VetStem Biopharma successfully completes large milestone efficacy study for its flagship canine osteoarthritis stem cell product.|
July 30, 2015 --
Leading Regenerative Veterinary Medicine Company, VetStem Biopharma, announced the successful completion of a field clinical study of its’ canine osteoarthritis stem cell product, currently under formal development for FDA approval. The product is being co-developed with Aratana Therapeutics (Kansas City, MO) and will be marketed in the US by Aratana. This product, termed AT-016, is an allogeneic adipose stem cell product for the treatment of osteoarthritis in the dog. The formal FDA Investigational New Drug Application was filed in 2011.
“I am extremely pleased to announce that our allogeneic adipose stem cell development program has reached a critical milestone with the successful completion of this significant field clinical efficacy study” said Dr. Robert Harman (CEO and Chief Scientific Officer). The study was a double-blinded, placebo-controlled field efficacy study conducted in nine clinical sites in the US. The primary outcome variable for success showed a statistically significant improvement in the treatment versus the control dogs (P≤0.05). The study final report is being prepared for FDA submission and for publication in a peer-reviewed journal. “This study is the first of its kind in the canine stem cell field and builds upon more than a decade of commitment to an evidenced-based approach to delivering regenerative medicine to our profession” said Dr. Harman. The independent investigators in this study are leaders in surgery and pain management and will co-author the study paper with Dr. Harman.
“VetStem has demonstrated professionalism and competence in developing this innovative approach to therapy of canine osteoarthritis” said Steven St. Peter, CEO of Aratana Therapeutics. “We chose VetStem as our partner and provider of this first-in-class stem cell product because of their decade-long leadership in the science and clinical application of veterinary regenerative medicine. Aratana is proud to be VetStem’s commercial partner and to support their development efforts” said St. Peter.
“Everything we do today is geared towards meeting and exceeding pharmaceutical industry standards for this new treatment modality. Our colleagues deserve good science and evidence-based products and services as veterinary regenerative medicines become a mainstay of therapy for difficult diseases like osteoarthritis” said Dr. Harman. VetStem will be publishing these results in a peer-reviewed journal and presenting at veterinary and human medical conferences.
About VetStem Biopharma.
VetStem Biopharma is a veterinarian led company that was formed in 2002 to bring regenerative medicine to the profession. This privately held biopharmaceutical enterprise, based near San Diego (California), currently offers veterinarians an autologous stem cell processing service (from patients’ own fat tissue) among other regenerative modalities. With a unique expertise acquired over the past 12 years and 11,000 patients treated by veterinarians for joint, tendon or ligament issues, VetStem has made regenerative medicine applications a therapeutic reality beyond the realm of research. The VetStem research team is focused on developing new clinically practical and affordable veterinary solutions that leverage the natural restorative abilities present in all living creatures. The company’s stated mission being “to extend and enhance companion animal lives by improving the quality of recovery in acute conditions, but also by unlocking ways to slow, stop and ultimately revert the course of chronic diseases”. In addition to its’ own portfolio of patents, Vet-Stem holds exclusive global veterinary licenses to a portfolio of over 55 issued patents in the field of regenerative medicine.
Dr. Robert Harman (CEO, Chief Scientific Officer)
12860 Danielson Court, Suite B
Poway, CA 92064
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