage biotechnology company focused on developing novel and proprietary best-in-class natural regenerative products. Vitro develops and commercializes adult stem cell technology for applications in stem cell research and drug development for the treatment of a vast variety of diseases and conditions. The companys innovative and proprietary technology platform manufactures umbilical cord derived stem cells, AlloRx Stem Cells, used in regenerative clinics to treat a variety of disease indications.

https://www.dvcstem.com/

The companies partnered clinics continue to expand and these wellness clinics utilize our cosmetic and nutraceutical products in conjunction with their regenerative therapies. A patient enjoys a beautiful foreign destination experiencing a regenerative treatment with AlloRx Stem Cells along with a spa backdrop featuring a topical cosmetic facial and supporting long term nutraceutical stem cell activator.

The offshore revenues support our clinical work in the US market. Authorization of our recent IND for COVID-19 now positions the company to move forward with Phase I and Phase II clinical trials for disease indications that have shown safety and efficacy in our offshore trials.https://www.vitrobiopharma.com/pages/pipeline

ABOUT FITORE NUTRITION

Fitore Nutrition is a direct to consumer (D2C) and SEO technology platform that creates clinically validated supplements that are formulated by world-leading doctors and stem cell scientists from Vitro Biopharma. Each Fitore nutrition ingredient is all-natural, sustainably-sourced, and of the highest-quality, manufactured in a GMP and FDA Registered facility in Commak New York. In 2021, Fitore sells its products direct to consumers through its unique digital marketing platform. Fitore Nutritions novel formulations include: Stemulife, Thought Calmer, Easy Sleep, and Spectrum +.

ABOUT INFINIVIVE MD

InfiniVive MD has created the highest quality cGMP-grade cosmetic stem cell and exosomes product line. InfiniVive MD cosmetic stem cell products contain ultra-pure mesenchymal stem cells and exosomes to be used topically by plastic surgeons, cosmetic surgeons, and aestheticians throughout the United States and internationally. Infinivive is looking to disrupt the cosmetic industry through next level skin quality results.

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Companys auditors. Certain statements contained herein, and subsequent statements made by and on behalf of the Company, whether oral or written may contain forward-looking statements. Such forward-looking statements are identified by words such as intends, anticipates, believes, expects and hopes and include, without limitation, statements regarding the Companys plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues, and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Companys products in the marketplace, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Companys filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. Jack Zamora, MDChief Executive Officer Vitro Biopharma, Inc.(303) 999-2130 x1www.vitrobiopharma

SOURCE: Vitro Biopharma, Inc.

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Vitro Biopharma Acquires Fitore Nutrition and Infinivive MD, Adding Revenues from Innovative Stem Cell Activation Products and Topical Cosmetic Stem...

Skin Stem Cells Comments Off on Vitro Biopharma Acquires Fitore Nutrition and Infinivive MD, Adding Revenues from Innovative Stem Cell Activation Products and Topical Cosmetic Stem… | September 1st, 2021

Senescent immune system cells are potentially among the most harmful of all senescent cells because they spread tissue damage and rapid aging across other body organs and systems. That is what a team of NIA-supported scientists at the University of Minnesota Medical School discovered through research using a mouse model that accelerated immune system aging by hindering DNA repair. The team recently published these findings in Nature.

Cellular senescence is defined as a condition in which a cell no longer has the ability to proliferate. These damaged cells resist the bodys usual system of disposal and then linger, excreting chemicals that spread inflammation and damage to neighboring normal cells.

For this study, the team made a cell-specific knockout of the gene Ercc1, which controls a protein crucial for DNA repair. Ercc1 was removed in blood-based young stem cells that normally develop into white blood cells cells important for immunity but the gene was expressed normally in all other tissues. This enabled the research team to understand whether senescence in the immune system affects other cells in the body. The engineered mice seemed healthy up until their adulthood (around three months) but then aged rapidly. At age five months, they biologically resembled 2-year-old mice, which is approximately equivalent to an 80-year-old human.

The prematurely older mice had a host of age-related conditions such as osteoporosis; visual and hearing impairment; and high blood pressure, even though the change was limited to cells of the immune system. The senescent immune system cells also spread age-related damage to other organs and tissues in the body, including the liver, lungs, and kidneys. Without the Ercc1 gene, the mice had lost much of their ability to repair DNA in these immune cells and thus experienced a build-up of inflammation and damage in other tissues.

The scientists saw this rapid aging and spread of damage throughout the body as evidence that senescent immune system cells are potentially among the most dangerous of all senescent cell types in the aging body. Because immune cells circulate throughout the body, when they become senescent, they can easily expose a wider range of organs and tissues to inflammation and other damaging factors, unlike more stationary senescent cells such as those in the skin.

