From Netdoctor

Lymphoma, a type of blood cancer, is the fifth most common cancer in the UK. Lymphomas can be hard to diagnose and with sixty different types, the treatments vary hugely from a watch and wait option to intensive chemotherapy, radiotherapy and even stem cell transplants. People can live for many years with lymphomas so lets look at how they present and what the treatment options are.

Lymphoma is a cancer of lymphocyte cells. Lymphocytes are one of our white blood cells and they play an important role in helping our body to fight off infection. They are present in lymph fluid which circulates around the body via a network of lymph nodes and lymph vessels which form the lymphatic system.

It is common for lymph nodes (also called lymph glands) to swell up when you have an infection. For example, you may notice swollen glands in your neck when you have a sore throat. The glands shrink back down again as the infection clears.

In lymphoma, something happens to the DNA of the lymphocytes which results in the lymphocytes behaving abnormally, they reproduce and multiply in an uncontrolled way. Large numbers of lymphocytes mean that the lymph nodes become congested and swollen without the presence of infection.

There are different type of lymphocyte cells and around sixty different types of lymphoma but they can be divided into two groups:

Non-Hodgkin can be further divided into:

People of any age can get lymphoma, including children. Hodgkin lymphoma occurs most commonly in people in their early twenties and in the over seventies. It affects around 2,000 people each year in the UK. Non-Hodgkin lymphoma is more common affecting around 14,000 people each year, a third of whom are over the age of 75.

The causes of lymphoma are largely unknown. There may be an inherited genetic mutation which causes the DNA to wrongly instruct the lymphocytes to multiply but its not known for certain if lymphoma runs in families.

Whilst it doesnt point to the cause, certain people are at higher risk of developing lymphoma. These include people who have a suppressed immune system. The suppression may come from the presence of a medical condition which directly affects the immune system such as HIV or from taking an immune suppressing medication. People who have previously been infected by the Epstein Barr virus (responsible for glandular fever) also seem to be at higher risk of lymphoma.

Because some of the symptoms of lymphoma such as swollen nodes and fatigue are common, it can be hard to diagnose lymphoma. Superficial lymph nodes in the neck and armpits are easy to feel but many nodes lie deep within the chest or abdomen and cant be seen or felt.

The most common symptoms of lymphoma are:

These are most commonly in the neck, armpits and groin area. Smooth, rubbery lumps can be felt. They arent usually painful and gradually enlarge although they may go up and down in a low grade, non-Hodgkin lymphoma.

If you have swollen glands that have persisted for over two to three weeks or are getting progressively bigger, then see your doctor.

Photo credit: Christopher Futcher - Getty Images

The following generalised symptoms, also called systemic symptoms may be present:

Story continues

When lymph nodes become enlarged they can press on the body tissues surrounding them resulting in a variety of symptoms depending on the location of the nodes. These include:

Some people may have only one symptom, whereas others will have multiple. Similarly, some people may become rapidly very unwell whilst others have a slower, milder form of lymphoma. The variety is huge due to the many different types and locations of lymphoma.

When you feel unwell or notice swollen glands, your first contact is usually with your GP. He or she will not be able to make a diagnosis of lymphoma but may have suspicions based on listening to your explanation of your symptoms and after examining you.

Blood tests will usually be ordered. These include a Full Blood Count (FBC) which gives details of the number of white blood cells, including lymphocytes in your blood. It cannot however give a diagnosis of lymphoma. To reach this you will be referred to a specialist who will arrange specific tests to not only confirm lymphoma but also to work out how advanced the lymphoma is. These include a biopsy where a sample of the tissue from a gland (or commonly a whole gland) is removed and examined under the microscope. Scans such as CT scans, ultrasound scans and X-rays all help to diagnose lymphoma and determine the best treatment plan.

Once the diagnosis has been made, the doctor will find out what stage the lymphoma is at. This means working out which parts of the body are affected and how advanced the disease is. Staging helps to plan the right treatment.

The following staging is for adults with Hodgkin and non-Hodgkin lymphoma. The staging is different in children

Stage 1 only one group of lymph nodes is affected

Stage 2 two groups of lymph nodes are affected but they are both on the same side of the diaphragm e.g. in the neck and armpit

Stage 3 Lymph nodes on both sides of the diaphragm are affected e.g. neck, armpit and groin

Stage 4 Lymphoma has spread to organs outside of the lymphatic system e.g. lungs, liver

Photo credit: Peathegee Inc - Getty Images

The treatment plan for lymphoma varies according to the type and stage of lymphoma however factors such as age, other medical conditions and general health can influence how effective and well tolerated treatment is.

Treatment plans are usually drawn up after a Multi-Disciplinary Team meeting. This is a discussion between a collection of specialists who all use their expertise and previous experience to determine the best course of action for each individual patient.

The aim of treatment is to push the lymphoma into complete remission where there is no evidence that it is still present in the body and to prevent relapses. Sometimes where the lymphoma is a low grade, non-Hodgkin type, the aim is for a partial remission, quietening the disease. In this situation, sometimes treatment isnt offered immediately and a watch and wait approach is taken.

Treatment options include:

The charity Lymphoma action states, In the UK, no alternative therapies are registered for the treatment of lymphoma. There is no evidence that they are effective and they are not recommended by the NHS. Although not recommended as a treatment, many patients gain benefit from complementary therapies alongside their medical treatment. Therapies such as massage, aromatherapy, meditation and mindfulness, can all help to lower stress and anxiety and improve wellbeing and quality of life.

Most cases of lymphoma are treatable.

In England, approximately 75 per cent of people with Hodgkin lymphoma will survive for ten years or more. Younger people and those who are diagnosed earliest have the best survival rates.

The survival rate for non-Hodgkin lymphoma has tripled in the last 40 years in the UK and almost two thirds of people will survive beyond ten years. The survival rates are highest in young people and 9 in 10 people diagnosed with non-Hodgkin lymphoma between the ages of 15 and 39 will survive for more than five years.

*stats from Cancer Research UK https://www.cancerresearchuk.org

Lymphoma action

Blood Cancer UK

Last medically reviewed: 08-07-2020

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CAR-T treatments and other immunotherapies have changed the treatment of some blood cancers, but they can target healthy cells as well as cancer cells, causing nasty side effects. Vor Biopharma is working on an engineered stem cell solution, and its raised $110 million to move its lead program into the clinic.

The Cambridge, Massachusetts-based company is developing the treatment, VOR33, for patients with acute myeloid leukemia (AML) whose disease has worsened despite undergoing chemotherapy or a stem cell transplant.

Thats the setting in which a lot of targeted agents are used. The trouble is, a great number of the targeted agents tend to failnot because they are not efficacious, but because the drug is too toxic for the patients bone marrow, Vor CEO Robert Ang told Fierce Biotech.

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The drugs home in on healthy cells as well as cancerous ones because they express the same proteins. This leads to myelosuppression, which means the bone marrow doesnt make enough white blood cells, platelets or red blood cells for the patient to survive, Ang said.

RELATED: Neon CBO Robert Ang jumps ship to take the helm at Vor Biopharma

Vors treatment is made from hematopoietic, or blood-forming, stem cells from healthy donors. The company uses gene editing to get rid of cancer drug targets in those cells that are biologically redundant, which means deleting them doesnt cause any harm. That target is CD33, in the case of VOR33.

Were trying to make the marrow treatment resistant such that the only cells that are expressing CD33 should be cancer cells, Ang said. We should be able to target them much more specifically, while minimizing the collateral damage that typically happens with these drugs.

RELATED: 5AM, JJDC get in on $42M series A round for cell therapy player Vor Biopharma

Vor believes its treatments could boost the reach of targeted therapies by improving their efficacy and increasing the amount of time patients can undergo those treatments.

And thats not all. In addition to protecting these transplants and the blood cells they produce from targeted drugs, Vor thinks its approach could change the way we think about bone marrow transplant.

To some degree, transplants have been relatively decentralized and less controlled A lot of hospitals develop their own unique practices as to what they think works and how to handle cells and process them, Ang said. Our product will be regulated by the FDA, so we will be able to provide controls and the proper manufacturing steps to ensure were making the best quality product for patients.

The series B will push VOR33 into clinical trials in the first half of 2021, a target the companys on track to meet despite the COVID-19 pandemic. And Vor plans to expand its portfolio beyond CD33, starting with an umbrella of targets in the myeloid space, namely in acute myeloid leukemia, myelodysplastic syndromes and related diseases.

But we are also looking beyond that to other cancers where there are similar potentially biologically redundant targets we could pursue, said Ang, who took the companys helm in August 2019.

Since then, Vor has grown from a staff of six to 50, and its about to move into new digs in west Cambridge as it moves VOR33 toward the clinic. Its got the backing of RA Capital Management, Fidelity, 5AM Ventures, Johnson & Johnson Innovation, Osage University Partners, PureTech Health, the Pagliuca Family Office and Alexandria Venture Investments to do it all.

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Hematopoietic Stem Cells Transplantation (HSCT) Marketreport provides in-depth COVID19 impact analysis ofMarket Overview, Product Scope, Market Drivers, Trends, Opportunities,Market Driving Force and Market Risks. It also profile the topmost prime manufacturers (Kite Pharma, Thermo Fisher Scientific, CellGenix Technologie Transfer, Cesca Therapeutics, R&D Systems) are analyzed emphatically by competitive landscape contrast, with respect toPrice, Sales,Capacity, Import, Export, Consumption, Gross, Gross Margin, Revenue and Market Share. Hematopoietic Stem Cells Transplantation (HSCT) industry breakdown data are shown at the regional level, to show the sales, revenue and growth by regions.Hematopoietic Stem Cells Transplantation (HSCT) Market describe Hematopoietic Stem Cells Transplantation (HSCT) Sales Channel,Distributors, Customers, Research Findings and Conclusion, Appendix and Data Source.

Key Target Audience of Hematopoietic Stem Cells Transplantation (HSCT) Market:Manufacturers of Hematopoietic Stem Cells Transplantation (HSCT), Raw material suppliers, Market research and consulting firms, Government bodies such as regulating authorities and policy makers, Organizations, forums and alliances related to Hematopoietic Stem Cells Transplantation (HSCT) market.

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Summary of Hematopoietic Stem Cells Transplantation (HSCT) Market:Hematopoietic stem cell transplants (HSCT) present to a valid treatment for several congenital and other hematopoietic system disorders, post chemotherapy, and immune sensitive diseases. HSCT is also preferred for replacement of cellular components and deficient cells. The indications for HSCT thus are wide; the most frequent indication as per reported by Worldwide Network for Blood and Marrow Transplantation Group (WNBT) (2013) is lymphoproliferative disorder (53.2% of all HSCT), 12% of whom received allogeneic and the rest received autologous transplant. Plasma cell disorders are the most frequent indication in this group. A multitude of literature published by researchers and organizations demonstrate that autologous transplant own a greater edge against allogeneic HSCT.

Over 30 years of studies in the field of blood-forming stem cells i.e. hematopoietic stem cells (HSC), researchers have developed significant understanding to use HSCs as a therapy. At present, no type of stem cell, adult, embryonic or fetal has attained such sufficient status. Hematopoietic stem cell transplantation (HSCT) is now routinely used for treating patients with malignant and non-malignant disorders of blood and the immune system. Currently, researchers have observed that through animal studies HSCs have the ability to form other cells such as blood vessels, muscles, and bone. Further application of this approach it may eventually be able to treat a wide array of conditions and replace ailing tissues. However, despite the vast experience with HSCs, researchers face major barriers in expanding their use beyond the replacement of immune and blood cells.

