Brainstorm Cell Therapeutics (BCLI) Gets a Buy Rating from Maxim Group – Smarter Analyst
By daniellenierenberg
Maxim Group analyst Jason McCarthy maintained a Buy rating on Brainstorm Cell Therapeutics (BCLI) yesterday and set a price target of $9.00. The companys shares closed last Monday at $3.92.
According to TipRanks.com, McCarthy s ranking currently consits of no stars on a 0-5 ranking scale, with an average return of -22.1% and a 25.6% success rate. McCarthy covers the Healthcare sector, focusing on stocks such as SELLAS Life Sciences Group, Hancock Jaffe Laboratories, and Lineage Cell Therapeutics.
Brainstorm Cell Therapeutics has an analyst consensus of Moderate Buy, with a price target consensus of $9.00.
See todays analyst top recommended stocks >>
Based on Brainstorm Cell Therapeutics latest earnings release for the quarter ending September 30, the company reported a quarterly GAAP net loss of $5.63 million. In comparison, last year the company had a GAAP net loss of $3.18 million.
Based on the recent corporate insider activity of 12 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of BCLI in relation to earlier this year. Most recently, in August 2019, Irit Arbel, a Director at BCLI sold 13,332 shares for a total of $48,795.
TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.
Brainstorm Cell Therapeutics, Inc. operates as a biotechnology company, which develops and commercializes adult stem cell therapeutic products. It focuses on utilizing the patients own bone marrow stem cells to generate neuron-like cells that may provide an effective treatment initially for amyotrophic lateral sclerosis, Parkinsons disease, multiple sclerosis and spinal cord injury. The company was founded on September 22, 2000 and is headquartered in New York, NJ.
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Brainstorm Cell Therapeutics (BCLI) Gets a Buy Rating from Maxim Group - Smarter Analyst
AI helps cells pull themselves together – Cosmos
By daniellenierenberg
By Paul Biegler
US scientists have overcome a major stumbling block in the creation of mini-organs, programming cells to take on the desired shape rather than relying on 3D printing or external scaffolds.
This inside out approach, described in a paper in the journal Cell Systems, could signal a paradigm shift in how mini-hearts, kidneys and brains are grown on the lab bench a technique used to study disease that may one day lead to personalised organ transplants.
The team, led by bioengineer Todd McDevitt at Gladstone Institutes in the US, was driven by an enduring issue with state-of-the-art ways of producing mini-organs such as 3D printing. The cells just wont stay put.
Making a mini-organ or organoid starts when scientists take a persons skin cell and, using the right mix of agents, turn it into an induced pluripotent stem cell. This IPS cell is the blank cheque of biology, capable of becoming almost any cell type.
Grow it into a mini-kidney, say, and you can reproduce kidney diseases and test treatments in a dish sitting on your lab bench. But how faithful that model is depends on the physical organisation of the cells; to mimic a real deal kidney, 3D printing is often used.
But cells, much like unruly teenagers, have a mind of their own and will often wander away from their printed position.
McDevitts team wanted to own those cellular minds and so took control of two genes that together make up something of a joystick that directs how the cells organise.
CDH1 and ROCK1 figure heavily in the complex moves that lead to the final configuration of a group of cells. The pair influences stickiness and repulsion between cells, the surface tension that makes them spherical and their overall speed of migration.
The researchers used the editing tool CRISPR to knock out the two genes at various stages in the evolution of a clump of cells. Their aim was to make a bulls eye pattern, a shape thats common in human development, including in early embryo formation.
To detect that aspirational pattern, they engineered another tweak making the cells fluoresce when CDH1 and ROCK1 were neutralised.
But there was a problem.
Factor in all the potential time points where the genes could be knocked out, the proportion of cells to be targeted, and a host of other variables, and the researchers calculated theyd need to do nearly 9000 trial-and-error experiments.
So they called on AI. They trained a machine learning model to compute the precise pattern of gene knockouts needed to realise their dream shape.
Machine learning can predict what movie you might like based on your viewing history, but it can also generate new insights into biological systems by mimicking them, says co-author Demarcus Briers, from the Boston University Bioinformatics Program.
Our machine-learning model allows us to predict new ways that stem cells can organise themselves, and produces instructions for how to recreate these predictions in the lab.
That model hit a bulls eye, quite literally, allowing the team to produce the concentric pattern of cells they were aiming at.
"We've shown how we can leverage the intrinsic ability of stem cells to organise," says McDevitt. "This gives us a new way of engineering tissues, rather than a printing approach where you try to physically force cells into a specific configuration."
Ultimately, that concrete target shape will give way to a target in the abstract, one with potential to shift the life course.
"We're now on the path to truly engineering multicellular organization, which is the precursor to engineering organs," McDevitt says. "When we can create human organs in the lab, we can use them to study aspects of biology and disease that we wouldn't otherwise be able to."
Ten brands blurring boundaries in personal care and beyond – The Drum
By daniellenierenberg
They always say time changes things, but you actually have to change them yourself. Andy Warhol
As the early adopter mindset filters out into mainstream thinking and behaviors, brands need no longer target their innovations towards a small group of consumers the floor is open and the consumer demand growing across all demographics for brand innovation.
The boundaries of what we might have traditionally considered as personal care are shifting with brands exploring new territories and opportunities to take care of the body and mind from a more holistic perspective.
Here we take a look at a selection of ten current and emerging trends from brands leading notable movements of change.
New occasions
Brands developing targeted personal care solutions for the more active amongst us are on the rise. Natural luxury spa brand Espa have launched a new body care collection designed for use post workout, and include a Muscle Rescue Balm and Fitness Shower Oil specially formulated to sooth tired muscles.
Mantastic expressions
Practical and affordable male grooming brand Harrys questions conventional definitions of what it means to be a man, celebrating the messiness of masculinity and championing social causes that challenge outdated stereotypes. The subtle and playful illustration of a Mammoth on the pack calls attention to the brand's message that extinct perceptions of masculinity need to be abolished.
Sustainable living
Born from a belief that small changes can have a big impact, Eco + Amour has collaborated with some of the trendiest eco-conscious brands to offer a refillable, more sustainable, beauty, personal care and home care shopping experience. No doubt Im not the only one with at least three different moisturizers and deodorants in the bathroom at any one time - refreshingly, Eco + Amour encourages consumers to only buy what they need.
Eco-friendly packaging
Netherlands based designer Don Yaw Kwaning is exploring sustainable innovation using the soft rush plant. Through a process of separating the pith from the fibers, you are left with a foam which has lightweight, shock-resistant and insulating properties all without the need for bonding agents. The fibers can be developed into materials such as paper and corrugated cardboard, a fantastic new eco-packaging solution.
Clean living, clean design
The broader trend towards clean living (both in terms of health and sustainability) and clean beauty has been broadly adopted across the personal care category particularly by more agile brands. For the most part, the fragrance category has been slow to respond, continuing to follow traditional premium colours, codes and cues. Minimalism is the new luxury and Le Labo is a great benchmark - a sight for sore eyes and indeed has clear stand out on shelf against the swathe of rose gold and metallic designs of other fragrance super brands. Taking cues from the premium spirits category with the bottles heavy foot, the label design also mimics tasting notes as though from a distillery. A fantastic example of the value in looking cross-category for design inspiration.
Leveraging health and wellness
In support of the ever-popular self-care movement, personal care brands have an opportunity to incorporate health and wellness solutions into their product functionality and design. Japanese haircare brand Feather Aqua explores holistic health and wellness for the scalp founded on the premise that taking care of your head takes care of your hair. The brand uses amino acids and natural plant extracts coupled with aromatherapy fragrances to also elevate the state of mind and mood of the consumer.
New wave supplements
Wellness start-up Hello.me has recently launched a special natural supplement designed to combat the negative effects of using contraceptive pills. The Top Up Tonic reportedly relives symptoms such as bloating, mood swings and breast tenderness.
Harnessing advances in technology
World leader in regenerative medicine, Professor Augustinus Bader has utilized the restorative power of stem-cell technology to provide consumers with the ultimate solution in high-end anti-ageing skincare. The TFC8 patented technology activates the bodys stem cells to biologically repair damage to the skin caused by lifestyle and environmental factors mobilizing our bodys natural abilities to renew.
Delicious derrires
Never has Sir Mix-A-Lot been more relevant. Products aimed at targeting elasticity, firmness, dry skin and sagging of the bottom have flooded the market over the last year. Masks in particular are on the rise. Niche Los Angeles brand Anese brings us Down with the thickness, a collagen mask that detoxes, plumps and softens your bottom.
A sculpting revolution
The onslaught of easily accessible fitness solutions across social media and personalized app technologies has begun to filter out into the personal care market. Be for Beauty brings us a BOD range (Body on Demand), a ritual of products designed to tighten and sculpt the body through the reduction of water retention. The range includes bath salts which are designed to tone the body, clear out excess toxins and can supposedly eliminate up to 3lbs of excess water retention weight all within a 20-minute soak.
Kirsty Cole, head of growth at Anthem Amsterdam & Brussels.
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Ten brands blurring boundaries in personal care and beyond - The Drum
Regenerative Medicine: Overcoming The Supply Chain Challenges – Contract Pharma
By daniellenierenberg
Regenerative medicine is one of modern sciences most exciting developments. Defined by the Medical Research Council, regenerative medicine is an interdisciplinary field that seeks to develop the science and tools that can help repair or replace damaged or diseased human cells or tissues to restore normal function.
In the human body, the liver is the only organ capable of regenerating itself spontaneouslyeven after serious injurybut in the future, any part of the human body may be capable of doing so. Our own cells will also be able to treat and cure diseases and conditions of the blood and immune system, as well as restore the blood system after treatments for specific cancers.
Once only imaginable in science fiction, the latest applications include engineered skin tissue to treat burn victims, custom-grown bones for implants and joint replacements, personalized dietary treatments using gut bacteria and just recently, the worlds first 3D vascularized engineered heart was created using a patients own cells and biological materials.
As scientists understanding and the tools at their disposal become more advanced, the closer to the widespread commercialization of regenerative medicine the pharmaceutical industry finds itself.However, offering regenerative medicine therapies at scale requires one of the biggest shake-ups to the global pharmaceutical supply chain ever seen. Without it, the world risks missing out on the curative promises of this next-generation medical technology.
Regenerative medicine is one of, if not the most, exciting advancements in modern science which has far-reaching benefits for big pharma, healthcare systems and patient outcomes.
Regenerative medicine is a growth industry in more than one sense of the word; as a sector, its growing from strength to strength. In fact, last year the global regenerative medicine market was worth $28 billion and its expected to grow to $81 billion by 2023.
As a more efficient and less invasive alternative to transplanting cells or organs to replace damaged or lost tissue, established pharma companies alongside small biotech start-ups are racing to discover and bring to market medicine-based approaches that stimulate the bodys natural ability to repair itself.The cutting-edge innovations of regenerative medicine generally fall into three distinct categories:
Replenish Replace Rejuvenate
Stem cells can generate vital growth factors to naturally reduce inflammation, increase muscle mass, repair joints, grow hair and boost the immune system, replenishing the body. Organ regeneration and 3D printing are replacing the reliance on the failing donor system and overcoming the issue of organ rejection. The root causes of aging are being better understood and delayed by using stem cells to rejuvenate the body.
