A Columbia-based biotechnology company said this week it received the worlds first government approval to market a stem cell drug, in Canada.

Osiris Therapeutics, founded in 1992, spent 17 years developing a stem cell therapy that offers anti-inflammatory and tissue-regeneration properties. The first treatment it has received approval for this week will help treat children whove received bone marrow transplants that their bodies have rejected. The condition, known as acute graft-versus-host disease, or GvHD, is fatal to 80 percent of the children who contract it, the company said.

C. Randal Mills, president and CEO of Osiris, said in a conference call Friday morning that the company has spent the past eight years navigating clinical trials and regulatory paperwork in a mission to be the first approved stem cell treatment in the world.

During the past eight years, we have not wavered from that mission, Mills said. We now need a new mission.

The two-decade path to market for Osiris drug, Prochymal, is par for the course in the biotechnology industry, where a new pharmaceutical is measured in multi-million dollar clinical trials and reviews that take years.

Prochymal is the first off-the-shelf stem cell drug approved for sale, and the first approved for GvHD, the company said. It derives its stem cells, it said, from the bone marrow of healthy adult donors between 18 and 30 years old.

Osiris is a small biotech company, with around 50 employees, in an industry where far larger competitors, with thousands of employees, usually grab the headlines with blockbuster drugs.

Yet Osiris is a key player in the states nascent stem cell therapies industry. Osiris is one of the worlds largest and most advanced stem cell firms, according to testimony provided by the leaders of the Maryland Stem Cell Research Fund this year in the General Assembly.

The taxpayer-subsidized fund doles out millions of dollars a year in grants to promote stem cell research; Osiris, however, has never received a grant from the fund, according to TEDCO.

This week, the fund said it will award $12.4 million in research grants to 40 projects led by university researchers from Johns Hopkins, University of Maryland and other institutions.

The rest is here:
Columbia firm is world's first to market with stem cell drug

Michael J. Fox, a long time proponent of stem cell research as a possible key to finding the cure for Parkinson's disease, said there have been "problems along the way," in an interview with ABC's Diane Sawyer.

"Stem cells are an avenue of research that weve pursued and continue to pursue but its part of a broad portfolio of things that we look at. There have been some issues with stem cells, some problems along the way," said Fox.

He continued, "Its not so much that [stem cell research has] diminished in its prospects for breakthroughs as much as its the other avenues of research have grown and multiplied and become as much or more promising. So, an answer may come from stem cell research but its more than likely to come from another area."

Fox said he still believes strongly in stem cell research and government support for those studies. He said that for Parkinson's the cure may come from drug therapies, experimental surgeries and earlier diagnosis, according to ABC News.

More on GlobalPost: It is not about what you eat but when you eat, study says

Parkinson's is a brain disorder which manifests itself in shaking and difficulty with walking and coordination, according to the National Institutes of Health. It can also cause anxiety, confusion, depression and memory loss.

According to The Los Angeles Times, an estimated 0.4 percent of people in industrialized countries suffer from Parkinson's, affecting 1 percent of those over the age of 60 and 4 percent of those over 80.

In April, the French pharmaceutical company Sanofi said it would collaborate with the Michael J. Fox Foundation to test an experimental drug treatment for Parkinson's disease, according to Reuters.

The collaboration would entail the foundation sponsoring a phase I clinical trial of the drug AVE8112, which has shown promise as a therapy for the psychiatric symptoms of the disease, said Reuters. Patient enrollment will begin later this year in the US.

More on GlobalPost: Traumatic brain injuries linked to roadside bombs

The rest is here:
Michael J. Fox talks about Parkinson's cure and stem cell research (VIDEO)

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics Inc. (NASDAQ:OSIR - News) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the worlds first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope," said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. "As a result of Health Canada's comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine."

Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.

Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.

Health Canadas authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal's safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.

Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses, said Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal. "I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD."

Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year.

Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research, said Peter Friedli, Chairman and Co-founder of Osiris. It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission.

In addition to the extensive intellectual property protection Osiris has around Prochymal, which includes 48 issued patents, Health Canada's decision will also provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.

The rest is here:
World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal

IRVINE, Calif.--(BUSINESS WIRE)--

California Stem Cell, Inc. (CSC) announced today that well-known stem cell & regenerative medicine industry veteran Gregory A. Bonfiglio, J.D. has joined its Board of Directors.

Gregory Bonfiglio has over 25 years of experience working with technology companies, and was an early investor in the stem cell industry. He is Managing Partner of Proteus Venture Partners, an investment & advisory firm he founded in early 2006 to provide venture funding and strategic advisory services in the stem cell & regenerative medicine space. Mr. Bonfiglio is on the Boards of VistaGen Therapeutics and StemCyte, Inc.; he is the Chairman of the Board of the Centre for Commercialization of Regenerative Medicine (RM Translation Center in Toronto, Canada). In addition, Mr. Bonfiglio sits on the Advisory Board and Finance Committee of the International Society for Stem Cell Research (ISSCR); he is on the Commercialization Committee of the International Society for Cellular Therapy (ISCT).

