If you notice flakes in your hair or it's simply looking drab, chances are there's something making its home on your head that you definitely don't want there. Depending on your own pH levels, it could be the oil from clogged follicles creating dandruff, but even if you consider your scalp on the normal-to-dry side, product buildup can still linger on the scalp long after you've showered with shampoo and conditioner.

If you'd like to say a final farewell to product buildup, dead skin cells, and excess sebum, using a purifying scalp scrub once a week can exfoliate away dirt and flakes and leave your hair feeling cleaner than you've ever imagined. Beyond scrubs, other treatments like serums and oils can also help fortify follicles so hair grows back in healthier and stronger, plus treat the protective cuticle layer that locks in moisture and keeps hair looking shiny, too.

Check out the best hair-care products at Sephora that tackle everything from itchiness to dullness ahead, and give your scalp the special treat it's not-so-secretly seeking.

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Don't Be Flaky: Try One of These Scalp Treatments From Sephora and Get Your Scalp Right - POPSUGAR

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Theres a great deal of innovation embedded in todays cutting-edge computer chips, but not much of it is as out-of-the-box as the thinking thats driving Australian startup Cortical Labs. The company, like so many startups with artificial intelligence in mind, is building computer chips that borrow their neural network inspiration from the biological brain. The difference? Cortical is using actual biological neurons, taken from mice and humans, to make their chips.

Were building the first hybrid computer chip which entails implanting biological neurons on silicon chips, Hon Weng Chong, CEO and co-founder of Cortical Labs, told Digital Trends.

This is done by first extracting neurons in two different ways, either from a mouse embryo or by transforming human skin cells back into stem cells and inducing those to grow into human neurons.

We then grow those neurons in our laboratory on high density CMOS-based multi-electrode devices that contain 22,000 electrodes on tiny surfaces no larger than 7mm squared, Chong continued. These neurons form neural networks which then start to spontaneously fire electrical signals, after a two-week incubation period, that is picked up by our multi-electrode device. The multi-electrode device is also able to provide electrical stimulation.

The researchers arent the first to develop neural networks based on real neurons. Recently, scientists in the U.K., Switzerland, Germany, and Italy fired up a working neural network that allowed biological and silicon-based artificial brain cells to communicate with one another over an internet connection.A California startup called Koniku, meanwhile, is building silicon chips, created using mouse neurons, which are able to sense certain chemicals.

For now, research like Cortical Labs is still in a relatively early proof-of-concept stage. According to a recent article in Fortune, Cortical Labs current approach has less processing power than a dragonfly brain. That means that, for now, its pursuing humbler ambitions than its eventual goal.

While were still in the process of building the hybrid computer chip, right now were focused on shaping our neurons behavior to play a game of [Ataris] Pong, Chong said. Thats our next big milestone, which will provide a proof-of-concept similar to DeepMinds demonstration [in 2013] of its A.I. playing Breakout.

Commercialization is still a number of years away, Chong continued. But hes convinced it could be a game-changer. When we eventually take our final product to market we believe it will have a wide array of applications across robotics, cloud computing, and computer brain interfaces, he said. This does not include industries that we might not have thought about yet because of the novelty of such a computation paradigm.

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Meet the sci-fi startup building computer chips with real biological neurons - Digital Trends

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The coronavirus crisis is affecting every aspect of our lives, including the condition of our skin. Have you noticed that your skin is particularly spotty, irritated and angry lately? That's another thing you can blame on COVID-19.

Express.co.ukspoke to Dr. Luca Russo, Dermatologist at Urban Retreat, to find out why.Dr. Russo says there are several reasons for your unexpected breakouts.He said: "There might be several reasons for noticing a tendency to break out during this national emergency."It's probably to do with what's going on inside, and what you're putting in your body, says Dr. Russo.

READ MORE- Coronavirus symptoms: Man reveals skin-related warning sign

Are you up all night worrying about the virus?Dr. Russo says: "The most likely cause of your breakout is stress."During such uncertain and stressful times, our system copes with increased production of Cortisol."Cortisol is an androgen hormone that is released when we are facing unusual challenges and prepare us to "fight'."However, it will also increase the sugar level in the bloodstream and production of sebum that might be a cause of the breakout."

In order to prevent breakouts that stem from high levels of stress, you'll need to calm yourself down.Dr Russo recommends doing activities that allow you to relax and unwind, such as yoga.He also suggests exercising regularly, so it's time to start making use of that daily government-approved walk, cycle, or run.