Marking a new era in healthcare and one which has the promise of addressing the needs of an aging population challenged by escalating chronic diseases, regenerative medicine is certainly a game-changer. Beyond more effective medical treatments that can be applied routinely despite age, comorbidities, or disease severity, it also has the potential to cure many of todays incurable diseases and support healthcare systems to move towards a preventative model.
Today, regenerative medicine is largely confined to a research environment. In fact, according to a recent report, there were 1,028 clinical trials for regenerative therapies taking place globally at the end of 2018.
Regenerative medicine is poised to transform healthcare as we know it, offering potential cures for deadly diseases which before would require long-term treatment to manage. However, while billions are being spent on regenerative medicine research and clinical studies, little resource has, so far, been allocated to the management and delivery of innovative medical therapies at scale.
Currently, the race appears to be on between smaller Medtech companies and large multi-national pharmaceutical companies to see who wins first-mover advantage in the regenerative medicine market. Today, many established pharmaceutical companies prefer to partner with Medtech startups to in-license products in early clinical development stages as opposed to conducting early development on their own which comes at a huge cost. This is a risk-reduction tactic, but it could mean big pharma misses the boat.
The question remains unanswered as to whether a peer-to-peer collaborative model will prosper where Medtech companieswho are in some instances one step ahead of big pharma in terms of drug developmentare happy to be a third-party provider to big pharma who have the budgets and networks to truly deliver the regenerative medicine revolution.
Regulation is, and will continue to, play a hugely important role in delivering regenerative medicines from a lab setting to a clinical setting. Only recently, the FDA announced a new policy framework for the development of regenerative medicine products, taking into account the dynamic and fast-moving nature of the field.
Ultimately, the governments aim is to protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies according to Former FDA Commissioner Dr. Scott Gottlieb. The FDA plans to achieve this over the coming years by driving stakeholder engagement with the developing regulatory framework in order to efficiently advance access to safe and effective regenerative medicine advanced therapies.
However, so far, progress by the pharma industry in coming into compliance with FDAs regulations for regenerative medicines has been slow, despite the grace period set by the FDA before it fully exercises enforcement fast approaching (ending in November 2020).
In order to speed up the process of bringing novel medicines to market, the FDA is toying with the idea of fast-tracking products that are deemed low risk to patients if sponsors have engaged with the regulatory process and demonstrated responsibility by filing Investigational New Drug Applications (INDs).
The FDA has also promised to strengthen its enforcement action against drug developers who are marketing unapproved products, prioritizing cases where the threat to patient health and safety is largest.For example, last November the FDA stepped in where a Californian business was selling stem cell products using umbilical cord blood for the treatment of arthritis and other conditions, despite this form of treatment not having FDA approval for that particular use. Several patients (at least 12) undergoing this treatment were hospitalized after developing infections of the bloodstream and joints, as well as abscesses along the spine and skull.
In summary, one of the FDAs central aims over the coming years is to drive stakeholder engagement with the developing regulatory framework for regenerative medicine advanced therapies in order to efficiently advance access to safe and effective new products.
The promise of regenerative medicine requires an innovative look at the complete product lifecycle, including the development of an efficient distribution network.
Once these novel drugs become mainstream, the entire healthcare ecosystem will have to adapt. Regulatory approval for any drug relies on it safely and successfully fulfilling its medical intent. As such, information about supply chain management needs to be submitted to the regulator after the completion of phase three clinical trials, including packaging, labeling, storage and distribution.
The clinical supply chains required to deliver these therapies are arguably the most complex the industry has seen so far, even more so than for biologic medicine. Thats because, unlike many mass-market drugs, regenerative medicine is either personalized or matched to a unique donor-recipient.
The distribution of regenerative medicine therapies is further complicated by the fact they are also extremely sensitive to exogenous factors like time and temperature. Therefore, there are strict conditions under which these therapies must be transported and received.
Advanced IT solutions and monitoring systems are being developed and employed to ensure end-to-end traceability across the pharma supply chain. These are giving clinicians access to view the progress of therapies and their distribution in real-time and allow users to automatically schedule or amend material collections in line with manufacturing capacity, helping to keep the supply chain as agile as possible and avoid costly wastage.
The live tissues and cells which form the basis of regenerative medicine products are highly sensitive and some have a shelf life of no more than a few hours, making distribution a complex task. Therefore, materials need to be transported from the site of harvest to manufacturing facilities, and from manufacturing facilities to medical institutions under strictly controlled conditions, within certain time periods and temperatures, according to different cell and tissue requirements which can vary from product to product.
Temperature-controlled logistics solutions are vital to ensure a safe, effective and financially viable supply chain network for these high-value shipments. Cryopreservation is one technique increasingly being used to deliver medicines at optimum temperature using vapor phase nitrogen, however, many clinical settings remain ill-equipped to handle such equipment.
Onsite production is an alternative manufacturing arrangement, particularly for autologous products which are derived from a patients own cells. However, this throws up a number of compliance and infrastructure challenges, as the hospital would need to comply with a host of regulations including installing a licensed clean room which may not be possible given budget restrictions and limited space onsite.As a first-generation technology, stakeholders will have a greater tolerance for higher pricing, but only for a limited time period. By streamlining the currently very expensive manufacturing process and improving supply chain management, yields will automatically get larger and costs will slowly come down.
While there are many challenges in the road ahead, 2019 certainly appears to be the start of regenerative medicines move to the big time. Just like big data and artificial intelligence is transforming the practice of medicine, regenerative medicine holds the promise of extending the bodys natural ability to replenish, replace and rejuvenate itself.
If the global health industry can work collaboratively on overcoming the challenges presented by delivering safe and effective advanced therapies, a dramatic extension of the human healthspan is possible. We may even reach the point where no disease is considered incurable, transforming healthcare as we know it.
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Regenerative Medicine: Overcoming The Supply Chain Challenges - Contract Pharma
What it means to be a cyborg in 2019 – Quartz
By daniellenierenberg
I have a four-foot-tall robot in my house that plays with my kids. Its name is Jethro.
Both my daughters, aged 5 and 9, are so enamored with Jethro that they have each asked to marry it. For fun, my wife and I put on mock weddings. Despite the robot being mainly for entertainment, its very basic artificial intelligence can perform thousands of functions, including dance and teach karate, which my kids love.
The most important thing Jethro has taught my kids is that its totally normal to have a walking, talking machine around the house that you can hang out with whenever you want to.
Given my daughters semi-regular use of smartphones and tablets, I have to wonder how this will affect them in the future. Will they have any fear of technologies like driverless cars? Will they take it for granted that machine intelligences and avatars on computers can be their best friends, or even their bosses?
Will marrying a super-intelligent robot in 20 years be a natural decision? Even though I love technology, Im not sure how I would feel about having a robot-in-law. But my kids might think nothing of it.
This is my story of transhumanism.
Courtesy of Zoltan Istvan
My transhumanism journey began in 2003 when I was reporting a story for National Geographic in Vietnams demilitarized zone and I almost stepped on a landmine.
I remember my guide roughly shoving me aside and pointing to the metal object half sticking out of the ground in front of me.
I stared at the device that would have completely blown my legs off had my boot tripped the mine. I had just turned 30. The experience left me shaken. And it kept haunting me.
That night as I lay tense and awake in my hotel room, I had the epiphany that has helped define the rest of my life: I decided that the most important thing in my existence was to fight for survival. To put it another way: My goal was to never die.
Because I was not religious, I immediately turned to the thing that gave meaning to my world: science and technology. I took a leap of faith and made a wager that day. I later called this (and even later, dedicated a book to it) the transhumanist wager.
The life extension business of transhumanism will be a $600 billion industry by 2025.
My idea for an immortality wager came from Pascals Wager, the famous bet that caught on in the 17th century that loosely argued it was better to believe in God than not to, because you would be granted an afterlife if there was indeed a God. My transhumanist wager was based in my belief that its better to dedicate our resources to science and technology to overcome death while were still aliveso we dont ever have to find out whether there is an afterlife or not. It turns out I wasnt alone in my passion to live indefinitely through science. A small social movement, mostly of academics and researchers, were tackling similar issues, starting organizations, and funding research.
Some of them called themselves transhumanists.
Fast-forward 16 years from my landmine incident, and transhumanism has grown way beyond its main mission of just overcoming death with science.
Now the movement is the de facto philosophy (maybe even the religion) of Silicon Valley. It encapsulates numerous futurist fields: singularitarianism, cyborgism, cryonics, genetic editing, robotics, AI, biohacking, and others.
Biohacking in particular has taken offthe practice of physically hacking ones body with science, changing and augmenting our physiology the same way computer hackers would infiltrate a mainframe.
Its pretty obvious why it has emerged as such a big trend: It attracts the youth.
Not surprisingly, worrying about death is something that older people usually do (and, apparently, those younger people who almost step on landmines). Most young people feel invincible. But tell young people they can take brain drugs called nootropics that make them super smart, or give them special eye drops that let them see in the dark, or give them a chip implant that enhances human ability (like the one I have), and a lot of young people will go for it.
In 2016, I ran for the US presidency as the Transhumanist Party nominee. To get support from younger biohackers, my team and I journeyed on the Immortality Busmy 38-foot coffin-shaped campaign busto Grindfest, the major annual biohacking meet-up in Tehachapi, California. In an old dentists chair in a garage, biohackers injected me with a horse syringe containing a small radio-frequency-identification implant that uses near-field communication technologythe same wireless frequency used in most smartphones. The tiny deviceits about the size of a grain of ricewas placed just under the skin in my hand. With my chip, I could start a car, pay with bitcoin, and open my front door with a lock reader.
Four years later, I still have the implant and use it almost every day. For surfers or joggers like myself, for example, its great because I dont have to carry keys around.
One thing I do have to navigate is how some religious people view me once they understand I have one. Evangelical Christians have told me that an implant is the mark of the beast, as in from the Bibles Book of Revelations.
Even though Im tagged by conspiracy theorists as a potential contender for the Antichrist, I cant think of any negatives in my own experiences to having a chip implant. But as my work in transhumanism has reached from the US Military to the World Bank to many of the worlds most well-known universities, my chip implant only exasperates this conspiracy.
While people often want to know what other things Ive done to my body, in reality becoming a cyborg is a lot less futuristic and drastic than people think.
For me and for the thousands of people around the world who have implants, its all about functionality. An implant simply makes our lives easier and more efficient. Mine also sends out pre-written text messages when peoples phones come within a few feet of me, which is a fun party trick.
But frankly, a lot of the most transformative technology is still being developed, and if youre healthy like me, theres really not much benefit in doing a lot of biohacking today.
I take nootropics for better brain memory, but theres no conclusive research I know of that it actually works yet. Ive done some brainwave therapy, sometimes called direct neurofeedback, or biofeedback, but I didnt see any lasting changes. I fly drones for fun, and of course I also have Jethro, our family robot.