Mr. Bonfiglio brings to CSC an extensive background in strategic consulting, having held partnership positions with various legal and venture firms, and having successfully led a team that took pioneering stem cell company Advanced Cell Technology public in early 2005. Were thrilled to welcome to our board someone with the breadth of industry experience that Greg has, and are very much looking forward to his participation in the continued growth of this Company, said COO Chris Airriess.

This appointment coincides with a ramp up of commercial product sales as well as advancements of CSCs active Phase II clinical trial in metastatic melanoma.

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company which has developed proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

Follow us on Twitter: http://twitter.com/castemcell

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50281529&lang=en

Excerpt from:
Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors

More Topics: Choose a Sector Accounting Firms Advertising/Media/Communications Capital CEO/Board General Business Health/Biotech Internet/Technology Investment Firms Law Firms Mergers & Acquisitions Money Managers People Private Companies Public Companies Venture Capital

Posted May 17, 2012

Awards to advance regenerative medicine address diverse, debilitating diseases and conditions

COLUMBIA, Md. - The Maryland Stem Cell Research Commissionhas completed its review of the 179 applications received in response to its three FY 2012 Requests for Applications (RFAs). The board of directors of the Maryland Technology Development Corporation (TEDCO) approved the Commission's recommendation to fund 40 new proposals with the Maryland Stem Cell Research Fund's (MSCRF) $12.4 million FY 2012 budget.

"We are pleased to announce our grant awards for FY 2012," said Margaret Conn Himelfarb, MPH, chair of the Commission. "These projects address a diverse array of debilitating and costly diseases and conditions, some of which are traditionally underfunded. Maryland's investment in cutting-edge stem cell research continues to advance the field and strengthens our State's national leadership position in the life sciences. We are grateful to Governor Martin O'Malley and the Maryland General Assembly for recognizing the tremendous economic and humanitarian benefits of this pioneering research."

This funding cycle, the Commission gave priority to proposals that focus on advancing regenerative medicine by selecting promising research that targets sickle cell anemia, schizophrenia, type 1 diabetes, nerve injury, Parkinson's disease, Crohn's disease, multiple sclerosis (MS), heart disease, osteoarthritis, Lou Gehrig's disease (ALS), retinal disease, and other debilitating medical conditions. Continuing the collaboration initiated last year with the California Institute of Regenerative Medicine (CIRM), the MSCRF will also support a Maryland researcher working with CIRM-funded scientists to study stem cell differentiation and bone repair.

This year's MSCRF awards include:

9 Investigator-Initiated Research Grants (RFA-MD-12-1) - providing up to $600,000 in direct costs over a maximum of three years to investigators with preliminary data to support their hypotheses.

17 Exploratory Research Grants (RFA-MD-12-2) - providing up to $200,000 in direct costs over a maximum of two years to researchers with novel approaches, mechanisms or models that may differ from current thinking in the field and/or new hypotheses that have little or no preliminary data.

14 Post-Doctoral Fellowship Research Grants (RFA-MD-12-3) - providing post-doctoral fellows up to $55,000 per year, for up to two years.

Read the rest here:
Maryland Stem Cell Research Commission Funds 40 New Proposals in FY 2012

Michael J. Fox, whose turn from Parkinsons disease patient to scientific crusader made him one of the countrys most visible advocates for stem cell research, now believes the controversial therapy may not ultimately yield a cure for his disease, he told ABCs Diane Sawyer in an exclusive interview.

There have been problems along the way, Fox said of stem cell studies, for which he has long advocated. Instead, he said, new drug therapies are showing real promise and are closer today to providing a cure for Parkinsons disease, a degenerative illness that over time causes the body to become rigid and the brain to shut down.

Stem cells are an avenue of research that weve pursued and continue to pursue but its part of a broad portfolio of things that we look at. There have been some issues with stem cells, some problems along the way, said Fox, who suffers from the diseases telltale tics and tremors.

Its not so much that [stem cell research has] diminished in its prospects for breakthroughs as much as its the other avenues of research have grown and multiplied and become as much or more promising. So, an answer may come from stem cell research but its more than likely to come from another area, he said.

Tune in to World News with Diane Sawyer Friday at 6:30 p.m. E.T. to see more of Diane Sawyers interview with Michael J. Fox

Fox, who recently appeared in episodes of Curb Your Enthusiasm and The Good Wife, has dedicated himself to finding a cure for Parkinsons, the disease with which he was diagnosed in 1991.

Fox said he still strongly believes in stem cell research and government support of those studies, praising ongoing research at New Yorks Memorial Sloan-Kettering Hospital. When asked about earlier criticism he received from conservative talk show host Rush Limbaugh about his advocacy, Fox said it only sharpens your resolve.

Scientists are conducting research and looking for a cure on multiple fronts, Fox said, including drug therapies, experimental surgeries, and developing tests to help make earlier diagnoses.

To that end, his Michael J. Fox Foundation for Parkinsons Research, the largest private funder of Parkinsons disease research worldwide, has recently launched an online initiative to increase studies across the country by pairing patients with clinical trials in their areas.

The Fox Trial Finder(Visit FoxTrialFinder.org for more info on clinical trial participation) harnesses the power of the Internet to find patients and, based on their profile of symptoms, pair them with research scientists conducting clinical trials.

Go here to read the rest:
Michael J. Fox Looks Past Stem Cells