FDA clears IND application for cell therapy to treat end-stage liver disease
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The FDA cleared an investigational new drug application for LYG-LIV0001, an allogeneic hepatocyte transplantation solution for end-stage liver disease, according to the agent’s manufacturer.
LYG-LIV0001 (LyGenesis) is a regenerative cellular therapy comprising allogeneic hepatocytes suspended in a buffered cell preservation solution that are transplanted into periduodenal lymph nodes. The novel therapy enables a patient’s lymph nodes “to be used as bioreactors to regrow functioning ectopic organs,” according to the manufacturer.
The IND clearance will allow LyGenesis to begin a first-in-human, phase 2a dose-escalation study to examine the safety, tolerability and efficacy of the therapy. The study will enroll adults with end-stage liver disease who are ineligible for a liver transplant.
The proof-of-concept study aims to confirm the minimal dose of transplanted hepatocytes to safely achieve adequate allogeneic hepatocyte engraftment in periduodenal lymph nodes. It also will evaluate efficacy of the therapy by using liver function panels to assess the ability of hepatocyte transplants to modify liver function.
“The FDA clearance for our IND and the start of our phase 2a study in patients with [end-stage liver disease] is a testimony to our robust preclinical research program, the unmet need in advanced liver disease, and our novel approach to organ regeneration,” Michael Hufford, PhD, co-founder and CEO of LyGenesis, said in company-issued press release. “Moreover, the lack of genetic manipulation, ease of administration and low cost of goods for our cell therapy forms the foundation for a promising and scalable first commercial product.”
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