Gallant Therapeutics announced the launch of a pivotal 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, the JEDI study.
- Multicenter study to investigate safety and efficacy of allogeneic stem cell therapy in cats with refractory feline chronic gingivostomatitis (FCGS)
- Potential first-in-class therapy for a deadly disease with high unmet medical need
SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Gallant Therapeutics, an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced the launch of a pivotal 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 studies1, 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.
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,” said Linda Black, DVM, Ph.D., CEO of Gallant Therapeutics, “and 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.1,2,3
The product’s ready-to-use formulation is a critical factor in ensuring its success as a first-in-class treatment in veterinary medicine. “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 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.
More Information About the JEDI Study
Cats with the following symptoms may have FCGS: excessive licking, drooling, decreased grooming, anorexia, weight loss, reduced socialization, vocalization, bleeding gums, and painful sores in the mouth. If a diagnosed cat has already undergone medical treatment and dental extraction and is still showing clinical signs of disease, they are considered refractory and have limited to no currently available treatment options.
For JEDI eligibility and other criteria, please visit https://www.gallanttherapeutics.com/fcgs
About Gallant Therapeutics
Gallant Therapeutics is a clinical-stage animal health biotechnology company setting a new standard in animal health by harnessing the power of stem cell therapy to treat the root cause of diseases in dogs and cats. Gallant’s pipeline of off-the-shelf mesenchymal stem cell (MSC) therapies has the potential to treat a broad range of diseases, including canine and feline osteoarthritis (OA), feline chronic kidney disease (CKD), and others. The first product, based on our uterine-derived MSC platform for feline chronic gingivostomatitis (FCGS), is on track for FDA conditional approval in 2025. United by a love of and commitment to animals, Gallant’s team includes industry pioneers in veterinary regenerative medicine with deep experience in cell therapy product development, manufacturing, and commercialization. To learn more about the potential of our stem cell therapies, visit GallantTherapeutics.com.
Media Contact:
Adam Silverstein
Adam@ScientPR.com
1 Taechangam et. al. 2023. Pilot Efficacy of Feline Uterine-Derived MSCs for the Treatment of Refractory FCGS. NAVRMA, Kona, Hawaii (Sept, 21st).
2 Soltero-Rivera M, Hart S, Blandino A, Vapniarsky N, Arzi B. Mesenchymal stromal cell therapy for feline chronic gingivostomatitis: Long term experience. Frontiers in Veterinary Science. 2023;10. doi:10.3389/fvets.2023.1171922
3 Arzi B, Clark KC, Sundaram A, et al. Therapeutic efficacy of fresh, allogeneic mesenchymal stem cells for severe refractory feline chronic gingivostomatitis. Stem Cells Translational Medicine. 2017;6(8):1710-1722. doi:10.1002/sctm.17-0035
