VetStem Biopharma Begins Enrollment in Pivotal FDA Clinical Study of Osteoarthritis in Dogs
VetStem Biopharma is proud to announce the initiation of a pivotal field effectiveness and safety study with its allogeneic adipose stem cell product in dogs with clinical osteoarthritis
VetStem Biopharma, Inc. announced initiation of a pivotal field effectiveness and safety study to evaluate the clinical efficacy and safety of its investigational allogeneic adipose stem cell product. The randomized and blinded placebo-controlled, multi-center study in dogs with clinical osteoarthritis is expected to be completed and submitted to U.S. Food and Drug Administration (FDA) in 2017. The study is being conducted under an FDA-concurred protocol and is supported by VetStem’s US commercial licensee, Aratana Therapeutics.
This pivotal field efficacy study will enroll more than 200 dogs at 17 US veterinary clinics. The stem cell product or placebo will be given as a single injection.
This stem cell product was tested in a large, blinded dose confirmation study and the results were published in the peer-reviewed publication, Frontiers in Veterinary Science and titled “A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs.” Study results showed dogs that received the intraarticular injection of stem cells demonstrated a statistically significant improvement in treatment versus placebo (p<0.05).
Bob Harman, DVM, MPVM, CEO of VetStem stated, “Stem cell therapy for osteoarthritis is a truly novel approach to treatment of a devastating clinical condition of dogs. Donor-derived allogeneic stem cells provide cell therapy in a “ready to use” format without the need for tissue collection, processing or cell culture. VetStem looks forward to the results from this pivotal study, and if favorable, to submitting a major part of the effectiveness data package to the FDA.” If approved, the Company will begin commercialization.
The Company’s stated mission is “to extend and enhance the lives of animals 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.” This pivotal study is a key milestone on the path to bring the Company’s first product to market. If approved, this product will be marketed in the US by Aratana Therapeutics, VetStem’s US licensee and commercial partner. VetStem is also in the process of seeking EMA authorization for launch of this product in the European markets and seeks EU and other ex-USA territory commercialization partners.