For the most part, members of the disabled community are the ones who are truly benefiting from transhumanist technologies today. If you have an arm shot off in a war, its cyborg science that gives you a robot arm controlled by your neural system that allows you to grab a beer, play the piano, or shake someones hand again.
But much more dramatic technology is soon to come. And the hope is that it will be availableand accessibleto everyone.
I asked to be added to a volunteer list for an experiment that will place implants in peoples brains that would allow us to communicate telepathically, using AI. (Biohacking trials like this are secretive because they are coming under more intense legal scrutiny.)Im also looking into getting a facial recognition security system for my home. I might even get a pet dog robot; these have become incredibly sophisticated, have fur softer than the real thing (that doesnt shed all over your couch or trigger allergies) and can even act as security systems.
Beyond that, people are using stem cells to grow new teeth, genetic editing to create designer babies, and exoskeleton technology that will likely allow a human to run on water in the near future.
Most people generally focus on one aspect of transhumanism, like just biohacking, or just AI, or just brainwave-tech devices. But I like to try it all, embrace it all, and support it all. Whatever new transhumanist direction technology takes, I try to take it all in and embrace the innovation.
This multi-faceted approach has worked well in helping me build a bridge connecting the various industries and factions of the transhumanist movement. Its what inspired me to launch presidential and California gubernatorial campaigns on a transhumanist platform. Now Im embarking on a new campaign in 2020 for US president as a Republican, hoping to get conservatives to become more open-minded about the future.
The amount of money flowing into transhumanist projects is growing into many billions of dollars. The life extension business of transhumanism will be a $600 billion industry by 2025, according to Bank of America. This is no time for transhumanism to break apart into many different divisions, and its no time to butt heads. We need to unite in our aim to truly change the human being forever.
Transhumanistsit doesnt matter what kind you arebelieve they can be more than just human. The word natural is not in our vocabulary. Theres only what transhumanists can do with the tools of science and technology they create. That is our great calling: to evolve the human being into something better than it is.
Because transhumanism has grown so broadly by now, not all transhumanists agree with me on substantially changing the human being. Some believe we should only use technology to eliminate suffering in our lives. Religious transhumanists believe we should use brain implants and virtual reality to improves our morality and religious behavior. Others tell me politics and transhumanism should never mix, and we must always keep science out of the hands of the government.
We need unity of some significant sort because as we grow at such a fast rate there are a lot of challenges ahead. For example, the conservative Christian Right wants to enact moratoriums against transhumanism. The anarcho-primativists, led by people like the primitivist philosopher and author John Zerzan (who I debated once at Stanford University), want to eliminate much technology and go back to a hunting-gathering lifestyle which they believe is more in tune with Earths original ecology. And finally, we must be careful that the so-called one percent doesnt take transhumanist technology and leave us all in the dust, by becoming gods themselves with radical tech and not sharing the benefits with humanity.
I personally believe the largest danger of the transhumanist era is the fact that within a few decades, we will have created super-intelligent AI. What if this new entity simply decides it doesnt like humans? If something is more sophisticated, powerful, intelligent, and resilient than humans, we will have a hard time stopping it if it wants to harm or eliminate us.
Whatever happens in the future, we must take greater care than we ever have before as our species enters the transhumanist age. For the first time, we are on the verge of transforming the physical structure of our bodies and our brains. And we are inventing machines that could end up being more intelligent and powerful than we are. This type of change requires that not only governments act together, but also cultures, religions, and humanity as a whole.
In the end, I believe that a lot more people will be on board with transhumanism than admit it. Nearly all of us want to eliminate disease, protect our families from death, and create a better path and purpose for science and technology.
But I also realize that this must be done ever so delicately, so as not to prematurely push our species into crisis with our unbridled arrogance. One day, we humans may look back and revel in how far our species has evolvedinto undying mammals, cyborgs, robots, and even pure living data. And the most important part will be to be able to look back and know we didnt destroy ourselves to get there.
Originally posted here:
What it means to be a cyborg in 2019 - Quartz
Seven beauty basics to buy right now that will help you forget winter’s early blast – The GrowthOp
By daniellenierenberg
Were still waiting for CBD-infused skincare products to hit shelves in Canada, but products have been at retail for years containing hemp seed oil and cannabis sativa seed oil that are full of omega fatty acids and can be quite hydrating. They may not have the anti-inflammatory benefits of CBD, but consumers have been relying on their skin-boosting affects for ages.
So, just in time for an early blast of winter, here are some online options available at Well.ca for keeping your skin and complexion in check this season including one for the boys:
Chapped lips are sadly on their way now that temperatures have dipped below zero. Arm yourself with an all-natural, hemp-infused lip balm that is so affordable you may want to buy two one to stash in your purse and the other at your desk. Bonus: It also contains antioxidant-packed matcha green tea. Hurraw! Green Tea Lip Balm, $5
If youre like me, your fingers and hands have already started to show signs of winters wear. My cuticles are tattered and my summer-soft hands are rough and dry. Last winter, I relied on North American Hemp Co.s hand cream, and I am reaching back into my wallet for this one. Aside from cannabis sativa seed oil, it also contains vitamins A and E for a powerful solution to dry digits. North American Hemp Co. Hemp Hang Nail Help Hand & Nail Cream, $21
One of the tricks of the beauty trade is switching up your cleanser in the colder months for one that wont leave your face feeling dry and tight. Enter Andalou Naturals CannaCell Cleansing Foam that contains 100 per cent pure hemp seed oil, as well as hemp stem cells, vitamins C, E, as well as B vitamins for good measure. Already added to cart. Andalou Natural CannaCell Cleansing Foam, $19
This cult favourite serum from clean beauty brand Herbivore contains glow-inducing ingredients like olive-derived squalane and cannabis sativa seed oil to hydrate, soften and tone the complexion. And it will look pretty in your shelfie pics on Instagram. Herbivore Emerald Deep Moisture Glow Oil, $60
Bar soap is back baby! Brands and consumers are focusing once again on bar soap as a way to help reduce plastics. Buck Nakeds Dead Sea Mud and Argan Oil soap is a powerful detoxifier, while also adding hydrating ingredients back into the skin with the help of Argan oil backed up by hemp oil. On top of all of that, the bar is biodegradable, so no icky ingredients are washing down your water drain. Buck Naked Soap Company Dead Sea Mud + Argan Soap, $9
This may be for men, but whos stopping you from slathering on this cedar and Bourbon-scented natural deodorant that also contains skin-soothing cannabis sativa seed oil. A holiday gift perhaps? Olivina Men Bourbon Cedar Deodorant, $11
The sole ingredient in these blotting papers from mass beauty line NYX is cannabis sativa seed oil. While the papers will help take away unwanted shine on your T-zone and forehead, the cannabis oil will add a slight bit of hydration back into your complexion, yet keeping it matte. These blotters, there are 50 in a pack, are perfect for your purse while youre trekking to all those holiday parties. NYX Bare With Me Hemp Seed Oil Blotting Papers, $8
Michelle Bilodeau is a writer and editor about fashion, beauty and cannabis. She is also a co-host on theOn A High podcast
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Seven beauty basics to buy right now that will help you forget winter's early blast - The GrowthOp
Takeda sees cell, gene therapy in its future. Is it too late? – BioPharma Dive
By daniellenierenberg
Thanks to a $62 billion acquisition of Shire, Takeda is one of the world's largest developers of rare disease drugs.
Despite that, the 238-year-old Japanese pharmaceutical company lacks any mid- or late-stage cell or gene therapies, two technologies that figure to play a large role in how many rare cancers and inherited diseases will eventually be treated.
It's a mismatch Takedais putting substantial effort into addressing. Last week, executives made cell and gene therapy a notable focus of the company's first R&D day since closing its Shire deal.
"We have a world-class gene therapy platform," Dan Curran, head of Takeda's rare disease therapeutic area unit, told investors and Wall Street analysts gathered in New York city.
"We intend to build on that over the next five years. Because as we look to lead in the second half of [next]decade, we believe patients will demand and we can deliver transformative and curative therapies to patients globally."
But right now that's just an ambition. While Takedahas begun to explore how it can improve on current gene therapies, its candidates are early stage and lag their would-be competitors.
"Our heme A program we're behind. Our heme B program we're behind," admitted Curran in an interview. "But we're behind the first generation and when has there only been one generation of anything?"
Takeda's hemophilia A program is currently in Phase 1, with the hemophilia B candidate about to join it in human testing well back from leaders BioMarin Pharmaceutical, Spark Therapeutics and SangamoTherapeutics in hemophilia A and UniQure in hemophilia B.
Curran laid out three priorities for Takeda'spush: exploring whether gene therapy, typically pitched as a one-time treatment, can be re-dosed; lowering the doses currently used for first-generation therapies; and developing alternative gene delivery vehicles than the adeno-associatedand lentiviralvectors that are predominant today.
"We need to figure out how to re-dose AAVvectors if we want to provide functional cures for patients for the rest of their lives."
How long a gene therapy's benefit lasts is a critical question. In theory, it could last decades or potentially for life, depending on the treatment's target.
But clinical evidence presented to date suggests that benefit for some therapies could wane over time. BioMarin, for example, presented data this year that it argued is proof its gene therapy could raise Factor VIII expression levels in patients with hemophilia A above the threshold for mild disease for at least eight years a long time, to be sure, but not life-long.
Still, it's an unusual objective. Much of gene therapy's promise lies in the potential for it to be given just once and still deliver lasting benefits. And the therapies that have reached market most notably Spark Therapeutics' Luxturna, Novartis' Zolgensma and Bluebird bio's Zynteglo are among the most expensive drugs to ever reach market. Were a gene therapy to be re-dosed, the current value proposition those drugmakers describe would need to be re-evaluated.
Curran recognizes that bringing down costs substantially will be essential to any attempt to advance a multi-use gene therapy. But Takeda might have an advantage. In buying Shire, the pharma inherited a viral vector manufacturing plant, originally built by Baxalta, that Curran calls the company's "best kept secret."
"It's an enormous competitive advantage," he said, adding that Takeda believes it's among the industry's top three facilities by production capacity. "Roche trying to acquire Spark, Novartis and AveXis a significant component of value of those transactions was that these companies had actually invested in manufacturing capabilities."
Curran emphasized that Takeda's ambitions in gene therapy will require it to partner with academic leaders in the field, a playbook that it's followed over the past three years as it's worked to expand into cell therapy.
"In the cell space, there's more innovation you can bring up into proof of principle milestones in academia," said Andy Plump,Takeda'shead of R&D, in an interview.
"An academic can manipulate a cell, but it's very hard in an academic setting to optimize a small molecule," he added. "This is a space where Novartis, and now we, have been quite successful in creating those relationships."
Takeda has put partnerships in place with Japan's Center for iPS Cell Research and Application, GammaDelta, Noile-Immune Biotech, Memorial Sloan Kettering Cancer Center and, just this month, The University of Texas MD Anderson Cancer Center.
