Stem Cell Clinic

Mesoblast jumps on stem cell asset purchase

Shares in stem cells group Mesoblast have surged back to their highest level in two months on news it is to spend up to $100 million buying a suite of patents in the US which have the potential to deliver revenues sooner than expected.

Earlier today, it disclosed details of the purchase of a clutch of assets from US-based Osiris Therapeutic for an initial $US20 million in cash, although the final price could reach $US100 million depending on progress in developing the acquired products, with provision for future royalty payments as well.

The purchase brings with it two products already in their final stage of clinical trials with approvals for launch in Canada and New Zealand, and with the potential to win clearance for launch in the key US market within two years.

These are substantially derisked, Mesoblast chief executive, Professor Silviu Itescu said of the two advanced products, an agent for treating some Crohns disease cases along with a treatment for some graft versus host disease cases resulting from stem cell transplants.

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In afternoon trading, the shares were up 5.1 per cent at $5.76.

Like Mesoblast, Osiris has been developing therapeutic products that use so-called mesenchymal stem cells which can help body tissue heal large wounds, repair cartilage and muscle tissue.

Osiris has been producing these stem cells in the US since 1999, and also has a joint venture in Japan.

The US companys product is already approved for use in selected bone marrow cases involving children in the US, Canada and New Zealand.

The purchase gives Mesoblast access to two products in phase 3 trials - a treatment for Crohns disease and for selected bone marrow cases involving adults as well, it said.

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Mesoblast jumps on stem cell asset purchase

Mesoblast Rises on Plan to Buy Stem-Cell Business: Sydney Mover

Mesoblast Ltd. (MSB) climbed the most in eight months in Sydney trading after agreeing to buy a stem-cell business of Osiris Therapeutics Inc. (OSIR) for as much as $100 million to gain new treatments.

The maker of stem-cell therapies rose as much as 11 percent, the largest advance since Feb. 7, and was up 6.2 percent to A$5.82 as of 11:47 a.m. in Sydney trading.

Mesoblast will buy the mesenchymal stem-cell unit of Osiris, including Prochymal, a treatment for acute graft versus host disease, Columbia, Maryland-based Osiris said in a statement. The price tag includes as much as $50 million in payments if certain trial and regulatory milestones are met, and Osiris may also receive royalties on sales of certain products, Melbourne-based Mesoblast said in a separate statement today.

Prochymal has received conditional approval in Canada and New Zealand for use in children with acute graft versus host disease, and is available under an access program in the U.S. for treating both children and adults, according to Osiriss statement. The illness is a complication that can occur after a stem-cell or bone-marrow transplant in which the newly transplanted donor cells attack the transplant recipients body, according to Medline Plus.

To contact the reporter on this story: Lena Lee in Singapore at llee42@bloomberg.net

To contact the editor responsible for this story: Jason Gale at j.gale@bloomberg.net

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Mesoblast Rises on Plan to Buy Stem-Cell Business: Sydney Mover

Mesoblast to aquire further stem cell assets

Shares in stem cells group Mesoblast have surged back to their highest level in two months on news it is to spend up to $100 million buying a suite of patents in the US which have the potential to deliver revenues sooner than expected.

Earlier today, it disclosed details of the purchase of a clutch of assets from US-based Osiris Therapeutic for an initial $US20 million in cash, although the final price could reach $US100 million depending on progress in developing the acquired products, with provision for future royalty payments as well.

The purchase brings with it two products already in their final stage of clinical trials with approvals for launch in Canada and New Zealand, and with the potential to win clearance for launch in the key US market within two years.

These are substantially derisked, Mesoblast chief executive, Professor Silviu Itescu said of the two advanced products, an agent for treating some Crohns disease cases along with a treatment for some graft versus host disease cases resulting from stem cell transplants.

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In afternoon trading, the shares were up 5.1 per cent at $5.76.

Like Mesoblast, Osiris has been developing therapeutic products that use so-called mesenchymal stem cells which can help body tissue heal large wounds, repair cartilage and muscle tissue.

