'Let me tell you about the very rich,' wrote F Scott Fitzgerald. 'They are different from you and me.' Above all, in the lengths they will go to acquire, and preserve, perfect skin.

Sheikha Moza bint Nasser, the consort of the former Emir of Qatar, may well be the richest person I've ever met. She certainly has skin like no one else on the planet. She's 61 but looks about 40, with a face that seems to have no visible pores, perhaps because it's sculpted out of alabaster.

Admittedly, she is carefully made-up on a regular basis, so she would have been unlikely to want to attend a recent dinner party of Gwyneth Paltrow's in Beverly Hills, at which guests were banned from wearing any cosmetics at all. Kate Hudson and Demi Moore were among those who gamely took the challenge, the idea of which was to allow the assembled LA A-listers to show off their natural glow.

But they don't, of course, rely wholly on nature for their radiance. Moore's evening beauty routine (pared back to the minimum because, she says, "I like to keep it simple") includes eight separate products, with a total cost of 743.50, from a cleansing elixir to a 355 replenishing facial oil and a rose-quartz facial massager in the shape of a butterfly.

No wonder that, far from being petrified at the thought of the make-up-free dinner, she felt 'full of joy', according to her Instagram posts. Her face wasn't coated in foundation, but it was insulated by a thick layer of cash.

With skincare that promises actually to reverse the visible signs of ageing, beauty brands feel entitled to charge impressive sums. La Prairie has one serum, its Platinum Night Elixir, that sells for over 1,000 for 20ml. It costs about 10 more per gram than solid gold. Imagine if your cat knocked that one off the dressing table.

On the other hand, the scientist who developed it says the peptides and amino acids contained in a single daily drop will leave your skin visibly younger-looking and fresher in two weeks. Users say it feels like wrapping your face in cashmere.

La Prairie Platinum Rare Cellular Night Elixir 20ml, 1,018, Harvey Nichols

I rely on Dr Phillip Levy, a Swiss dermatologist and wound-healing specialist based in Geneva, whose moisturisers and serums are proven to revitalise dermal stem cells to kick-start your skin's own production of collagen. Another doctor - German-born Michael Prager, who operates from a clinic in Wimpole Street - emphasises the rejuvenating effects of combating pollution with an antioxidant cream that fights off free radicals.

Neither of these medical-grade ranges comes cheap, but though Dr Prager's day oil contains pure gold, at 225 for 30ml (drmichaelprager.com), it's not actually as expensive as buying the precious metal itself.

If you're going down the Sheikha Moza route to moneyed perfection with a lavish use of make-up, Gucci Westman is a name to conjure with. This make-up artist, who has worked with Natalie Portman and Nicole Kidman, has her own range, Westman Atelier.

Lip suede in Les Rouges, 75, Westman Atelier (net-a-porter.com)

Yes, the colours are lush but, even better, the brand is 'clean' - beauty-speak for vegan, against animal-testing, paraben-free and so on. Plus, the products moisturise, plump up collagen and soothe as you apply them. Even the mascara conditions your lashes. So what if it costs 58?

Equally impressive is Shiseido's luxury line, Cl de Peau, which does a foundation that's 250 for 27ml, in 13 shades. Again, it's a beauty treatment with SPF and moisturiser as much as a make-up product, and it's what I'll put on if I want anyone to tell me I look glowing.

But, of course, more precious than any cream or blush stick is a little personal attention. Dr Costas Papageorgiou operates out of Harrods and has fairly expensive-looking skin himself. He makes use of a battery of lasers, Botox, fillers and ultrasound, but the key to his success is the consultation that starts off the process.

The Foundation,250, Cl de Peau Beaut (harrods.com)

Seeing your own face in unforgiving 3D on a computer may be a shock, but it certainly helps pinpoint the areas you'd like him to focus on. He's very hot on correcting facial symmetry, which starts out pretty good in babies, but with time and use, the muscles on the face become less symmetrical as bits start to droop or wrinkle. Generally, the more lopsided you are, the more antique you look, and he can address that with filler, Botox and even thread lifts.

But I'm not one for the injectables. It's his Hybrid Energy Lift - a combination of ultrasound, infrared, light and laser - that I really rate (from 6,000 for 120 minutes, facialplasticslondon.com). It, too, stimulates collagen production, but it also gets rid of visible veins and redness, and even reduces big pores. I have had to change the tone of my foundation for a paler one since he did for my (mild) rosacea.

Radical3 Reboot Pro Peel, 89, Dr Levy (editorslist.co.uk)

The key, says Dr Papageorgiou, is to delay and reverse the "ageing cascade". This slow car crash of fine lines around the eyes, sun damage and heavy jowls is all thanks, he says, to "fat atrophy and bone resorption".

But subtlety is all - "A great result is one that shows no signs of intervention"- and nothing, he warns, can really be achieved unless you have a healthy diet, exercise and take vitamins.

Debbie Thomas, at her D.Thomas clinic in London, has a similarly personalised approach. You don't book in for a single treatment, you book for an hour of her expert time, and she'll use a cocktail of lasers, micro-needling and products depending on what you need (475 for a DNA Laser Complete 2 session, dthomas.com).

"I'm afraid,"she says, "traditional facials are not going to transform your skin for more than a few days. You need to upgrade to more advanced treatments if you want long-term results. And those will be more costly."And who can say it's not worth the money?

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The rise of 'rich woman face': how to halt the ageing process (for a certain price) - Telegraph.co.uk

Skin Stem Cells Comments Off on The rise of ‘rich woman face’: how to halt the ageing process (for a certain price) – Telegraph.co.uk | April 4th, 2020

TEL AVIV, Israel, April 3, 2020 /PRNewswire/ -- Cellect BiotechnologyLtd. (Nasdaq: APOP), a developer of a novel stem cell production technology, today announced operating and financial results for the fourth quarter and full year ended December 31, 2019.

"We achieved a number of strategic priorities in 2019, including the IND approval to commence our first-ever trial in the U.S.," commented Dr. Shai Yarkoni, Chief Executive Officer."We plan to begin enrolling patients for this trial and completing the trial in Israel when the COVID-19 pandemic is mitigated. While these near-term events are value-enhancers, I believe that our recently announced prospective partnership with Canndoc could be a game-changer for Cellect and change our growth trajectory. It has the potential to significantly enhance our short and long term business prospects and shareholder value. As a player in the fast-growing pain management market, we would anticipate significant revenue opportunities already this year."

Recent Strategic Development

As previously announced, on March 4, 2020, the Company entered into a commercial binding Letter Of Intent (LOI) with Canndoc Ltd, a leading pharma grade medical cannabis pioneer and a wholly owned subsidiary of publicly-traded Intercure Ltd. (TASE: INCR),to acquire from Canndoc all rights to the use and sell Canndoc products for the reduction of opioid usage, including accumulated data, as well as on-going and pipeline of clinical trials. This commercial arrangement is subject to negotiation and approval by each company's board of directors and definitive agreements.

Additionally, the two companies signed a non-binding LOI for a full merger. Under preliminary details, Cellect will acquire from Intercure all of Canndoc outstanding shares, in exchange for additional Cellect ADRs to be in total ~95% (~93% on a fully diluted basis) of the merged company. The proposed merger is subject to independent valuation of both companies, fairness opinion by a third party, negotiation of a definitive agreement, approval of the agreement by the Company's Board of Directors and shareholders, internal approvals by Canndoc and Intercure, and customary closing conditions, including the approval of the IMCA (Israeli Medical Cannabis Agency). Upon the closing of the merger, Cellect and Canndoc will aim to fulfill all of the requirements to ensure the Company's ADRs and warrants continue trading on the Nasdaq Stock Market (Nasdaq) and, for this purpose, Intercure would commit to invest a cash sum of at least $3.0 million in any public offering that is undertaken by the Company, at a price of not less than $4.50 per ADR.

Based on the progress to date, the Company continues to expect the commercial and merger transactions will close in the second quarter of 2020.

Additional Operating Highlights:

Clinical Progress Update:

Due to the ongoing COVID-19 pandemic, the Company is experiencing clinical disruption such as:

The Company continues to take all the necessary precautions advised by global health officials to ensure the health and safety of its employees and partners. The Company is unaware of any impact on employees from pandemic related exposure or illness and is continuing to perform in-house research, including in the opioid/pain management area.

Fourth Quarter and Full Year 2019 Financial Results:

Balance Sheet Highlights:

For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2019 (U.S. $1 = NIS 3.456).

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's intent regarding the future potential of Cellect's technology. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Cellect Biotechnology Ltd

Consolidated Statement of Operation

Convenience

translation

Twelvemonths

ended

Twelve months ended

Three months ended

December 31,

December 31,

December 31,

2019

2019

2018

2019

2018

Unaudited

Audited

Audited

Unaudited

Unaudited

U.S. dollars

NIS

(In thousands, except share and pershare data)

Research and development expenses

3,508

12,122

13,513

2,571

4,040

General and administrative expenses

2,954

10,210

15,734

2,378

4,733

Operating loss

6,462

22,332

29,247

4,949

8,773

Financial expenses (income) due towarrants exercisable into ADS

(2,032)

(7,022)

(7,719)

998

(4,784)

Other financial expenses (income), net

433

1,498

(1,415)

129

(238)

Total comprehensive loss

4,863

16,808

20,113

6,076

3,751

Loss per share:

Basic and diluted loss per share

0.023

0.079

0.155

0.027

0.029

Weighted average number of sharesoutstanding used to compute basic anddiluted loss per share

212,642,505

212,6432,505

129,426,091

224,087,799

130,274,953

Cellect Biotechnology Ltd

Consolidated Balance Sheet Data

ASSETS

Convenience

translation

View original post here:
Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results - BioSpace

Bone Marrow Stem Cells Comments Off on Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results – BioSpace | April 4th, 2020

Warm weather will soon be coming back and lots of people will be outside enjoying outdoor activities. Bike riding and outdoor walks are all great ways to enjoy the return of beautiful and warm weather.

