Posted on Mar 20, 2020, 3 p.m.
The FDA has announced that it is lifting the hold and cleared ImStem’s investigational drug IMS001 which utilizes AgeX’s pluripotent stem cell technology ESI-053, thus it will be allowed to be made available for the treatment of multiple sclerosis in clinical trial settings.
“Since pluripotent stem cells are capable of differentiating into all human cell types potentially genetically modified in any manner, they open the door to a wide array of new therapies,” said Dr. Michael D. West, PhD, founder and CEO of AgeX. “This collaboration with ImStem is consistent with our aim to make our clinical-grade pluripotent stem cell banks widely available for diverse therapeutic applications.”
IMS001 is derived from ES1-053 pluripotent stem cells induced to differential into mesenchymal cells through a proprietary method using a trophoblast intermediate stage for the treatment of neurological, autoimmune, and rare orphan disease. This is an allogeneic cell product that will be administered intravenously to those with multiple sclerosis, and may be the first to be accepted for clinical trial settings.
The company hopes to launch phase 1 clinical trials this year in America, and the trial will involve patients suffering with relapsing-remitting, secondary and progressive forms of multiple sclerosis.
“The clinical-grade pluripotent stem cell lines from AgeX were the first published GMP-compatible lines ever created,” said Xiaofang Wang, MD, PhD, Founder and Chief Technology Officer of ImStem. “As such, they have been widely distributed in the scientific community and demonstrated to meet the needs of industry for relatively rapid product development.”
The investigational drug has “...undergone IND-enabling, preclinical biodistribution, engraftment, tumorigenicity, toxicology, immunogenicity, and pharmacology studies. IMS001 has demonstrated preclinical immunomodulatory activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs.Previously published in-vitro data, in collaboration with scientists at the University of Connecticut (UConn) Health, have demonstrated potential advantages of hESC-MSCs in terms of their immunomodulatory effects, as well as the potential to stabilize the blood-brain-barrier (BBB). These mechanistic properties may lead to therapeutic benefits in diseases such as MS, potentially reducing relapses, disability progression, and inducing disease arrest,” according to a release from AgeX Therapeutics.
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