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Article: VetStem moves towards first FDA approval for pet stem cell product

17 June 2020

This article is taken from our animal health platform dated 10/06/20.

Established in 2002, VetStem Biopharma has become the leading proponent of regenerative medicine for companion animals in the US. Animal Pharm editor Joseph Harvey spoke to the company's founder and chief executive Robert Harman about how stem cells will become an embedded part of the US pet care sector.

VetStem Biopharma was the first business in the US to provide an adipose-derived stem cell service to veterinarians for companion animals.

The firm provides its stem cell service to treat traumatic and degenerative diseases - such as bowed tendons, ligament injuries, osteoarthritis and osteochondral defects - in horses, dogs and cats.

VetStem pioneered the use of autologous veterinary adipose-derived stem cells in 2003, when the first horse was successfully treated with its technology for a tendon injury that would normally have been career-ending. In 2004, the service was launched for use in horses.

The next milestone for the firm was in 2007, when it expanded into stem cell therapy for dogs and cats with osteoarthritis and orthopedic soft tissue injuries. To date, over 17,000 veterinary patients have now been treated with VetStem's cell processing technology.

VetStem has been educating veterinarians on the benefits of its services since 2003, which the company believes has led to stem cells becoming more accepted as a treatment modality.

In 2015, Dr Harman told Animal Pharm how stem cells were an emerging therapy in the veterinary mainstream in the US. Five years down the line, he pointed out "veterinary stem cell treatments are now available at nearly every veterinary school but principally in research studies".

Five years ago, less than 10% of vets had administered a stem cell therapy. Now, Dr Harman claimed this figure had risen to about 25% "or perhaps higher when you include products like platelet-rich-plasma treatments".

He said VetStem has seen a broadening of the type of procedures its stem cells are being used for over recent years. The firm has now provided stem cell therapies to over 34 species (including exotic animals) and cells for treatment of more than 44 different diseases. Key new diseases include feline stomatitis, inflammatory bowel disease, renal failure and back pain.

He said public awareness and acceptance of veterinary stem cells has very much improved over the last five years.

"The stigma of embryonic stem cells has faded and there are now globally a number of exciting, new and approved human stem cell products that show the promise is reality," Dr Harman explained.

VetStem holds exclusive licenses to more than 70 patents including worldwide veterinary rights for use of adipose-derived stem cells. It is investigating stem cell therapy for immune-mediated and inflammatory diseases, as well as organ disease and failure. Recently, VetStem entered the pet cancer space after receiving an exclusive license to an immunotherapy from Calidi Biotherapeutics.

Unique offering

VetStem said there are currently no other firms in the US that offer an autologous central laboratory service for veterinary stem cell therapies.

"It is difficult to do and requires considerable expertise in logistics," Dr Harman noted. "Most pharma prefer an off-the-shelf model. We will have off-the-shelf products but feel this service model was the right choice from a safety standpoint.

"Prior to VetStem, we operated two large medical service businesses and developed the ability to deliver services at an affordable cost, while meeting regulatory standards. We will be expanding the range of products and digital services in coming months and years to meet the needs of the practicing veterinarian."

Landmark ahead

The next big landmark for VetStem and the wider US veterinary stem cell sector will be the firm's debut US FDA authorization.

VetStem expects its first product - a canine osteoarthritis therapy - to secure FDA approval within the next 24 months. The firm is currently in final phase III testing of this product candidate.

In 2019, Belgian business Global Stem Cell Technology (GST) gained marketing approval for the first EU veterinary stem cell product. The firm's Arti-Cell Forte, which is for the reduction of mild-to-moderate recurrent lameness associated with non-septic joint inflammation in horses, is marketed by Boehringer Ingelheim Animal Health.

Dr Harman said GST's landmark approval in the EU will help VetStem's ongoing regulatory processes with the FDA.

"It shows the regulators understand cell therapy much better and are following human counterparts in the approval process," he noted. "The FDA has become very educated on cell therapy. The regulators attend almost every major stem cell meeting, including the veterinary meetings."

Dr Harman said he still retains the opinion that veterinary stem cell products can become future animal health blockbusters (with annual sales of around $100 million or higher) as "they have a great safety profile and can be used across a spectrum of diseases".

According to a report by MarketWatch, the global animal stem cell therapy space was valued at $16m in 2018 and is expected to reach $200m by the end of 2025 - growing at a compound annual growth rate of around 37% between 2019 and 2025. The research firm said the US is the largest consumption region of animal stem cell therapies and accounted for nearly 59% market share in 2017.

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