Osiris has been producing these stem cells in the US since 1999, and also has a joint venture in Japan.

The US companys product is already approved for use in selected bone marrow cases involving children in the US, Canada and New Zealand.

The purchase gives Mesoblast access to two products in phase 3 trials - a treatment for Crohns disease and for selected bone marrow cases involving adults as well, it said.

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Mesoblast to aquire further stem cell assets

Mesoblast's US patents deal lifts shares

Silviu Itescu.

Shares in stem cell group Mesoblast surged to two-month highs on its decision on Friday to outlay up to $US100 million to buy a suite of patents in the US that hold the potential to deliver revenues sooner than expected.

In a deal with US-based Osiris Therapeutic for an initial $US20 million in cash, along with further future payments, Mesoblast is to gain access to two products in their final stage of clinical trials which already hold approvals for sale in Canada and New Zealand, and with the potential to win clearance for launch in the key US market within two years.

''These are substantially derisked,'' Mesoblast chief executive Silviu Itescu said of the two advanced products, an agent for treating some Crohn's disease cases along with a treatment for bone marrow cases resulting from stem cell transplants.

Mesoblast shares closed up 4.7 per cent on Friday at $5.74.

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Like Mesoblast, Osiris has been developing therapeutic products that use so-called mesenchymal stem cells that can help body tissue heal large wounds and repair cartilage and muscle tissue.

Osiris has been producing these stem cells in the US since 1999, and also has a joint venture in Japan.

The acquisition consolidates Mesoblast's position in the regenerative therapies sector, while providing additional growth options, Professor Itescu said.

The acquisition includes approved products in several countries and will ''more than double our portfolio of granted patent families encompassing all mesenchymal lineage stem cells'', he said. The products will bring forward Mesoblast's projected revenues and provide earlier launch opportunities for products, he said.

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Mesoblast's US patents deal lifts shares

Parents risk all for better life

Denelle Brockhurst hopes overseas stem cell treatment will benefit her daughter Talia, 6. Source: News Limited

PARENTS of autistic children are pinning their hopes on controversial "stem cell" clinics in countries such as China, India and Germany.

Australian doctors and scientists are warning against the trend towards stem cell tourism, which costs patients up to $60,000.

But with autism, the most prevalent disorder affecting today's children, there are plenty of people willing to give it a go.

Sunshine Coast mum Denelle Brockhurst believes a better life for autistic daughter Talia, 6, could lie in the Wu Stem Cells Medical Center in Beijing.

The Chinese doctors claim they will inject human stem cells into the girl's body to help repair whatever is causing her severe autism and epilepsy.

Dr James Best, a GP who specialises in autism, said parents were being duped and exploited into wasting family resources on unproven therapies.

"Whether it (stem cell treatment for autism) works effectively, the answer is almost certainly 'no'," he said.

"Even the concept is really implausible."

There was also the danger of unregulated treatments being administered under questionable supervision and ethical standards.

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Parents risk all for better life

Stem cell meeting focuses on business

LA JOLLA Stem cell science is at last moving into clinical trials. But delivering its results to patients will require huge investments by drug and biotech companies, and health insurers must decide on how to reimburse for such therapy.

Just how thats going to happen is part of the Stem Cell Meeting on the Mesa, which begins Monday and ends Wednesday. The annual conference, which began as a scientific symposium, has extended into business matters as research get closer to patient treatments.

The meeting in La Jolla includes scientific updates on stem cell research and presentations from more than 50 companies and research institutes, seeking investment or offering their science skills.

The business push into whats called regenerative medicine takes place as the United States is adopting a new health care system. Biotech executives speaking at the conference said their job is to document the benefits in restoring patient health and replacing less effective and more costly alternatives.

Regenerative medicine aims to do what until very recently has been impossible: regrow lost tissues or organs and reverse degenerative diseases such as Parkinsons. The need for such treatments is becoming greater as baby boomers reach retirement age, and thousands of young veterans struggle with disabling injuries.

The field faces the same business challenges as any new area of medicine, said Perry Karsen, executive vice president of Celgene Corp. The biotech giant is based in Summit, N.J., and has an office in San Diego.