Hematopoietic stem cells are unable to proliferate and differentiate in-vitro. Researchers have yet to evolve an accurate method to differentiate stem cells from other cells derived from blood or bone marrow. Once such technical barriers are overcome, the avenues for realizing the full potential of HSCT. The type of transplant a person receives depends on several different factors, including the type and course of the disease, availability of suitable donors, and the patients overall health. There are three different sources of hematopoietic stem cells such as bone marrow, peripheral blood stem cells, and umbilical cord blood. The stem cell source used for a given transplant depends upon the underlying disease, the type of transplant (allogeneic or autologous), and size of the patient.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Hematopoietic Stem Cells Transplantation (HSCT) market foreach application, including-

Leukemia Lymphoproliferative Disorders Solid Tumors Non-Malignant Disorders Others

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Autologous Transplant Allogenic Transplant

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Patient dosing has finished in the pivotal Phase 3 trial assessing the safety and efficacy of repeat administrations of NurOwn, acell-based therapy forpeople with amyotrophic lateral sclerosis (ALS), BrainStorm Cell Therapeutics, the therapys developer, announced.

The Phase 3 trial (NCT03280056), which enrolled about 200 participants, is underway at six U.S. sites: the University of California, Irvine;Cedars-Sinai Medical Center;California Pacific Medical Center;Massachusetts General Hospital; the University of Massachusetts Medical School; and the Mayo Clinic.

Patients were randomly assigned to either three doses of NurOwn or a placebo, both administered every other month by injections directly into the spinal canal (intrathecal) over a period of four months.

The studys main goal is to assess the safety and efficacy of NurOwn, as measured by changes in the amyotrophic lateral sclerosis functional rating scale (ALSFRS-R) score seen at 28 weeks (seven months) following the first treatment. ALSFRS-R assess such daily life abilities as swallowing, speaking, dressing and washing oneself, climbing stairs, and turning over in bed.

Secondary goals include treatment effects on the levels of several disease biomarkers, as found in samples of patients blood and cerebrospinal fluid (the liquid circulating in the brain and spinal cord).

BrainStorm expects top-line trial data to be available before the end of the year.

Completion of participant dosing in this clinical trial is an important milestone and brings us a step closer to potentially filing a biologics license application to make MSC-NTF cells [NurOwn] available to people with ALS, Chaim Lebovits, CEO of BrainStorm, said in the companyspress release.

NurOwn is a cell-based therapy that usesmesenchymal stem cells (MSCs) cells that are able to give rise to nearly all tissues found in the body, including bones, muscles, and connective tissue isolated from a patients own bone marrow.

After isolation, MSCs are grown in a lab dish and differentiated into cells that produce high levels of neurotrophic factors compounds that promote the growth and survival of nerve cells. The modified cells are then returned to patients through an injection into spinal canal.

Brainstorm is also investigating the potential of NurOwn treat other neurological disorders, including multiple sclerosis (MS), Huntingtons disease, Parkinsons disease, and autism spectrum disorder.

The open-label Phase 2 trial (NCT03799718) assessing three doses of NurOwn in people with progressive MSmay still be recruitingat two sites in the U.S. The cell-based therapy has not yet entered clinical testing for other disorders.

Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells cells that made up the lining of blood vessels found in the umbilical cord of newborns.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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ONE simple act could save this little girl's life.

Little Shahera Khan has a fault with her immune system that means her body can't produce enough white blood cells.

3

It means the toddler is susceptible to infections, meaning a seemingly innocuous bug could kill her.

Shahera's life is very different to those of other tot's her age.

She can't go to nursery, make friends or really interact with too many other kids, for fear of picking up infections.

While she loves to play with her big brother, Amaan, five, she has to take daily medication and has blood transfusions each week.

If she picks up a common cold or cough, it can leave her in hospital for days while her tiny body fights the bacteria or virus.

Now, her parents are pleading for help from strangers, to offer their little girl a chance at a normal life.

Shahera's only hope of growing up like her peers is a stem cell transplant.

Speaking to The Sun her Mum Amina said she just wants her daughter to get better and to lead a normal life.

Shahera was born a healthy child and she was okay when she was small.

She picked up bronchiolitis when she was eight months old and had to be hospitalised. We were there for a week and she also picked up an ear and nose infection.

A lot of people say she has been through the wars and she has, she hasnt had an easy childhood and theres always something new with her illness

Amina, who lives in Croydon with Shahera, her husband and Sharehas little brother said that she had Shahera at home for just a couple of days before she had to go back to hospital due to coughing fits.

She recovered at home but within two weeks the family were sent a letter that detailed she had low immunity.

Amina said that little Shahera had a rash on her face and said doctors then had to do a biopsy.

They were scratching their heads really. After a biopsy they found that she was an unusual case.

3

Her skin was pretty bad at that point and they gave her steroids and antibiotics.

At the Evelina hospital they ran further tests on Shahera, but sadly she then had to be hospitalised for bacterial sepsis.

Amina said that all of this happened during the 2018 World Cup and said she remembers it so well as temperatures were soaring and she was trying to control little Shaheras temperature.

She was so thirsty and her temperature was 38/39C.

How to join the stem cell register

Little Shahera needs a stem cell donor - here's how you can register

You can join the stem cell register online. All you need to do is fill out a registration form and you will be sent out some swabs.

You will need to take some samples, usually from the inside of your mouth and then send them back. As soon as they are received you'll be added to the register.

You'll remain on the register until you are 61-years-old.

If you are a match for someone in need charities such as Anthony Nolan will help guide you through the process.

Around 90 per cent of people are able to donate via their blood stream with 10 per cent donating from bone marrow while under general anaesthetic.

To find out more and to register you can visit the below sites:

Then the hospital found that one of her white blood cells was completely wiped out, she was very sick and it was at that point that the doctors mentioned a bone marrow transplant.

Once again Shahera was allowed to return home and she made a good recovery.

Then when she was just one her rash appeared again and more tests found that she had a rare immunodeficiency.

Shahera now has antibody immunoglobulin treatments every week and Amina said this makes a big difference to her quality of life.

3

The issue now Amina says, is that doctors need to find a way to continue to treat Shahera so she can do all the things that other little girls can.

Doctors have given the family several months to find a donor and have said the transplant could take place as early as next spring.

Finding a donor though will be a struggle for the family as just 20 per cent of patients from BAME backgrounds find the best possible donor match.

This is in comparison to 69 per cent for people with white European heritage.

Finding a donor would be a big relief for us, because hopefully it will maker her better

Shahera is of Bangladeshi origin and Amina said its difficult for the family to find someone from their community.

We are part of her journey and it has been difficult but we have been very patient and we are still working with consultants and professors.

At the moment she is doing as well as she can be and she has been shielding due to Covid-19.

Finding a donor would be a big relief for us, because hopefully it will maker her better.

Amina said that the family are not only campaigning to find a donor for Shahera but for others in the same situation.

What is immunoglobulin therapy?

Little Shahera has to have antibody immunoglobulin treatments to keep her well

It is a blood-based treatment that contains antibodies in order to fight against infections.

People are given this treatment when their immune systems do not produce enough antibodies.

Some patients are at a higher risk than others.

Charity PID UK states: "Clinical trials have shown that for people with immune deficiency, immunoglobulin treatments result in fewer infections, and those infections that do occur tend to be less serious.

"There is also evidence that people with immune deficiency are more likely to enjoy good health over many years if they receive immunoglobulin correctly. Finally, your wellbeing and your energy levels are likely to be better if you are on immunoglobulin.

"It may take several months before you feel these benefits.

Everything has been put on hold because of Covid but donating is such a simple process.

A lot of people have misconceptions about stem cell donation, but donors can save lives.

Due to the coronavirus lockdown little Shahera has spent lots of quality time with her family.

Amina said she is doing well and has enjoyed spending even more time with her older brother.

She likes to play cops and robbers and fireman Sam but she also enjoys doing girly things too like looking after her dolls.

Now that Shahera is a little bit older, Amina said she is more aware of her rash and will sometimes look at it and point.

She is very aware of the transfusions and understands what is happening and she is very well known in the ward.

She doesnt really cry when they prepare her for transfusions.

A lot of people say she has been through the wars and she has, she hasnt had an easy childhood and theres always something new with her illness.

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But shes a tough little girl and she is doing really well.

Sarah Rogers, register development manager at Anthony Nolan says: Little Shahera wants to go to nursery, learn and make more friends just like other toddlers olds across the UK. For this to happen she needs a stranger to donate their stem cells.

"If youre aged 16-30 you can join the register online and well send you a cheek swab in the post.

"If youre found to be a match for a patient, you could donate your stem cells and give hope to families like Shaheras. Your support could help us give a patient, their family and their friends a second chance of life."

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The FDA has put a phase 1 trial of Cellectis off-the-shelf CAR-T therapy UCARTCS1A on clinical hold after learning of a death in the study. Cellectis said the multiple myeloma patient suffered a cardiac arrest after receiving the highest dose of the anti-CS1 allogeneic CAR-T.

Before joining the Cellectis trial, the patient underwent multiple prior lines of treatment, including with autologous CAR-T cells, without success. In the Cellectis trial, the patient was the first person to receive the higher, 3 million cells per kilogram dose of UCARTCS1A. The patient experienced cytokine release syndrome of undisclosed severity and died of a cardiac arrest 25 days after treatment.

The FDA has placed the trial on clinical hold while Cellectis evaluates the case. According to Cellectis, plans were already afoot to expand the lower, 1 million cells per kilogram dose cohort before the patient death. Preliminary data suggest 1 million cells per kilogram may be the phase 2 dose.

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There are signs the lower dose also has some safety issues. Analysts at Jefferies think investigators gave one or more of the three low-dose patients rituximab to activate the CAR-T safety switch. Work is underway to update the phase 1 protocol to mitigate the potential risks posed by UCARTCS1A.

The modifications may include increased monitoring of parameters related to cytokines. The Jefferies analysts think Cellectis should exclude patients previously treated with anti-BCMA CAR-Ts, such as Johnson & Johnsons JNJ-4528, due to risks related to back-to-back rounds of lymphodepletion, but note that management at the biotech think it is important to enroll that pre-treated population.

In a follow-up note, the analysts identified the use of cyclophosphamide, a chemotherapy drug, in the lymphodepletion regimen as a potential cause of the cardiac arrest. The argument is based on a 2017 paper that describes the case of a patient who died of acute heart failure after receiving a high dose of cyclophosphamide as part of an autologous stem cell transplantation treatment.

Many patients receive cyclophosphamide without suffering cardiac complications, but the analysts see reasons to think the subject enrolled in the Cellectis trial may have been at higher risk. Notably, prior exposure may increase risk, according to the analysts, suggesting the patients previous round of lymphodepletion may have been a factor.

Even if cyclophosphamide is at the heart of the problem, the analysts still think the UCARTCS1A dose is a contributing factor. With patients in the low-dose cohort also experiencing adverse events, the analysts see dosing at below 1 million cells per kilogram as one possible outcome of the situation.