If you hate exercising, don't worry, the antidote to high cortisol levels doesn't have to be physical.Laughing, a solid night of sleep, or practising your favourite hobby are all effective options.

Having a soak in the bath and doing a face-mask may help you feel more in control of your skin.

This relief may cause a decrease in oil production and pimples.

DON'T MISS...How to help your brain through the coronavirus crisis stress [EXPLAINER]Coronavirus: How to look after your mental health during lockdown [EXPLAINER]Lockdown exercise: The eight exercises you can do at home [INFORMER]

Can you honestly say you have been eating well throughout the lockdown?Most people have stocked up on sugary treats and salty snacks in order to cheer themselves up in the face of COVID-19.And what about the good-old "support local businesses" excuse you use every time you order a greasy takeaway?Dr Russo says: "During isolation food becomes one of the few focal points of the day with more consumption of comfort food."Just like any other organ in your body, a poor diet affects your skin negatively.The body breaks down our food into tiny particles of proteins, fats, and carbs, and circulates it to the organs that need them.These nutrients make their way to your skin too, impacting its condition.It makes sense that inflammatory foods, such as sweets, some dairy, processed meat, and refined carbohydrates, will cause a flare-up in your complexion.

Dr. Russo says: "To improve your skin, you must eat well."Eat foods that are packed with vitamins and proteins and snack on fruit and veg."Drinking lots of water will replace the moisture that is lost through sweat and other processes, keeping your skin hydrated.If you fill up on foods rich in healthy oils and omega-3 fatty acids, you will improve the collagen production in your skin.This makes your skin smoother, suppler, and will help you in the longterm by preventing premature ageing.These oils and fats are found in fish, nuts, olive oil, and many more commonly found items.

During the lockdown, we're stuck inside all day and often don't get a chance to let our skin feel the sun.Dr. Russo says: "At the moment, skin isn't being exposed to natural light much at all."When your skin is exposed to natural light, the production of Vitamin D is increased."Endorphins are also produced, and this boosts your immune system and well-being."Make sure you get some fresh air every day, in order to reap these benefits of the sun.The sun is a great natural resource to improve your skin, but make sure you protect yourself with sun protection before you go out.You should wear an SPF of at least 30 on your face whenever you leave the house or are in front of a window for a prolonged amount of time.

Most people are shunning makeup in favour of the natural look since no one other than our household is going to see our faces.This means you may be tempted to skip your cleansing routine and go straight to bed once the day is over.

If you normally get facials and now can't, this may also be why you are breaking out or seeing changes.Dr. Russo explains: "You have probably been unable to receive professional treatments over this time, and this will contribute towards your breakouts."Dr. Russo recommends continuing with your normal skincare routine.He says: "Carry on as normal, but add an exfoliating cleanser to your routine."Exfoliating cleansers make your skincare routine shorter, by combining exfoliating and cleansing in one step.They remove dead skin cells and any build-up of dirt and oil in one go.There are hundreds of physical exfoliating cleansers on the market, as well as chemical exfoliating cleansers, so take your pick!

While surgical masks are thought to protect us against coronavirus, they're not great for our skin, said Dr. Russo.Wearing a mask over your face for many hours is damaging to your skin, especially when it's hot outside.The mask offers the perfect spot for bacteria and germs to harbour.Try double cleansing on the lower half of your face if you've worn a surgical mask for a prolonged period of time.

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Lockdown skin: Why is my skin worse even though I'm not wearing any makeup? - Express

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Theres a great deal of innovation embedded in todays cutting-edge computer chips, but not much of it is as out-of-the-box as the thinking thats driving Australian startup Cortical Labs. The company, like so many startups with artificial intelligence in mind, is building computer chips that borrow their neural network inspiration from the biological brain. The difference? Cortical is using actual biological neurons, taken from mice and humans, to make their chips.

Were building the first hybrid computer chip which entails implanting biological neurons on silicon chips, Hon Weng Chong, CEO and co-founder of Cortical Labs, told Digital Trends.

This is done by first extracting neurons in two different ways, either from a mouse embryo or by transforming human skin cells back into stem cells and inducing those to grow into human neurons.