That last collaboration gives Takeda access to a chimeric antigen receptor-directed natural killer, or NK, cell therapy.The drugmaker believes NK cells could offer advantages over the T cells modified to create the currently available cell therapies Kymriah and Yescarta.
Most notably, MD Anderson's approach uses NK cells isolated from umbilical cord blood, rather than extracting T cells from each individual patient a time-consuming and expensive process that has complicated the market launch of Kymriah and Yescarta. Cord blood-derived NK cells are designed to be allogeneic, or administered "off the shelf."
Additionally, CAR NK cells haven't been associated (yet) with cytokine release syndrome or neurotoxicity, two significant side effects often associated with CAR-T cell therapies. That could help Takeda position its cell therapies as an outpatient option.
"Even if we were a company that entered a little bit later into the immuno-oncology space, we've very much tried to turn this into an advantage," said Chris Arendt, head of Takeda's oncology drug discovery unit, at the company's event.
"We believe we have a chance to establish a leadership position rather than jumping on the bandwagon and being a follower."
While Takeda's choice to pursue NK cell therapy stands out, its choice of target does not. TAK-007, a drug candidate from MD Anderson that is now Takeda's lead cell therapy program, is aimed at a cell surface protein called CD19 that's found in leukemias and lymphomas.
Both Yescarta and Kymriah target CD19, and a recent count by the Cancer Research Institute tracked 181 cell therapy projects aimed at the antigen.
Takeda is planning to advance TAK-007 into pivotal studies in two types of lymphoma and chronic lymphocytic leukemia by 2021, with a potential filing for approval in 2023.
By then, Kymriah and Yescarta will have been on the market for six years and current bottlenecks in cell therapy treatment could be solved, helping both Takeda's potential entry as well as the host of competitors it will likely face.
Next year will be a test of how productive Takeda'scell therapy unit can be. In addition to TAK-007, the pharmaexpects to have four other CAR-T and gamma delta cell therapies in the clinic, two of which will target solid tumors.
Cell and gene therapy are part of what Takeda calls its "second wave" of R&D projects, a group of early-stage drugs and programs that it sees as progressing to regulatory stages by 2025 or later.
In the nearer term, the drugmakeris advancing a "first wave" of clinical candidates that it told investors will deliver 14 new molecular entities by 2024. Five of those will come in rare disease, with the others spread across oncology, neuroscience, gastro-enterology and vaccines.
"We think the cascade of news coming forward on these programs will transform how people view Takeda," Curran said.
More importantly to the investors gathered in New York, Takeda expects these experimental drugs will eventually earn $10 billion in peak annual sales, which would represent a sizable addition to a business that generated $30 billion in sales last year.
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Takeda sees cell, gene therapy in its future. Is it too late? - BioPharma Dive
1st SCD Trial Patient Shows CTX001 Gene Editing to be Safe, Effective – Sickle Cell Anemia News
By daniellenierenberg
CTX001 safely and effectively increased the levels of fetal hemoglobin and prevented vaso-occlusive crisesin the first severesickle cell disease(SCD) patient receiving the therapy, according to preliminary data from a Phase 1/2 clinical trial.
CTX001 is a CRISPR-based gene editing therapy developed byCRISPR TherapeuticsandVertex Pharmaceuticals as a potential treatment for hemoglobin-associated diseases, includingSCD and beta-thalassemia.
It uses the CRISPR-Cas9 gene editing system to genetically modify a patients hematopoietic (bone marrow) stem cellsto produce high levels of fetal hemoglobin in red blood cells, which are then delivered back to the patient as part of a stem cell transplant.
The CRISPR-Cas9 system, which is similar to the editing system used by bacteria as a defense mechanism, allows researchers to edit parts of the genome by adding, removing, or changing specific sections of DNA.
Fetal hemoglobin, the main form of oxygen-carrying hemoglobin in the human fetus and newborn, largely disappears between six months to one year after birth, being replaced by its adult form.
Since the adult form is the one containing the defective component of hemoglobin in people with SCD and beta-thalassemia, an artificial increase of fetal hemoglobin has the potential to compensatefor the defective hemoglobin produced by these patients and reduce or prevent theirsymptoms.
The open-label, multi-center Phase 1/2 CLIMB-SCD-121 study (NCT03745287) is currently evaluating the safety and effectiveness of a single administration of CTX001 in people ages 18 to 35 with severe SCD.
The trial, which is expected to enroll up to 45 people, is stillrecruiting at 12 clinical sites in the United States, Canada, and Europe. Participants will be followed for approximately two years after treatment, and have the opportunity to enter a long-term follow-up study.
Before receiving CTX001, participants will undergo myeloablativechemotherapy, a strategy that kills cells in the bone marrow, thereby lowering the number of blood-forming cells. This way, the stem cell transplant will have more chances to rebuild a healthy bone marrow.
Researchers will first determine when the transplanted modified cells begin to produce mature blood cells in the patients, a process known as engraftment. After confirmation of engraftment, safety and effectiveness will be assessed as part of the trials primary and secondary goals.
One primary goal is to assess the proportion of people with an increase of at least 20% in the production of fetal hemoglobin, starting six months after CTX001 treatment. This increase must be sustained for more than three months at the time of analysis.
Among secondary goals is determining whether CTX001 reduces the annualized rate of vaso-occlusive crises.
In February, CRISPR Therapeutics and Vertex announced the enrollment of the first patient in the CLIMB-SCD-121 study, who was recruited in the U.S. and received CTX001 in mid-2019.
Now, the companies have shared the preliminary four-month data of this patient, a 33-year-old woman who had experienced seven vaso-occlusive crises per year the annualized rate of the two years before her enrollment in the trial.
Results showed that she had a confirmed engraftment 30 days after receiving CTX001 treatment. Four months after treatment, no vaso-occlusive crises were reported and she had stopped blood transfusion treatments.
After four months, her total hemoglobin levels were 11.3 g/dL, fetal hemoglobin levels had increased from 9.1% to 46.6%, and the percentage of fetal hemoglobin-producing red blood cells had increased from 33.9% to 94.7%.
CTX001s early safety profile was consistent with that previously reported for myeloablative chemotherapy followed by stem cell transplant. The woman experienced three serious adverse events, all of them resolved and considered to be unrelated to treatment.
Positive preliminary data were also announced for the first patient with beta-thalassemia receiving CTX001 in the Phase 1/2 CLIMB-Thal-111 study (NCT03655678).
We are very encouraged by these preliminary data [which] support our belief in the potential of our therapies to have meaningful benefit for patients following a one-time intervention, Samarth Kulkarni, PhD, CRISPR Therapeutics CEO, said in a press release.
A webcast and presentation about these preliminary results are available on the companys website.
The data are remarkable and demonstrate that CTX001 has the potential to be a curative CRISPR/Cas9-based gene-editing therapy for people with sickle cell disease and beta thalassemia, said Jeffrey Leiden, MD, PhD, Vertexs chairman, president, and CEO.
Leiden added that the trial is still in its early phase and that he looks forward to its final results.
Early this year, CTX001 receivedfast track statusfor the treatment of sickle cell disease by theU.S. Food and Drug Administration, which is expected to accelerate CTX001s development and regulatory approval process.
Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.
Total Posts: 94
Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Tcnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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1st SCD Trial Patient Shows CTX001 Gene Editing to be Safe, Effective - Sickle Cell Anemia News
Arthritis drugs could be repurposed to help prevent breast cancer spreading to the bone, study suggests – The University of Manchester
By daniellenierenberg
Drugs commonly used to treat arthritis may help to prevent breast cancer spreading to the bone, where it is incurable, new research suggests.
In a major new study published in Nature Communications, scientists propose that NHS arthritis drugs anakinra, canakinumab and sulfasalazine could in future be repurposed to help treat breast cancer, following the discovery of the role of bone marrow in the spread of the disease to the bone.
The study, largely funded by Breast Cancer Now, found that bone marrow releases a protein called interleukin 1-beta (IL-1) which encourages breast cancer cells to form secondary tumours once they reach the bone.
Crucially, the scientists at The University of Manchester and The University of Sheffield established that the process started by this molecule can be blocked by drugs already used in treating arthritis, with anakinra found to be able to prevent breast cancer forming secondary tumours in the bone in a study in mice.
While further research is needed to understand how these drugs may interact with the immune system or work together with other cancer therapies, it is hoped the findings could be quickly advanced into trials in women with breast cancer to try to prevent the disease spreading to the bone.
Research and care charity Breast Cancer Now said the findings offered another promising step in repurposing existing drugs to try to prevent the spread of breast cancer, following the recent addition of osteoporosis drugs bisphosphonates to NHS breast cancer treatment for certain patients.
Breast cancer is the UKs most common cancer, with around 55,000 women and 370 men being diagnosed each year and around 11,500 women still losing their lives each year in the UK.
Almost all of these deaths are attributable to secondary breast cancer, where breast cancer has spread to form tumours in other parts of the body. While secondary breast cancer (also known as metastatic breast cancer) can be controlled for some time, it currently cannot be cured.
One of the most common parts of the body for breast cancer to spread to is the bone, which can cause debilitating symptoms such as joint pain or fractures that often require surgery.
Special types of cells, called breast cancer stem cells, are thought to be responsible for the disease spreading around the body with previous research suggesting that healthy cells in different parts of the body can release certain molecules that help cancer stem cells settle and grow in new locations.
In a new study, research teams led by Dr Rachel Eyre and Professor Rob Clarke at The University of Manchester and Dr Penelope Ottewell from the Department of Oncology and Metabolism at The University of Sheffield investigated the growth of breast cancer cells in the lab and in mice to establish what helps the disease settle and grow in this location. They discovered the importance of certain factors released by the bone, and these findings were supported using data from patients with secondary breast cancer1.
The researchers first grew human breast cancer cells using liquid that human bone marrow had previously been grown in. They found that these cancer cells grew into tumours more easily than breast cancer cells that werent exposed to bone marrow liquid, suggesting bone marrow releases a molecule that helps cancer growth.
By tracking which signalling pathways2 became active in breast cancer cells after they had been exposed to bone marrow, the researchers discovered that the molecule IL-1 (which is released by bone marrow) was responsible for helping breast cancer stem cells grow into tumours.
They found that IL-1 activates a signalling pathway called NFKB/CREB-Wnt, which promotes the formation of secondary tumours a discovery that identifies multiple new targets (IL-1 receptor, NFKB, Wnt) for drugs to try to prevent the growth of breast cancer tumours in the bone.
Drugs that can inhibit the action of IL-1 already exist and are used in treating other conditions on the NHS. The researchers tested whether blocking the effect of IL-1 with clinically available arthritis drugs such as anakinra, as well as another drug, currently in trials for treating cancer, called vantictumab, could prevent the formation and growth of secondary breast cancer in the bone in mice.
They found that blocking the role of IL-1 using these drugs significantly reduced the ability of breast cancer cells to form secondary tumours in the bone in mice. For example, following treatment with anakinra, only 14% of mice developed secondary tumours in the bone, compared to 42% of controls.