Shares in Cellectis fell 13% in after-hours trading following news of the clinical hold. The value of Allogene Therapeutics, which licensed CAR-T assets that originated at Cellectis, held steady, likely reflecting a belief that the safety issue is limited to UCARTCS1A.

The Jefferies analysts see little or no read-through to other allogeneic programs, noting that the UCARTCS1A trial started at a higher dose than Cellectis two other clinical programs and that Allogene is testing several lymphodepletion regimens. The FDA placed a clinical trial of another Cellectis CAR-T, UCART123, on hold in 2017 after a patient died, but cleared it to resume months later.

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Central nervous system comprises brain and spinal cord, and is responsible for integration of sensory information. Brain is the largest and one of the most complex organs in the human body. It is made up of 100 billion nerves that communicate with 100 trillion synapses. It is responsible for the thought and movement produced by the body. Spinal cord is connected to a section of brain known as brain stem and runs through the spinal canal. The brain processes and interprets sensory information sent from the spinal cord. Brain and spinal cord serve as the primary processing centers for the entire nervous system, and control the working of the body. Neuroprosthetics improves or replaces the function of the central nervous system. Neuroprosthetics, also known as neural prosthetics, are devices implanted in the body that stimulate the function of an organ or organ system that has failed due to disease or injury. It is a brain-computer interface device used to detect and translate neural activity into command sequences for prostheses. Its primary aim is to restore functionality in patients suffering from loss of motor control such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, and stroke. The major types of neuroprosthetics include sensory implants, motor prosthetics, and cognitive prosthetics. Motor prosthetics support the autonomous system and assist in the regulation or stimulation of affected motor functions.

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Similarly, cognitive prosthetics restore the function of brain tissue loss in conditions such as paralysis, Parkinsons disease, traumatic brain injury, and speech deficit. Sensory implants pass information into the bodys sensory areas such as sight or hearing, and it is further classified as auditory (cochlear implant), visual, and spinal cord stimulator. Some key functions of neuroprosthetics include providing hearing, seeing, feeling abilities, pain relief, and restoring damaged brain cells. Cochlear implant is among the most popular neuroprosthetics. In addition, auditory brain stem implant is also a neuroprosthetic meant to improve hearing damage.

North America dominates the global market for neuroprosthetics due to the rising incidence of neurological diseases and growth in geriatric population in the region. Asia is expected to display a high growth rate in the next five years in the global neuroprosthetics market, with China and India being the fastest growing markets in the Asia-Pacific region. Among the key driving forces for the neuroprosthetics market in developing countries are the large pool of patients, increasing awareness about the disease, improving healthcare infrastructure, and rising government funding in the region.

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Increasing prevalence of neurological diseases such as traumatic brain injury, stroke and Parkinsons disease, rise in geriatric population, increase in healthcare expenditure, growing awareness about healthcare, rapid progression of technology, and increasing number of initiatives by various governments and government associations are some key factors driving growth of the global neuroprosthetics market. However, factors such as high cost of devices, reimbursement issues, and adverse effects pose a major restraint to the growth of the global neuroprosthetics market.

Innovative self-charging neural implants that eliminate the need for high risk and costly surgery to replace the discharge battery and controlling machinery with thoughts would help to develop opportunities for the growth of the global neuroprosthetics market. The major companies operating in the global neuroprosthetics market are Boston Scientific Corporation, Cochlear Limited, Medtronic, Inc., Cyberonics, Inc., NDI Medical LLC, NeuroPace, Inc., Nervo Corp., Retina Implant AG, St. Jude Medical, and Sonova Group.

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Growing population and economies in the developing countries such as India and China are expected to drive growth of the prosthetic heart valves market in Asia. In addition, introduction of innovative products with technological advancements, increasing demand for minimally-invasive devices, and rise in incidences of cardiac valve disorders are expected to create opportunities for the global prosthetic heart valves market. Increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and product launches are some of the latest trends in the global prosthetic heart valves market.Some of the major companies operating in the global prosthetic heart valves market are Edwards Lifesciences, Medtronic, Abbott Laboratories,ON-X LIFE TECHNOLOGIES, INC.,and St. Jude Medical.In addition, some of the other companies operating in the global prosthetic heart valves market are Sorin Group, CryoLife, LepuMedical, and Braile Biomedica, Ltda.

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Revenue from the Sales of Neuroprosthetics Market to Increase Exponentially During 2015 2021 - 3rd Watch News

Spinal Cord Stem Cells Comments Off on Revenue from the Sales of Neuroprosthetics Market to Increase Exponentially During 2015 2021 – 3rd Watch News | July 7th, 2020

Spinal Fusion Market 2020: Latest Analysis

Chicago, United States:-TheSpinal Fusion market report5 Years Forecast [2020-2025]focuses on theCOVID19 Outbreak Impact analysis of key points influencing the growth of the market. The research report on the Spinal Fusion Market is a deep analysis of the market. This is a latest report, covering the current COVID-19 impact on the Spinal Fusion market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. Experts have studied the historical data and compared it with the changing market situations. The report covers all the necessary information required by new entrants as well as the existing players to gain deeper insight.

Furthermore, the statistical survey in the report focuses on product specifications, costs, production capacities, marketing channels, and market players. Upstream raw materials, downstream demand analysis, and a list of end-user industries have been studied systematically, along with the suppliers in this market. The product flow and distribution channel have also been presented in this research report.

Top Players of Spinal Fusion Market are studied:CharterWorthington IndustriesCesca TherapeuticsShengjie Cryogenic EquipmentSichuan mountain verticalQingdao Beol

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Note: Covid-19 pandemic affects most industries in the globe. Here at acquire market research we offer you comprehensive data of related industry which will help and support your business in all possible ways.Due to the pandemic of COVID-19 businesses have seen a decrease in their profits. While our intention is to help businesses regain their profits we also provide information regarding the COVID-19 virus to help our customers stay safe during the pandemic

Spinal FusionSegmentation by Product

Liquid phaseVapor phase

Spinal FusionSegmentation by Application

Cord Blood Stem Cells CryopreservationOther Stem Cells Cryopreservation

The analysis includes market size, upstream situation, market segmentation, market segmentation, price & cost and industry environment. In addition, the report outlines the factors driving industry growth and the description of market channels.The report begins from overview of industrial chain structure, and describes the upstream. Besides, the report analyses market size and forecast in different geographies, type and end-use segment, in addition, the report introduces market competition overview among the major companies and companies profiles, besides, market price and channel features are covered in the report.

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Our exploration specialists acutely ascertain the significant aspects of the global Spinal Fusion market report. It also provides an in-depth valuation in regards to the future advancements relying on the past data and present circumstance of Spinal Fusion market situation. In this Spinal Fusion report, we have investigated the principals, players in the market, geological regions, product type, and market end-client applications. The global Spinal Fusion report comprises of primary and secondary data which is exemplified in the form of pie outlines, Spinal Fusion tables, analytical figures, and reference diagrams. The Spinal Fusion report is presented in an efficient way that involves basic dialect, basic Spinal Fusion outline, agreements, and certain facts as per solace and comprehension.

Table of Contents.

Report Overview:It includes major players of the globalkeywordmarket covered in the research study, research scope, and market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the globalkeywordmarket. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the globalkeywordmarket are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the globalkeywordmarket by application, it gives a study on the consumption in the globalkeywordmarket by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the globalkeywordmarket are profiled in this section. The analysts have provided information about their recent developments in the globalkeywordmarket, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the globalkeywordmarket as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the globalkeywordmarket as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the globalkeywordmarket.

Key Findings:This section gives a quick look at the important findings of the research study.

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COVID-19 impact on Spinal Fusion Market Growth Analysis, Demand by Regions and Global Forecasts To 2025 | Charter, Worthington Industries, Cesca...

Spinal Cord Stem Cells Comments Off on COVID-19 impact on Spinal Fusion Market Growth Analysis, Demand by Regions and Global Forecasts To 2025 | Charter, Worthington Industries, Cesca… | July 7th, 2020

Medical skin care products are used for beautifying or to address some other skin care problems. The cosmetic industry is booming and skin care forms a very huge part of this industry. The aesthetic appearance is so important that people spend a lot on skin care products and treatment. People being more technologically aware of the various new skin care products trending in the market. In addition to the aesthetic application, the medical skin care products are also used to address issues such as acne, pimples or scars.

Medical Skin Care Products Market: Drivers and Restraints

The medical skin care products is primarily driven by the need of natural based active ingredients products which are now trending in the market. Consumers demand medical skin care products which favor health and environment. Moreover, the consumers are updated with the trends so that various companies end up providing such products to satisfy the customers. For instance, a single product face mask has thousands of different variants. This offers consumers different options to select the product depending on the skin type. Moreover, the market players catering to the medical skin care products are offering products with advanced technologies. For instance, Santinov launched the CICABEL mask using stem cell material based on advanced technologies. The stem cells used in the skin care product helps to to protect and activate the cells and promote the proliferation of skin epidermal cells and the anagenesis of skin fibrosis.

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Medical Skin Care Products Market: Segmentation

On the basis of product type the medical skin care products market can be segmented as:

On the basis of application, the medical skin care products market can be segment as:

On the basis of distribution channel, the medical skin care products market can be segment as:

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Medical Skin Care Products Market: Overview

Medical skin care products are used to address basic skin problems ranging from acne to scars. There are various advancements in the ingredients used to offer skin care products to the consumers. For instance, the use of hyaluronic acid and retinoids is the latest development in the industry. The anti-aging creams are at the forefront as the help treating issues such as wrinkles, scars, acne, and sun damage. Another, product in demand is the probiotic skincare which include lactobacillus and bifidobacterium.

Medical Skin Care Products Market: Region-wise Outlook

In terms of geography, medical skin care products market has been divided into five regions including North- America, Asia- Pacific, Middle-East & Africa, Latin America and Europe. North America dominated the global medical skin care products market as international players are acquiring domestic companies to make their hold strong in the U.S. LOral is accelerating its U.S. market by signing a definitive agreement with Valeant Pharmaceuticals International Inc. to acquire CeraVe, AcneFree and Ambi skin-care brands for US$ 1.3 billion. The acquisition is expected LOreal to get hold of the brands in the price-accessible segment. Asia Pacific is expected to be the fastest growing region owing to the increasing disposable income and rising awareness towards the skin care products.

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Medical Skin Care Products Market: Key Market Participants

Some of the medical skin care products market participants are

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Increasing Demand for Medical Skin Care Products Market to Fuel Revenue Growth Through 2025 - Lake Shore Gazette

Skin Stem Cells Comments Off on Increasing Demand for Medical Skin Care Products Market to Fuel Revenue Growth Through 2025 – Lake Shore Gazette | July 6th, 2020

Myelofibrosis or osteomyelofibrosis is a myeloproliferative disorder which is characterized by proliferation of abnormal clone of hematopoietic stem cells. Myelofibrosis is a rare type of chronic leukemia which affects the blood forming function of the bone marrow tissue. National Institute of Health (NIH) has listed it as a rare disease as the prevalence of myelofibrosis in UK is as low as 0.5 cases per 100,000 population. The cause of myelofibrosis is the genetic mutation in bone marrow stem cells. The disorder is found to occur mainly in the people of age 50 or more and shows no symptoms at an early stage. The common symptoms associated with myelofibrosis include weakness, fatigue, anemia, splenomegaly (spleen enlargement) and gout. However, the disease progresses very slowly and 10% of the patients eventually develop acute myeloid leukemia. Treatment options for myelofibrosis are mainly to prevent the complications associated with low blood count and splenomegaly.