With all of this, its likely people will have some joint and muscle pain return. This is standard for many, and it will usually go away within weeks. If pain lingers past 3-4 weeks after some painkillers and ice, its likely time to visit a doctor.

Over 163 million people in the US have chronic pain, according to a Harris Poll that was commissioned by the AOA (American Osteopathic Association). Pain becomes chronic when it interferes with the normal life and work of a person. The person may be preoccupied by this pain, and thus become upset and depressed. The pain may also go on and off, and damage peoples ability to eat, move, and generally enjoy life.

When chronic pain is treated, its usually the right thing to try regular medicine first. Prior to considering an operation, people are encouraged to look into a consultation regarding regenerative medicine. These medicines are a breakthrough treatment that avoid surgery, and are innovating orthopedics. It utilizes an individuals stem cells to treat damaged joints and tissues, as well as issues like spinal discs or a tendon injury.

PRP and stem cell therapy are the two most common forms of this treatment.

The former uses blood platelets in the patients plasma, received from blood draw. The platelet rich plasma consists of platelets and growth factors. Stem cell therapy utilizes an individuals own stem cells, taken out of bone marrow. Stem cells are extracted and integrated into damaged areas.

These treatments function by altering the surrounding area of the tendon/joint, and help repair the tissue. The treatments are effective by having the patients tissue essentially heal itself. Precision placement remains the key to their success; cells are moved into place via ultrasound guidance, then once theyre in place theyre able to begin repairing the damaged tissues.

This type of medicine has evolved this last decade. More recent ultrasound methods focus on placement and accuracy, the result being stronger cell counts and a higher concentration of the platelet rich plasma. Another development is A2M, also known as alpha 2 macroglobulin. A2M is a protein injected directly inside the joint which decreases inflammation quickly.

Nearly 100,000 procedures of the regenerative medicine classification have been done in the US, and that number will keep growing as more and more insurance providers cover this. Its vital for individuals to know they cant repair everything with stem cells, and that they should do a lot of research before moving forward with any treatments.

Another great benefit of this treatment is that, often, patients can go home the same day. Thus, they can begin enjoying physical and outdoor activities soon again.

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Approaches to Healing the Body Via Regeneration - - VENTS Magazine

Bone Marrow Stem Cells Comments Off on Approaches to Healing the Body Via Regeneration – – VENTS Magazine | April 4th, 2020

Cancer Research UK logo.

Cancer Research UK is constantly updating its website with information for people with cancer and their families.

It believes that the constant news about the coronavirus pandemic can be worrying for cancer patients and its treatment can lower their ability to fight infection.

What is coronavirus?

The coronavirus is a flu-like virus. It causes an illness called Covid-19 which can affect your lungs and airways. For most people, the virus wont cause serious problems. But for some people, the virus can have serious complications.

People with cancer are among those at higher risk of complications. This is because cancer and treatment can weaken their immune systems.

How can cancer and treatment weaken immunity?

The immune system protects the body against illness and infection caused by viruses like coronavirus. Some people with cancer have a weak immune system which reduces their ability to fight these infections.

This is because some treatments, like chemotherapy, can stop the bone marrow from making enough white blood cells. White blood cells are part of your immune system.

Some types of cancer can also lower your ability to fight infection. This is usually cancer that affects your immune system like leukaemia or lymphoma.

What do I do if I have symptoms?

The symptoms of coronavirus include:

Contact your cancer advice line, chemotherapy helpline or Acute Oncology Service if you have these symptoms and you are having cancer treatment or have cancer that affects your immune system.

You should do this as soon as possible if you have these symptoms and/ or you feel unwell.

Your healthcare team will assess you over the phone and might ask you to stay at home. But you should speak to your advice line or healthcare team in the first instance.

Contact your advice line or healthcare team as soon as possible if you have symptoms. Or call 999 immediately if you are seriously ill.

If you have symptoms but you are not having cancer treatment, you can look at the NHS 111 online coronavirus service or call NHS 111.

Whats the advice for people with cancer who have no symptoms of coronavirus?

Staying at home (vulnerable groups)

Some people with cancer are more at risk of being seriously ill if they develop the Covid-19 infection. If you are in one of these groups, you are encouraged to follow particular measures to protect yourself. These groups of people include those:

If you are unsure what treatment you are having and whether you are in one of these groups speak to the team caring for you.

What is shielding?

Shielding means you stay home and avoid face-to-face contact for at least 12 weeks. You can continue to have visits from anyone who helps you with essential support. For example, healthcare staff or carers.

All visitors should wash their hands with soap and water for at least 20 seconds when they arrive at your home and often during the visit.

Shielding means you should:

You may receive a letter about shielding if you belong to a vulnerable group. If you think you belong to one of these groups and you have not had a letter, talk to your GP or cancer specialist. The 12-week time period may change if the guidance changes.

I live with other people, what should we do?

Anyone who lives with you should reduce their contact outside their home where possible. But they do not have to practice the same shielding measures. They should practice social distancing.

Depending on your situation, it could be very difficult to stay separate from others at home. Do what you can. It is important that you feel you can support each other through this.

The decision to protect yourself from coronavirus with shielding measures is down to your personal choice and circumstances. For example, there are some people who, because of their cancer, may have a limited time to live, so they may decide not to fully follow the shielding measures.

For more information about shielding, visit the NHS Inform website

Guidance on shielding and protecting people in vulnerable groups

Help with shopping and medicines

Ask friends and family to help pick up shopping or organise deliveries if possible. If this is difficult, there may be a local volunteer group or charities that can help. Some of these have been formed as a result of the virus.

I have cancer but Im not in one of the vulnerable groups, what should I do?

If you are not in one of the above vulnerable groups, you should follow guidance for social distancing. The aim is to reduce your risk of catching and spreading the coronavirus.

Social distancing means reducing your social contact with other people.

Guidance from NHS 111 includes:

Doctors are looking at ways to try and minimise the impact of the coronavirus outbreak on cancer patients. They will aim to continue with your treatment wherever possible. But they might need to change your treatment or prioritise certain treatments over others.

Your team will contact you if there are any changes to your care or treatment.

How do doctors decide about changes to my treatment plan?

When you start cancer treatment, your doctors weigh up the risks and benefits of treatment and discuss these with you. But the risks of your current treatment plan might have changed because of the coronavirus.

Treatment risks include:

Treatment benefit usually refers to the aim of your treatment.

Your treatment might aim to:

Your doctors will carefully weigh up the treatment benefit with the risks of treatment.They will also consider how urgent it is to give you cancer treatment at the moment. They will discuss this with you.

Your doctors also have to consider the impact of the coronavirus outbreak on all health services. For example, its likely that there will be staff and bed shortages. This means they might need to delay or rearrange treatments. Because of this they might need to prioritise some treatments over others.

Talk to your health care team about the effect of the coronavirus outbreak on your treatment plan. They know about your individual situation and will try to work with you to find the best plan for you. Speak to them about any concerns or questions you might have.

Radiotherapy

Your doctor will talk to you if there are any changes to your radiotherapy treatment plan.

To lower the risk of spreading the coronavirus, your team will ask you to come to your appointments on your own. They will also try to reduce the amount of time you spend in the radiotherapy department. For example, they might text you when theyre ready to start the treatment so you dont have to wait around inside the hospital.

Your healthcare team will assess you before your treatment to see if you might have Covid-19or have been exposed to Covid-19.

You might be able to continue with your radiotherapy treatment even if you have confirmed or suspected Covid-19. This will depend on your situation. The radiotherapy team will follow strict guidance on infection control to protect themselves and other radiotherapy patients.

Access to cancer drugs

There isnt currently a shortage of medicines due to the coronavirus outbreak.For example, we have stockpiles of drugs like paracetamol in case there are any issues with supply.

The government is working closely with the NHS and those involved in supplying medicines. They are making sure that patients can get the medicines they need. There are measures in place to prevent medicine shortages in the future.

Hospital Appointments

Contact your GP or cancer specialist if you are due to go to a hospital appointment. You might have some appointments over the phone, or they may be postponed.

Cancer clinical trials

Due to the coronavirus outbreak, some clinical trials for cancer patients may stop recruiting new patients for now. This is so that time and money can be redirected towards:

Your healthcare team will continue to support and monitor you if you are part of a clinical trial. Talk to your team if you have questions or concerns about a trial you are taking part in.

Coping

Coping with a diagnosis of cancer is difficult. For many, the coronavirus is an extra concern and worry. As a result of the outbreak, there may be changes to your hospital appointments and treatment plan. Some people are having telephone appointments with their consultant or specialist nurse instead. You might miss the reassurance of going into the hospital clinic to see familiar faces.

Your healthcare team are doing their best to support you and protect you from developing Covid-19. If coronavirus is a particular worry for you, do mention this. Write down any questions you have so that you remember to ask them.

It can be very difficult if you have been advised to stay at home and reduce face-to-face contact. Try to stay in touch in whatever way you can, whether by phone, online or letter.

If you are feeling scared or anxious about coronavirus, it might be sensible to limit the time you spend looking at social media or news on TV. Only use reliable sources of information, such as websites mentioned on this page.

Talk to those close to you when you can. It helps to share what is making you anxious. And knowing you are not alone can help you cope better. There are different charities and organisations that offer online support or telephone support.

You can call our nurse freephone helpline on 0808 800 4040. They are available from Monday to Friday, 9am to 5pm. Or you can send them a question online.

Contact our cancer information nurses

Tips on helping you keep physically and mentally well

Cancer Chat is the online forum where you can share experiences.

Tips on helping you keep physically and mentally well

In Scotland further information and support is available for people.

NHS inform has further information about the coronavirus for people living in Scotland.

Visit the NHS inform website.

Read more:
Cancer Research UK issues information for people living with cancer during the coronavirus outbreak - Inverness Courier

Bone Marrow Stem Cells Comments Off on Cancer Research UK issues information for people living with cancer during the coronavirus outbreak – Inverness Courier | April 4th, 2020

Evotec SE- a Germany based biotechnology firm has reportedly signed a licensing and investment agreement with panCELLa Inc. a Canadian innovative biotechnology company.

