Phase 2a Trial Initiates for LyGenesis' Regenerative ESLD Cell Therapy

In a groundbreaking development, LyGenesis, a biotech firm specializing in cell therapy, has administered the first dose to a patient in a Phase 2a clinical trial for end-stage liver disease (ESLD). The treatment involves an innovative allogeneic regenerative cell therapy, which is transplanted into the patient's lymph nodes, with the aim of growing new liver tissue.

The company's CEO, Dr. Michael Hufford, highlighted the significance of this advancement, stating that the use of lymph nodes as living bioreactors to cultivate an ectopic organ is a medical first. He expressed hope that the therapy could become a milestone in regenerative medicine, potentially allowing one liver donation to treat multiple ESLD patients and address the organ shortage.

The trial is supported by Juvenescence and Prime Movers Lab, both investors in LyGenesis. Dr. Richard Marshall from Juvenescence emphasized the trial's importance in translating scientific breakthroughs into clinical applications for life-threatening diseases. Justin Briggs from Prime Movers Lab noted the cell therapy's commercial potential and its transformative impact for patients without liver donor access.

LyGenesis's therapy, LYG-LIV-001, is an allogeneic cell therapy derived from unmatched liver donations. It involves a meticulous process that isolates hepatocytes and suspends them in a solution, ready for transplantation via endoscopic ultrasound into the patient's lymph nodes. These nodes facilitate the hepatocytes' integration and proliferation, resulting in new liver tissue. The therapy's non-genetic engineering approach minimizes manufacturing and commercialization risks and costs.

The Phase 2a clinical trial, LYG-LIV-02-001, is an open-label study recruiting 12 ESLD patients. It focuses on the safety, tolerability, and effectiveness of the transplanted hepatocytes over a one-year period, with a data safety monitoring board overseeing patient cohorts.

ESLD is a severe, potentially fatal condition characterized by symptoms and complications that impact survival and quality of life. It is often a consequence of cirrhosis, where scar tissue replaces liver tissue, leading to liver failure. Many ESLD patients are not eligible for traditional liver transplants, and a significant number of those on the waiting list pass away each year.

LyGenesis, headquartered in Pittsburgh, Pennsylvania, is developing a platform of regenerative cell therapies with applications beyond ESLD, including treatments for Type 1 diabetes, renal disease, and aging. The company's innovative approach holds promise for addressing significant unmet medical needs.