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The global market for myelofibrosis treatment is expected to grow moderately due to low incidence of a disease. However, increasing incidence of genetic disorders, lifestyle up-gradation and rise in smoking population are the factors which can boost the growth of global myelofibrosis treatment market. The high cost of therapy will the growth of global myelofibrosis treatment market.

The global market for myelofibrosis treatment is segmented on basis of treatment type, end user and geography:

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As myelofibrosis is considered as non-curable disease treatment options mainly depend on visible symptoms of a disease. Primary stages of the myelofibrosis are treated with supportive therapies such as chemotherapy and radiation therapy. However, there are serious unmet needs in myelofibrosis treatment market due to lack of disease modifying agents. Approval of JAK1/JAK2 inhibitor Ruxolitinib in 2011 is considered as a breakthrough in myelofibrosis treatment. Stem cell transplantation for the treatment of myelofibrosis also holds tremendous potential for market growth but high cost of therapy is foreseen to limits the growth of the segment.

On the basis of treatment type, the global myelofibrosis treatment market has been segmented into blood transfusion, chemotherapy, androgen therapy and stem cell or bone marrow transplantation. Chemotherapy segment is expected to contribute major share due to easy availability of chemotherapeutic agents. Ruxolitinib is the only chemotherapeutic agent approved by the USFDA specifically for the treatment of myelofibrosis, which will drive the global myelofibrosis treatment market over the forecast period.

Geographically, global myelofibrosis treatment market is segmented into five regions viz. North America, Latin America, Europe, Asia Pacific and Middle East & Africa. Northe America is anticipated to lead the global myelofibrosis treatment market due to comparatively high prevalence of the disease in the region.

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Some of the key market players in the global myelofibrosis treatment market are

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Growing Demand for Myelofibrosis Treatment Market to Significantly Increase Revenues Through 2022 - Jewish Life News

Bone Marrow Stem Cells Comments Off on Growing Demand for Myelofibrosis Treatment Market to Significantly Increase Revenues Through 2022 – Jewish Life News | July 6th, 2020

LONDON, July 6,2020 /PRNewswire/ --IVIRMA, a global network of fertility clinics and world-leading pioneer in fertility research, are presenting a breakthrough study at the 36th Congress of the European Society of Human Reproduction and Embryology (ESHRE) today, demonstrating the possibility of 're-awakening' the ovaries in women under 40 (38 years and below) with the lowest reproductive reserve at the ovarian level.1 The ASCOT technique (involving infusion of stem cells in the ovarian artery), which has recently been shown to be successful in low-responder patients, has now shown it can achieve pregnancy in a woman with premature ovarian failure (POF).1

The study, 'Bone marrow derived stem cells restore ovarian function and fertility in premature ovarian insufficiency women. Interim report of a randomized trial: mobilization versus ovarian injection',1 which is still ongoing, includes two study arms: one using the ASCOT technique, that is, the infusion of stem cells in the ovarian artery* and, second, a less invasive option consisting of mobilising the stem cells, and allowing them to reach the ovaries through the bloodstream directly. The preliminary results have shown that ovarian follicle development was achieved in both groups, with some patients re-starting menstruation, and a decrease in menopausal symptoms. As a result of this procedure, embryos were obtained in 2 out of the 10 participants, and even one pregnancy through the ASCOT technique was achieved.

Dr. Diaz, Medical Director, IVI London, a leading fertility specialist and co-pioneer of the world's first womb transplant, commented, "We are truly excited by these very promising results achieving ovary re-awakening and pregnancy using stem cells in a woman who previously may not have had the option to conceive using her own eggs. We continually strive to pioneer on the cutting-edge of fertility research, as we know how harrowing it can be for every person struggling to conceive. These new techniques may give us potential new options for women with premature ovarian failure, in addition to those with low ovarian reserve."

It is estimated that 1 in 100 women under 40 years of age suffer from premature ovarian failure (POF) in the UK. 2.5% of all patients with POF are adolescents.2 This premature cessation of ovarian activity is one of the most challenging scenarios in terms of reproduction and can be devastating. Now, thanks to the findings of this study, led by Dr. Sonia Herraiz, researcher at the IVI Foundation-IIS la Fe, Spain and Dr. Nuria Pellicer, gynaecologist at Hospital la Fe in Valencia, Spain, there might be hope for women suffering from this fertility issue.

Dr. Nuria Pellicer, Gynaecologist, Hospital la Fe, Valencia, Spain added, "So far, we obtained embryos in 2 of the 10 patients included and one 37-week pregnancy in the ASCOT arm, in patients with almost no chance of successful pregnancy with classic in vitro fertilisation procedures. We found that both arms promoted the development of follicles, and some patients have even recovered their menstruation, thus reducing menopausal symptoms However, these are preliminary results of an ongoing study, so we remain cautious until the study is complete. We aim to develop a technique that is as minimally invasive as possible over time and standardise it so that it can be implemented in all our clinics. We would like to make it possible to offer any woman who wishes to become a mother the possibility of doing so, even when her reproductive circumstances are unfavourable."

"This is a very encouraging line of research in which we will continue to work with a single goal: to improve assisted reproduction techniques and treatments in order to obtain the best results, however difficult the reproductive prognosis may seem,"concluded Dr. Herraiz, researcher at the IVI Foundation-IIS, la Fe, Spain.

More About the Study1

In addition to this research, IVI are presenting three more studies at the ESHRE Congress:

These new techniques and other research conducted by IVI is translated and applied to the treatments available in their clinics across the world, which is in turn reflected in the achieved results. The London clinic has achieved 71.4% clinical pregnancy rates per embryos transferred in women under the age of 386 and recent data shows that with PGT-A genetic screening the evolutive pregnancy rate is 57% in women undergoing treatment at IVI London as compared to the national average of 42%.7 Furthermore, 100% of these pregnancies have been achieved through single embryo transfer, eliminating chances of multiple pregnancy and the complications that arise with it.7

More about the ASCOT technique development: 3 babies and 6 pregnancies achieved so far in low-responder patients

To date, 3 babies and 6 pregnancies have been achieved using the ASCOT technique for ovarian rejuvenation in low-responder patients with low ovarian reserve, pioneered by IVIRMA Global. The technique involves transplanting bone marrow-derived stem cells (BMDSC) into the ovarian artery, achieving a partial reversal of ageing of the ovary, the organ responsible for ovulation, and activating the dormant follicles that would otherwise remain arrested in the ovary. After its first phase in animal models to test the effectiveness of the technique with stem cells, this study went to its second phase in low-responder patients. A total of 20 patients had their stem cells mobilized, extracted from peripheral blood and implanted back into the ovary in order to reverse the ageing process and activate the dormant follicles. This technique has improved ovarian function biomarkers in 81% of low responder patients. In addition, spontaneous pregnancies occurred. In view of the success of this phase, the next stage was undertaken, which consisted of recruiting women under 38 years of age, this time with early ovarian failure (a situation with a worse reproductive prognosis that of low responders). From here the above-mentioned study arose.

IVIRMA Global and IVI London, UK

IVI was founded in 1990, as the first medical institution in Spain fully dedicated to Assisted Reproduction. Since then it has helped with the birth of more than 200,000 babies thanks to the application of the latest Assisted Reproduction technologies. In early 2017, IVI merged with RMANJ, becoming the largest Assisted Reproduction group in the world. It currently has more than 65 clinics in 9 countries and is the leading centre for Reproductive Medicine. In 2016 IVI opened its doors in London, located in the heart of the medical district.www.rmanetwork.com https://ivi-fertility.co.uk/

References

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Breakthrough study demonstrates the 're-awakening' of the ovaries and achieves pregnancy in woman with premature ovarian failure using stem cells - PR...

Bone Marrow Stem Cells Comments Off on Breakthrough study demonstrates the ‘re-awakening’ of the ovaries and achieves pregnancy in woman with premature ovarian failure using stem cells – PR… | July 6th, 2020

Poseida Therapeutics, which is developing targeted treatments for blood-based and other cancers, set the terms for its initial public stock offering expected this week, where it is seeking to raise $150 million.

The San Diego-based company has one drug advancing to Phase 2 clinical trials for multiple myeloma, a type of cancer that develops in certain cells in the bone marrow.

The company expects to file for investigational new drug authorization with the U.S. Food and Drug Administration for its myeloma treatment later this year.

It also is developing other cancer therapies, including treatments for solid tumors and prostate cancer.

Poseida Therapeutics looks to become the third San Diego life science company to go public in the past two months, joining Progenity and Avidity Biosciences. Its stock offering highlights that investor appetite for new biotech companies remains strong in the midst of stock market turbulence from the coronavirus pandemic.

At the end of March, the company employed 149 workers, including 86 with advanced college degrees.

Since its inception, the company has raised $334 million from life sciences institutional investors who support its drug development efforts, including $75 million from Swiss pharmaceutical giant Novartis.

Poseida set the price for its initial public stock offering at $14 to $16 per share. It plans to trade under the ticker symbol PSTX on the Nasdaq exchange. If its shares get out at the midpoint of that range, Poseida Therapeutics would achieve a market value of $890 million.

Founded in 2015, Poseida Therapeutics is making its own version of what are called CAR T cells immune cells genetically engineered to fight cancers. It is developing CAR T cell treatments made from cancer patients own cells.

The process produces stem cell memory T cells. These T cells stick around, both replenishing their population and creating more differentiated group of T cells to attack cancers. They can potentially resume activity if the cancer recurs. This persistence makes it possible to produce the activity needed to eradicate tumors, which up to this point has been beyond the reach of this type of therapy.

The company has its roots in Transposagen Biopharmaceuticals, which founder Eric Ostertag ran for 13 years. Poseida was spun out to pursue gene engineering technologies.

Other members of the companys management teams have worked in executive roles at San Diego biotech firms including Amylin Pharmaceuticals, Halozyme Therapeutics and Mirati Therapeutics.

In addition to Novartis, additional investors include Adage Capital, Aisling Capital, Boxer Capital, Fidelity, Longitude Capital, Malin Corp., Millennium Capital, Pentwater Capital, Perceptive Advisors, Schonfeld and Vivo Capital.

Bank of America Securities, Piper Sandler and William Blair are joint underwriters on the initial public stock offering.

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Poseida Therapeutics sets terms for upcoming IPO, aims to raise $150M for cancer treatments - The San Diego Union-Tribune

Bone Marrow Stem Cells Comments Off on Poseida Therapeutics sets terms for upcoming IPO, aims to raise $150M for cancer treatments – The San Diego Union-Tribune | July 6th, 2020

This Agreement will allow for immediate distribution of leronlimab to patients for the treatment of COVID-19 upon successful completion of CytoDyn’s ongoing clinical trials and FDA approval

VANCOUVER, Washington, July 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn” or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has signed an exclusive Distribution and Supply Agreement with American Regent, Inc. (American Regent”) for the distribution of leronlimab for the treatment of COVID-19 in the United States.