Reportedly, as per the deal, Evotec is expected to receive a non-exclusive license to use panCELLas patented iPS cell lines known as- iACT Stealth Cells that is genetically enhanced to stop immune rejection of derived cell therapy products. Evotec has also invested in panCELLa to own a minority stake in the company, appointing a member to its supervisory board as well.

In addition to the above, the German biotech giant will also be able to access hypoimmunogenic cells, a next generation cloaking technology. The FailSafe solution meets the challenge in iPSC based cell therapy, which is the probable formation of tumors by remaining undifferentiated cells.

Apparently, with the help of the cell lines, Evotec will gain the ability to develop iPSC-based cell therapies that have long term effectiveness and may be safely administered to a wide base of patients without the use of medicines to need to suppress their immune system.

Notably, with an increase in the number of iPSC- based cell therapy technologies at Evotec, access to research and GMP-grade iPSC lines altered with one or both of the technologies offered by PanCELLa will be available to facilitate the development of novel cell therapy approaches across a wide range of indications by the German company and its potential partners.

In a statement by Dr Cord Dohrmann, Chief Scientific Officer, Evotec, cell therapies carry the potential to cure a wide range of different diseases with considerable unmet medical needs. Integrating the advanced technology of PanCELLa and cell lines into the current research and development will boost Evotecs cell therapy offerings. The company primarily aims at rendering safe and reliable cell therapy solutions to a large number of patients, he further added.

According to Mahendra Rao, MD, PhD and panCELLa CEO, Evotecs product expertise and current range of iPSC-based technology will permit panCELLa to advance its own therapeutic interest in NK cell therapy, iPSC-derived MSC platform and pancreatic islet production at a faster rate along with allowing the company to make its technology widely available.

Source Credits: https://www.evotec.com/en/invest/news--announcements/p/evotec-expands-its-ipsc-based-cell-therapy-platform-evocells-through-licensing-agreement-with-pancella-5921

Read the original post:
Evotec partners with panCELLa to enhance cell therapy plaform - ITResearchBrief.com

IPS Cell Therapy Comments Off on Evotec partners with panCELLa to enhance cell therapy plaform – ITResearchBrief.com | April 4th, 2020

There are plenty of hair products out there that promise all kinds of miraculous results. If youre experiencing hair loss, hair thinning, or damaged hair, you might be at your wits end trying products to bring your hair back to health. With so many different options out there, its hard to know which product to choose. And how can you be sure whether any of them really work?

One of the latest big trends in the beauty industry is the use of natural plant stem cells to help replenish your hair and promote healthy growth. Companies claim that stem cell shampoo could be the answer to all your hair problems. We decided to test out the latest product from Cel MD, the Biotin shampoo and conditioner, and see the results it produced.

What is Cel MD?

Cel MD is a cosmetics company that utilizes patented techniques and cutting-edge science. Its aim is to bring the best in beauty treatments to retail. The company offers lots of different products, most of which use plant stem cells. These and other natural extracts help promote healthy skin and hair.

Stem cells are non-specialized cells that are found in our bodies. They can form any cell, meaning they have great potential for regenerating lost cells, particularly in our hair and skin. Stem cell products like shampoos use plant stem cells and extracts, which can help the body produce more stem cells naturally. This can, in turn, lead to healthier hair.

Biotin Shampoo and Conditioner Ingredients

Cel MDs Biotin shampoo and conditioner include the following active ingredients:

Biotin Stem Cell Shampoo and Conditioner Results

Biotin Stem cell Shampoo and conditioner are most effective for thin and flat hair. These products are supposed to promote new hair growth while also strengthening hair and preventing breakages and damage.

The shampoo is listed as being hypoallergenic, meaning its unlikely to cause any rashes or discomfort. I used the Biotin shampoo and conditioner for six weeks, during which time we followed the instructions provided. Both the shampoo and conditioner were used together, with a short, cold water rinse in between.

After just two weeks of using the product, I found that my hair was softer and looking healthier. I was able to grow my hair longer without suffering from the damaged look that had always happened previously. At the end of the six weeks, my hair was noticeably looking a lot thicker, shinier, and was softer to the touch. My hairstylist commented on how it had improved, and it was clear that the shampoo and conditioner were working their magic.

Originally posted here:
Cel MD Biotin Shampoo and Conditioner Review - Explosion

Skin Stem Cells Comments Off on Cel MD Biotin Shampoo and Conditioner Review – Explosion | April 3rd, 2020

TEL AVIV, Israel, April 3, 2020 /PRNewswire/ -- Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of a novel stem cell production technology, today announced operating and financial results for the fourth quarter and full year ended December 31, 2019.

"We achieved a number of strategic priorities in 2019, including the IND approval to commence our first-ever trial in the U.S.," commented Dr. Shai Yarkoni, Chief Executive Officer."We plan to begin enrolling patients for this trial and completing the trial in Israel when the COVID-19 pandemic is mitigated. While these near-term events are value-enhancers, I believe that our recently announced prospective partnership with Canndoc could be a game-changer for Cellect and change our growth trajectory. It has the potential to significantly enhance our short and long term business prospects and shareholder value. As a player in the fast-growing pain management market, we would anticipate significant revenue opportunities already this year."

Recent Strategic Development

As previously announced, on March 4, 2020, the Company entered into a commercial binding Letter Of Intent (LOI) with Canndoc Ltd, a leading pharma grade medical cannabis pioneer and a wholly owned subsidiary of publicly-traded Intercure Ltd. (TASE: INCR),to acquire from Canndoc all rights to the use and sell Canndoc products for the reduction of opioid usage, including accumulated data, as well as on-going and pipeline of clinical trials. This commercial arrangement is subject to negotiation and approval by each company's board of directors and definitive agreements.

Additionally, the two companies signed a non-binding LOI for a full merger. Under preliminary details, Cellect will acquire from Intercure all of Canndoc outstanding shares, in exchange for additional Cellect ADRs to be in total ~95% (~93% on a fully diluted basis) of the merged company. The proposed merger is subject to independent valuation of both companies, fairness opinion by a third party, negotiation of a definitive agreement, approval of the agreement by the Company's Board of Directors and shareholders, internal approvals by Canndoc and Intercure, and customary closing conditions, including the approval of the IMCA (Israeli Medical Cannabis Agency). Upon the closing of the merger, Cellect and Canndoc will aim to fulfill all of the requirements to ensure the Company's ADRs and warrants continue trading on the Nasdaq Stock Market (Nasdaq) and, for this purpose, Intercure would commit to invest a cash sum of at least $3.0 million in any public offering that is undertaken by the Company, at a price of not less than $4.50 per ADR.

Based on the progress to date, the Company continues to expect the commercial and merger transactions will close in the second quarter of 2020.

Additional Operating Highlights:

Clinical Progress Update:

Due to the ongoing COVID-19 pandemic, the Company is experiencing clinical disruption such as:

The Company continues to take all the necessary precautions advised by global health officials to ensure the health and safety of its employees and partners. The Company is unaware of any impact on employees from pandemic related exposure or illness and is continuing to perform in-house research, including in the opioid/pain management area.

Fourth Quarter and Full Year 2019 Financial Results:

Balance Sheet Highlights:

For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2019 (U.S. $1 = NIS 3.456).

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's intent regarding the future potential of Cellect's technology. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Cellect Biotechnology Ltd

Consolidated Statement of Operation

Convenience

translation

Twelve months

ended

Twelve months ended

Three months ended

December 31,

December 31,

December 31,

2019

2019

2018

2019

2018

Unaudited

Audited

Audited

Unaudited

Unaudited

U.S. dollars

NIS

(In thousands, except share and pershare data)

Research and development expenses

3,508

12,122

13,513

2,571

4,040

General and administrative expenses

2,954

10,210

15,734

2,378

4,733

Operating loss

6,462

22,332

29,247

4,949

8,773

Financial expenses (income) due towarrants exercisable into ADS

(2,032)

(7,022)

(7,719)

998

(4,784)

Other financial expenses (income), net

433

1,498

(1,415)

129

(238)

Total comprehensive loss

4,863

16,808

20,113

6,076

3,751

Loss per share:

Basic and diluted loss per share

0.023

0.079

0.155

0.027

0.029

Weighted average number of sharesoutstanding used to compute basic anddiluted loss per share

212,642,505

212,6432,505

129,426,091

224,087,799

130,274,953

Cellect Biotechnology Ltd

Consolidated Balance Sheet Data

ASSETS

Convenience

translation

December 31,

See original here:
Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results - P&T Community

Bone Marrow Stem Cells Comments Off on Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results – P&T Community | April 3rd, 2020

NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of approximately $1.5 million by the Israel Innovation Authority (IIA). The grant enables Brainstorm to continue development of advanced cellular manufacturing capabilities, furthers development of MSC-derived exosomes as a novel therapeutic platform, and will ultimately enable Brainstorm to expand the therapeutic pipeline in neurodegenerative disorders.

BrainStorm's CEO Chaim Lebovits, commented, "The Israel Innovation Authority's support of our programs provides further validation for the potential of our treatments to help patients suffering from neurodegenerative disorders. The continued financial support for our research and development will further our ability to execute our strategic objectives, as we finalize our Phase 3 pivotal trial with NurOwn in ALS patients and advance our cellular technology pipeline."

The IIA has supported BrainStorm Cell Therapeutics Ltd. since 2007, providing grants totaling approximately 11.4 million USD in support of the development of NurOwn and other projects. BrainStorm will be required to pay mid-single digit royalties to the IIA based on sales of the products, up to a total of the cumulative amount of IIA grants received plus accumulated interest.

About NurOwnNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

Story continues

AboutBrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in theU.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

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

CONTACTSInvestor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: + 1.862.397.1860pshah@brainstorm-cell.comMedia:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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Maggie L. Shaw

Mantle cell lymphoma is a type of B-cell non-Hodgkin lymphoma with a typically poor prognosis. Even with an allogeneic stem cell transplant, patients can become resistant to chemotherapy. Most do not survive 4 or 5 years after diagnosis, and the 10-year survival rate hovers between 5% and 10%.