We then grow those neurons in our laboratory on high density CMOS-based multi-electrode devices that contain 22,000 electrodes on tiny surfaces no larger than 7mm squared, Chong continued. These neurons form neural networks which then start to spontaneously fire electrical signals, after a two-week incubation period, that is picked up by our multi-electrode device. The multi-electrode device is also able to provide electrical stimulation.

The researchers arent the first to develop neural networks based on real neurons. Recently, scientists in the U.K., Switzerland, Germany, and Italy fired up a working neural network that allowed biological and silicon-based artificial brain cells to communicate with one another over an internet connection.A California startup called Koniku, meanwhile, is building silicon chips, created using mouse neurons, which are able to sense certain chemicals.

For now, research like Cortical Labs is still in a relatively early proof-of-concept stage. According to a recent article in Fortune, Cortical Labs current approach has less processing power than a dragonfly brain. That means that, for now, its pursuing humbler ambitions than its eventual goal.

While were still in the process of building the hybrid computer chip, right now were focused on shaping our neurons behavior to play a game of [Ataris] Pong, Chong said. Thats our next big milestone, which will provide a proof-of-concept similar to DeepMinds demonstration [in 2013] of its A.I. playing Breakout.

Commercialization is still a number of years away, Chong continued. But hes convinced it could be a game-changer. When we eventually take our final product to market we believe it will have a wide array of applications across robotics, cloud computing, and computer brain interfaces, he said. This does not include industries that we might not have thought about yet because of the novelty of such a computation paradigm.

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Meet the sci-fi startup building computer chips with real biological neurons - Yahoo Tech

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'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

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Just when you thought the world couldnt get any spookier, say hello to the newly born xenobot, a new kind of living thing.

Its hard to say with certainty who the father is.

Or maybe its just hard to admit whats actually happened: Like a bright child making a weirdo companion from Play-Doh, artificial intelligence has mated with the living cells of a frog to create an eerie hybrid of life and machine.

In a statement from the University of Vermont (UVM), the researchers explain it this way: A team of scientists has repurposed living cells, scraped from frog embryos, and assembled them into entirely new life forms.

These millimetre-wide xenobots can live for weeks, travel about with intent, work in groups autonomously, and heal themselves after being cut.

The idea is they could be set sail in their billions to clean the oceans of microplastics.

The really smart ones could be stationed in your organs, where theyd carry out renovating surgery or deliver drugs.

These are novel living machines, says Professor Joshua Bongard, a computer scientist and robotics expert at the University of Vermont who co-led the research.

Theyre neither a traditional robot, nor a known species of animal. Its a new class of artefact: A living, programmable organism.

The new creatures were designed on the Deep Green supercomputer at UVM and then assembled and tested by biologists at Tufts University.

The Deep Green supercomputer cluster at UVMs Vermont Advanced Computing Core used an evolutionary algorithm to create thousands of candidate designs for the new life forms.

Essentially, the computer was told here are your buildings blocks, literally abstract cubes with the physical parameters and limitations of skin and heart cells of an African frog.

The computer was then given an assignment: Arrange the cells so they could move forward. Or side to side. Or herd tiny sheep (no kidding).

And this is where the Play-Doh analogy comes in: The computer would, over and over, reassemble a few hundred simulated cells into myriad forms and body shapes. Is this one OK? What about this one?

Following the same pattern as human beings leaving behind its long-dead ancestors, Homo Erectus and the other hominins that followed, some of the creatures were selected to survive, but the less-successful species went extinct and were tossed to oblivion.

Eventually, the most promising designs were selected for testing.

And this is where it gets spooky.

Because the next step was to bring those building blocks, those red and green cubes, to life.

Here the research shifted from the UVM supercomputer to the biology labs at Tufts University, where stem cells were harvested from the embryos of African frogs, the species Xenopus laevis. (from which the name xenobot is derived).

The cells were separated into single cells and left to incubate.

The creepy yet wondrous thing is, not kept apart, the cells clump together and try to make something of themselves.

Next step: A microsurgeon, Dr Douglas Blackiston, used tiny forceps and an even tinier electrode, to cut the cells and join them under a microscope into a close approximation of the designs specified by the computer.

Assembled into body forms never seen in nature, the cells began to work together, the researchers advise.

The skin cells formed a more passive architecture, while the once-random contractions of heart muscle cells were put to work creating ordered forward motion as guided by the computers design, and aided by spontaneous self-organising patterns allowing the robots to move on their own.