Under the terms of the agreement, CytoDyn will supply leronlimab for the treatment of COVID-19 for distribution by American Regent and receive quarterly payments based on a profit-sharing arrangement.

Having this distribution agreement in place ahead of the readout from CytoDyn’s COVID-19 clinical trials further emphasizes CytoDyn’s commitment to making leronlimab immediately available to patients based on the successful completion of its ongoing clinical trials,” said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn. We are particularly happy to be partnering with a company with the proven expertise, unparalleled commercial reach and stellar reputation of American Regent.”

American Regent is looking forward to partnering with CytoDyn to provide COVID-19 patients rapid and efficient access to a potentially life-saving drug,” said Mr. Harsher Singh, American Regent’s Vice President and Chief Commercial Officer.

CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 severe and critically ill COVID-19 patients, which is a randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). The Company has also completed its enrollment of a Phase 2 randomized clinical trial with 75 patients in the mild-to-moderate COVID-19 population. CytoDyn has been granted more than sixty emergency Investigational New Drug (eIND) authorizations by the U.S. Food and Drug Administration (FDA) and plans to provide clinical updates for this patient population in the coming weeks.

About American Regent American Regent, Inc., a Daiichi Sankyo Group company, is a top-10 injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing and supplying quality generic and branded injectables for healthcare providers. For nearly 20 years, American Regent have been a leader in IV iron therapy. American Regent is committed to U.S.-based manufacturing. In 2018, more than 99% of units supplied were manufactured in its U.S.-based facilities making it uniquely positioned to quickly mobilize and respond to shortages or changes in market needs. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit http://www.americanregent.com.

About Coronavirus Disease 2019 CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

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

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

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA. The Company filed a request for Priority Review designation for its BLA to shorten the FDA’s review time from 10 to 6 months, an FDA goal for BLA applications given Priority Review designation.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

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

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes,” hopes,” intends,” estimates,” expects,” projects,” plans,” anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTS Investors: Cristina De Leon Office: 360.980.8524, ext. 106 Mobile: 503.214.0872 cdeleon@cytodyn.com

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CytoDyn Announces Execution of Exclusive Agreement with American Regent for Distribution and Supply of Leronlimab for Treatment of COVID-19 in United...

Bone Marrow Stem Cells Comments Off on CytoDyn Announces Execution of Exclusive Agreement with American Regent for Distribution and Supply of Leronlimab for Treatment of COVID-19 in United… | July 6th, 2020

NEW YORK, July 06, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that an expanded access protocol (EAP) has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP.

The protocol was filed with the United States Food and Drug Administration (FDA) and provides physicians with access to remestemcel-L for an intermediate-size patient population1 under Mesoblasts existing Investigational New Drug (IND) application. According to the FDA, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

MIS-C is a life-threatening complication of COVID-19 in otherwise healthy children and adolescents that includes massive simultaneous inflammation of multiple critical organs and their vasculature. In approximately 50% of cases this inflammation is associated with significant cardiovascular complications that directly involve heart muscle and may result in decreased cardiac function. In addition, the virus can result in dilation of coronary arteries with unknown future consequences. Recent articles from Europe and the United States have described this disease in detail.2-5

Mesoblast Chief Medical Officer Dr Fred Grossman said: The extensive body of safety and efficacy data generated to date using remestemcel-L in children with graft versus host disease suggest that our cellular therapy could provide a clinically important therapeutic benefit in MIS-C patients, especially if the heart is involved as a target organ for inflammation. Use of remestemcel-L in children with COVID-19 builds on and extends the potential application of this cell therapy in COVID-19 cytokine storm beyond the most severe adults with acute respiratory distress syndrome.

Remestemcel-L Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor and is administered in a series of intravenous infusions. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

1.www.clinicaltrials.gov; NCT044564392.Lancet2020; May 7. DOI: https://doi.org/10.1016/S0140-6736(20)31094-13.Lancet. 2020; (May 13) https://doi.org/10.1016/S0140-6736(20)31103-X4.https://www.nejm.org/doi/full/10.1056/NEJMoa20217565.https://www.nejm.org/doi/full/10.1056/NEJMoa2021680

About MesoblastMesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 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.

Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. 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

Forward-Looking StatementsThis 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 timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement. 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.

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Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19...

Cardiac Stem Cells Comments Off on Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19… | July 6th, 2020

Stem cells have been holding great promise for regenerative medicine for years. In the last decade, several studies have shown that this type of cell, which in Spanish is called mother cell because of its ability to give rise to a variety of different cell types, can be applied in regenerative medicine for diseases such as muscular and nervous system disorders, among others. Researchers and stem cell pioneers Sir John B. Gurdon and Shinya Yamanaka received the Nobel Prize in Physiology and Medicine in 2012 for this idea. However, one of the main limitations in the application of these cell therapies is the quality of the stem cells that can be generated in the laboratory, which impedes their use for therapeutic purposes.Now, a team from the Cell Division and Cancer Group of the Spanish National Cancer Research Centre (CNIO), led by researcher Marcos Malumbres, has developed a new, simple and fast technology that enhances in vitro and in vivo the potential of stem cells to differentiate into adult cells. The research results are published in The EMBO Journal.

In recent years, several protocols have been proposed to obtain reprogrammed stem cells in the laboratory from adult cells, but very few to improve the cells we already have. The method we developed is able to significantly increase the quality of stem cells obtained by any other protocol, thus favouring the efficiency of the production of specialised cell types, says Mara Salazar-Roa, researcher at the CNIO, first author of the article and co-corresponding author.

In this study, the researchers identified an RNA sequence, called microRNA 203, which is found in the earliest embryonic stages before the embryo implants in the womb and when stem cells still have their maximum capacity to generate all the different tissues. When they added this molecule to stem cells in the laboratory, they discovered that the cells ability to convert to other cell types improved significantly.

To corroborate this, they used stem cells of human and murine origin, and of genetically modified mice. The results were spectacular, both in mouse cells and in human cells. Application of this microRNA for just 5 days boosts the potential of stem cells in all scenarios we tested and improves their ability to become other specialised cells, even months after having been in contact with the microRNA, says Salazar-Roa.

According to the study, cells modified by this new protocol are more efficient in generating functional cardiac cells, opening the door to an improved generation of different cell types necessary for the treatment of degenerative diseases.

Malumbres, head of the CNIO Cell and Cancer Division Group, says: To bring this asset to the clinic, collaboration with laboratories or companies that want to exploit this technology is now necessary in each specific case. In this context, Salazar-Roa recently participated, in close collaboration with the CNIOs Innovation team, in prestigious innovation programs such as IDEA2 Global of the Massachusetts Institute of Technology (MIT) and CaixaImpulse of the la Caixa Foundation, from which they also obtained funding to start the development of this technology.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Quick and Simple Technology Enhances the Potential of Stem Cells To Differentiate Into Adult Cells - Technology Networks

Cardiac Stem Cells Comments Off on Quick and Simple Technology Enhances the Potential of Stem Cells To Differentiate Into Adult Cells – Technology Networks | July 6th, 2020

Canine Stem Cell Therapy Marketreport provides in-depth COVID19 impact analysis ofMarket Overview, Product Scope, Market Drivers, Trends, Opportunities,Market Driving Force and Market Risks. It also profile the topmost prime manufacturers (VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics, VetMatrix, Magellan Stem Cells, ANIMAL CELL THERAPIES, Stemcellvet) are analyzed emphatically by competitive landscape contrast, with respect toPrice, Sales,Capacity, Import, Export, Consumption, Gross, Gross Margin, Revenue and Market Share. Canine Stem Cell Therapy industry breakdown data are shown at the regional level, to show the sales, revenue and growth by regions.Canine Stem Cell Therapy Market describe Canine Stem Cell Therapy Sales Channel,Distributors, Customers, Research Findings and Conclusion, Appendix and Data Source.

Key Target Audience of Canine Stem Cell Therapy Market:Manufacturers of Canine Stem Cell Therapy, Raw material suppliers, Market research and consulting firms, Government bodies such as regulating authorities and policy makers, Organizations, forums and alliances related to Canine Stem Cell Therapy market.

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In-Depth Qualitative Analyses Include Identification and Investigation Of The Following Aspects:Canine Stem Cell Therapy Market Structure, Growth Drivers, Restraints and Challenges, Emerging Product Trends & Market Opportunities, Porters Fiver Forces.

Summary of Canine Stem Cell Therapy Market:The non-invasive stem cell obtaining procedure, augmented possibility of accomplishing high quality cells, and lower price of therapy coupled with high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Canine Stem Cell Therapy market foreach application, including-

Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

On the basis of product,this report displays the sales volume, revenue (Million USD), product price, market share and growth rate ofeach type, primarily split into-

Allogeneic Stem Cells Autologous Stem cells

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Canine Stem Cell Therapy Market-Segmentation And Analysis By Recent Trends, Top 4 Manufactures -VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus,...

Cardiac Stem Cells Comments Off on Canine Stem Cell Therapy Market-Segmentation And Analysis By Recent Trends, Top 4 Manufactures -VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus,… | July 6th, 2020

A team of researchers from Rice University has uncovered a promising strategy to generate vascular networks, one of the most daunting structures in the human body. Using powdered sugar and selective laser sintering, the researchers were able to build large structures from complex, branching, and intricate sugar networks that dissolve to create pathways for blood in lab-grown tissue.

This is the teams latest effort to build complex vascular networks for engineered tissues to show that they could keep densely packed cells alive for two weeks. The findings of their studypublished in the Nature Biomedical Engineering journalprove that developing new technologies and materials to mimic and recapitulate the complex hierarchical networks of vessels gets them closer to providing oxygen and nutrients to a sufficient number of cells to get a meaningful long-term therapeutic function.

One of the biggest hurdles to engineering clinically relevant tissues is packing a large tissue structure with hundreds of millions of living cells, said study lead author Ian Kinstlinger, a bioengineering graduate student at Rices Brown School of Engineering. Delivering enough oxygen and nutrients to all the cells across that large volume of tissue becomes a monumental challenge. Nature solved this problem through the evolution of complex vascular networks, which weave through our tissues and organs in patterns reminiscent of tree limbs. The vessels simultaneously become smaller in thickness but greater in number as they branch away from a central trunk, allowing oxygen and nutrients to be efficiently delivered to cells throughout the body.

Overcoming the complications of 3D printing vascularization has remained a critical challenge in tissue engineering for decades, as only a handful of 3D printing processes have come close to mimic the in vivo conditions needed to generate blood vessels. Without them, the future of bioprinted organs and tissues for transplantation will remain elusive. Many organs have uniquely intricate vessels, like the kidney, which is highly vascularized and normally receives a fifth of the cardiac output, or the liver, in charge of receiving over 30% of the blood flow from the heart. By far, kidney transplantation is the most common type of organ transplantation worldwide, followed by transplants of the liver, making it crucial for regenerative medicine experts to tackle vascularization.

Ian Kinstlinger with a blood vessel template he 3D printed from powdered sugar (Credit: Jeff Fitlow/Rice University)

In the last few years, extrusion-based 3D printing techniques have been developed for vascular tissue engineering, however, the authors of this study considered that the method presented certain challenges, which led them to use a customizedopen-source, modified laser cutter to 3D print the sugar templates in the lab of study co-authorJordan Miller, an assistant professor ofbioengineering at Rice.