Chimeric antigen receptor (CAR) T-cell therapy has been making great inroads as targeted treatment for many types of cancers highly resistant to other treatments, by prolonging patient survival and increasing their quality of life. Until now, similar results have not been seen in patients with MCL. However, with their successful phase 2 ZUMA-2 trial results just published in the New England Journal of Medicine, a group of researchers led by Michael Wang, MD, from The University of Texas MD Anderson Cancer Center, are able to show that these patients can benefit from the specialized therapy.

In this study conducted in the United States and Europe, the patient population had relapsed/refractory progressive disease despite receiving Brutons tyrosine kinase (BTK) inhibitor therapy and from 3 to 5 prior therapies.

BTK inhibitor therapy has greatly improved outcomes in patients with relapsed or refractory mantle cell lymphoma, yet patients who have disease progression after receiving the treatment are likely to have poor outcomes, with median overall survival of just 6 to 10 months, the authors said.

The median patient age was 65 years (range, 38-79). They were evaluated for response to a single infusion of KTE-X19, an anti-CD19 CAR T-cell therapy, that was dosed at 2106 CAR T cells/kg of body weight. Seventy-four patients were enrolled between October 24, 2016, and April 16, 2019; the treatment was manufactured for 71 and ultimately administered to 68.

There was a follow-up after 60 patients were monitored for 7 months, at which time a primary efficacy analysis was conducted. The primary endpoint was objective response (complete [CR] or partial [PR]), which was confirmed via bone marrow evaluation and positron emission tomography-computed tomography.

Overall, 85% of the entire study cohort of 74 patients was able to reach an objective response to KTE-X19, 59% of whom had a CR. These numbers were even higher among the group of 60 patients. Ninety-three percent (95% CI, 84%-98%) achieved an objective response, which was evaluated by an independent radiologic review committee. And of this group, 67% (95% CI, 53%-78%) had a CR.

The median times to response were impressive, with there being 1 month (range, 0.8-3.1) to initial response and 3 months (range, 0.9-9.3) to CR. In addition, of the 42 patients who initially had a PR or stable disease (SD), 24 (21 who had a PR, 3 who had SD) progressed to a CR in a median 2.2 months (range, 1.8-8.3).

Progression-free (PFS) and overall survival (OS) results also show promise to treatment with KTE-X19. As of the data cutoff date, there was evidence of remission in 78% patients who had a CR, with similar results seen in 57% of patients from the primary efficacy analysis. Overall, at 12 months, the PFS and OS were 61% and 83%, respectively.

Common adverse events to the treatment of grade 3 or higher included cytopenias (94%) and infections (32%). Ninety-one percent also experienced cytokine release syndrome, with a median time to onset of 2 days (range, 1-13) for any grade and 4 days (range, 1-9) for at least grade 3, but none died as a result. According to the study authors, most symptoms were reversible.

ZUMA-2 is the first multi-center, phase 2 study of CAR T-cell therapy for relapsed/refractory mantle cell lymphoma, and these efficacy and safety results are encouraging, stated Wang. Although this study continues, our reported results, including a manageable safety profile, point to this therapy as an effective and viable option for patients with relapsed or refractory mantle cell lymphoma.

Reference

Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-Cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382;1331-1342. doi: 10.1056/NEJM0a1914347.

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Both Phase 2 and Phase 2b/3 trials for COVID-19 patients will be discussed

VANCOUVER, Washington, April 03, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (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 that Nader Pourhassan, Ph.D., President and Chief executive Officer of CytoDyn will appear on Fox Business Network on the Making Money with Charles Payne program. The program will air from 2:00 pm ET to 3:00 pm ET (11:00 am PT to 12 noon PT) and is also available via live streaming at https://www.foxbusiness.com/shows/making-money-with-charles-payne.

The Companys investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The Company recently initiated enrollment in a Phase 2 trial for leronlimab treatment of COVID-19 patients with mild-to-moderate indications and under the same IND, is now proceeding with its second COVID-19 clinical, a Phase 2b/3 trial for the treatment of critically ill patients.

About Coronavirus Disease 2019SARS-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) 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.

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 aPhase 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.

Story continues

About CytoDynCytoDyn 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 plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. 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 with no reported drug-related serious adverse events (SAEs). 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 atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys 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 Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys 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 Companys 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 Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

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

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CytoDyn CEO Dr. Pourhassan to Appear on Fox Business Network Friday, April 3, 2020 at 2:00 pm ET to Discuss Leronlimab Treatment of 10 Severely Ill...

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By: Explained Desk | New Delhi | Updated: April 3, 2020 7:55:52 pm What are the risks if those suffering from cancer contract coronavirus? Image source: Pixabay

The number of people infected with COVID-19 across the world has now reached a million. It is well known now that while people of all age groups are vulnerable to infection from the disease caused by the SARS-CoV-2 virus, the people likely to develop severe COVID-19 are those above the age of 60 years.

Especially vulnerable are those people who have comorbidities such as heart disease, hypertension, diabetes, chronic respiratory disease and cancer.

For some cancer patients receiving treatment, the global pandemic poses a different set of challenges, even if they do not have COVID-19. Heres a look at some of those challenges and how doctors and cancer specialists have been advised to alter treatments during this time.

Are cancer patients at higher risk of developing serious illness due to COVID-19?

Yes, a subset of cancer patients are more vulnerable to developing serious illness due to COVID-19. This subset includes people with cancer who are undergoing active chemotherapy, those undergoing radical radiotherapy for lung cancer, people with cancers of the blood or bone marrow such as leukaemia, lymphoma or myeloma (at any stage of treatment), those getting immunotherapy or antibody treatments for cancer, those having other types of targetted cancer treatments which may affect the immune system and cancer patients who have undergone bone marrow or stem cell transplants in the last six months or who are still taking immunosuppressive drugs.

Further, a cancer patient who is over the age of 60 and has comorbodities such as cardiovascular or respiratory issues will also be especially vulnerable to illness due to COVID-19. As per a recent analysis of patients in Italy, 20 percent of those who died in the country had active cancer.

Also in Explained: The cancer crisis in India

Some cancer patients are more vulnerable because of their weakened immune systems. The immune system has an important role to play to fight off infection or repair an injured tissue. With COVID-19 as well, the role of the immune system is to try and fight off the virus. For this to happen, the immune system should not be overstimulated so as to cause hyper inflammation caused when more than necessary number of white blood cells are deployed by the immune system, which can lead to sepsis or even death. The immune system should also not be weak that it is unable to fight off the infection.

Some cancer treatments such as chemotherapy and radiotherapy might weaken the immune system of the patient, since such treatments can stop the bone marrow from making enough white blood cells. Due to this, the immune system is weakened, reducing the persons ability to fight off infection.c

Also Read: How to make a face mask a step-by-step guide

What about cancer patients who do not have COVID-19?

The UKs National Health Service (NHS) has placed guidelines for treatment of cancer patients who do not have COVID-19. These guidelines state that cancer patients may need to consider if the risks of beginning or continuing their cancer treatment could outweigh the benefits, since patients receiving therapies are more at risk from becoming seriously ill if they were to contract COVID-19. When deciding on whether a particular cancer treatment should be undertaken, doctors may also take into account the exposure of the patient to the virus during hospital visits.

Further doctors dealing with cancer patients will also have to consider the overall impact of the coronavirus on health services, Cancer Research UK points out. For example, its likely that there will be staff and bed shortages. This means they might need to delay or rearrange treatments. Because of this, they might need to prioritise some treatments over others, it says.

Heres a quick Coronavirus guide from Express Explained to keep you updated: What can cause a COVID-19 patient to relapse after recovery? | COVID-19 lockdown has cleaned up the air, but this may not be good news. Heres why | Can alternative medicine work against the coronavirus? | A five-minute test for COVID-19 has been readied, India may get it too | How India is building up defence during lockdown | Why only a fraction of those with coronavirus suffer acutely | How do healthcare workers protect themselves from getting infected? | What does it take to set up isolation wards?

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Explained: Why are cancer patients more vulnerable to coronavirus? - The Indian Express

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WASHINGTON, April 2, 2020 /PRNewswire/ -- An article published in Experimental Biology and Medicine (Volume 245, Issue 6, March 2020) (https://journals.sagepub.com/doi/pdf/10.1177/1535370220910690) examines the safety of stem cell therapy for the treatment of colon cancer.The study, led by Dr. J. Liu in the State Key Laboratory of Bioreactor Engineering and Shanghai Key Laboratory of New Drug Design at the East China University of Science and Technology in Shanghai (China), reports that mesenchymal stem cells from a variety of sources promote the growth and metastasis of colon cancer cells in an animal model.

Mesenchymal stem (MSCs), a category of adult stem cells, are being evaluated as therapy for numerous cancers.MSCs are excellent carriers for tumor treatment because they migrate to tumor tissues, can be genetically modified to secrete anticancer molecules and do not elicit immune responses.Clinical trials have shown that MSCs carrying modified genes can be used to treat colon cancer as well as ulcerative colitis. However, some studies have demonstrated MSCs can differentiate into cancer-associated fibroblasts and promote tumor growth.Therefore, additional studies are needed to evaluate the safety of MSCs for targeted treatment of colon cancer.

In the current study, Dr. Liu and colleagues examined the effects of mesenchymal stem cells (MSCs) from three sources (bone marrow, adipose and placenta) on colon cancer cells.MSCs from all three sources promoted tumor growth and metastasis in vivo. In vitro studies demonstrated that MSCs promote colon cancer cell stemness and epithelial to mesenchymal transition, which would enhance tumor growth and metastasis respectively.Finally, the detrimental effects of MSCs could be reversed by blocking IL-8 signaling pathways. Dr. Ma, co-author on the study, said that "Mesenchymal stem cells have a dual role: promoting and/or suppressing cancer. Which effect is dominant depends on the type of tumor cell, the tissue source of the MSC and the interaction between the MSC and the cancer cell. This is the major issue in the clinical application research of MSCs, and additional preclinical experimental data will be needed to evaluate the safety of MSCs for colon cancer treatment."