The team also studied and confirmed some mechanisms that contribute to senescence in the immune system. First, they showed that senescent immune cells trigger and drive senescence elsewhere in the body by observing senescence triggered across systems in young mice after transplanting spleen cells from old mice into them. Next, they observed that when immune cells from young healthy mice were transplanted into older mice, senescence was reduced, providing further evidence that old immune cells lose function. The scientists also used the drug rapamycin, which tamps down the inflammatory secretions from senescent cells, to show that reducing senescence improved immune function.

While the field of senescence is still very far from any reliable application for humans, the investigators aim to pursue follow-up efforts to pinpoint a precise type of senolytic a drug that selectively clears senescent cells from the body to target reducing immune system senescence as a potential future intervention to aid healthy aging. They hope to conduct additional studies in this realm to find new immune system biomarkers to help gauge which people are at the highest risk for senescence-related tissue damage and faster aging, and thus would be candidates to benefit from senolytic therapies.

This work was supported by NIH grants P01 AG043376, RO1 AG063543, R56 AG059676, U19 AG056278, P01 AG062413, R56 AG058543 and R01 AG044376.

Reference: Yousefzadeh, Matthew J et al. An aged immune system drives senescence and ageing of solid organs. Nature vol. 594,7861 (2021): 100-105. doi:10.1038/s41586-021-03547-7

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Senescent immune cells spread damage throughout the aging body - National Institute on Aging

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Prolymphocytic leukemia (PLL) is a very rare subtype of chronic leukemia. Although most forms of chronic leukemia progress slowly, PPL is often aggressive and can be difficult to treat.

Well walk you through what you need to know about PLL, including the symptoms, how its diagnosed, current treatment options, and more.

PLL is a rare and aggressive type of chronic leukemia.

The American Cancer Society estimates that more than 60,000 people will receive a diagnosis of leukemia in the United States in 2021.

Less than 1 percent of all people with chronic leukemia have PLL. Its most often diagnosed in people between ages 65 and 70 and is slightly more common in men than in women.

Like all types of leukemia, PLL affects blood cells. PLL is caused by the overgrowth of cells called lymphocytes. These cells usually help your body fight infection. In PLL, large immature lymphocyte cells called prolymphocytes are produced too quickly and overwhelm the other blood cells.

There are two subtypes of PLL:

PLL, like other chronic leukemias, is often found on lab work before any symptoms develop. When symptoms develop, they might include:

There are a few additional symptoms that are specific to T-PLL, which include:

Many of these are general leukemia symptoms and are also found in less serious conditions. The presence of any of these symptoms doesnt always indicate PLL.

In fact, since PLL is rare, its unlikely that its causing your symptoms.

However, its a good idea to see a healthcare professional if youve been experiencing any of these symptoms for more than a week or two.

Because PLL is very rare, it can be hard to diagnose. PLL sometimes develops from existing chronic lymphocytic leukemia (CLL) and is found during lab work when monitoring CLL.

PLL is diagnosed when more than 55 percent of the lymphocytes in your blood sample are prolymphocytes. Blood work can also be checked for antibodies and antigens that can signal PLL.

If PLL isnt found during routine blood work, a healthcare professional will order more tests if you have symptoms that might indicate PLL. These tests may include:

Currently, theres no one specific treatment for either type of PLL. Your treatment will depend on how fast your PLL progresses, the type you have, your age, and your symptoms.

Since PLL is rare, your doctor will likely come up with a treatment plan specific to your case. Healthcare professionals may often encourage people with PLL to sign up for clinical trials to try new medications.

Treatments you might receive for PLL include:

PLL is an aggressive form of chronic leukemia. Therefore, the outlook is generally poor due to how quickly it may spread. But outcomes and survival rates can vary greatly between people.

As mentioned earlier, one potential cure for PLL is a stem cell transplant, although not all people with PLL are eligible to receive stem cell transplants.

Newer treatments have improved survival rates in recent years, and research into new therapies is ongoing.

PLL is a rare type of chronic leukemia. Its most commonly diagnosed in people between 65 and 70 years old. It often progresses more quickly and is treatment-resistant than other forms of chronic leukemia.

Treatment options depend on your overall health, age, symptoms, and the type of PLL you have. People are often encouraged to take part in clinical trials to take advantage of new therapies.

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Prolymphocytic Leukemia: What Is It and How Is It Treated? - Healthline

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A patient recently came in to our dermatology clinic with a rash and a story similar to so many others. He had been out camping with friends a few days earlier and helped carry some logs to stoke the fire. Little did he know he was going to pay for lending a helping hand. A couple days later, red patches appeared on his forearms and chest, which soon began to itch miserably and form water blisters.

If you have ever spent any time outdoors in the woods, working in the yard, even at the edges of a playground maybe youve experienced something similar after encountering poison ivy. Its not easy to forget.

Poison ivy is found everywhere in the continental U.S., mostly in Eastern and Midwestern states. Unfortunately for us humans, it is a hardy plant that can grow under many different conditions. Its favorite places are in wooded areas, gardens and roadsides with partial shade or full sunlight.