Miller began work on the laser-sintering approach shortly after joining Rice in 2013. The 3D printing process fuses minute grains of powder into solid 3D objects, making possible some complex and detailed structures. In contrast to more common extrusion 3D printing, where melted strands of material are deposited through a nozzle, laser sintering works by gently melting and fusing small regions in a packed bed of dry powder. According to Miller, both extrusion and laser sintering build 3D shapes one 2D layer at a time, but the laser method enables the generation of structures that would otherwise be prone to collapse if extruded.

There are certain architecturessuch as overhanging structures, branched networks and multivascular networkswhich you really cant do well with extrusion printing, said Miller, who demonstrated the concept of sugar templating with a 3D extrusion printer during his postdoctoral studies at the University of Pennsylvania. Selective laser sintering gives us far more control in all three dimensions, allowing us to easily access complex topologies while still preserving the utility of the sugar material.

Assistant professor ofbioengineering at Rice University, Jordan Miller (Credit: Jeff Fitlow/Rice University)

Generating new 3D printing processes and biomaterials for vascularization is among the top priorities for the researchers at Millers Bioengineering Lab at Rice. The lab has a rich history of using sugar to construct vascular network templates. Miller has described in the past how sugar is biocompatible with the human body, structurally strong, and overall, a great material that could be 3D printed in the shape of blood vessel networks. His original inspiration for the project was an intricate dessert, even going as far as suggesting that the 3D printing process we developed here is like making a very precise creme brulee.

To make tissues, Kinstlinger chose a special blend of sugars to print the templates and then filled the volume around the printed sugar network with a mixture of cells in a liquid gel. Within minutes, the gel became semisolid and the sugar dissolved and flushed away to leave an open passageway for nutrients and oxygen. Clearly, sugar was a great choice for the team, providing an opportunity to create blood vessel templates because it is durable when dry, and it rapidly dissolves in water without damaging nearby cells.

A sample of blood vessel templates that Rice University bioengineers 3D printed using a special blend of powdered sugars. (Credit: B. Martin/Rice University)

In order to create the treelike vascular architectures in the study, the researchers developed a computational algorithm in collaboration with Nervous System, a design studio that uses computer simulation to make unique art, jewelry, and housewares that are inspired by patterns found in nature. After creating tissues patterned with these computationally generated vascular architectures, the team demonstrated the seeding of endothelial cells inside the channels and focused on studying the survival and function of cells grown in the surrounding tissue, which included rodent liver cells called hepatocytes.

The hepatocyte experiments were conducted in collaboration with the University of Washington (UW)s bioengineer and study co-author Kelly Stevens, whose research group specializes in studying these delicate cells, which are notoriously difficult to maintain outside the body.

This method could be used with a much wider range of material cocktails than many other bioprinting technologies. This makes it incredibly versatile, explained Stevens,an assistant professor of bioengineering in the UW College of Engineering, assistant professor of pathology in the UW School of Medicine and an investigator at the UW Medicine Institute for Stem Cell and Regenerative Medicine.

The results from the study allowed the team to continue their work towards creating translationally relevant engineered tissue. Using sugar as a special ingredient and selective laser sintering techniques could help advance the field towards mimicking the function of vascular networks in the body, to finally deliver enough oxygen and nutrients to all the cells across a large volume of tissue.

Miller considered that along with the team they were able to prove that perfusion through 3D vascular networks allows us to sustain these large liverlike tissues. While there are still long-standing challenges associated with maintaining hepatocyte function, the ability to both generate large volumes of tissue and sustain the cells in those volumes for sufficient time to assess their function is an exciting step forward.

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Rice Researchers 3D Print with Lasers and Sugar to Build Complex Vascular Networks - 3DPrint.com

Cardiac Stem Cells Comments Off on Rice Researchers 3D Print with Lasers and Sugar to Build Complex Vascular Networks – 3DPrint.com | July 6th, 2020

There has been a large push to the development of a coronavirus vaccine and antiviral medicines. Having observed promising premises for an effective vaccine, researchers are cautiously optimistic about its clinical launch. A widespread vaccine deployment within 1-2 years would effectively end the COVID-19 pandemic, as per the emerging scientific advances from the US and other countries. Dr D Samba Reddy, Professor, College of Medicine Texas A&M University Health Science Center, USA, explains how developments for a new vaccine and repurposed antiviral medicines can help combat the coronavirus crisis

The coronavirus pandemic has created huge challenges in our daily lives and great uncertainty worldwide. Our working environments, education, family lives, business and financial prosperity, and daily routines have been reshaped significantly, perhaps even permanently. The coronavirus disease 2019 (COVID-19) outbreak urgently requires new medicines for prevention and treatment. The 3-15 per cent mortality rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the strain of the virus that causes COVID-19, ranks as one of the deadliest respiratory viruses, especially in aged and vulnerable people with health risk conditions. To date, this virus has infected more than 11 million people and killed over 525,000 worldwide. Currently, there are no effective, US FDA-approved agents for the prevention and treatment of COVID-19.

Given the steady emergence of positive cases even under social distancing and extended lockdowns, many are desperately awaiting a vaccine or silver bullet treatment for COVID-19. Despite great mitigation efforts and huge economic sacrifices, the virus is asynchronously circulating in many countries including India, which is currently experiencing a rapid surge. Now, the US is experiencing a coronavirus resurgence; the number of daily new COVID-19 cases is hitting levels not seen since the early part of the pandemic. This virus is spreading in large part from asymptomatic persons who have been unknowing carriers. Two questions that frequently appear in many peoples minds are how long they should practise social distancing measures and when this pandemic situation will return to normalcy. For both questions, a vaccine would be our most concrete answer for preventing future infection and ultimately totally eradicating the coronavirus outbreak.

To fight this battle of a lifetime, scientists around the world are making rapid progress in the discovery of two types of medicines for coronavirus: vaccines to prevent the infection and antivirals to treat the infection. It normally takes 5 to 10 years to develop a vaccine or new drug, but due to the urgency of the COVID-19 pandemic, normal development activity and testing have been accelerated with some caveats.

A vaccine would be our most concrete answer

Vaccines are biological agents with a potential for immunological reactions or efficacy issues. They require extensive testing and safety trials the bottleneck in development time along with tedious production and scale-up for producing millions of doses of a formulated injectable product with optimal stability. Many top experts predict a COVID-19 vaccine could take 6-18 months to reach the market.

Currently, there are approximately 160 corona vaccines in development. These vaccines are being tested in ongoing clinical trials to prove their safety and effectiveness. Constantly-updated knowledge about virus strains and the science underlying neutralizing antibodies has provided a number of potential vaccine platforms or antigen components, such as the purified spike protein, envelope protein, recombinant viral vectors expressing the spike or other viral protein, RNA packaged within a vector such as lipid nanoparticles, and killed or inactivated virus particles. Immunization with these injectable components can produce high levels of neutralizing antibodies and protect against detrimental infection after exposure to the virus.

A realistic timeline for development and widespread vaccination

Currently, three vaccines have reached Phase 2 and would enter pivotal Phase 3 trials this summer. This timetable indicates rapid progress in advancing vaccines through clinical testing. The main hurdle for these solutions is proof-of-efficacy: the trials must demonstrate with certainty whether people who receive the vaccines develop COVID-19 after viral exposure at lower rates than those who get placebo or dummy injections. Successful clinical trials would eventually lead to the FDA approval of a vaccine. FDA approval represents the final phase of a bench-to-bedside journey for any new vaccine a long journey that begins within vitro or test tube studies to animal testing and clinical phase 13 trials. When its data demonstrates proof of safety and efficacy, the vaccine can earn FDA approval for marketing. Yet, there remain some uneasy questions regarding this process, particularly the possibility that a coronavirus vaccine is delayed or hits a roadblock. However, some solid research theory provides hope in light of such concerns.

As noted by NIH Director Dr Francis Collins in his blog, research has shown that patients who recover from COVID-19 produce small levels of antibodies to the virus, some of which are strongly neutralising, which indicates that some patients may be able to ward off reinfection. This premise suggests that the immune systems of people who survive COVID-19 may be primed to recognise SARS-CoV-2 and possibly thwart a second infection, which supports the potential feasibility of antibody-based vaccination. Regarding the durability of such a vaccine, the neutralising antibodies against SARS-CoV-2 are projected to last 15-18 months, based on the duration of antibody responses against other human coronaviruses. The lessons learned from SARS and MERS underscores the current vaccine approaches to the prevention of COVID-19.

Despite the potential viability of a vaccine for COVID-19, researchers remain cautiously optimistic about its efficacy and timeline, considering the hurdles yet to be overcome. Currently, in a global search for a COVID-19 vaccine, no clear winner has emerged yet. When a safe and effective corona vaccine is approved, a widespread vaccine deployment within 1-2 years will effectively end the COVID-19 crisis, as per the emerging scientific advances from the US. An international consortium is needed to coordinate such large-scale production and distribution around the globe. Thus, current projections indicate that the coronavirus pandemic will continue for 1-2 years, a critical timeline for development, deployment, and widespread vaccination.

Besides vaccines, there have been dedicated efforts to develop other pharmaceutical options for coronavirus, namely antivirals and immune modulators, some of which are now in clinical trials or have been approved for COVID-19.

The current race for repurposed antiviral medicines

Antivirals are medicines that act directly on coronavirus. The main advantage of an antiviral agent is that it can be given to treat asymptomatic person already infected with the coronavirus. Most antivirals are made of small molecules that can be synthesised in the lab and tested much faster than vaccines. In contrast to a vaccine that prevents infection, antivirals act more like bandages: they can alleviate the recovery and reduce the severity or risk of morbidity, but cannot prevent an infection from happening.

There are many antivirals under experimental and clinical trials for coronavirus infection. According to the University of Pennsylvanias CORONA database, 115 repurposed drugs have been used to treat COVID19 patients, with around a dozen which seem most promising. Like vaccines, FDA approval of antivirals represents the final phase of a big development journey from preclinical to clinical phase 1, 2 and 3 trials. When the data demonstrate compelling proof of safety and efficacy or favourable risk-benefit ratio, such new medicines can receive FDA approval for marketing. To address urgent needs, the FDA has granted emergency use authorization (EUA) for clinical testing and compassionate use of certain medicines for COVID-19, bypassing typical time- and sample-related roadblocks. This is helping scientists more quickly test existing drugs, and such repurposing is offering great hope in our COVID-19 fight. Some of the more notable explored treatments are detailed below.

Chloroquine and hydroxychloroquine (HCQ) have been proposed as new treatments for COVID-19. They have broad-spectrum effects against coronaviruses via multimodal mechanisms. Additionally, millions of people have safely used these medicines for malaria worldwide; however, they are not indicated in certain people with cardiac risk factors. Based on early positive indications of its benefits from pilot trials in China, chloroquine has been used for the treatment of COVID-19 in clinical trials or emergency use programs. HCQ, a safer version of chloroquine, is on the WHOs list of essential medicines a designation given for the safest and most effective medicines needed in a healthcare system. Based on reports of its antiviral effect against the coronavirus, HCQ was granted EUA status for use against COVID-19 by the FDA on April 7. It was tested as a specific treatment in the hospital setting and in clinical trials. Later, the Indian ICMR recommended HCQ as a prophylactic for healthcare personnel.