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology & Medicine, said: "Lui and colleagues have performed elegant studies on the impact of mesenchymal stem cells (MSCs), from various sources, upon the proliferation, stemness and metastasis of colon cancer stem cells (CSCs) in vitro and in vivo. They further demonstrate that IL-8 stimulates the interaction between colon CSCs and MSCs, and activates the MAPK signaling pathway in colon CSCs.This provides a basis for the further study of MSCs as a biologic therapy for colon cancer."

Experimental Biology and Medicine is a global journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. The journal was first established in 1903. Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership, visit http://www.sebm.org. For anyone interested in publishing in the journal, please visit http://ebm.sagepub.com.

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Stem Cell Therapy for Colon Cancer - Yahoo Finance

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy for Colon Cancer – Yahoo Finance | April 2nd, 2020

Global Bone Marrow Aspirate Concentrates Market was valued US$ XX Bn in 2018 and is expected to reach US$ XX Bn by 2026, at CAGR of 6.5 % during forecast period of 2019 to 2026

Bone marrow concentrate (BMC) uses stem cells that are harvested from your own bone marrow to help the body heal itself. These cells when injected directly into an injury site, prompt a rapid and efficient restoration of the tissue, returning it to a more healthy state by stimulating the bodys natural healing response. It is non-surgical treatment for various orthopedic injuries, including mild to moderate osteoarthritis, disc degeneration and soft tissue injuries.

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Global Bone Marrow Aspirate Concentrates Market Drivers and RestrainsBone marrow-derived stem cell treatment is considered a promising and advanced therapy. It reduces the injury healing time in orthopedic diseases to five to six weeks from four to six months in case of surgery. Reduction in the healing time is a factor likely to fuel the Bone Marrow Aspirate Concentrates market during the forecast period.

Pain associated with the treatment, lack of awareness, and use of alternative treatments are major restraints to the Global Bone Marrow Aspirate Concentrates Market. Furthermore, increased investments in R&D and clinical trials attributed to slow approval processes entailing sunken costs, and marginal returns on investment for manufacturers are factors hindering Global Bone Marrow Aspirate Concentrates Market.

Global Bone Marrow Aspirate Concentrates Market key segmentationBy end-use market is divided into hospitals & clinics, pharmaceutical & biotechnology companies, Contract Research Organizations (CROs) & Contract Manufacturing Organizations (CMOs), and academic & research institutes. The hospitals & clinics segment dominated the bone marrow aspirate concentrates market in 2018 and is expected to maintain its dominance during the forecast period. The hospitals & clinics segmental growth is boosted by the biotechnology & biopharmaceutical companies in terms of revenue during the forecast period. Growth of the segment is attributed to increasing number of biotechnology companies and rising partnerships among the market players to expand globally.

Global Bone Marrow Aspirate Concentrates Market regional analysisBy regional analysis, global bone marrow aspirate concentrates market is divided into major five geographical regions, including North America, Europe, Asia-Pacific, Latin America and Middle East and Africa. North America held largest share of the Global Bone Marrow Aspirate Concentrates market owing to technological advancements and regulatory approval for new devices, rising awareness about stem cell therapy, and number of cosmetic surgical procedures. Furthermore, Asia Pacific orthopedic market is key driver, which led to this massive and augmented growth. The orthopedic market in Asia including bone graft, spine, and bone substitute is anticipated to grow as fast as the overall orthopedic market which will further boost growth of BMAC market in the region during forecast period.

The objective of the report is to present comprehensive analysis of Global Bone Marrow Aspirate Concentrates Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of industry with dedicated study of key players that includes market leaders, followers and new entrants by region. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors by region on the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give clear futuristic view of the industry to the decision makers.

The report also helps in understanding Global Bone Marrow Aspirate Concentrates Market dynamics, structure by analyzing the market segments, and project the Global Bone Marrow Aspirate Concentrates Market size. Clear representation of competitive analysis of key players by Bone Marrow Aspirate Concentrates Type, price, financial position, product portfolio, growth strategies, and regional presence in the Global Bone Marrow Aspirate Concentrates Market make the report investors guide.

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Global Bone Marrow Aspirate Concentrates Market by product type

Bone Marrow Aspirate Concentrates Systems Bone Marrow Aspirate Concentrates AccessoriesGlobal Bone Marrow Aspirate Concentrates Market Application

Orthopaedic Surgery, Wound Healing, Chronic Pain, Peripheral Vascular Disease, Dermatology;Global Bone Marrow Aspirate Concentrates Market by region

Asia Pacific North America Europe Latin America Middle East AfricaGlobal Bone Marrow Aspirate Concentrates Market by end-user

Hospitals & Clinics Pharmaceutical & Biotechnology Companies Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) Academic & Research InstitutesKey players operating on Global Bone Marrow Aspirate Concentrates Market

Terumo Corporation (Terumo BCT), Ranfac Corp., Arthrex, Inc., Globus Medical, Inc., Cesca Therapeutics Inc., MK Alliance Inc. (TotipotentSC), and Zimmer Biomet Holdings, Inc Cesca Therapeutics Inc. Stryker Paul Medical Systems LIFELINX SURGIMED PVT. LTD.

MAJOR TOC OF THE REPORT

Chapter One: Bone Marrow Aspirate Concentrates (BMAC) Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Bone Marrow Aspirate Concentrates (BMAC) Market Competition, by Players

Chapter Four: Global Bone Marrow Aspirate Concentrates (BMAC) Market Size by Regions

Chapter Five: North America Bone Marrow Aspirate Concentrates (BMAC) Revenue by Countries

Chapter Six: Europe Bone Marrow Aspirate Concentrates (BMAC) Revenue by Countries

Chapter Seven: Asia-Pacific Bone Marrow Aspirate Concentrates (BMAC) Revenue by Countries

Chapter Eight: South America Bone Marrow Aspirate Concentrates (BMAC) Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Bone Marrow Aspirate Concentrates (BMAC) by Countries

Chapter Ten: Global Bone Marrow Aspirate Concentrates (BMAC) Market Segment by Type

Chapter Eleven: Global Bone Marrow Aspirate Concentrates (BMAC) Market Segment by Application

Chapter Twelve: Global Bone Marrow Aspirate Concentrates (BMAC) Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Bone Marrow Aspirate Concentrates (BMAC) Market Report at: https://www.maximizemarketresearch.com/market-report/global-bone-marrow-aspirate-concentrates-bmac-market/37078/

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Global Bone Marrow Aspirate Concentrates (BMAC) Market: Industry Analysis and forecast (2019 to 2026): By product Type, Application, End Users, and...

Bone Marrow Stem Cells Comments Off on Global Bone Marrow Aspirate Concentrates (BMAC) Market: Industry Analysis and forecast (2019 to 2026): By product Type, Application, End Users, and… | April 2nd, 2020

, which were found to produce high levels of Interleukin-6 (IL-6), was abated in the presence of anti-IL-6 monoclonal antibodies, according to study results intended to be presented at the annual meeting of the American College of Cardiology (ACC.20).

In a diseased state, cardiacmesenchymal stromal cells (cMSCs) remodel and secrete inflammatory cytokines,including IL-6. IL-6 has been shown to be a potent inducer of Ca2+-mediatedarrhythmia substrates in human myocytes. While anti-IL-6 monoclonal antibodies havean established role in the treatment of autoimmune diseases and malignancies, theiruse in the treatment of cardiac disease has not been well studied.

Using extracted device leads and explanted hearts from patients with and without heart failure, investigators isolated cMSCs (failing and non-failing cMSCs, respectively), and quantified IL-6 using an enzyme-linked immunosorbent assay. Myocytes were derived from induced pluripotent stem cells (iPSCs) from individuals without heart failure and cultured in monolayers. Myocytes were treated with exogenous IL-6 or cocultured with failing cMSCs with and without anti-IL-6 monoclonal antibody. Fluorescent indicators were used to detect the presence of Ca2+ alternans during steady state pacing.

The secretion of IL-6 was found tobe 5.6 times higher in failing vs nonfailing cMSCs (n=4; P <.005) and 66 times higher in cMSCs vs iPSC-derived humanmyocytes (n=5; P <.002). Myocytes thatwere cocultured with failing cMSCs or were exposed to exogenous IL-6 had largeincreases in Ca2+ alternans compared with myocytes cultured alone (343%,n=12, P <.001 and 300%, n=5, P <.002, respectively). These Ca2+alternans were reduced to baseline levels in myocyte/cMSC cocultures treated vsnot treated with IL-6 (reduction, 400%; n=18, P <.001).

These results suggest anovel anti-arrhythmic therapeutic strategy in heart failure using anti-IL-6drugs such as tocilizumab, sarilumab, or siltuximab, concluded theresearchers.

Reference

Vasireddi S, Sattayaprasert P,Moravec C, et al. Targeted anti-inflammatory treatment with anti-Il-6monoclonal antibody for calcium-mediated arrhythmia substrates in heartfailure. Intended to be presented at: American College of Cardiologys 69thAnnual Scientific Session; March 28-30, 2020; Chicago, IL. Presentation 915-09.

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Anti-IL-6 Monoclonal Antibodies as Antiarrhythmic Treatment for HF - The Cardiology Advisor

Cardiac Stem Cells Comments Off on Anti-IL-6 Monoclonal Antibodies as Antiarrhythmic Treatment for HF – The Cardiology Advisor | April 2nd, 2020

HAMBURG, Germany and TORONTO, April 2, 2020 /CNW/ - Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the innovative biotechnology company panCELLa Inc. announced today that the companies have entered into a licensing and investment agreement.

Under the terms of the agreement, Evotec will receive a non-exclusive licence to access panCELLa's proprietary iPS cell lines "iACT Stealth Cells", which are genetically modified to prevent immune rejection of derived cell therapy products ("cloaking"). Furthermore, Evotec will also have access to a new-generation cloaking technology known as hypoimmunogenic cells. In addition, the "FailSafe" mechanism effectively addresses a key challenge in iPSC-based cell therapy, potential tumour formation by residual undifferentiated cells.