Research is ongoing to understand how blocking the action of IL-1 to stop breast cancer spreading may affect the immune system, and whether drugs such as anakinra, canakinumab and sulfalazine could work with existing therapies including bisphosphonates to prevent the spread of the disease to the bone. With these drugs being well-tolerated and already in use in treating arthritis, the authors hope the findings could be quickly progressed into clinical trials for breast cancer in the future.
The researchers are also now working to understand whether the same signalling pathway (NFKB/CREB-Wnt) may be important in the spread of breast cancer to other parts of the body such as the liver or lungs.
The study was largely funded by Breast Cancer Now, with additional support from Weston Park Cancer Charity and the Medical Research Council.
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Arthritis drugs could be repurposed to help prevent breast cancer spreading to the bone, study suggests - The University of Manchester
Decoding the building blocks of life: bit bio races toward a sustainable source of human cells – Proactive Investors UK
By daniellenierenberg
The ability to turn human cells into anything we want sounds like the stuff of science fiction. But one Cambridge biotech says it's cracked the code
A sustainable source of human stem cells is one of the holy grails of modern medicine.
With applications as broad as re-growing failed organs, fighting cancer, and stopping animal testing, stem cell therapy is predicted to be worth US$35bn by 2023.
Now, Cambridge startup bit bio, has a new approach to re-coding skin cells from adult humans, and rewinding the clock to give them the power of stem cells, and then turn them into whatever we want them to be all without the controversial involvement of human embryos.
This, says neurosurgeon and founder Dr Mark Kotter, will democratise stem cells, so that anyone can use them, at any time.
The private sector is already placing big bets on the technology, with start-ups in the space raising as much as US$16mln in recent funding rounds.
Kotter says that our inability to produce enough human stem cells to match our need puts troubling limits on research and drug development.
In drug discovery, the biggest bottleneck is the mismatch between animal models and animal cell lines used for drug discovery, and then human setting used in the clinical trial, he explains.
Around 3% of new drugs make it all the way through trials and to market, he says, and the biggest reasons treatments tend to fail in clinical study is that they are either toxic to humans, or they dont work.
The only solution is to bring the human element back to the early stages, says Kotter.
If new therapies were tested on human tissue first, it would reduce or even bypass the need to test on animals, as well as speeding up development.
Kotter founded bit bio, formerly known as Elpis BioMed, in 2016, in addition to startup Meatable, which produces meat by growing cultures in the lab, rather than rearing animals for the table.
The time is now for bit bio, because what it is doing has only been possible since a Nobel Prize-winning discovery twelve years ago, which turned the world of stem cell research upside down.
Kyoto University researcher Shinya Yamanaka proved that it was possible to take a mature human skin cell and reprogram it to be like the stem cell of an embryo.
Until this revelation, stem cell research had been dogged by controversy and expense, as scientists had to use human embryos and umbilical cords as a source of stem cells, and then simulate complex conditions inside the womb in order to make them develop into the cells they desired.
One big problem in early cell reprogramming was that stem cells are incredibly alert to invading DNA and silences any foreign material it detects.
This meant that past attempts run a different program inside a cell often failed, because the cell destroyed it.
What happened next was a moment of "serendipity" in the lab, says Kotter.
Through trial and error, bit bio found they could use certain safe harbours where information is protected within cells, to stop theinterference.
By taking the genetic switch for gene silencing and placing it inside a safe harbour, and then separately running the new cell program inside another safe harbour, scientists found they could override gene silencing in order to change the cell type.
This approach is what Kotter says makes bit bio unique.
The lab can produce up to a kilogram of human cells now, and its tech platform OptiOx has also proved that it can generate two human cell types with 100% accuracy.
Kotter says that now the range of cells able to be produced matters more than the quantity.
The company is now focused on discovering what separates one type of cell from another, which Kotter says will allow the firm to decode the building blocks of life.
To this end, bit bio is using machine learning to analyse the differences between every type of human cell, from bone marrow cells to liver cells, and create a reference map for all the different types.
Once the research is complete, the company hopes it willbe able to generate any type of human cell, at scale, and with ultimate precision.
Preparations are underway for a Series A funding round, and Kotter says that he is determined not to sell the business, having already rejected offers from would-be buyers.
Bit bio though is in an area hot with competition, which moves quickly.
A US$16mln Series A mega funding round was recently announced in October by another Cambridge start-up, Mogrify, which is hoping to master direct cell reprogramming and turn blood cells straight into brain cells, or any other type.
Mogrify uses big data to identify the small molecules needed to convert, maintain and culture a target cell type.
While both companies were finalists in the 2018 Cambridge Startup of the Year award, bit bio was the one to scoop the prize.
One aspect that separates the two companies is that Mogrify uses its technology to turn cells directly into other cell types, rather than using it to rewindto the stem cell phase, which is when cells can reproduce very quickly,
Kotter says that this stem cell phase focusis whatallows bit bio to havea stable supply of human cells.
If bit bio completes a similar, or even bigger, fundraise, it could advance the fledgling firm from seed to stem, in its attempt to stabilise a production line for essential cell technology.
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Decoding the building blocks of life: bit bio races toward a sustainable source of human cells - Proactive Investors UK
Arthritis drugs could halt the spread of breast cancer, study suggests – sciencefocus.com
By daniellenierenberg
Simple arthritis drugs used on the NHS could help stop breast cancer spreading, research suggests.
Scientists propose that arthritis drugs anakinra, canakinumab and sulfasalazine could be re-purposed to help block cancer reaching bones.
Research teams from the University of Manchester and the University of Sheffield discovered that a protein released by bone marrow, called interleukin 1-beta encouraged breast cancer cells to form secondary tumours once they reach the bone.
Tests on mice found that this molecule can be blocked by drugs already used to treat arthritis.
Read more about cancer treatment:
The study, largely funded by charity Breast Cancer Now and published in the Nature Communications journal, revealed that anakinra was able to prevent breast cancer forming secondary tumours in the bone.
Follow treatment with anakinra, only 14 per cent of mice in the study developed secondary tumours in the bone, compared to 42 per cent of control animals.
According to Breast Cancer Now, around 55,000 women and 370 men are diagnosed with breast cancer each year, making it the UKs most common cancer.About 11,500 women die from the disease each year, almost all from tumours that have spread to other parts of the body.Breast cancer most commonly spreads to the bones, brain, lungs or liver.
Breast cancer stem cells are thought to be responsible for the spread of the disease, with previous research suggesting healthy cells released certain molecules to help the cancer stem cells settle and grow in new locations.
In their new study, researchers grew breast cancer cells using liquid that bone marrow had grown in. They found the cancer cells grew more easily than cells not exposed to these conditions and then identified interleukin 1-beta as the molecule responsible.
It is hoped the findings will lead to trials in women with breast cancer to help prevent cancer spreading to the bone.
Scientists believe more work is needed to understand how Arthritis drugs could halt the spread of breast cancer, study suggestsritis drugs might interact with the immune system and other cancer therapies.
Read more about breast cancer:
Lead author of the study, Dr Rachel Eyre, from the University of Manchester, said: We will now look to see if similar processes are also involved in breast cancer growing in other organs, such as the liver and lungs.
We hope that by continuing this work, we could in future identify those at high risk of their breast cancer spreading, and where possible use drugs already available to prevent this from happening.
Baroness Delyth Morgan, chief executive of Breast Cancer Now, said: These major findings offer another promising step forward in re-purposing existing drugs to prevent the spread of breast cancer.
While more research is needed, its really exciting that these well-tolerated and widely-available arthritis drugs may help prevent secondary breast cancer in the bone.
Continued here:
Arthritis drugs could halt the spread of breast cancer, study suggests - sciencefocus.com
Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results – Yahoo Finance
By daniellenierenberg
TEL AVIV, Israel, Nov. 19, 2019 /PRNewswire/ --Cellect Biotechnology Ltd. (APOP), a developer of innovative technology which enables the functional selection of stem cells, today reported financial and operating results for the third quarter ended September 30, 2019 and provided a corporate update.
Recent Highlights
"Our clinical and regulatory teams remained focused during the third quarter and the more recent positive developments position us to achieve our goals, both in the U.S. and Israel," commented Dr. Shai Yarkoni, Chief Executive Officer. "In the U.S., the IND approval is a significant achievement and represents our first-ever FDA IND in the U.S., with Washington University School of Medicine. In Israel, our Phase 1/2 clinical study of ApoGraft is progressing slowly and we expect to complete the recruitment around the end of the year."
"With our prudent use of cash during the third quarter and the anticipated cash usage needs over the coming quarters, we continue to believe we have the resources to execute our clinical and regulatory plans for the foreseeable future," said Eyal Leibovitz, Chief Financial Officer.
ThirdQuarter 2019 Financial Results:
*For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2019 (U.S. $1 = NIS 3.482).
Strategic Review Progress Update
On May 16, 2019, the Company disclosed that it commenced plans to explore strategic alternatives to maximize shareholder value. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, including in other business fields than the Company's in-licensing, or other strategic transaction involving the Company or its assets. The Company continues to evaluate business development opportunities and will keep investors informed as they mature or warrant investor disclosure.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (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. 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; or maintain its current operations; uncertainties involving any strategic transaction the Company may decide to enter into as the result of its current efforts to explore new strategic alternatives; 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, 2018 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.
Story continues
Cellect Biotechnology Ltd
Consolidated Statement of Operation
Convenience
translation
Nine months
ended
Nine months ended
Three months ended
September 30,
September 30,
September 30,
2019
2019
2018
2019
2018
Unaudited
Unaudited
U.S. dollars
NIS
(In thousands, except share and per
share data)
Research and development expenses
2,743
9,551
9,473
2,465
4,125
General and administrative expenses
2,249
7,832
11,001
2,768
3,929
Operating loss
4,992
17,383
20,474
5,233
8,054
Financial expenses (income) due to warrants exercisable into shares
(2,303)
(8,020)
(2,935)
(910)
(1,320)
Other financial expenses (income), net
393
1,369
(1,177)
489
64
Total comprehensive loss
3,082
10,732
16,362
4,812
6,798
Loss per share:
Basic and diluted loss per share
0.015
0.051
0.127
0.021
0.052
Basic and diluted loss per ADS
0.30
1.02
2.54
0.42
1.04
Weighted average number of shares outstanding used to compute basic and diluted loss per share
208,771,303
208,771,303
129,139,278
224,087,799
130,192,799
Cellect Biotechnology Ltd.
Consolidated Balance Sheet Data
ASSETS
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Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results - Yahoo Finance
Bone Marrow Processing Systems Market With Industry Overview, Supply Chain, Key Players, & Analysis To 2025 – Guru Online News
By daniellenierenberg
Bone marrow aspirationand trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.
The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.
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Europe and North America spearheaded the market as of 2018, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants areconducted in Europe, and it is oneof the major factors contributing to the lucrative share in the cell harvesting system market.
In 2018, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.
Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy.
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Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.
Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others.