Its a new area of science. Its very similar to what we saw with monoclonal antibodies 20-25 years ago, Karsen said.

Monoclonal antibody drugs represent one of biotechs biggest success stories. They include drugs such as Humira, for autoimmune diseases, which brought in $9.3 billion in 2012. But many early attempts to develop monoclonal drugs failed spectacularly. Making these drugs work well took years of persistence.

Regenerative medicine is that next wave of innovation in the industry, and it has the same inherent risks as any new technology, Karsen said.

Celgene is investing in regenerative medicine because it will transform how health care is practiced, Karsen said, declining to say how much the company is spending.

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Stem cell meeting focuses on business

Avita Medical to Present at 2013 Stem Cell Meeting on the Mesa

NORTHRIDGE, CA and CAMBRIDGE, UK--(Marketwired - Oct 9, 2013) - Regenerative medicine company Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY) today announced that it will be presenting at the upcoming 2013 Stem Cell Meeting on the Mesa. The event will take place on October 14-16, 2013 at the Estancia La Jolla Hotel in La Jolla, California.

The Company will be presenting in Track 1 at 11:30 AM on Monday, October 14th as part of the conference's 3rd Annual Regen Med Partnering Forum.Presentation will be live-streamed on the day of the program.

"We are pleased to be presenting at this leading regenerative medicine industry conference," said Dr. William Dolphin, Avita Medical's CEO. "ReCell SprayOn Skin is on the market in other countries and undergoing FDA clinical trials in the US. This conference is a great venue to generate awareness among potential corporate partners and institutional investors as we approach FDA submission."

This is a three-day conference organized annually by the Alliance for Regenerative Medicine, the California Institute for Regenerative Medicine and the Sanford Consortium for Regenerative Medicine with the intention of bringing together senior members of the regenerative medicine industry with the scientific research community to advance stem cell science into cures.For more information on the conference: http://stemcellmeetingonthemesa.com/

ABOUT AVITA MEDICAL LTD.Avita Medical (http://www.avitamedical.com) develops and distributes regenerative and tissueengineered products for the treatment ofabroadrangeofwounds,scarsandskindefects.Avita's patented and proprietary tissueculture, collection and application technology provides innovative treatment solutions derived from a patient's own skin. The company's lead product, ReCell SprayOn Skin, is used in a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell is patented, CEmarked for Europe, TGAregistered in Australia, and SFDAcleared in China. ReCell is on market and generating early revenues. ReCell is not available for sale in the United States; in the U.S. ReCell is an investigational device limited by federal law to investigational use. A Phase III FDA trial is in process.

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Avita Medical to Present at 2013 Stem Cell Meeting on the Mesa

Vet-Stem, Inc. Announces Publication of the Food and Drug Law Institute Primer Including a Chapter Authored by CEO, Dr …

Poway, California (PRWEB) October 10, 2013

Vet-Stem, Inc. proudly announces the publication of the most recent Food and Drug Law Institute Primer covering Food and Drug Administrations Regulation of Veterinary Drug Products, which includes a chapter authored by Vet-Stems Founder and CEO, Robert J. Harman, DVM, MVPM. Dr. Harman worked closely with Karl M. Nobert JD, MBA to compose the chapter on FDAs Possible Regulation of Veterinary Stem Cell Therapy.

Some of the main points from this chapter are that commercialization has thus far utilized autologous stem cells and allogeneic use of all sources of stem cells is still in the research phase, and currently no products on the market in the United States have Food and Drug Administration (FDA) approval. Also, Dr. Harman suggests, Adopting quality controls based on a combination of FDAs human current Good Manufacturing Practices (cGMPs) and Good Tissue Practice (cGTP) would represent an appropriate quality system to mitigate the risk of contamination and infection; and ensure the production of a safe product.