These reconfigurable organisms were shown to be able move in a coherent fashion and explore their watery environment for days or weeks, powered by embryonic energy stores.

Turned over, however, they failed, like beetles flipped on their backs.

Later tests showed that groups of xenobots would work together like cowboys, moving around in circles, pushing pellets into a central location.

They did this spontaneously and collectively. Others were built with a hole through the centre to reduce drag.

In simulated versions, the scientists were able to repurpose this hole as a pouch to successfully carry an object.

We can imagine many useful applications of these living robots that other machines cant do, said co-leader Professor Michael Levin who directs the Centre for Regenerative and Developmental Biology at Tufts, like searching out nasty compounds or radioactive contamination, gathering microplastic in the oceans, travelling in arteries to scrape out plaque.

That fear is not unreasonable, Dr Levin said. When we start to mess around with complex systems that we dont understand, were going to get unintended consequences.

How might the creatures eventually work together in bigger systems?

As the researchers admit, who the heck knows?

A lot of complex systems, like an ant colony, begin with a simple unit an ant from which it would be impossible to predict the shape of their colony or how they can build bridges over water with their interlinked bodies.

Dr Levin said its an absolute necessity for society going forward to get a better handle on systems where the outcome is very complex.

A first step towards doing that is to explore: How do living systems decide what an overall behaviour should be and how do we manipulate the pieces to get the behaviours we want?

In other words, he suggested: This study is a direct contribution to getting a handle on what people are afraid of, which is unintended consequences.

If this was a horror movie, it would go like this: The world is under siege from a malevolent virus.

The frightened populace can think of nothing else.

Meanwhile, creepy monsters made from frog skin decide to take over the joint

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Half frog, half machine: The rise of the xenobot - The New Daily

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Limbs regenerate, embryos grow, and cancers invade.

In each of these processes, cells change dramatically. Betty Hay studied fascinating biological phenomena, relentlessly asking questions with her students and colleagues to understand how cellsbehaved. By the end of her life, she had made enormous research contributions in developmental biology, on top ofcommitting herself to mentoring the next generation of scientists and advocating for more representation of women in science.

She made significant contributions towards understanding cell and developmental biology

Betty Hay began as an undergraduate at Smith College in 1944. She lovedher first biology course and started working for Meryl Rose, a professor at Smith who studied limb regeneration in frogs. I was self-motivated and very attracted to science, she saidin an interview in 2004, Meryl at that time was working on regeneration and by the end of my first year at Smith I was also studying regeneration.

Hay regarded Rose as a significant scientific mentor in her life and followed his advice to apply for medical school instead of graduate school. She ended up attending Johns Hopkins School of Medicine for her medical degree while continuing her research on limb regeneration over the summers with Rose at Woods Holes Marine Biological Laboratory. She stayed at Johns Hopkins after to teach Anatomy and became an Assistant Professor in 1956.

The year after, she moved her studiesto Cornell Universitys Medical College as an Assistant Professor to learn how to use the powerful microscopes located there. Her goal was to use transmission electron microscopy (TEM), a method of taking high-resolution images, toseehow salamanders could regenerate an amputated limb. Nothing couldve kept me from going into TEM, she said later.

With her student, Don Fischman, they concluded that upon amputation, cells with specialized roles,known as differentiated cells and thought to be unchangeable, were able to de-differentiate and become unspecialized stem cells again. These cells without an assigned role could then have the freedom to adopt whatever new roles they required to regenerate a perfectly new limb.

Already making leaps in figuring out an explanation for the process of limb regeneration, Hay turned her attention from salamanders to bird eyes when she moved to Harvard University. She studied the outermost layer of cells on the cornea, known as the cornea epithelium. With the help of a postdoctoral scholar in her lab, Jib Dobson, and a faculty colleague, Jean-Paul Revel, they isolated, grew, and took pictures of cornea epithelium cells and demonstrated the epithelial cells could produce collagen.

Collagen is the main type of protein that weaves together to form the extracellular matrix, a connective tissue (the matrix) found outside of cells (extracellular). The collagen in the extracellular matrix provide structure, acting as a foundation for connective tissues and organs such as skin, tendons, and ligaments. Other scientists in the field were skeptical of the conclusion. They thought that one dedicated cell produced collagen, and nothing else.They dismissed the idea that cells in the cornea could somehow do the same. Despite their doubt, Hay, along with postdoctoral scholar Steve Meier, continued their studies. In 1974, they further showed that not only could epithelial cells produce collagen and extracellular matrix in different organ systems, but that the matrix could also tell other cells what type of cell to become.

