VetStem submits trial data to FDA in bid to win OK for canine stem cell therapy

VetStem Biopharma is developing a stem-cell-based treatment for dogs with arthritis.

California-based VetStem Biopharma has treated more than 12,000 companion animals with stem cells removed from their own bodies and then reinjected to treat a variety of joint disorders, including osteoarthritis. Although the company has built its business around such “autologous” treatments, its executives have long believed that the real market opportunity lies in “allogeneic,” or off-the-shelf, stem cells. And it may have just come one step closer to seeing that vision through to a marketable product.

On Oct. 27, VetStem announced it has published results from a large trial of allogeneic stem cells, derived from donated fat tissue and being developed to treat osteoarthritis in dogs. The trial was double-blinded and placebo-controlled, and it enrolled more than 90 dogs. The cells produced a statistically significant improvement in symptoms within 60 days, the company said in a press release.

VetStem is developing the treatment in conjunction with Aratana Therapeutics ($PETX), which will provide marketing and sales support in the U.S. Data from the trial was submitted to the FDA as part of a licensing application, according to VetStem.

During the trial, which was conducted at nine veterinary clinics in the U.S., dogs were treated with a single dose of stem cells in one or two joints. The effect of the treatment was measured by collecting observations from the dogs’ owners, as well as the veterinarians’ reports about how the pets responded to having their limbs manipulated, according to the study, which was published in the journal Frontiers in Veterinary Science.

VetStem hopes stem cells will fill a need in the market for long-acting arthritis treatments. Several drugs are on the market to treat the disorder in pets, including nonsteroidal anti-inflammatories (NSAIDs), but they must be administered daily, and they can have dangerous side effects. During VetStem’s trial, only 15 out of 93 dogs had adverse events, and there were no noticeable differences in side effects between stem-cell-treated dogs and those that received the placebo, the study reported.

Bob Harman, founder and CEO of VetStem, said in the release that the company hopes to win FDA approval for its allogeneic treatment in 2018. VetStem is also applying for approval to market the cells in Europe.

Osteoarthritis is one of the hottest targets in animal health. In fact, VetStem will be facing competition from its own partner, Aratana, which won approval earlier this year for Galliprant (grapiprant), a non-NSAID treatment for osteoarthritis in dogs. Aratana is teaming up with Eli Lilly’s ($LLY) Elanco on the marketing of that drug, which has yet to begin. Several other companies are developing osteoarthritis treatments for dogs, including Nexvet Biopharma ($NVET) and Parnell Pharmaceuticals ($PARN).

VetStem is developing a variety of regenerative treatments for other companion animals. Last year, for example, the company started a trial of a stem-cell treatment for exercise-induced pulmonary hemorrhage, a dangerous disorder in racehorses.

- here’s the release
- get the journal article

Related Articles:
VetStem launches trial of drug-free method for preventing hemorrhage in horses
Aratana shares soar on first FDA approval of canine arthritis drug
Animal health entrepreneurs pitch investors at well-attended KC forum
Parnell records strong sales growth, stays focused on arthritis approval
Nexvet charts positive turnaround in trial of osteoarthritis antibody for dogs