Dr. Harmans experience in authoring more than 500 contract study reports for animal health companies throughout the world and for submission to the U.S. Food and Drug Administration and U.S. Department of Agriculture in support of the development of new animal and human health products as well as his expertise in stem cells and Regenerative Veterinary Medicine made him a valuable resource in discussing veterinary regenerative medicine, the commercialization of veterinary stem cell therapy, and the FDAs regulation of veterinary stem cell therapy. Dr. Harman founded Vet-Stem, Inc., the leading Regenerative Veterinary Medicine Company. Vet-Stem uses a process that utilizes autologous adult stem cells from adipose tissue to help reduce pain, inflammation, and to stimulate the regeneration of damaged tissues. Over the last decade Vet-Stem has processed the tissue of 10,000 animals to provide treatment with their own stem cells.

About Vet-Stem, Inc. Vet-Stem, Inc. was formed in 2002 to bring regenerative medicine to the veterinary profession. The privately held company is working to develop therapies in veterinary medicine that apply regenerative technologies while utilizing the natural healing properties inherent in all animals. As the first company in the United States to provide an adipose-derived stem cell service to veterinarians for their patients, Vet-Stem, Inc. pioneered the use of regenerative stem cells in veterinary medicine. The company holds exclusive licenses to over 50 patents including world-wide veterinary rights for use of adipose derived stem cells. In the last decade over 10,000 animals have been treated using Vet-Stem, Inc.s services, and Vet-Stem is actively investigating stem cell therapy for immune-mediated and inflammatory disease, as well as organ disease and failure. For more on Vet-Stem, Inc. and Veterinary Regenerative Medicine visit http://www.vet-stem.com or call 858-748-2004.

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Vet-Stem, Inc. Announces Publication of the Food and Drug Law Institute Primer Including a Chapter Authored by CEO, Dr ...

Gene and Stem Cell Therapy Combination Could Aid Wound Healing

Johns Hopkins Medicine Media Relations and Public Affairs

JOHNS HOPKINS MEDICINE NEWS TIPS FROM THE 2013 ANNUAL CLINICAL CONFERENCE OF THE AMERICAN COLLEGE OF SURGEONS, OCT. 6-10, WASHINGTON, D.C.

GENE AND STEM CELL THERAPY COMBINATION COULD AID WOUND HEALING

--Findings in elderly mice offer insight into helping elderly people recover from burns

Newswise Johns Hopkins researchers, working with elderly mice, have determined that combining gene therapy with an extra boost of the same stem cells the body already uses to repair itself leads to faster healing of burns and greater blood flow to the site of the wound.

Their findings offer insight into why older people with burns fail to heal as well as younger patients, and how to potentially harness the power of the bodys own bone marrow stem cells to reverse this age-related discrepancy.

As we get older, it is harder for our wounds to heal, says John W. Harmon, M.D., a professor of surgery at the Johns Hopkins University School of Medicine, who will present his findings to the American College of Surgeons Surgical Biology Club on Sunday at 9 a.m. Our research suggests there may be a way to remedy that.

To heal burns or other wounds, stem cells from the bone marrow rush into action, homing to the wound where they can become blood vessels, skin and other reparative tissue. The migration and homing of the stem cells is organized by a protein called Hypoxia-Inducible Factor-1 (HIF-1). In older people, Harmon says, fewer of these stem cells are released from the bone marrow and there is a deficiency of HIF-1. The protein was first discovered about 15 years ago at Johns Hopkins by Gregg L. Semenza, M.D., Ph.D., one of Harmons collaborators.

Harmon and his colleagues first attempted to boost the healing process in mice with burn wounds by increasing levels of HIF-1 using gene therapy, a process that included injecting the rodents with a better working copy of the gene that codes for the protein. That had worked to improve healing of wounds in diabetic animals, but the burn wound is particularly difficult to heal, and that approach was insufficient. So they supplemented the gene therapy by removing bone marrow from a young mouse and growing out the needed stem cells in the lab. When they had enough, they injected those supercharged cells back into the mice.

After 17 days, there were significantly more mice with completely healed burns in the group treated with the combination therapy than in the other groups, Harmon says. The animals that got the combination therapy also showed better blood flow and more blood vessels supplying the wounds.

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Gene and Stem Cell Therapy Combination Could Aid Wound Healing