However, the safety of HCQ in COVID-19 patients is a topic of controversy, stemming from a scandal regarding the retraction of two papers about the negative safety of HCQ published in the top-ranked medical journals Lancet and NEJM. The retractions occurred on account of a lack of data integrity, making safety claims of HCQ still inconclusive. Additionally, the results of recent clinical trials show limited efficacy of HCQ therapy in COVID-19 patients. Therefore, the WHO and NIH have pulled out of HCQ trials due to questionable efficacy that has greatly diminished further interest in this drug. Effective June 22, the sponsoring company made the decision to stop and discontinue its sponsored HCQ clinical trial for COVID-19. They did not cite safety reasons. On June 15, the FDA revoked the EUA for emergency use of chloroquine and HCQ for COVID-19. As of June 25, the NIH treatment guidelines recommend against the use of chloroquineorHCQfor the treatment of COVID-19, except in a clinical trial.

Remdesivir is another repurposed antiviral drug with promising effects on coronavirus. It inhibits a viral protein called RNA-dependent RNA polymerase, which is vital for virus production. It has potent in vitro inhibitory activity against SARS-CoV-2. In real-world practice, however, it has shown mixed results. In early trials published in Lancet, remdesivir was not associated with clinical benefits in patients with severe COVID-19. On March 1, the FDA granted an EUA for emergency treatment of hospitalized patients with severe COVID-19. On April 29, in results from a pilot trial sponsored by the NIH, remdesivir was found to shorten the duration of illness by about 31% compared to placebo in hospitalised patients with severe COVID19. The data, now published in the New England Journal of Medicine, show that the drug shortened the course of illness from an average of 15 days to about 11 days. However, mortality rates were not significantly different (7 per cent drug vs 12 per cent placebo), indicating that remdesivir alone is not likely to be sufficient.

Currently, remdesivir is being tested in Phase 3 trials for severe infection, but it is not FDA-approved yet. It is given by intravenous infusion for up to a 10-day total course. On June 1, some early Phase 3 trial results became available, which indicated it has only small benefit in large samples. In this large trial, a group of moderately ill, hospitalized patients with 5-days therapy showed a modest improvement (76 per cent) compared to standard-of-care control (66 per cent). The other group on 10-days therapy did not show any significant improvement. There were no new safety risks identified in either group. Remdesivir is also only available intravenously, meaning it is only able to be administered in a clinical setting, which could limit its impact for ambulatory patients and persons staying at home with mild symptoms. So, the results of ongoing pivotal trials will determine its capacity for use against COVID-19.

The NIH treatment guidelines recommend the investigational new drug remdesivir for hospitalised patients with severe COVID-19. Those who are not intubated are to receive 5 days of remdesivir, while for mechanically ventilated patients or patients who have not shown improvement after 5 days of therapy, thetreatment can be extended to up to 10 days. Remdesivir is not recommended for the treatment of patients with mild or moderate COVID-19.

Other promising antivirals for COVID-19 include protease inhibitors (Lopinavir, Ritonavir), RNA polymerase inhibitors (Ribavirin, Favipiravir), viral fusion inhibitors (Arbidol), viral receptor entry inhibitors (Camostat), and anti-parasitic agents (Ivermectin). However, most of them are still in clinical trials. To accelerate trials and identify an effective drug, the WHO is coordinating an international Solidarity trial of the most promising antivirals for COVID-19, including Remdesivir, Lopinavir, Ritonavir and others.

On June 20, the Drugs Controller General of India (DCGI), the national drug regulation authority, approved the antiviral drug Favipiravir for the treatment of mild to moderate COVID-19. In a landmark development, an Indian generic pharma company received the approval for manufacturing and marketing of Favipiravir. Now, Favipiravir has become the first approved oral medication for the treatment of COVID-19 in India. Favipiravir, known for treating influenza in Japan, has a unique mechanism of action against the coronavirus. First, it is converted into an active phosphoribosylated form in host cells and serves as a substrate for viral RNA polymerase. Then, it inhibits the viral RNA polymerase, a key protein for viral replication in the body. In India, Favipiravir is available as prescription tablets for a 14-day therapy for mild to moderate infection. It offers broad coverage, including children, adults, the elderly, and people with health conditions. It is claimed to significantly improve symptoms in mild to moderate COVID-19 patients. Presently, it is still undertrials in the USA and other countries and not yet approved by the FDA for the treatment of COVID-19.

The hype about new antivirals needs to be verified by large, randomized trials or future meta-analysis. Some caution should be exercised on the boon of new antivirals, as we have learned harsh lessons from previous antivirals. The launching of generic versions of remdesivir and favipiravir is a highly positive development for supportive treatment. Yet, the results of ongoing or pivotal trials will decide the potential of these and other antivirals for COVID-19.

Immunity boosters as critical adjunct medicines for survival

Another class of treatment known as Immunity modulators have been proposed as adjunct therapies for symptomatic management of COVID-19, especially for at-risk populations (elderly, immunocompromised, very young, people with certain health conditions). Currently, there are no FDA-approved immunity boosters. Some experimental agents include interferons, cytokine inhibitors or monoclonal antibodies (Tacosilizumab, Sarilumab), and immunoglobulins. They are targeted to control the heightened immune response in COVID-19, principally to check the cytokine storm, a state of uncontrolled inflammation that can damage vital organs. Hence, anticytokines are considered as an alternative for combination therapy with antivirals. Tocilizumab, an injectable monoclonal antibody for use in autoimmune diseases such as rheumatoid arthritis, has shown in early trials to dampen the cytokine response in COVID-19 patients.

The WHO advisory says that corticosteroids, which suppress the immune response and cytokine storm, should not be used as they could delay recovery or increase morbidity. However, a recent study shows some benefits of dexamethasone in severely ill patients. Dexamethasone is the first drug to be shown to improve survival in severe COVID-19 patients. However, it did not appear to help mild or moderately infected patients. Consequently, the NIH guidelines panel recommends using dexamethasone (6 mg daily for up to 10 days) in patients with COVID-19 who are mechanically ventilated and in patients who require supplemental oxygen. Similar to the WHO, they recommend against using dexamethasone in patients with COVID-19 who do not require supplemental oxygen. There are insufficient data for the NIH panel to recommend either for or against any other immunomodulatory therapy in patients with severe COVID-19 disease. In patients with COVID-19 and severe or critical illness, there are insufficient data to recommend empiric broad-spectrum antimicrobial therapy in the absence of another indication.

Plasma therapy works

Plasma therapy or convalescent plasma has proven effective in reducing the severity or mortality of corona infection. In such immunoglobulin therapy, the liquid portion of the blood that has antibodies from recovered patients is given to patients with severe COVID-19. Although plasma therapy may help accelerate recovery, limited donor availability may limit the widespread use of the convalescent plasma.

A BCG vaccine is touted to reduce the impact of COVID-19 because it has beneficial nonspecific (off-target) effects strengthening the immune system and thereby reducing viremia after coronavirus exposure. A trial is underway to study if BCG vaccine can strengthen immune response, with consequent less severe infection or rapid recovery.

Some vitamins and nutraceuticals have been claimed to help against coronavirus infection. Currently, there is a lack of systematic studies evaluating these supplements in COVID-19 patients.

Stem cells are also touted as promising immune boosters to combat COVID-19, especially for critically ill patients. Stem cells are thought to slow down the immune response and prevent the body from damaging itself from cytokine storm. Such therapy is not yet proven effective or safe, so has not been approved for the treatment of COVID-19.

Herd immunity is a natural catastrophe

Herd immunity, while not touted as a solution for COVID-19 by any agency, is a natural process relevant when there are a massive surge and widespread hotspots in a town or city. Herd immunity is reached when the majority of a given population 70 to 90% becomes immune to the virus, either by recovery from infection or through vaccination. In that scenario, the virus does not spread to people who are not immune due to a lack of carriers. At its worst, catastrophic hotspots may have to rely on herd immunity if a vaccine is still not available in a timely fashion. However, how long immunity lasts varies depending on the coronavirus, and it is not yet known how long COVID-19 survivors might have that protection.

In the US, India, Brazil, and many other countries, there has been a rapid surge or resurgence of cases. About 40% of cases are asymptomatic, which may be driving the community spread. Besides social distance measures, widespread testing and isolation are critical steps in containing the virus. Pool testing could find asymptomatic persons quickly by strategically testing groups of people together. It could test more people with fewer tests in a much broader net and positive cases could be quickly isolated. Meanwhile, scientific experts are advising for the traditional mitigation toolsidentify, isolate and contact trace for curbing the spread and flattening the infection curve.

We will ultimately prevail

Lets follow the scientific guidelines for surviving the coronavirus pandemic. The primary mode of transmission is the airborne route. Infected persons, both asymptomatic and symptomatic, have the great potential to generate aerosol (from a sneeze, cough, breathing or talking) in the size range that can remain suspended in air and reach others when a healthy person inhales such contaminated air. Confining aerosols as close as possible to their point of generation is the first critical steps in the standard healthcare protocols. Aerosols represent a risk of both inhalation and contamination of surfaces, personal clothing and objects. Hence, confining aerosols reduces the extent of contamination and minimises potential exposure opportunities.

The ultimate goal of public health advisories and mitigation strategies (eg, social distancing, mask-wearing, good hygiene) is to reduce the risk of acquiring an infection and of spreading the virus onto others. Its a personal responsibility to adhere to safe practises at home, workplace and outside. A deeper awareness is critical to accomplish the two basic principles of biosafety from coronavirus: risk assessment and containment. To put this complex science into common practice, strive to follow two essential practices: (a) stay away from the bug, a vital precaution to avoid being exposed to the virus, and (b) stay healthy, a preemptive step to combat the corona disease. In essence, in the COVID-19 disease triangle, lets enforce an unfavourable environment for interaction between the host (human) and the bug (virus) a personal step to end the pandemic.

In summary, the US FDA to date has approved no therapies for coronavirus. COVID-19 pandemic is an unprecedented challenge for millions of people worldwide. Thus, aside from new diagnostic tests such as pool testing, development of novel antivirals and vaccines will remain highest-priority scientific research for the next few years. There is cautious optimism about the coronavirus vaccine, but it is too early to make concrete judgments. In the meantime, the two best ways to prevent coronavirus infection are to limit potential exposure and strengthen our health and immunity. It may even take a couple of years, but we will ultimately prevail.

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Scientific Race for New Medicines and Vaccines for COVID-19 - Express Healthcare

Cardiac Stem Cells Comments Off on Scientific Race for New Medicines and Vaccines for COVID-19 – Express Healthcare | July 6th, 2020

Hitachi, Ltd and ThinkCyte, Inc. announced that they have entered into a collaboration focused on developing an artificial intelligence (AI)-driven cell analysis and sorting system. Hitachi and ThinkCyte are promoting collaboration with pharmaceutical companies and research institutes working in the field of regenerative medicine and cell therapy to expedite the development of the system toward commercialization.