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Arthritis drugs available on the NHS help stop the spread of breast cancer to bones – The Sun
By daniellenierenberg
ARTHRITIS drugs available on the NHS help stop the spread of breast cancer, a study suggests.
They blocked secondary tumours fuelled by a bone marrow protein called interleukin 1-beta, researchers found.
1
In tests, just 14 per cent of mice treated with arthritis drug anakinra developed secondary tumours in the bone, compared with 42 per cent in a control group.
Other arthritis drugs canakinumab and sulfasalazine had similar effects, the Manchester University and Sheffield University researchers found.
Dr Rachel Eyre told journal Nature Communications: We will now look to see if similar processes are also involved in breast cancer growing in organs such as the liver and lungs.
The study was largely funded by charity Breast Cancer Now.
According to Breast Cancer Now, around 55,000 women and 370 men are diagnosed with breast cancer each year, making it the UK's most common cancer.
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About 11,500 women die from the disease each year, almost all from tumours that have spread to other parts of the body.
Breast cancer most commonly spreads to the bones, brain, lungs or liver.
Breast cancer stem cells are thought to be responsible for the spread of the disease, with previous research suggesting healthy cells released certain molecules to help the cancer stem cells settle and grow in new locations.
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Arthritis drugs available on the NHS help stop the spread of breast cancer to bones - The Sun
Breaking News: Cardiol Therapeutics Announces Clinical Steering Committee for Phase 2 International Trial in Acute Myocarditis Using CardiolRx(TM) 100…
By daniellenierenberg
Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF), a leader in the production of pharmaceutical cannabidiol (CBD) products and in the development of innovative cannabidiol medicines for heart disease, is pleased to announce the formation of the Clinical Steering Committee (CSC) for a Phase 2 international trial in acute myocarditis using the Companys CardiolRx100 cannabidiol formulation.
The CSC, which comprises key opinion leaders in acute myocarditis from North America and Europe, recently met during the American Heart Associations Scientific Sessions in Philadelphia held November 16th to 18th. The role of the CSC is to advise on the trial design, provide overall supervision of the trial, and ensure that it is being conducted in accordance with the principles of Good Clinical Practice. The CSC has oversight of the protocol, any protocol amendments, and provides advice to the investigators on all aspects of the trial.
Acute myocarditis is characterized by inflammation of the heart muscle (myocardium). The most common cause is viral infection of the heart tissue which is initially responsible for the inflammation. In a significant number of cases, perhaps due to an autoimmune process, the inflammation persists with ongoing myocardial damage and depressed heart function. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is the most common cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Symptoms include chest pain, fatigue, shortness of breath, and arrhythmias. Because of the progressive damage to heart cells, heart failure develops (defined as the inability of the heart to pump sufficient blood to meet the needs of the body). The study will use left ventricular ejection fraction (LVEF) as one measure of heart function.
CardiolRx100 is Cardiol Therapeutics pure pharmaceutically (cGMP) produced high concentration cannabidiol formulation that is THC free (<10ppm). Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, Cardiol believes there is an opportunity to develop a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan drug. In the United States, an orphan drug designation is granted for pharmaceuticals being developed to treat medical conditions affecting fewer than 200,000 people. These conditions are referred to as orphan diseases. In the U.S. and the European Union, orphan drugs are eligible for accelerated marketing approvals and companies developing orphan drugs typically receive other incentives, including a prolonged period of market exclusivity that can extend over seven years, during which the drug developer has sole rights to market the drug.
Cardiol has assembled eight highly distinguished thought leaders in cardiology from North America and Europe to oversee and guide our acute myocarditis trial that is being planned at world leading heart institutes, including the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, and Charit University Medicine Berlin, stated David Elsley, President and CEO of Cardiol Therapeutics. The U.S. orphan drug program was successfully utilized to accelerate the first FDA approval of cannabidiol for the treatment of two pediatric epilepsy orphan diseases. We see a similar opportunity with our international trial in acute myocarditis to fast track the development of our CardiolRx formulation for a serious cardiovascular orphan disease for which there is currently no accepted standard of care.
Members of Cardiols Acute Myocarditis CSC include:
Dennis M. McNamara, MD (Chair)
Dr. Dennis McNamara is a Professor of Medicine at the University of Pittsburgh. He is also the Director of the Heart Failure/Transplantation Program at the University of Pittsburgh Medical Center. Dr. McNamara received his undergraduate/graduate education at Yale University, New Haven, Connecticut, and Harvard Medical School, Boston, Massachusetts, respectively. He completed his internship, residency, and cardiology fellowship at Massachusetts General Hospital in Boston. McNamaras current research interests include etiology and pathogenesis of dilated cardiomyopathies; inflammatory syndromes of cardiovascular disease; myocardial recovery in recent onset non-ischemic primary cardiomyopathy; etiology and management of peripartum cardiomyopathy; and genetic modulation of outcomes in cardiovascular disease.
Leslie T. Cooper, Jr., MD (Co-Chair)
Dr. Leslie T. Cooper, Jr., is a general cardiologist and the chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine, as well as chair of the Department of Cardiovascular Medicine at the Mayo Clinic in Florida. Dr. Coopers clinical interests and research focus on clinical and translational studies of rare and undiagnosed cardiomyopathies, myocarditis, and inflammatory cardiac and vascular diseases, such as giant cell myocarditis, cardiac sarcoidosis, eosinophilic myocarditis, and Takayasus arteritis. He has published over 130 original peer-reviewed papers, as well as contributing to and editing books on myocarditis. In addition to his clinical and research work, Dr. Cooper is a fellow of the American College of Cardiology, the American Heart Association, the European Society of Cardiology Heart Failure Association, the International Society for Heart and Lung Transplantation, and the Society for Vascular Medicine and Biology. He is also the founder and former president of the Myocarditis Foundation and continues to serve on its Board of Directors.
Arvind Bhimaraj, MD
Dr. Arvind Bhimaraj is a specialist in Heart Failure and Transplantation Cardiology and is Assistant Professor of Cardiology, Institute for Academic Medicine, at Houston Methodist and at Weill Cornell Medical College, NYC. He has been Co-Director of the Heart Failure Research Laboratory at Houston Methodist since 2016. His area of focus is anti-fibrotic mechanisms and how to promote recovery of a damaged heart. Dr. Bhimaraj was a Heart Failure Fellow at the Cleveland Clinic from July 2010 to September 2011. Dr. Bhimaraj also specializes in Interventional Cardiology, is board certified in Cardiovascular Disease, and the author of numerous cardiovascular publications.
Matthias Friedrich, MD
Dr. Matthias Friedrich is Full Professor with the Departments of Medicine and Diagnostic Radiology at the McGill University in Montreal and Chief, Cardiovascular Imaging at the McGill University Health Centre. He is also Professor of Medicine at Heidelberg University in Germany. Dr. Friedrich earned his MD at the Friedrich-Alexander-University Erlangen-Nrnberg, Germany. He completed his training as an internist and cardiologist at the Charit University Medicine Center, Humboldt University in Berlin. Dr. Friedrich founded one of the first large Cardiovascular Magnetic Resonance centres in Germany at the Charit University Hospital in Berlin. After his move to Canada, from 2004 to 2011, he was Director of the Stephenson Cardiovascular MR Centre at the Libin Cardiovascular Institute of Alberta and Professor of Medicine within the Departments of Cardiac Sciences and Radiology at the University of Calgary, Canada. From 2011 to 2015, he directed the Philippa and Marvin Carsley Cardiovascular MR Centre at the Montreal Heart Institute and was Michel and Renata Hornstein Chair in Cardiac Imaging at the Universit de Montral.
Peter Liu, MD
Dr. Peter Liu is the Chief Scientific Officer and Vice President, Research, of the University of Ottawa Heart Institute, and Professor of Medicine and Physiology at the University of Toronto and University of Ottawa. He was the former Scientific Director of the Institute of Circulatory and Respiratory Health at the Canadian Institutes of Health Research, the major federal funding agency for health research in Canada. Prior to that role, he was the inaugural Director of the Heart & Stroke/Lewar Centre of Excellence in Cardiovascular Research at University of Toronto. Dr. Liu received his MD from the University of Toronto, and postgraduate training at Harvard University. His laboratory investigates the causes and treatments of heart failure, the role of inflammation, and the identification of novel biomarkers and interventions in cardiovascular disease. Dr. Liu has published over 300 peer-reviewed articles in high impact journals and received numerous awards in recognition of his research and scientific accomplishments.
Wai Hong Wilson Tang, MD
Dr. Wai Hong Wilson Tang is the Advanced Heart Failure and Transplant Cardiology specialist at the Cleveland Clinic in Cleveland, Ohio. Dr. Tang is also the Director of the Cleveland Clinics Center for Clinical Genomics; Research Director, and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine in the Sydell and Arnold Miller Family Heart & Vascular Institute at the Cleveland Clinic. He attended and graduated from Harvard Medical School in 1996, having over 23 years of diverse experience, especially in Advanced Heart Failure and Transplant Cardiology. Dr. Tang is affiliated with many hospitals including the Cleveland Clinic and cooperates with other doctors and physicians in medical groups including The Cleveland Clinic Foundation.
Barry Trachtenberg, MD
Dr. Barry H. Trachtenberg is a cardiologist specializing in heart failure and cardiac transplantation. He is also the director of the Michael DeBakey Cardiology Associates Cardio-Oncology program, an evolving field devoted to prevention and management of cardiovascular complications of cancer therapies such as chemotherapy and radiation. His clinical experience includes heart failure and heart transplantation, mechanical support pumps, and cardio-oncology. He has contributed to multiple publications related to advanced heart failure, cardiac transplantation, regenerative therapies, and ventricular assist devices. Dr. Trachtenberg is a member of the American Heart Association, the International Society for Heart and Lung Transplantation, the Heart Failure Society of America, and the International CardiOncology Society of North America.
Carsten Tschpe, MD
Dr. Carsten Tschpe is Professor of Medicine and Cardiology and Vice Director of the Department of Internal Medicine and Cardiology, Charit University Medicine Berlin. He received his doctorate in medicine in 1993 and has over 140 peer-reviewed publications, including overview and book articles, and 120 international original articles. His research interests include inflammatory cardiomyopathy, diabetic cardiopathy, and ischemic cardiopathy. He also includes diastolic dysfunction, endothelial dysfunction, peptide systems, and experimental and clinical studies in cardiology and stem cells in his research studies. For his outstanding research work, Dr. Tschpe was awarded the prestigious Arthur Weber Prize by the German Cardiac Society Cardiovascular Research.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL)(OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Companys lead product, CardiolRx, is designed to be one of the safest and most consistent CBD formulations on the market. CardiolRx is pharmaceutically produced, cGMP certified, and is THC free. The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.
In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical CBD and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visitwww.cardiolrx.com.
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Breaking News: Cardiol Therapeutics Announces Clinical Steering Committee for Phase 2 International Trial in Acute Myocarditis Using CardiolRx(TM) 100...
Stem Cell Therapy Market to Surge at a Robust Pace in Terms of Revenue Over 2025 – The Denton Chronicle
By daniellenierenberg
Stem Cell Therapy Market: Snapshot
Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.
