Today DARA BioSciences announced a strategic partnership with America Stem Cell Inc. (ASC) for the R&D of transplants in which the adult stem cells known as hematopoietic stem cells (HSCs) are used. The announcement represents a logical continuation of preclinical studies in which dipeptidylpeptidase (DPPIV) inhibitors were found to improve the efficacy of HSC transplantation, which is often employed in the treatment of many malignant as well as non-malignant hematological disorders.

Scientists at DARA will provide the DPPIV inhibitors to scientists at ASC, who in turn will collaborate with DARA in the further development and commercialization of the inhibitors for the clinical therapeutic treatment of patients who need HSC transplants.

Based in Raleigh, North Carolina, the pharmaceutical company DARA BioSciences specializes in the acquisition and development of "small molecule" therapeutics for the subsequent sale or out-licensing of the therapies to larger pharmaceutical companies. The company’s portfolio includes several drug candidates for the treatment of Type II diabetes, psoriasis, and neuropathic pain in cancer patients. One of DARA’s proprietary products, KRN5500, has already successfully completed a Phase II-a clinical trial for neuropathic pain that is secondary to cancer.

Founded in 2005 and located in Carlsbad, California, America Stem Cell Inc. describes itself as "a privately held biotechnology company dedicated to the development and commercialization of enabling technologies to enhance and expand the therapeutic potential of stem cell transplants." The company employs hematopoietic stem cells derived from cord blood, peripheral blood and bone marrow, from which the proprietary products ASC-101 and ASC-201 are formulated, and which, as described on the company’s website, have demonstrated "potential for many other clinical applications such as treatment of inflammation from chemotherapy/radiation, treatment of cancer tumors, autoimmune diseases and myocardial infarction." Previously, ASC has formed a number of other strategic partnerships with other organizations which include the Oklahoma Medical Research Foundation, Vidacord Technologia Biomedica, and the University of Texas M.D. Anderson Cancer Center.

Today Osiris Therapeutics announced a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for progress in its Phase II clinical trial for the treatment of Type I diabetes. The clinical trial is testing the company’s proprietary product, Prochymal, which is formulated from adult mesenchymal stem cells (MSCs). The milestone payment was triggered when one-half of the patients were enrolled in the study, which has a target enrollment of 60 participants. Additionally, the clinical trial is now being expanded to include pediatric patients and is also conducting enrollment for patients between 12 and 35 years of age.

According to C. Randal Mills, Ph.D., president and CEO of Osiris, "We are proud to be working alongside the JDRF in this landmark trial to evaluate the role of mesenchymal stem cells in patients with Type I diabetes. Caring for kids with limited medical options is a very special part of life at Osiris and we take that responsibility seriously. The progress we are making in this clinical program is remarkable and would not be possible without our patients, clinical teams, and the FDA’s thoughtful and responsive assistance."

Osiris and the JDRF originally entered into the partnership in 2007, for the development of Prochymal as a therapy for Type I diabetes, especially in the early stages of the disease when it has been newly diagnosed.

One of the many autoimmune diseases, Type I diabetes is characterized by the body’s destruction of its own beta islet cells – the cells of the pancreas which produce insulin. Conventional medical therapies currently offer no known effective treatment for the disease, but adult stem cell therapy may now offer the first therapy which not only reverses the course of diabetes but also regenerates lost beta cells. MSCs were shown in a preclinical trial conducted by Genzyme to preserve beta cell function, and a number of other studies have also demonstrated that MSCs have the ability to generate new cells that resemble beta islet cells in morphology and function.

In addition to this Phase II clinical trial for Type I diabetes, Prochymal is also currently in Phase III clinical trials for acute steroid-refractory graft-versus-host-disease (GvHD), as well as Phase II clinical trials for the treatment of acute myocardial infarction, Crohn’s disease, and chronic obstructive pulmonary disease (COPD). Prochymal is the only stem cell product currently on the market which has been granted both Fast Track and Orphan status by both the U.S. FDA (Food and Drug Administration) and the European Medicines Agency. The MSCs contained in Prochymal are obtained from the bone marrow of healthy adult donors and are specially formulated according to a proprietary process for intravenous infusion. Osiris is also developing another adult stem cell product, Chondrogen, which is currently in clinical trials for the treatment of osteoarthritis of the knee.

A leader in adult stem cell therapies, Osiris Therapeutics is focused on the development of products for the treatment of inflammatory, orthopedic and cardiovascular diseases. In November of last year, Osiris formed a strategic alliance with the biotech company Genzyme that was valued at over $1.3 billion. In 2007, the two companies were awarded a $224.7 million contract from the U.S. Department of Defense for the development of Prochymal in the treatment of radiation sickness.

(Please see a number of related news articles on this website pertaining to Osiris Therapeutics, including, "Adult Stem Cells Treat Diabetes", dated June 29, 2009).