And despite being a nuisance to people, poison ivy is an important member of the ecosystem. Its leaves, stems and berries are food for animals, and its vines can be shelter for small animals like toads and mice, even helping them climb trees. Climate change is turning out to benefit poison ivy, allowing for larger and more irritating plants.

You can usually spot poison ivy by its infamous three dull or glossy green leaves coming off a red stem. Sometimes there are flowers or fruits coming off the end of a branch.

Despite its name, poison ivy is not poisonous. It carries an oily sap on its leaves and stems called urushiol, which is irritating to most peoples skin. In fact, 85% to 90% of people are allergic to poison ivys urushiol to some degree, while the rest lack sensitivity to this oil. You can occasionally see the urushiol oil as black spots on poison ivy leaves. Urushiol is what gives poison oak and poison sumac their evil power, too.

Touching poison ivy directly is obviously a bad idea. You can even get into trouble by touching clothing, pets or anything else that has brushed against the plant and picked up some of the urushiol. If a contaminated object isnt cleaned, the urushiol will remain lying in wait it can still cause a rash after hours, days or even years. Another danger is smoke from burning poison ivy, which can also affect your skin, as well as your nose, mouth, windpipe and lungs if you breathe it in.

Poison ivys rash can come in many forms, from small, red bumps to blisters or red patches. Whichever way it shows up, it is almost always mindbogglingly itchy.

When you get poisoned, you wont know right away. It can take anywhere from four hours to 10 days for the rash to appear, depending on how much urushiol gets on your skin, how sensitive you are to it and how many times you have been exposed to poison ivy previously.

Between exposure and itchy anguish, your body goes through a complex identification and reaction process. When the oil gets into your skin, your immune systems sensor cells recognize urushiol as foreign to your body. These sensor cells then call in protector cells to the area, warning them of the invasion. The protector cells defend your body against the intruder by attacking the urushiol in the skin. Unfortunately, some of your bodys normal skin cells are casualties of this war, which is what leads to the itchiness and swelling of a poison ivy rash.

Your protector cells will then sit near the skin for many years and stand guard for urushiol if it ever shows up again. If it does, they remember having encountered this bad guy before, and their response is often faster and more powerful than the first time.

This rash is a type of allergic contact dermatitis in the same family as the rashes some people get from wearing jewelry or metal belt buckles or from using certain fragrances or cosmetics.

The saying leaves of three; leave them be highlights the best strategy to prevent poison ivy: avoidance. But if you do happen to come into contact with poison ivy, the first step should always be to remove and wash any clothing that has touched the plant. Gently but thoroughly wash your skin immediately with soap and water. It can also help to clean under your fingernails and cut your nails short to prevent the urushiol from spreading if you scratch your skin.

Allergic contact dermatitis from poison ivy almost always results in a rash that usually lasts two to three weeks before it completely goes away.

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It will eventually clear up on its own, but you can try some over-the-counter and home remedies to keep the itchiness and spread of the rash at bay. The blisters that form are not infected and do not normally require antibiotics. If you scratch though and it can be very hard to resist open skin can get infected.

To reduce itchiness, cool, wet compresses can help, as can a soak in a cool bath with baking soda or oatmeal bath products. Calamine lotions or creams containing menthol can also cut the itch a bit. Over-the-counter cortisone cream or ointment can be used for the first several days after contact with poison ivy to quiet down your bodys reaction and keep the rash from getting severe. Taking antihistamines like diphenhydramine at night can slightly reduce itchiness and it has the benefit of helping you sleep better.

Seeing your doctor usually is not necessary for a poison ivy rash unless it spreads over large areas, becomes infected, lasts more than three weeks or is a rare extreme case that affects your breathing.

The best offense is a good defense. When youre in the great outdoors, be careful what you touch and, when in doubt, if it has leaves of three, leave them be.

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Poison ivy can work itchy evil on your skin here's how - The Conversation US

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– Veteran biotech executive adds financial and operational expertise to growing Pyxis team – – Veteran biotech executive adds financial and operational expertise to growing Pyxis team –

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Pyxis Oncology Appoints Pamela Yanchik Connealy as Chief Financial Officer

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WINNIPEG, Manitoba, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Kane Biotech Inc. announces that STEM Animal Health Inc., has shipped its first order of bluestem™ products to PetSmart® Canada, Canada largest specialty pet retailer of services and solutions for the lifetime needs of pets. Bluestem™ oral care products will be distributed to all 150 stores and will be available via PetSmart®’s online store.

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STEM Animal Health completes first shipment of bluestem™ oral care products to PetSmart® Canada

Global News Feed Comments Off on STEM Animal Health completes first shipment of bluestem™ oral care products to PetSmart® Canada | September 1st, 2021