One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.
It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.
Global Stem Cell Therapy Market: Overview
Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.
Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.
Global Stem Cell Therapy Market: Key Trends
The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.
On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.
Global Stem Cell Therapy Market: Market Potential
A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.
In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.
Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.
Global Stem Cell Therapy Market: Regional Outlook
The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.
Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.
Global Stem Cell Therapy Market: Competitive Analysis
Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.
Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.
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Stem Cell Therapy Market to Surge at a Robust Pace in Terms of Revenue Over 2025 - The Denton Chronicle
European Commission Approves Two New Regimens of Merck’s KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent…
By daniellenierenberg
This disease is especially debilitating since it can be highly visible and affect a patients appearance and their daily functions, such as eating and speaking, said Professor Kevin Harrington, investigator for KEYNOTE-048, professor of biological cancer therapies at The Institute of Cancer Research, London, and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust. Considering the great need for new treatment options, we are encouraged by todays KEYTRUDA approval in Europe, which will allow certain patients to be treated with immunotherapy earlier in the course of their treatment.
This approval allows marketing of the KEYTRUDA monotherapy and combination regimen in all 28 EU member states plus Iceland, Lichtenstein and Norway.
KEYTRUDA is now the first anti-PD-1 treatment option in the first-line setting for metastatic or unresectable recurrent head and neck cancer, a disease that has been treated the same way in the EU for more than a decade, said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. The European Commission approval underscores our commitment to transforming the way cancer is treated around the world.
Data Supporting the European Approval
This approval is based on data from the Phase 3 KEYNOTE-048 trial, a multi-center, randomized, open-label, active-controlled trial conducted in 882 patients with histologically confirmed metastatic or recurrent HNSCC of the oral cavity, pharynx or larynx, who had not previously received systemic therapy for recurrent or metastatic disease and who were considered incurable by local therapies. Randomization was stratified by tumor PD-L1 expression (Tumor Proportion Score [TPS] 50% or <50%), HPV status (positive or negative), and ECOG Performance Status (PS) (0 vs. 1). The dual primary endpoints were OS and progression-free survival (PFS). Patients were randomized 1:1:1 to one of the following treatment arms:
Treatment with KEYTRUDA continued until RECIST v1.1-defined progression of disease as determined by the investigator, unacceptable toxicity or a maximum of 24 months.
Efficacy Results for KEYTRUDA as Monotherapy in KEYNOTE-048 with PD-L1 Expression(CPS 1)
Endpoint
KEYTRUDA
n=257
Standard
Treatment*
n=255
OS
Number (%) of patients with event
197 (77%)
229 (90%)
Median in months (95% CI)
12.3 (10.8, 14.3)
10.3 (9.0, 11.5)
Hazard ratio (95% CI)
0.74 (0.61, 0.90)
p-Value
0.00133
PFS
Number (%) of patients with event
228 (89%)
237 (93%)
Median in months (95% CI)
3.2 (2.2, 3.4)
5.0 (4.8, 6.0)
Hazard ratio (95% CI)
1.13 (0.94, 1.36)
p-Value
0.89580
ORR
Objective response rate (95% CI)
19.1% (14.5, 24.4)
35% (29.1, 41.1)
Complete response
5%
3%
Partial response
14%
32%
p-Value
1.0000
Duration of Response
Median in months (range)
23.4 (1.5+, 43.0+)
4.5 (1.2+, 38.7+)
% with duration 6 months
81%
36%
*
Cetuximab, platinum, and 5-FU
Based on the stratified Cox proportional hazard model
Based on stratified log-rank test
Response: Best objective response as confirmed complete response or partial response
Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)
Efficacy Results for KEYTRUDA plus Chemotherapy in KEYNOTE-048 with PD-L1 Expression(CPS 1)
Endpoint
KEYTRUDA +
Platinum Chemotherapy +
5-FU
n=242
Standard
Treatment*
n=235
OS
Number (%) of patients with event
177 (73%)
213 (91%)
Median in months (95% CI)
13.6 (10.7, 15.5)
10.4 (9.1, 11.7)
Hazard ratio (95% CI)
0.65 (0.53, 0.80)
p-Value
0.00002
PFS
Number (%) of patients with event
212 (88%)
221 (94%)
Median in months (95% CI)
5.1 (4.7, 6.2)
5.0 (4.8, 6.0)
Hazard ratio (95% CI)
0.84 (0.69, 1.02)
p-Value
0.03697
ORR
Objective response rate (95% CI)
36% (30.3, 42.8)
36% (29.6, 42.2)
Complete response
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European Commission Approves Two New Regimens of Merck's KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent...
New Process can 3D Print Living Cells with Precision and Speed – DesignNews
By daniellenierenberg
3D bioprinting has come a long way in recent years, with scientists using living tissue to print organs as complex as human skin. Researchers in Austria have unveiled an advancement with a process that can integrate living cells into structures at unprecedented speeds and resolution.
TU Wien developed the new technique using a novel bioink that allows cells to be embedded in a 3D matrix and printed with micrometer precision. The technique performs at a speed of one meter per second, much faster than past methods.
Images show living cells spreading in a 3D scaffold -- from left to right: week 1, week 3 week 5. Top: 3D setup, bottom: one layer only. The process was developed by researchers at TU Wien to create precision bioprinting. (Source: TU Wien)
"Using these 3D scaffolds, it is possible to investigate the behavior of cells with previously unattainable accuracy, said Aleksandr Ovsianikov, head of the 3D Printing and Biofabrication research group at the Institute of Materials Science and Technology at TU Wien. It is possible to study the spread of diseases, and if stem cells are used, it is even possible to produce tailor-made tissue in this way.
Exact Science
To successfully bioprint cells that can turn into living tissue with various characteristics, its key to process the cells in a certain way. While there are many techniques for 3D bioprinting, not all are created equal, said Ovsianikov. Some methods are imprecise or only allow a very short time window in which the cells can be processed without being damaged, while others have material challenges.
He noted that the behavior of a cell behaves depends crucially on the mechanical, chemical and geometric properties of its environment. "The structures in which the cells are embedded must be permeable to nutrients so that the cells can survive and multiply, said Ovsianikov. But it is also important whether the structures are stiff or flexible, whether they are stable or degrade over time.
The team can print 3D objects at microscopically fine resolutions, but using living cells at this size has been challenging. "You need liquids or gels that solidify precisely where you illuminate them with a focused laser beam, Ovsianikov noted. However, these materials must not be harmful to the cells, and the whole process has to happen extremely quickly.
Speeding the Process
To solve this issue, TU Wien researchers have been using what are called two-photon polymerization methods, which use a chemical reaction that is only initiated when a molecule of the material simultaneously absorbs two photons of a laser beam with particularly high intensity. At the point of photon absorption, the substance hardens, while it remains liquid everywhere else, which makes this method best suited to produce extremely fine structures with high precision.
While this allows for high resolution, its a rather slow processtypically in the range of micrometers or a few millimeters per second. This means the cells could die before printing is complete.
Now using the scaffolds, researchers have developed a method that fabricates cell-friendly materials at greater speeds. This means they can print a structure in just a few hours, giving cells a good chance of surviving and developing further. "Our method provides many possibilities to adapt the environment of the cells," said Ovsianikov.. Depending on how the structure is built, it can be made stiffer or softer.
He added that even fine, continuous gradients are possible. In this way, it is possible to define exactly how the structure should look in order to allow the desired kind of cell growth and cell migration. The process can also alter the laser intensity to determine how easily the structure will be degraded over time.
Based on the research, the team has created a company, UPNano, to further develop this technique and create bioprinting innovations. They also published a paper on their work in the journal Advanced Healthcare Materials.
Elizabeth Montalbano is a freelance writer who has written about technology and culture for more than 20 years. She has lived and worked as a professional journalist in Phoenix, San Francisco and New York City. In her free time she enjoys surfing, traveling, music, yoga and cooking. She currently resides in a village on the southwest coast of Portugal.
January 28-30:North America's largest chip, board, and systems event,DesignCon, returns to Silicon Valleyfor its 25th year!The premier educational conference and technology exhibition, this three-day event brings together the brightest minds across the high-speed communications and semiconductor industries, who are looking to engineer the technology of tomorrow. DesignCon is your rocket to the future. Ready to come aboard?Register to attend!
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New Process can 3D Print Living Cells with Precision and Speed - DesignNews
Chemotherapy and constant pills but DWP tells Hull man Kye Eastwood ‘you’re fit for work’ – Hull Daily Mail
By daniellenierenberg
A young Hull man whose life was saved by the generous people of Hull after being diagnosed with terminal cancer says he is looking forward to the future.
In 2014, Kye Eastwood, now 28, faced an unimaginable battle after being told there was nothing more UK doctors could do for him in his battle against Hodgkins Lymphoma - but there was hope.
The people of Hull heroically clubbed together and raised 46,000 within a month, paying for ground breaking - and life-saving - stem cell - treatment in Maryland, US.
Now, five years on, Kye and his fianc Chanelle Urquhart, 24, of Kingswood, are looking forward to their lives together - after what Kye has described as one of the most difficult years of his life.
Although the pioneering treatment cleared Kye of cancer, Kye has ongoing health issues. He is still undergoing chemotherapy and he is unable to work.
Despite this, he was told he was not allowed his PIP (Personal Independence Payment) benefits from the Department for Work and Pensions (DWP) after he underwent an eligibility assessment.
He said the report was "all wrong", stating he could do a number of things he could not do, which meant he was deemed fit for work.
He said: The report said I had a healthy complexion - that is completely wrong in the first place because of the vitiligo (pigmentation of the skin) I have.
Chanelle said he also split open a sore on his back trying to lift his arms further above his head during the assessment and it still needs treatment months later.
Although he has since had his benefits reinstated after the report was proved to be wrong, the trauma of living without any income and the strain it put on him for months has taken its toll.
He said: Someone came around in March theyd decided I was poorly enough for them to come to me rather than me go to them. I was on my cycle of chemo at the time and having massive allergic reactions.
Everything in the report was wrong and the woman who came didnt even look at any of the medical evidence and made out that I could move more.
"What the report said was not reflective of what happened in the meeting. We got a letter saying I wasnt entitled and why, and the report shed sent off.
Kye appealed and received another assessment and a complaint was put into the DWP by Chanelle, who sent pictures of Kyes skin and statements from every one of his doctors and specialists who see him in Rotherham.
Three months later, Kyes benefits were reinstated.
Chanelle said: He was three months without them, which help with his mobility. He was struggling to get to Rotherham, the treatment which ultimately keeps him alive.
She added the complaint has been escalated and is being looked at by an independent case examiner.
A DWP spokesman said: "We have apologised to Mr Eastwood for the confusion over his reapplication for PIP. It was resolved promptly and he is in receipt of all the benefits he is entitled to."
Chanelle said Kye would love nothing more than to go back to work but he needs something flexible that could work around treatment and hospital appointments.