Using the cell lines, Evotec will be able to develop iPSC-based, off-the-shelf cell therapies with long-lasting efficacy that can be safely administered to a broad population of patients without the use of medication to supress the patients' immune system. With a growing portfolio of iPSC-based cell therapy projects at Evotec, access to research as well as GMP-grade iPSC lines modified with one or both of the panCELLa technologies significantly accelerates Evotec's cell therapy discovery and development efforts. Modified iPSC lines will be available for the development of cell therapy approaches across a broad range of indications by Evotec and potential partners. Furthermore, Evotec has made an investment to take a minority stake in panCELLa and has nominated Dr Andreas Scheel to join panCELLa's supervisory board.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Cell therapies hold enormous potential as truly regenerative or curative approaches for a broad range of different diseases with significant medical need. Integrating panCELLa's technology and cell lines into our ongoing proprietary research and development efforts strengthens Evotec's position in cell therapy. It is our goal to provide safe highly-effective cell therapy products to as many patients as possible. In addition to small molecules and biologics, cell therapy will become yet another major pillar of Evotec's multimodality discovery and development platform."

Mahendra Rao, MD, PhD, CEO at panCELLa, added: "We welcome the partnership with Evotec. Evotec's widely recognised expertise and existing portfolio of iPSC-related technology platforms will allow panCELLa to rapidly advance its own therapeutic interests in NK cell therapy, pancreatic islet production and iPSC-derived MSC platform, in addition to enabling panCELLa to make its platform technologies widely available. I believe that the investment by Evotec in our company is a strong validation of the leading role of panCELLa in the field of regenerative medicine and in the utility of its platform technologies. We welcome Dr Andreas Scheel to our Board."

No financial details of the agreement were disclosed.

About Evotec and iPSCInduced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka's lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon "for the discovery that mature cells can be reprogrammed to become pluripotent". Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec's iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company's proprietary EVOcells platform.

About cell therapy and panCELLa's FailSafe iPSC technologyCell therapy, one of the most promising regenerative medicine approaches, replaces a patient's missing or broken cells with functioning cells from a range of different sources, either from a donor, from the patient's own material, or from stem cells. The advent of induced pluripotent stem cells ("iPSC") has opened up stem cells as an almost unlimited source of consistent-quality material for such cell therapies. At the same time, differentiating cell therapies from a single validated source circumvents critical risks of contamination associated with administering both donor and patient cell material.

However, the patient's immune system will treat such iPSC-based transplant as "foreign" and use the body's immune system to counteract the therapy, thus undermining its long-term efficacy. While organ transplants require an often lifelong regimen of immunosuppressants, iPSC-derived cells used for cell therapies can be cloaked to make them undetectable by the patient's immune system, thus avoiding rejection and enabling effective long-term relief of the patient's symptoms.

To increase the safety of such iPSC-derived cell products, panCELLa's proprietary FailSafe technology is able to inactivate any iPSC-derived proliferating cell before and after transplantation through the use of a readily available anti-infective medication. FailSafe is the only quantifiable "safety switch" on the market which is expected to be critical for regulators, clinicians and patients to make informed decisions when evaluating treatment options.

About panCELLa Inc. Incorporated in August 2015, panCELLa (www.pancella.com) was founded by Dr Andras Nagy and Dr Armand Keating based on Dr Nagy's ground-breaking work in the area of stem cell research. Through panCELLa, Drs Keating and Nagy are seeking to create an effective cell therapy derived from stem cells, which are modified to provide a sufficient and very high level of safety before and after the cells are introduced to the patient. panCELLa serves those companies developing products from stem cells. panCELLa seeks to create universal "off the shelf" FailSafe Cells and to assist pharmaceutical and biotechnology sectors to achieve such with their own cell lines. Targeted medical applications include deadly, debilitating, or aggressive diseases requiring immediate treatment where there is no time to cultivate a customized stem cell treatment from the patient (i.e. cancer, cardiac infarct, diabetes, stroke and spinal cord injury).

About Evotec SEEvotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,000 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to http://www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTSInformation set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

SOURCE panCELLa Inc.

Company Codes: Frankfurt:EVT, OTC-PINK:EVTCY

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Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa - BioSpace

IPS Cell Therapy Comments Off on Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa – BioSpace | April 2nd, 2020

Lonza has announced the launch of the TheraPEAK SfAAV Medium, the first chemically defined, non-animal origin medium designed specifically for the production of Adeno Associated Virus (AAV) in Spodoptera fuigiperda (Sf9) insect cells for gene therapy applications. The new high-performance medium aims to accelerate cell growth, increase productivity, and reduce process variability and costs, expediting time-to-market for safe, scalable, life-saving gene therapies.

Gene therapy holds great promise for the treatment of rare disorders and diseases, and viral vectors are commonly used to facilitate the delivery of the gene of interest into patient cells. AAV has been established as a viral vector of choice, due to not replicating in patients, thus posing a lower health risk. Owing to their ability to be grown at high densities, the Sf9 insect cells are ideal for use as hosts for the production of large AAV quantities. To date, however, translational scientists and researchers have been challenged with the lack of a medium dedicated to AAV production in Sf9 insect cells.

Lonzas TheraPEAK SfAAV Medium has been explicitly designed to address this need, providing a cost and time efficient solution for the production of AAV in Sf9 insect cells. Allowing for rapid cell growth, the TheraPEAK SfAAV Medium can reduce processing time significantly, enabling cell infection one day earlier than similar media available on the market, and boosting laboratory performance. Due to its chemically defined nature, the new hydrolysate free medium produces AAV that requires less purification, further decreasing the overall processing time and minimizing labor requirements. Furthermore, the TheraPEAK SfAAV Medium supports consistent cell growth throughout all phases of the culturing process, considerably reducing process variability.

As a chemically defined, non-animal origin product, the TheraPEAK SfAAV Medium can be considered safer to use than media containing animal or human components, thereby facilitating regulatory compliance. Additionally, the medium is supplied with a U.S. Food and Drug Administration drug master file, alleviating the relevant preparation and submission burden.

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Optimizing the Production of AAV in Sf9 Insect Cells - Technology Networks

IPS Cell Therapy Comments Off on Optimizing the Production of AAV in Sf9 Insect Cells – Technology Networks | April 2nd, 2020

Australian startup Cortical Labs is building computer chips that use biological neurons extracted from mice and humans, Fortune reports.

The goal is to dramatically lower the amount of power current artificial intelligence systems need to operate by mimicking the way the human brain.

According to Cortical Labs announcement, the company is planning to build technology that harnesses the power of synthetic biology and the full potential of the human brain in order to create a new class of AI that could solve societys greatest challenges.

The mouse neurons are extracted from embryos, according to Fortune, but the human ones are created by turning skin cells back into stem cells and then into neurons.

The idea of using biological neurons to power computers isnt new. Cortical Labs announcement comes one week after a group of European researchers managed to turn on a working neural network that allows biological and silicon-based brain cells to communicate with each other over the internet.

Researchers at MIT have also attempted to use bacteria, not neurons, to build a computing system in 2016.

As of right now, Corticals mini-brains have less processing power than a dragonfly brain. The company is looking to get its mouse-neuron-powered chips to be capable of playing a game of Pong, as CEO Hon Weng Chong told Fortune, following the footsteps of AI company DeepMind, which used the game to test the power of its AI algorithms back in 2013.

What we are trying to do is show we can shape the behavior of these neurons, Chong told Fortune.

READ MORE: A startup is building computer chips using human neurons [Fortune]

More on neurons: Artificial and Biological Neurons Just Talked Over the Internet

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This Startup's Computer Chips Are Powered by Human Neurons - Futurism

Skin Stem Cells Comments Off on This Startup’s Computer Chips Are Powered by Human Neurons – Futurism | April 2nd, 2020

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group he didnt give a name for the group to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinsons cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

I started thinking rather early onThere might be something on the horizon that we dont fully understand, Federoff told Endpoints News. We knew that if something did change, it could change rather quickly.

Operating with insight and knowledge other biotechs lacked access to, Federoff went into overdrive trying to close before Covid-19 hit the US, and he emerged today with $70 million in Series A funding led by OrbiMed. The other investors included Frazier Health Partners, Sam Altman and ARCH Venture Partners, the VC whose leader Robert Nelsen became one of the earliest and most prominent voices calling for change.

Weve had long conversations, Federoff said of him and Nelsen.

With the Series A, Federoff has convinced A-list investors to back one version of a long-sought solution to Parkinsons. Aspen will use stem cells grown from Parkinsons patients own skin tissue to grow dopamine neurons that can be implanted into the brain and hopefully replace the degenerating neurons. The idea has been around for decades, with the first transplant occurring in the 80s, but it was never scaleable. The technology to produce stem cells on demand didnt exist.

The company has a rival in BlueRock, which uses donor stem cells and which Bayer acquired in August at a valuation of $1 billion.

Over the winter, though, the investor hunt became less about pitching the science which Federoff says everyone agreed was promising than about beating the clock and investors rising worries about the economy. He prepared to work fast, turning an early meeting with Frazier at the JP Morgan Healthcare Conference into a pivotal one. As the months passed, he phoned investors multiple times a day to keep funding on track.

They were already in from the standpoint of the science, Federoff said. I could tell that there was a growing weariness about whether all that they had previously considered as part of their own respective portfolios outside of Aspen would all be possible.

The money he secured will help fund their Phase I trial on Parkinsons and a second program that uses a form of gene therapy to implant stem cells that have a genetic marker for Parkinsons edited out. The plan had been to start a trial in 2021, but Federoff knows there are no more guarantees.

At this time its not clear what Covid-19 will do to projections, he said.