Founded in 2016 and headquartered in Tokyo, Japan, ThinkCyte, is a biotechnology company that develops life science research, diagnostics, and treatments using integrated multidisciplinary technologies. It has been performing research and development focused on high-throughput single cell analysis and sorting technology to precisely analyze and isolate target cells. ThinkCyte has developed the Ghost Cytometry technology to achieve high-throughput and high-content single cell sorting and has been conducting collaborative research projects with multiple pharmaceutical companies and research institutes to utilize this technology in life science and medical fields.

Hitachi has been providing large-scale automated induced pluripotent stem (iPS) cell culture equipment, cell processing facilities (CPFs), manufacturing execution systems(MES), and biosafety cabinets among other products to pharmaceutical companies and research institutes, and has developed a value chain to meet a variety of customer needs in the regenerative medicine and cell therapy industry. Hitachi has also been carrying out collaborative research projects with universities, research institutes, and other companies to develop core technologies for pharmaceutical manufacturing instruments and in vitro diagnostic medical devices, prototyping for mass production, and working on manufacturing cost reduction and the development of stable and reliable instruments.

Hitachi and ThinkCyte have initiated a joint development of the AI-driven cell analysis and sorting system based on their respective technologies, expertise, and know-how. By combining ThinkCyte's high-throughput and high-content label-free single cell sorting technology and Hitachi's know-how and capability to producing stably operative instruments on a large scale, the two companies will together develop a novel reliable system to enable high-speed label-free cell isolation with high accuracy, which has been difficult to achieve with the existing cell sorting techniques, and to realize stable, low-cost and large-scale production of cells for regenerative medicine and cell therapy.

Hitachi and ThinkCyte will further advance partnerships with pharmaceutical companies and research institutes that have been developing and manufacturing regenerative medicines and cell therapy products in Japan and other countries where demand is expected to be significant, such as North America, in order to make this technology a platform for the production of regenerative medicines and cell therapy products.

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Hitachi and ThinkCyte to Develop an AI-driven Cell Analysis | ARC Advisory - ARC Viewpoints

IPS Cell Therapy Comments Off on Hitachi and ThinkCyte to Develop an AI-driven Cell Analysis | ARC Advisory – ARC Viewpoints | July 6th, 2020

The worlds biggest listed pure-play stem cell developer has a busy slate of clinical work, notably in therapies for advanced heart failure, chronic back pain and graft-versus-host disease (GvHD).

Now these programs are approaching a thrilling denouement and, as the Demtel man enthused, theres more: Mesoblast (ASX:MSB) is also undertaking an expanded coronavirus trial after a 12-patient effort showed promising results in treating acute respiratory distress syndrome (Ards), the usual cause of death with COVID-19.

The patients received infusions of Mesoblasts allogeneic (off the shelf) mesenchymal stem cell candidate, remestemcel-L, acquired from Osiris for $106m in 2013.

Meanwhile, results from two phase III trials are expected this (September) quarter: a 566-patient effort for chronic heart failure and a 404-patient trial for chronic lower back pain caused by disc degeneration.

And in September, the US Food and Drug Administration will rule on whether or not the company can market its GvHD therapy on American shores.

Mesoblast founder and CEO Prof Silviu Itescu notes that across all its therapies the company is targeting the most severe cases where alternative therapies dont exist.

Mesoblasts proprietary process selects precursor and stem cells from the bone marrow of healthy adults, creating a master cell bank. This cell kitty is then expanded into thousands of doses for off-the-shelf use, without the need for tissue matching.

Mesoblast is targeting a common market across all its disease indications: inflammation. In the case of heart disease, tissue macrophages (cells) churn out inflammatory factors that damage heart muscle and cause fibrosis and vascular dysfunction.

The stem cells respond to severe inflammation by switching the culprit macrophages off and converting them to nice cells that actually protect the heart muscle.

This is the central mechanism in each of our disease states: heart failure, back pain, GvHD and rheumatoid arthritis, Professor Itescu says. We have the potential to make a big difference in some very big disease states where inflammation is central.

Backed by the Pratt familys listed investment vehicle Thorney Investments, Mesoblast debuted on the ASX in 2004 and reached a peak valuation of $2.5bn in 2011 before suffering a reality check.

Culprits included a phase II heart trial that failed to meet primary endpoints, a badly executed Nasdaq listing and Israel pharma house Teva Pharmaceuticals decision to walk away from a heart program partnership in 2016.

Mesoblast dual listed on the Nasdaq in November 2015, accompanied by a $US63m capital raising.

The companys Ards and GvHD programs are based on mesenchymal stem cell assets acquired from US pharma group Osiris Therapeutics in October 2013.

Mesoblasts own-developed cells are called mesenchymal precursor cells and they are being developed for rheumatoid arthritis and diabetic nephropathy, as well as the aforementioned heart failure and lower back pain programs.

Ards is bought on by an excessive immune response to the virus in the lungs. The immune cells produce inflammatory cytokines, which destroy lung tissue and can also damage the liver, kidney and heart.

Remestemcell-L has the potential to tame the cytokine storm in Ards and may offer a life-saving treatment for those unfortunate individual sufferers of COVID-19 Ards, Professor Itescu says.

Mesoblasts COVID-19 proclamations have been coming so thick and fast that its been Ard(s) just to keep up. But the core excitement cluster was around Mesoblasts April 23 disclosure of the results of the trial at New Yorks Mt Sinai Hospital, covering moderate to acute Ards cases.

Under the compassionate use protocol, the patients were treated with two infusions of remestemcel-L over the first five days.

The results? Nine of the 12 patients came off a ventilator within a median 10 days, with 83 per cent survival (the Grim Reapers spin on this is that two of them died).

In comparison, only 9 per cent of patients at one reference hospital (38 out of 445 patients) were able to come off the ventilator with standard-of-care treatment.

Another US hospital reported that only 38 patients of 320 or 12 per cent survived.

Of course, 12 people good and true are adequate numbers for a jury, but sub-optimal to comprise a statistically significant trial.

Thus, the company is enrolling 300 patients in a phase III, randomised, controlled trial of severe Ards patients at 30 sites.

The first patients were dosed in early May, with about 15 sites established as the company chases the disease from the northeast to the southern states.

Mesoblast chief medical officer Professor Fred Grossman says the company is carefully choosing hot spots such as Alabama which, as of late May had the no vacancy signs outside its intensive care wards.

The sites are recruiting quite quickly, he says. There is a tremendous interest in this study.

The trial leaders will undertake an interim analysis at 30 days, and when 30 per cent of patients have reached their primary endpoint. At that point the trial can be dumped on futility grounds, or expanded to the control group because it appears to be working.

Remestemcell-L has investigational new drug (IND) status with the US Food and Drug Administration, meaning the company swiftly can initiate trials on patients with very dismal prospects.

Long-suffering Mesoblast investors will recall that the companys shares tumbled 28 per cent in November 2018 after a 159-patient trial of Rexlemestrocel-L (Revascor) for end-stage heart failure did not meet its primary endpoint of weaning patients from left ventricle assist devices (LVADs or heart pumps).

The company claimed the endpoint was set by the independent !!! investigators and was of little real clinical interest. What really mattered was that the trial showed reduced gastrointestinal bleeding by 76 per cent and hospitalisations by 65 per cent.

Investors are now nervously awaiting the first readout of the broader 566-patient chronic heart failure trial across 59 US sites.

Mesoblast targeted patients with class three or four disease, the sickest 15 to 20 per cent of patients who have failed standard-of-care drugs.

Class three patients have a 20 per cent chance of dying within two years while with class four its a case of flip a coin that you will be around in 12 months.

At this stage, Mesoblast retains its heart treatment rights except in China, where it is partnered with Tasly Pharmaceutical.

Mesoblasts phase III back pain trial aimed to enroll 404 patients with lower back pain caused by degenerative disc disease.

The endpoint of the trial, dubbed MPC-06-ID, is an improvement in pain and function over 24 months.

As with the heart trial, results are imminent and its a toss-up as to what release will hit the ASX announcements feed first.

The company is liaising with its global back pain partner Grunenthal GmbH about the clinical protocol for a European phase III confirmatory trial.

In Japan, Mesoblast is partnered with JCR Pharmaceutical for its approved GvHD treatment called Temcell and its off and racing in that smallish but enthusiastic market.

Meanwhile, the company is angling to enter the US market for a similar GvHD treatment, branded Ryoncil.

GvHD afflicts about half of the 30,000 patients annually undergoing allogeneic bone marrow transplant, typically for blood cancers, with their bodies rejecting the alien transplant.

In March, the FDA granted priority review with a September 30 action date, but we might have a good idea of the outcome in August.

Why? Because thats when the FDAs relevant advisory committee meets to vote on the matter and the (virtual) gathering is open to the public.

A date is yet to be set. While advisory committee views are not binding on the FDA, they usually presage the final decision.

If approved, Mesoblast could be selling Ryoncil in the US by the time were carving the Christmas turkey (badly, in the case of your columnist).

Buoyed by the COVID-19 results, Mesoblast in May wasted no time tapping institutional investors for an idle $US90m ($129.6m) in a placement.

Mesoblast already had a healthy cash balance of $US60m.

The raising was struck at $3.20 a share, a modest 7 per cent discount to the prevailing price.

The funds, in the main, will be used to scale-up manufacturing of remestemcell-L and to support the phase III trial, as well as for working capital and general corporate purposes.

The company also has $US67m available through existing financing facilities and partnerships.

Mesoblast reported revenue of $US31.45m for the nine months to March 2020, up 113 per cent. The reported loss narrowed 34 per cent to $US45.3m, reflecting curtailed research and development spend by $US7.5m, or 15 per cent.

The revenue included $US5.9m of JCR royalties from Temcell sales in Japan and milestone revenue of $US25m.

The company stands to pocket up to $US150m of royalties and milestones from Grunenthal prior to any European launch of Revascor.

Successful sales could result in up to $US1bn in milestone payments.

Over the last decade, Mesoblasts ASX shares have traded as high as $9 (October 2011) and as low as $1.03 (December last year).

To the Meso-sceptics the company has promised far too much with limited commercial success, while raising $1bn since listing 16 years ago.

Dare we say that Mesoblast now looks more focused and to be getting somewhere?

When we last covered Mesoblast in March 2019, Professor Itescu said he was 95 per cent certain the company would do what no other Aussie biotech in phase III had done: win FDA drug approval.

Well, Clinuvel has stolen that Aussie first honour, but Mesoblast is well placed to get over the line with a GvHD treatment in the US, which presents a market eight times the size of Japans.

Its certainly rare for a biotech to expect results for three major trials and a key regulatory decision in the space of months.

If the heart and back pain results are definitively positive and the FDA green lights GvHD, the company hits the jackpot. If two or more of them bomb lets not go there.

Your ultra conservative columnist regards the COVID-19 stuff as the icing on the cake with an outside chance of success, especially given the hundreds of other programs in the coronavirus-busting sector.

Disclosure: Dr Boreham is not a qualified medical practitioner and does not possess a doctorate of any sort. But he hopes to become proficient in turkey carving by December 25.

This column first appeared in Biotech Daily.

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Dr Borehams Crucible: Mesoblast within months of 3 major trial results, key regulatory decision - Stockhead

Bone Marrow Stem Cells Comments Off on Dr Borehams Crucible: Mesoblast within months of 3 major trial results, key regulatory decision – Stockhead | July 6th, 2020