She said: He was always working before the cancer and would love to go back to work and do things but its trying to find something he would be able to do safely, and something that would work around his health problems.
Kye added: I dont know an employer that would want me to be off at least a week every month while I go to my appointments.
During Kye's treatment the couple flew back and forth to Washington for a period of seven months and were able to stay at the amazing centre along with other families of people having treatment there.
During the time between treatments, they were able to explore the country and while staying in San Antonio in 2015 when they had been together for just six months, Kye proposed.
Chanelle said: At the time it happened, we hadnt been together for very long but we didnt know if he was going to survive. We instantly clicked and it was obvious it was going to work out.
Kye said: I knew I was going to do it. Wed known each other for years.
Five years later and they are still going strong - Chanelle even got to be the one to tell Kye he was cancer-free.
She said: He was in America and Id had to stay at home because I couldnt get the time off work.
"Theyd done a scan and the doctor had emailed me and told me he was completely clear. I was in Morrisons and was crying. I was trying to call him but he didnt have any signal.
I got through to him and just said, your cancer has completely gone'. Then he went to the car and told his mum.
Despite the relief at being given the all clear, Kye has faced difficulty during his recovery and still suffers side effects from all of his treatments.
Not long after he was told he was in remission, he started to suffer with a condition called Graft Versus Host Disease (GvHD).
The disease is classed as a medical complication of receiving of transplanted tissue from a different person such as Kyes stem cell treatment.
The white blood cells left in the donated tissue only recognise the receiver as foreign and begin to attack the receivers cells.
This has left Key with patches of dry skin on his body. His skin is thinner and he has vitiligo, which changes the pigment and colour.
Kye said: It started with a bit of itchy skin and I had a dry patch that wouldnt go away and we went for blood tests and they kept coming back really abnormal, my liver levels were through the roof.
Chanelle said: That was quite worrying as its quite dangerous and they were trying all sorts of things.
He now goes to Rotherham every week for treatment for the GvHD, and is on daily chemotherapy tablets.
He says he has tried a lot of different treatments but at the moment, this combination is working - although doctors are looking at other methods.
The GvHD in itself keeps the cancer at bay so doctors want to try and find a healthy balance.
Chanelle said: Hes hooked up to a machine that removes a certain volume of blood cells, which they separate. They give him his red blood cells back and treat the white blood cells with a UV light before putting them back in his body."
As well as GvHD Kye suffers with fatigue, breathlessness, bad sinuses and says he is now going deaf.
He has tried to get back to his fitness level before the cancer, even trying out BMXing, but he tires easily and becomes weak.
Despite all of the stress and heartache throughout this year, the pair are now looking forward to the future.
Kye said: Chanelle wants to finish her degree and get a job and a nice house. Were quite different to a lot of people who get engaged and start planning a wedding straight away. Weve got all the time in the world.
Ill have to be five years in remission before no more check ups, but the scares are always there.
They always will be, Chanelle added.
Kye and Chanelle say a few years down the line, they are still hugely grateful to the people of Hull for helping them to save his life.
Chanelle said: We would like to say thank you to everyone who contributed any money, or shared the story, or got involved in any of the fundraisers.
"They are what made this possible and have given Kye this second chance at life and they are why he is still here.
He was on palliative care and was going to die he probably wouldnt have made it to Christmas.
Kye said: It feels like such a long time ago. Im definitely looking forward to 2020."
Sophie Corcoran is a reporter for Hull Live and the Hull Daily Mail. Her interests include positive news, news about homelessness, court news and breaking news.
You can follow all the latest stories on her Facebook page here , her Twitter page here or on the Hull Live website here.
You can also call her on 01482 315174 or email sophie.corcoran@reachplc.com
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Chemotherapy and constant pills but DWP tells Hull man Kye Eastwood 'you're fit for work' - Hull Daily Mail
10 promising ways to prevent, diagnose and treat Alzheimer’s – ISRAEL21c
By daniellenierenberg
November is Alzheimers Awareness Month. Its a fitting time to look at the latest Israeli advances in preventing, diagnosing and treating the progressive and incurable brain disorder.
Alzheimers disease (AD) is the most common cause of the 9.9 million new cases of dementia diagnosed each year worldwide. The disease primarily strikes the elderly population, affecting 30 percent of those over age of 85.
AD impacts memory, thinking and language skills, and even the ability to carry out simple tasks.
The disease occurs when a protein called amyloid beta aggregates in brain tissues. These protein clumps kill nerve cells, leading to damage in the brain-function mechanisms.
Here are 10 examples of promising Israeli approaches reported within the past two years alone.
PREVENTION
Various genetic, lifestyle and environmental factors can put a person at risk for AD. Among them are diabetes, high blood pressure, obesity, smoking, depression, cognitive inactivity or low education, and physical inactivity.
Preventing the onset of AD is the focus of these approaches:
Eitan Okun, Alzheimers disease researcher at Bar-Ilan University. Photo: courtesy
Most vaccines work by mounting an immune response toward a weakened pathogen to boost the immune systems ability to fight the real pathogen.
Okuns approach primes the body to attack amyloid beta protein clumps in the brain, the signature sign of AD.
Following experiments on mice, Okun is preparing for human trials on people at known risk of developing the disease in their 50s or younger: those genetically inclined toward Alzheimers and people with Down syndrome.
These critical trials will determine whether the vaccine actually works in humans, said Okun. Depending on the success rate and side effects from [human] testing, we will be able to know how much more time is needed to make the vaccine available on a global scale.
Okun also is investigating new ways to diagnose AD earlier and more accurately using advanced MRI (magnetic resonance imaging) technologies to detect initial signs of amyloid protein aggregation in the brain.
BGU Prof. Alon Friedman has invented a new treatment to prevent neurological diseases. Photo courtesy of Dr. Merav Shamir
Introduced by BGN Technologies of Ben-Gurion University of the Negev, the novel therapy hinges on the fact that a malfunctioning BBB allows neurotoxic blood products to enter the brain and cause damage leading to neurological diseases.
The lab of Prof. Alon Friedman discovered that treating the BBB at early stages can protect the brain and prevent disease development.
Their proposed treatment would combine Memantine and Losartan, which have been shown in preclinical studies to protect the integrity of the BBB when administered together. Partners are being sought to continue development.
Prof. Ester Segal of the Technion. Photo: courtesy
They reported on this advance in a recent cover story of the journal Small.
Nanoscale silicon chips invented in Prof. Ester Segals lab allow for the direct insertion of neural growth factor protein into the brain and its gradual release into the target tissue, bypassing the BBB (see above). Afterward delivering all the therapeutic protein loaded onto them, the chips safely dissolve.
In a series of experiments, we showed in mice that the two ways of delivering the platform into the brain led to the desired result, said Technion doctoral student Michal Rosenberg.
Our technology has also been tested in a cellular model of Alzheimers disease and indeed, the protein release has led to rescuing the nerve cells.
DIAGNOSIS
PET scans and spinal taps are now the gold standard for diagnosing AD. Theyre both expensive and carry risks.
Cheaper, noninvasive tests being developed in Israel also could be critical in providing a much earlier diagnosis, when treatment would be most effective.
Thats because the same beta-amyloid proteins that clump in the brain of AD patients appear in the retina of the eyes up to 15 years before the onset of AD symptoms.
RetiSpec developed the retinal scanner at the Ontario Brain Institute in Canada. Clinical studies are ongoing in Israel and Canada.
In October, RetiSpec received the Alzheimers Drug Discovery Foundations Diagnostics Accelerator Award to fund continued development of its hyperspectral imaging technology.
This could allow doctors to compare brain scans taken over time from the same patient, and to differentiate between healthy and diseased brain tissue, without resorting to invasive or dangerous procedures such as brain tissue biopsies, explained lead researcher Dr. Aviv Mezer.
Clara is based on a relatively recent understanding that AD affects the brains orientation system before it affects memory.
The overlap between how the self is oriented to the world and the brain mechanisms that are disturbed by Alzheimers disease is astonishing, Arzy told ISRAEL21c.
Clara asks patients questions about themselves and their relationships to people, places and events. It then compares that information to a baseline and generates a computer-based test tailored for the individual that can diagnose very early Alzheimers.
The team from Dr. Shahar Arzys computational neuropsychiatry lab at Hadassah Hebrew University Medical Center in Jerusalem. Photo: courtesy
According to a study Arzys team published in the Proceedings of the National Academy of Sciences and in the American Psychological Associations journal Neuropsychology, Clara is 95 percent accurate.
Clara is now in the midst of a five-year test at Harvard to compare data generated by the system with data from AD markers taken via amyloid PET scan, quantitative and functional MRI and other neuropsychological tests.
Jaul and Oded Meiron (a cognitive neuroscientist who heads the Electrophysiology and Neuro-cognition Lab in Herzogs Clinical Research Center for Brain Sciences) published an articlein the Journal of Alzheimers Disease outlining their discovery of the link between the two conditions.
The reason is that the abnormal changes in the brain that lead to dementia are happening in other parts of the body, including the skin. Skin tissue and brain tissue derive from the same embryonic stem cells.
Jaul and Meiron are working with an American company to develop a test to identify a biomarker for abnormal cell density in the skin of dementia patients. They hope that this skin test could pinpoint an individuals type and stage of dementia. The biomarkers show the most promise in identifying AD, they say.
TREATMENT
A variety of approved medications for AD including Exelon, developed in Israel cannot cure or stop the progression of the disease. They only relieve or delay AD symptoms, such as memory loss and confusion.
A few Israeli pharmaceuticals under development aim to improve Alzheimer treatment options.
Breathing in pure oxygen in a pressurized room or chamber stimulates the release of growth factors and stem cells, which promote healing.
This revolutionary treatment for Alzheimers disease uses a hyperbaric oxygen chamber, which has been shown in the past to be extremely effective in treating wounds that were slow to heal, said lead researcher Prof. Uri Ashery.
Asherys group tested the therapy on a mouse model of Alzheimers disease. The treatment was found to reduce behavioral deficiencies compared to control mice.
Remarkably, the treatment also reduced plaque pathology and neuroinflammation in the test mice by about 40 percent.
Further research will investigate the underlying mechanisms of the therapy and evaluate its beneficial effects in Alzheimer patients.
Yotam Nisemblat, CEO of ProteKt Therapeutics. Photo: courtesy
Incubated at FutuRx in Ness Ziona, ProteKt was spun out of PKR kinase inhibitor research by University of Haifa Prof. Kobi Rosenblum. Inhibition of the enzyme PKR is a unique idea for improving memory consolidation.
Protein aggregation tends to increase with age and can lead to neurodegeneration because proteins can adopt an erroneous configuration, where theyre misfolded, explains Prof. Martin Kupiec.
The paper he and his colleagues published in Molecular Cell describes how removing glucose from a particular aggregated protein made the blob dissolve.
If the results can be replicated in more complex proteins, scientists will have a new research avenue toward treatments that could reverse the neurodegenerative effect of protein aggregates, Kupiec says.
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10 promising ways to prevent, diagnose and treat Alzheimer's - ISRAEL21c