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'There was a growing weariness': Rushing against a pandemic clock, Aspen Neurosciences secures $70M Series A - Endpoints News

Skin Stem Cells Comments Off on ‘There was a growing weariness’: Rushing against a pandemic clock, Aspen Neurosciences secures $70M Series A – Endpoints News | April 2nd, 2020

Disclosure: Dr Henderson is the president and principal owner of The Synaptic Space, a neuroimaging consulting firm, and owner of Neuro-Luminance Corporation. Please see the listed studies for a full list of disclosures.

During the last 20 years, a large body of research has accumulated on the beneficial effects of infrared light in the range of 600 to 1000 nm. Infrared light can activate mitochondria, which in turn stimulate second messenger systems, DNA transcription, and growth factors.1,2 As a result, new synapses are formed, circuits regrow, and pluripotent stem cells differentiate into neurons.

Animal studies have shown that infrared photobiomodulation (PBM) may reduce the size and severity of brain injury and stroke, as well as diminish damage and physiological symptoms in depression, posttraumatic stress disorder (PTSD), Parkinson disease, and Alzheimer disease.1,3-6 Michael Hamblin, PhD, from the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, a leader in the field, describes PBM as the use of red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has either been injured, is degenerating, or else is at risk of dying.1

Generally in medicine we shy away from the word heal when referring to the brain, and regenerate stirs vague recollections of Frankenstein. Nevertheless, early findings in mouse models of brain injury and disease have spawned a different sort of monster in the commercial world. The internet is now loaded with companies offering infrared LED helmets or pads for the treatment of traumatic brain injury (TBI) and other brain disorders, often based on exaggerated claims about healing the brain. Exorbitant prices in the thousands of dollars are charged for a device that can be made for less than $30. As a result, the public is misled and the potential scientific benefits of infrared light are sullied.

It is time to separate fact from fiction. Yes, infrared light can induce the cellular events described here, reduce the size of stroke injury or TBI in mouse models, and protect neurons from neurotoxins. But is treating a human with a 0.5-W LED the same as treating a mouse? Certainly not! When it comes to infrared light treatment, it is all a matter of getting there: the infrared light must be able to penetrate all the overlying tissue to reach the brain.

Can Infrared Light Reach the Brain?

Can 0.5-W LEDs penetrate human scalp and skull to reach the brain? The answer is No.2 My colleague, Larry Morries, DC, and I showed that these LEDs did not even penetrate 2 mm of human skin. In contrast, our laser device, which emits infrared light in the range of 10 to 15 W, was able to effectively penetrate human tissue. We found that 33% of our 10-W infrared laser energy penetrated 2 mm of human skin and delivered from 1.2% to 2.4% of the energy from our device 3 cm into the brain. These data were replicated in a study by Juanita Anders, PhD, and colleagues at the Uniformed Services University of Health Sciences.7

The human scalp and skull provide a significant barrier. Infrared light energy needs to be in the range of 0.9 to 15 J/cm2 at the target tissue to activate mitochondria and other cellular events.2-3,8-9 Even if a 0.5-W LED only had to penetrate the skull to reach the surface of the brain, it could only deliver 0.0064 J/cm2, or 1/140th of the minimum energy necessary to induce PBM.10 No energy would be expected to reach the depths of the brain needed to treat stroke, Parkinson disease, Alzheimer disease, or many brain injuries. Although more than 40% of the incident light from a light source may penetrate mouse skull, only 4.2% penetrates human skull.8,10

There is a hairier problem facing LED devices: human hair blocks infrared light. More than 98% of infrared light can be blocked by 2 mm of hair (ie, 9.764 W of a 10-W beam of 810 nm infrared light is absorbed by human hair).11 If 98% of the energy from a 0.5-W LED is absorbed by hair, 80% to 90% is absorbed by 2 mm of skin, and 96% of incident energy is attenuated by skull, then claims of neurophysiological benefits of LED-based devices become highly questionable.

Another misconception propagated by companies selling LED-based devices is that multiple LEDs somehow increase light penetration, even though each LED projects light on its own path. For example, 100 0.5-W LEDs do not generate 50 W on the brain, they generate 0.5 W on 100 spots.11 The argument that light scattering in the brain provides the cumulative value of multiple LEDs also falls apart if nothing can get through the overlying tissues.

Given that a small percentage (<1%) of incident infrared light gets through human scalp and skull, we must question the results of human trials of LEDs. Studies demonstrated small yet almost insignificant positive effects, and the benefits are generally transient.12 In contrast, our protocol yields persistent and robust clinical changes in patients with TBI, PTSD, and depression.

Treating TBI, PTSD, and Depression with Infrared Light

Our patented multi-Watt Neuro-Luminance approach involves transcranial infrared laser treatment (NILT), and in 2015 we published an initial open-label trial of 10 subjects with mild to moderate TBI.13 After a course of 10 NILT treatments (20 treatments in a subset of 4 patients), all patients experienced significant clinical improvement of symptoms, including headaches, cognitive problems, sleep disturbances, irritability, and depression. In telephone interviews every 6 months after treatment, patients report sustained improvements.12

An open-label clinical trial (n=39) of multi-Watt Neuro-Luminance demonstrated effectiveness for depression.4 Overall, 92% of patients responded and 82% remitted, which is notably better than the response rate for oral antidepressants. Patients saw benefits within 4 treatments, and some achieved resolution of depressive symptoms within 8 treatments. In follow-up telephone interviews, patients report sustained improvements. Similarly, in our unpublished data, using a protocol of 20 treatments, each lasting 24 minutes, over the course of 9 weeks, 20 patients with PTSD treated with multi-Watt NILT experienced reduced hyperarousal, anxiety, sleep disturbance, and nightmares.

LED Photobiomodulation in Comparison

Naeser and colleagues15 treated 2 patients with TBI daily for approximately 1 hour by applying 3 separate LED cluster heads (2 head; 1 foot). The first patient, who was 7 years post-TBI and had significant postconcussive symptoms, received weekly treatments over the course of 7 months and then daily treatments at home for more than 6 years. The patient experienced transient benefits, and if treatment was stopped, symptoms returned within 2 weeks.15 The second patient received daily treatments, and in 4 months, most symptoms improved, allowing her to return to work. This patient also noted that symptoms returned if treatments were stopped for more than 1 week.15

In an open-label study,16 11 patients with TBI and persistent cognitive dysfunction were treated for 18 sessions, each lasting 20 minutes, over the course of 6 weeks. At follow-up, there had been a significant effect on attention, inhibition, verbal learning and memory, and long-delay free recall.16 The LED treatment led to mild improvement in 3 of 5 cases of depression.

In 12 patients with TBI treated with 220 0.5-W LEDs for 18 sessions, each lasting 20 minutes, over the course of 6 weeks, there was significant improvement in psychological testing results (P =.45).17 However, the study did not correct for multiple comparisons, instead using parallel paired t-tests, which could exaggerate findings.18 PTSD has received considerably less attention.19,20

Cassano and colleagues21 described a 5-W laser treatment of 4 patients with depression. In a double-blind, sham-controlled extension of their initial findings, subjects in the treatment group received 16 treatments, each lasting 30 minutes, over the course of 8 weeks.22 In 13 completers, Hamilton-D-17 scores separated the treatment group from sham controls (mean score, 15.74.41 vs 6.17.86; P =.031). In contrast, in our open-label trial of a 13-W laser, the mean Hamilton-D-17 score decreased from baseline (mean score, 21.485.24 to 6.05.12; P =6.4510-13).23

Table. Case series, open-label, and double-blind studies of infrared light therapy for TBI, PTSD, and depression

Alternative Explanation for Clinical Response to LED Brain Treatments

Researchers, along with the human PBM field, need to reconsider the potential mechanisms underlying the meager improvements derived from LED-based devices. The light from LED devices may not penetrate beyond the skin, but could induce central nervous system benefits via a remote or systemic effect in irradiated skin, dubbed remote photobiomodulation.24

Infrared irradiation can have remote or indirect effects on tissue that has not been irradiated. For example, Braverman and colleagues25 demonstrated this indirect effect by creating matching skin lesions on the left and right dorsum of a rabbit, treating 1 side with infrared light. Both lesions showed accelerated healing relative to nonirradiated controls. Rochkind and colleagues26 demonstrated that remote PBM could occur in the peripheral nervous system and the central nervous system. After bilateral sciatic nerve crush, 1 side was irradiated with infrared light and the other side was not. Nerves on both sides showed enhanced recovery of function, and the number of anterior horn motor neurons was greater on both sides compared with nonirradiated controls.

Ganeshan and colleagues27 irradiated the dorsum and hind limbs of a rat with infrared light (670 nm) before injection of a neurotoxin (MPTP) and demonstrated reduced loss of dopaminergic neurons in rodents treated with indirect PBM to the skin compared with untreated controls. Given the overwhelming evidence that low-power LEDs do not penetrate the brain, it is more likely that the benefits of LED-based devices result from an effect mediated by the skin, where most, if not all, of the infrared energy is absorbed. In other words, LED-based devices may be working by remote PBM.

Conclusions

The excitement about the potential of infrared light therapy is not merely that it does not involve taking a pill. There is considerable enthusiasm about its potential to treat conditions such as TBI, dementia, and Parkinson disease. In our excitement, we must not overlook the unique physical limitations of light. Similarly, we must not imbue infrared light with magical powers. Infrared light can only work if it reaches target tissue.

Thus, a sharp divide can be drawn between LED-based treatment technologies, which offer minimal results and may not even reach the brain, and multi-Watt technologies that demonstrably reach the brain and offer lasting clinical benefit. Potentially, infrared light may prove to be effective for numerous neuropsychiatric conditions. However, for infrared light to work on the brain, it must be able to reach the brain.

References

1. Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016;6:113-124.

2. Henderson TA, Morries, LD. Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain? Neuropsychiatr Dis Treat. 2015;11:2191-2208.

3. Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012;40(2):516-533.

4. Henderson TA, Morries LD. Multi-Watt near-infrared phototherapy for the treatment of comorbid depression: an open-label single-arm study. Front Psychiatry. 2017;8:187.