She was a committed educator and mentor

Kathy Svoboda and Marion Gordon, two colleagues of hers, wrote about Betty Hay and described her not only as a superb cell and developmental biologist, but also as an educator and beloved mentor.

Limb regeneration in salamanders

Russell et al BMC Biology 2017

She was dedicated to teaching and influenced the careers of many junior and early-career scientists. In addition to working with and training her students to produce successful research and results, others mentioned how she would take the time to introduce students in her department to more established and prominent scientists in the field of cell biology. These actions reflected her belief that every student was worthy of being heard and introduced.

She held influential positions and advocated for more representation of women in science

At the time of her graduation from Johns Hopkins in 1952, she was one of only four women in her graduating class of 74 people. Afterwards, she experienced frequent moves for her career, going from Baltimore, to New York, to Boston. Despite how difficult it felt moving alone and leaving her personal relationships behind every time, she felt it was necessary for her career. In her mind, she strongly believed her research always came first, fueled by her intense desire to find answers, using the scientific approach.

She went on to serve as president for multiple professional societies, such as the American Association of Anatomists, the American Society for Cell Biology, and the Society for Developmental Biology, demonstrating her commitment to leadership and service. In two of these societies, she was the first woman to ever hold the position.

In 1975, she became the first female chair of what is now the Department of Cell Biology at Harvard University and held that position for 18 years. Even with these impressive milestones, she acknowledged one of her biggest obstacles to be achieving acceptance in the male professional world.

In 2004 and nearing retirement, Betty Hay would go on to say, I am very glad to see in my lifetime the emergence of significantly more career women in science, in an interview with editor-in-chief Fiona Watt for the Journal of Cell Science, this so enriches the intellectual power being applied to the field of cell biology.

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Meet Betty Hay, the scientist who saw how cells grow and limbs regenerate - Massive Science

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DetailsCategory: AntibodiesPublished on Monday, 06 April 2020 18:54Hits: 142

Fifteen (15) severely ill COVID-19 patients have been treated under an EIND;

7-day results from the first four patients are available and are very promising;

7-day results for the first 10 patients will be available this week

VANCOUVER, Canada I April 06, 2020 I CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients have been treated with leronlimab under the Companys Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.

In addition, the Companys investigational new drug, leronlimab, has now been administered to 15 severely ill COVID-19 patients atfour hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals, all under an emergency investigational new drug (EIND), which were granted by the U.S. Food and Drug Administration (FDA) for each individual patient.

CytoDyn also anticipates initiating its other COVID-19 trial this week. This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, We are encouraged by the positive results demonstrated with leronlimab in the New York patients. Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimabs mechanism of action.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, Our partnership with the New York medical team and now other hospitals has been exemplary. We are collaborating in every aspect to deliver leronlimab to patients in order to provide proof of concept as soon as possible. The outstanding coordination among the physicians, the hospital administrators, the FDA, and our team, will hopefully help mitigate the deleterious effects from this pandemic should we prove leronlimab as a solution. The lead physician in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the pandemic of COVID-19. We are very hopeful of sending the day three and day seven results of the first ten EIND patients to the FDA by the end of this week.

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.

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.

SOURCE: Cytodyn

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First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency...

Bone Marrow Stem Cells Comments Off on First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency… | April 6th, 2020

An article published in Experimental Biology and Medicine(Volume 245, Issue 6, March 2020)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 a 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, a co-author of 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 sebm.org.

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Stem Cell Therapy for Colon Cancer - The Ritz Herald

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy for Colon Cancer – The Ritz Herald | April 6th, 2020

Located on the Tufts University Medford, MA campus, this new donor center will enable delivery of fresh blood, leukopaks and buffy coats for COVID-19, cell and gene therapy research within hours of collection

WESTBURY, N.Y., April 6, 2020 /PRNewswire/ --BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced the opening of its new blood donor center on the Tufts University campus in Medford, MA to support academic and pharmaceutical researchers involved in COVID-19, cell and gene therapy research.

"BioIVT wants to play a leading role in supporting COVID-19 research efforts and blood donations are a vital resource for the research and development of new therapies, vaccines, and diagnostics. We have many years' experience developing blood products, including blood-derived immune cells for cell and gene therapy research, and we want to make that expertise count," said BioIVT CEO Jeff Gatz. "Researchers recognize and appreciate BioIVT's rapid response and commitment to high quality, fresh blood products and this new donor center will allow us to offer those attributes and services to additional US clients."

