New therapies could result in improved quality of life for pets
The studies will evaluate the safety and efficacy of ACT’s pluripotent stem cell-derived MSCs in ten spontaneous disease models in dogs, which are similar to various human inflammatory and immune-mediated diseases. While these companion animal studies represent research intended for ultimate licensure of veterinary therapeutics, ACT anticipates that the trial results may be relevant to its path to clinical trials in human patients and may provide a more robust assessment of safety and therapeutic endpoints than what can be obtained from inbred rodent models. The INAD is directed to ten canine disorders corresponding to hepatitis, glomerulonephritis, osteoarthritis, Crohn’s disease, inflammatory bowel disease, spinal cord/disc disease, meningoencephalitis, hemolytic anemia, pancreatitis and sepsis.
“This INAD filing extends our ongoing work with world experts in veterinary and regenerative medicine ,” said
ACT’s proprietary MSCs have been extensively characterized both in vivo and in vitro, and their effects have been shown to be superior in animals to those of their bone marrow (BM)-derived MSCs counterparts. ACT’s proprietary MSCs are immunoprivileged and therefore, may be used “off the shelf” in a wide range of clinical indications. In addition to increased efficacy, hESC-MSCs can be expanded to large numbers in vitro (approximately 30,000 times greater yields per unit than adult BM sources). Since MSCs are derived from an inexhaustible starting stem cell line, the cost and regulatory burden of requiring many donors is thereby removed, as is the case with the adult sources of MSCs currently in the clinic. Having a single, donor-less source of pluripotent stem cells for manufacturing MSCs also removes the batch-to-batch variability in potency and the risk of communicable diseases that comes with relying on bone marrow or other adult tissue donors in the current MSC setting.
“The preclinical studies that Dr. Lanza and our team have carried out can now be translated into companion animal studies and, hopefully, human clinical studies in the not-too-distant future,” said