Valentine Williams, DVM, MS, SVP, of Clinical Development and Regulatory at Gallant Therapeutics. Courtesy Gallant Therapeutics
Gallant Therapeutics, an animal health biotechnology company announced the launch of a study to evaluate the safety and efficacy of its novel allogeneic stem cell therapy candidate to support FDA conditional approval in cats with refractory feline chronic gingivostomatitis (FCGS), the JEDI study.
FCGS is a debilitating disease affecting about 2 million domestic cats, resulting in reduced quality of life, and painful mucosal lesions, often resulting in the death of affected cats. Current therapies include long-term immunosuppressive therapy and dental extraction. More than 50% of these cats do not respond to therapy (are refractory) and are euthanized or die. In pilot studies, Gallant’s investigational stem cell therapy has been demonstrated effective for refractory FCGS, improving painful lesions and quality of life, allowing these cats to live longer and healthier lives, reports Gallant.
The multicenter pivotal JEDI study includes veterinary dental specialist sites across the United States and is currently enrolling cats under an FDA-concurred protocol.
“We have seen the power of stem cells to promote healing and save pet’s lives,” says Linda Black, DVM, Ph.D., CEO of Gallant Therapeutics. “The launch of our JEDI study is an exciting clinical milestone to fast-track our mission to bring regenerative medicine to all pets and their families.”
The JEDI Study builds on multiple pilot studies demonstrating the efficacy of MSCs in improving clinical status and lesion scores in cats with refractory FCGS.. “It’s not just about creating a therapy that treats the root cause of FCGS and other immune-mediated or inflammatory conditions; It’s about ensuring compliance and ease of use in a busy practice setting,” said Valentine Williams, DVM, MS, SVP of Clinical Development and Regulatory at Gallant Therapeutics.
The company states the name of the JEDI study embodies the idea of a noble order of protectors unified in their ability to channel the power of the force for healing and aligns with Gallant’s mission to harness the power of regenerative medicine for all pets.