BioIVT's new Boston blood donor center is its seventh. The company has similar facilities located in California, Tennessee and Pennsylvania to serve US clients and in London, UK for EU-based clients.

"While the initial focus at our Boston donor center will be on delivering fresh blood, leukopaks and buffy coats within hours of collection, we plan to add more capabilities and donors over time," said Jeff Widdoss, Vice President of Donor Center Operations at BioIVT.

Leukopaks, which contain concentrated white blood cells, are used to help identify promising new drug candidates, assess toxicity levels, and conduct stem cell and gene therapy research. They are particularly useful for researchers who need to obtain large numbers of leukocytes from a single donor.

BioIVT blood products can be supplied with specific clinical data, such as the donor age, ethnicity, gender, BMI and smoking status. Its leukopaks are also human leukocyte antigen (HLA), FC receptor and cytomegalovirus typed. HLA typing is used to match patients and donors for bone marrow or cord blood transplants. FC receptors play an important role in antibody-dependent immune responses.

COVID-19-related Precautions Blood donor centers are considered essential businesses and will remain open during the COVID-19 quarantine. BioIVT is taking additional safety measures to protect both blood donors and its staff during this difficult time. It has instituted several social distancing measures, including increasing the space between chairs in the waiting room and between donor beds, and limiting the entrance of non-essential personnel. The screening rooms are disinfected between donors and all areas of the center continue to be cleaned at regular intervals.

As soon as each blood donor signs their informed consent form, their temperature is taken. If they have a fever, their appointment is postponed, and they are referred to their physician. Any donor who develops COVID-19 symptoms after donating blood is required to inform the center immediately.

All BioIVT blood collections are conducted under institutional review board (IRB) oversight and according to US Food and Drug Administration (FDA) regulations and American Association of Blood Banks (AABB) guidelines.

Those who would like to donate blood at BioIVT's new Boston-area donor center should call 1-833-GO-4-CURE or visit http://www.biospecialty.com to make an appointment.

Further information about the products available from BioIVT's new donor center can be found at https://info.bioivt.com/ma-donor-ctr-req.

About BioIVTBioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. Our PHASEZERO Research Services team works collaboratively with clients to provide target and biomarker validation, phenotypic assays to characterize novel therapeutics, clinical assay development and in vitro hepatic modeling solutions. And as the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly-discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit http://www.bioivt.com or follow the company on Twitter @BioIVT.

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BioIVT Opens New Blood Donor Center to Support Boston-area Research into COVID-19 Therapies, Vaccines and Diagnostics - Yahoo Finance

Bone Marrow Stem Cells Comments Off on BioIVT Opens New Blood Donor Center to Support Boston-area Research into COVID-19 Therapies, Vaccines and Diagnostics – Yahoo Finance | April 6th, 2020

NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has accepted for priority review the Companys Biologics License Application (BLA) filing for RYONCILTM (remestemcel-L), its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.

A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA has advised that they are planning to hold an Advisory Committee Meeting to discuss this application.

Mesoblast Chief Executive Dr Silviu Itescu stated: There is a critical need to improve survival outcomes in children suffering from the more advanced stages of this devastating disease. The acceptance of the BLA represents an important milestone for the Company. Mesoblast is on track in its preparation for the potential launch of RYONCIL, including meeting its target inventory build and commercial team roll-out.

About Acute GVHD Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.

About RYONCILTM Mesoblasts lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture- expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SR- aGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

References

About Mesoblast Mesoblast Limited(Nasdaq: MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has filed a Biologics License Application to theUnited States Food and Drug Administration(FDA) to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched inthe United Statesin 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized inJapanandEuropeby Mesoblasts licensees, and the Company has established commercial partnerships inEuropeandChinafor certain Phase 3 assets.

Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.