5. Johnstone DM, Moro C, Stone J, Benabid AL, Mitrofanis J. Turning on lights to stop neurodegeneration: the potential of near infrared light therapy in Alzheimers and Parkinsons disease. Front Neurosci. 2016;11;9:500.

6. Hamblin MR. Photobiomodulation for Alzheimers disease: has the light dawned? Photonics. 2019;6(3):77.

7. Tedford CE, DeLapp S, Jacques S, Anders J. Quantitative analysis of transcranial and intraparenchymal light penetration in human cadaver brain tissue. Lasers Surg Med. 2015;47(4):312-322.

8. Ando T, Xuan W, Xu T, et al. Comparison of therapeutic effects between pulsed and continuous wave 810-nm wavelength laser irradiation for traumatic brain injury in mice. PLoS One. 2011;6(10):e26212.

9. Yip KK, Lo SC, Leung MC, So SK, Tang CY, Poon DM. The effect of low-energy laser irradiation on apoptotic factors following experimentally induced transient cerebral ischemia. Neuroscience. 2011;190:301-306.

10. Lapchak PA, Boitano PD, Butte PV, et al. Transcranial near-infrared laser transmission (NILT) profiles (800 nm): systematic comparison in four common research species. PLoS One. 2015;3;10(6):e0127580.

11. Henderson TA, Morries LD. Near-infrared photonic energy penetration principles and practice. In: Hamblin, MR and Huang YY, eds. Photobiomodulation and the Brain: Low-level Laser (Light) Therapy in Neurology and Neuroscience. London: Academic Press; 2019.

12. Morries LD, Henderson TA. Treatment of traumatic brain injury with near-infrared light. In: Hamblin, MR and Huang YY, eds. Photobiomodulation and the Brain: Low-level Laser (Light) Therapy in Neurology and Neuroscience. London: Academic Press; 2019.

13. Morries LD, Cassano P, Henderson TA. Treatments for traumatic brain injury with emphasis on transcranial near-infrared laser phototherapy. Neuropsychiatr Dis Treat. 2015;11:2159-75.

14. Connolly KR, Thase ME. If at first you dont succeed: a review of the evidence for antidepressant augmentation, combination and switching strategies. Drugs. 2011;71(1):43-64.

15. Naeser MA, Saltmarche A, Krengel MA, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011;29(5):351-358.

16. Naeser MA, Zafonte R, Krengel MH, et al. Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study. J Neurotrauma. 2014;31(11):1008-1017.

17. Hipskind SG, Grover FL Jr, Fort TR, et al. Pulsed transcranial red/near-infrared light therapy using light-emitting diodes improves cerebral blood flow and cognitive function in veterans with chronic traumatic brain injury: a case series. Photobiomodul Photomed Laser Surg. 2019;37(2):77-84.

18. Henderson TA, Morries LD. Infrared light cannot be doing what you think it is doing (re: DOI: 10.1089/photob.2018.4489). Photobiomodul Photomed Laser Surg. 2019;37(2):124-125.

19. Schiffer F, Johnston AL, Ravichandran C, et al. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009;5:46.

20. LED light therapy to improve cognitive & psychosocial function in TBI-PTSD veterans. ClinicalTrials.gov. NCT02356861. https://clinicaltrials.gov/ct2/show/NCT02356861. Accessed February 29, 2020.

21. Cassano P, Cusin C, Mischoulon D, et al. Near-infrared transcranial radiation for major depressive disorder: proof of concept study. Psychiatry J. 2015;2015:352979.

22. Cassano P, Petrie SR, Mischoulon D, et al. Transcranial photobiomodulation for the treatment of major depressive disorder. The ELATED-2 Pilot Trial. Photomed Laser Surg. 2018;36(12):634-646.

23. Henderson TA, Morries LD. Multi-Watt near-infrared phototherapy for the treatment of comorbid depression: an open-label single-arm study. Front Psychiatry. 2017;8:187.

24. Gordon LC, Johnstone DM. Remote photobiomodulation: an emerging strategy for neuroprotection. Neural Regen Res. 2019;14(12):2086-2087.

25. Braverman B, McCarthy RJ, Ivankovich AD, Forde DE, Overfield M, Bapna MS. Effect of helium-neon and infrared laser irradiation on wound healing in rabbits. Lasers Surg Med. 1989;9(1):50-58.

26. Rochkind S, Rousso M, Nissan M, Villarreal M, Barr-Nea L, Rees DG. Systemic effects of low-power laser irradiation on the peripheral and central nervous system, cutaneous wounds, and burns. Lasers Surg Med. 1989;9(2):174-182.

27. Ganeshan V, Skladnev NV, Kim JY, Mitrofanis J, Stone J, Johnstone DM. Pre-conditioning with remote photobiomodulation modulates the brain transcriptome and protects against MPTP insult in mice. Neuroscience. 2019;400:85-97.

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Infrared Laser Treatment of TBI, PTSD, and Depression: An Expert Perspective - Psychiatry Advisor

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BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc.. (Nasdaq:SGEN) today provided an update on the phase 1b/2 multicohort EV-103 trial (also known as KEYNOTE-869) of PADCEVTM (enfortumab vedotin-ejfv) in combination with anti-PD-1 therapy pembrolizumab for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. Based on recent discussions with the U.S. Food and Drug Administration (FDA), data from the randomized cohort K, along with other data from the EV-103 trial evaluating PADCEV combined with pembrolizumab as first-line therapy for cisplatin-ineligible patients, could potentially support registration under accelerated approval regulations in the United States. PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1

We are excited that EV-103 provides PADCEV with a potential pathway for U.S. accelerated approval in first-line metastatic urothelial cancer, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. Our initial data on the combination of PADCEV and pembrolizumab in previously untreated patients who could not receive cisplatin are encouraging.

EV-103 is a multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive urothelial cancer, and in locally advanced or metastatic urothelial cancer in first- or second-line settings. Cohort K from EV-103 is intended to enroll 150 patients randomized 1:1 to PADCEV monotherapy or PADCEV in combination with pembrolizumab in locally advanced or metastatic urothelial cancer patients who are ineligible for cisplatin-based chemotherapy. The primary outcome measure is objective response rate (ORR) per blinded independent central review (BICR) using RECIST 1.1 and duration of response (DoR).

In addition to EV-103, the recently initiated EV-302 phase 3 randomized clinical trial is intended to support global registrations and potentially serve as a confirmatory trial if accelerated approval is granted based on EV-103. The EV-302 trial is evaluating the combination of PADCEV and pembrolizumab with or without chemotherapy versus chemotherapy alone in patients with previously untreated locally advanced or metastatic urothelial cancer. Importantly, EV-302 includes metastatic urothelial cancer patients that are either eligible or ineligible for cisplatin-based chemotherapy. The trial is expected to enroll 1,095 patients and has dual primary endpoints of progression-free survival and overall survival. Both the EV-103 and EV-302 trials are being conducted in collaboration with Astellas and Merck.

FDA recently granted Breakthrough Therapy designation for PADCEV in combination with pembrolizumab for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting based on initial results from the EV-103 trial.

PADCEV (enfortumab vedotin-ejfv) was approved by the FDA in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDAs Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.2

About Bladder and Urothelial Cancer

It is estimated that approximately 81,000 people in the U.S. will be diagnosed with bladder cancer in 2020.3 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.4 Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide.5

About PADCEV

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.6,7 Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).8 PADCEV is co-developed by Astellas and Seattle Genetics.

Important Safety Information

Warnings and Precautions

Adverse Reactions

Serious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab Abnormalities

In one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased, hemoglobin decreased, phosphate decreased, lipase increased, sodium decreased, glucose increased, urate increased, neutrophils decreased.

Drug Interactions

Specific Populations

For more information, please see the full Prescribing Information for PADCEV here.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in peoples lives. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit https://www.seattlegenetics.com and follow @SeattleGenetics on Twitter. For information on our response to the COVID-19 pandemic, please visit our website.

About the Astellas and Seattle Genetics Collaboration

Seattle Genetics and Astellas are co-developing PADCEV under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.

About the Seattle Genetics, Astellas and Merck Collaboration

Seattle Genetics and Astellas entered a clinical collaboration agreement with Merck to evaluate the combination of Seattle Genetics and Astellas PADCEV and Mercks KEYTRUDA (pembrolizumab), in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Seattle Genetics Forward-Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the potential of data from the EV-103 clinical trial to support accelerated approval in the U.S. of PADCEV in combination with pembrolizumab for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting; the possibility of using data from the EV-302 clinical trial to obtain global regulatory approval or confirm accelerated approval of PADCEV in the referenced first line setting; clinical development plans relating to PADCEV; the therapeutic potential of PADCEV; and its possible safety, efficacy, and therapeutic uses, including in the first-line setting. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that ongoing and subsequent clinical trials of PADCEV may fail to produce data sufficient to support regulatory approvals; the fact that FDA has not made a final determination regarding whether the data from the EV-103 clinical trial will be sufficient to support accelerated approval in the U.S.; the risk that the COVID-19 pandemic could delay our ability to conduct the EV-103 clinical trial and delay FDAs regulatory timelines, including with respect to any potential accelerated approval; the fact that adverse events or safety signals may occur and that adverse regulatory actions or other setbacks could occur as PADCEV advances in clinical trials even after promising results in earlier clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

1Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.2 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.3 American Cancer Society. Cancer Facts & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed 02-20-2020.4 American Society of Clinical Oncology. Bladder cancer: introduction (10-2017). https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed 05-09-2019.5 International Agency for Research on Cancer. Cancer Tomorrow: Bladder. http://gco.iarc.fr/tomorrow.6 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.7 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.8 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.

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Seattle Genetics Announces Potential Accelerated Approval Pathway in the US for PADCEV (enfortumab vedotin-ejfv) in Combination with Immune Therapy...

Skin Stem Cells Comments Off on Seattle Genetics Announces Potential Accelerated Approval Pathway in the US for PADCEV (enfortumab vedotin-ejfv) in Combination with Immune Therapy… | April 2nd, 2020