Mesoblast has locations inAustralia,the United StatesandSingaporeand is listed on theAustralian Securities Exchange(MSB) and on the Nasdaq (MESO). For more information, please seewww.mesoblast.com, LinkedIn:Mesoblast Limitedand Twitter: @Mesoblast

Forward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward- looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact: Julie Meldrum Corporate Communications T: +61 3 9639 6036 E: julie.meldrum@mesoblast.com

Schond Greenway Investor RelationsT: +1 212 880 2060E: schond.greenway@mesoblast.com

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FDA ACCEPTS MESOBLAST'S BIOLOGICS LICENCE APPLICATION FOR RYONCIL AND AGREES TO PRIORITY REVIEW - GlobeNewswire

Bone Marrow Stem Cells Comments Off on FDA ACCEPTS MESOBLAST’S BIOLOGICS LICENCE APPLICATION FOR RYONCIL AND AGREES TO PRIORITY REVIEW – GlobeNewswire | April 6th, 2020

Global Stem Cell Reconstructive Market was valued US$ XX Mn in 2019 and is expected to reach US$ XX Mn by 2027, at a CAGR of 24.5% during a forecast period.

Global Stem Cell Reconstructive Market

Market Dynamics

The Research Report gives an in-depth account of the drivers and restraints in the stem cell reconstructive market. Stem cell reconstructive surgery includes the treatment of injured or dented part of body. Stem cells are undifferentiated biological cells, which divide to produce more stem cells. Growing reconstructive surgeries led by the rising number of limbs elimination and implants and accidents are boosting the growth in the stem cell reconstructive market. Additionally, rising number of aged population, number of patients suffering from chronic diseases, and unceasing development in the technology, these are factors which promoting the growth of the stem cell reconstructive market. Stem cell reconstructive is a procedure containing the use of a patients own adipose tissue to rise the fat volume in the area of reconstruction and therefore helping 3Dimentional reconstruction in patients who have experienced a trauma or in a post-surgical event such as a mastectomy or lumpectomy, brain surgery, or reconstructive surgery as a result of an accident or injury. Stem cell reconstructive surgeries are also used in plastic or cosmetic surgeries as well. Stem cell and regenerative therapies gives many opportunities for development in the practice of medicine and the possibility of an array of novel treatment options for patients experiencing a variety of symptoms and conditions. Stem cell therapy, also recognised as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives.

The common guarantee of all the undifferentiated embryonic stem cells (ESCs), foetal, amniotic, UCB, and adult stem cell types is their indefinite self-renewal capacity and high multilineage differentiation potential that confer them a primitive and dynamic role throughout the developmental process and the lifespan in adult mammal.However, the high expenditure of stem cell reconstructive surgeries and strict regulatory approvals are restraining the market growth.

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Global Stem Cell Reconstructive Market Segment analysis

Based on Cell Type, the embryonic stem cells segment is expected to grow at a CAGR of XX% during the forecast period. Embryonic stem cells (ESCs), derived from the blastocyst stage of early mammalian embryos, are distinguished by their capability to distinguish into any embryonic cell type and by their ability to self-renew. Owing to their plasticity and potentially limitless capacity for self-renewal, embryonic stem cell therapies have been suggested for regenerative medicine and tissue replacement after injury or disease. Additionally, their potential in regenerative medicine, embryonic stem cells provide a possible another source of tissue/organs which serves as a possible solution to the donor shortage dilemma. Researchers have differentiated ESCs into dopamine-producing cells with the hope that these neurons could be used in the treatment of Parkinsons disease. Upsurge occurrence of cardiac and malignant diseases is promoting the segment growth. Rapid developments in this vertical contain protocols for directed differentiation, defined culture systems, demonstration of applications in drug screening, establishment of several disease models, and evaluation of therapeutic potential in treating incurable diseases.

Global Stem Cell Reconstructive Market Regional analysis

The North American region has dominated the market with US$ XX Mn. America accounts for the largest and fastest-growing market of stem cell reconstructive because of the huge patient population and well-built healthcare sector. Americas stem cell reconstructive market is segmented into two major regions such as North America and South America. More than 80% of the market is shared by North America due to the presence of the US and Canada.

Europe accounts for the second-largest market which is followed by the Asia Pacific. Germany and UK account for the major share in the European market due to government support for research and development, well-developed technology and high healthcare expenditure have fuelled the growth of the market. This growing occurrence of cancer and diabetes in America is the main boosting factor for the growth of this market.

The objective of the report is to present a comprehensive analysis of the Global Stem Cell Reconstructive 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 the industry with a dedicated study of key players that includes market leaders, followers and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market has been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analysed, which will give a clear futuristic view of the industry to the decision-makers.

The report also helps in understanding Global Stem Cell Reconstructive Market dynamics, structure by analysing the market segments and projects the Global Stem Cell Reconstructive Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Stem Cell Reconstructive Market make the report investors guide.Scope of the Global Stem Cell Reconstructive Market

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Global Stem Cell Reconstructive Market, By Sources

Allogeneic Autologouso Bone Marrowo Adipose Tissueo Blood Syngeneic OtherGlobal Stem Cell Reconstructive Market, By Cell Type

Embryonic Stem Cell Adult Stem CellGlobal Stem Cell Reconstructive Market, By Application

Cancer Diabetes Traumatic Skin Defect Severe Burn OtherGlobal Stem Cell Reconstructive Market, By End-User

Hospitals Research Institute OthersGlobal Stem Cell Reconstructive Market, By Regions

North America Europe Asia-Pacific South America Middle East and Africa (MEA)Key Players operating the Global Stem Cell Reconstructive Market

Osiris Therapeutics NuVasives Cytori Therapeutics Takeda (TiGenix) Cynata Celyad Medi-post Anterogen Molmed Baxter Eleveflow Mesoblast Ltd. Micronit Microfluidics TAKARA BIO INC. Tigenix Capricor Therapeutics Astellas Pharma US, Inc. Pfizer Inc. STEMCELL Technologies Inc.

MAJOR TOC OF THE REPORT

Chapter One: Stem Cell Reconstructive Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Stem Cell Reconstructive Market Competition, by Players

Chapter Four: Global Stem Cell Reconstructive Market Size by Regions

Chapter Five: North America Stem Cell Reconstructive Revenue by Countries

Chapter Six: Europe Stem Cell Reconstructive Revenue by Countries

Chapter Seven: Asia-Pacific Stem Cell Reconstructive Revenue by Countries

Chapter Eight: South America Stem Cell Reconstructive Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Stem Cell Reconstructive by Countries

Chapter Ten: Global Stem Cell Reconstructive Market Segment by Type

Chapter Eleven: Global Stem Cell Reconstructive Market Segment by Application

Chapter Twelve: Global Stem Cell Reconstructive Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Stem Cell Reconstructive Market Report at: https://www.maximizemarketresearch.com/market-report/global-stem-cell-reconstructive-market/54666/

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Global Stem Cell Reconstructive Market- Industry Analysis and Forecast (2020-2027) - Publicist360

Cardiac Stem Cells Comments Off on Global Stem Cell Reconstructive Market- Industry Analysis and Forecast (2020-2027) – Publicist360 | April 6th, 2020

DetailsCategory: More NewsPublished on Thursday, 02 April 2020 14:06Hits: 400

HAMBURG, Germany, and TORONTO, Canada I April 02, 2020 I 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 panCELLas 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 Evotecs 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 panCELLas 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 panCELLas technology and cell lines into our ongoing proprietary research and development efforts strengthens Evotecs 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 Evotecs multimodality discovery and development platform.

Mahendra Rao, MD, PhD, CEO at panCELLa, added: We welcome the partnership with Evotec. Evotecs 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 iPSC

Induced 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 Yamanakas 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. Evotecs 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 Companys proprietary EVOcells platform.

About cell therapy and panCELLas FailSafe iPSC technology

Cell therapy, one of the most promising regenerative medicine approaches, replaces a patients missing or broken cells with functioning cells from a range of different sources, either from a donor, from the patients 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 patients immune system will treat such iPSC-based transplants as foreign and use the bodys 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 patients immune system, thus avoiding rejection and enabling effective long-term relief of the patients symptoms.

To increase the safety of such iPSC-derived cell products, panCELLas 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 Nagys 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).

SOURCE: Evotec

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Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa | More News | News Channels -...

IPS Cell Therapy Comments Off on Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa | More News | News Channels -… | April 6th, 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

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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 6th, 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.

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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

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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BrainStorm Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority - Yahoo Finance

Bone Marrow Stem Cells Comments Off on BrainStorm Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority – Yahoo Finance | 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

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...

Bone Marrow Stem Cells Comments Off on 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… | April 3rd, 2020

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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Is There a New CAR T-Cell Treatment for Mantle Cell Lymphoma? - AJMC.com Managed Markets Network

Bone Marrow Stem Cells Comments Off on Is There a New CAR T-Cell Treatment for Mantle Cell Lymphoma? – AJMC.com Managed Markets Network | April 3rd, 2020

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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