Salt Lake City, UT – January 7, 2019 – DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that IDCT has passed the initial planned safety review of its Phase I/II trial evaluating the allogeneic, injectable disc cell therapy in patients with mild to moderate degenerative disc disease (DDD).
In this first planned safety review, an independent data safety monitoring committee (DSMC) reviewed the first six subjects, each of whom was randomly assigned to receive an intradiscal injection of the low dose IDCT study treatment, vehicle or placebo.
The DSMC reported there were no safety issues and recommended that the trial continue with no changes to the protocol.
“This is the first time IDCT has been administered to patients, and we are thrilled that there were no issues reported in this initial safety review,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. “As an organization, we are committed to protecting patient safety and are very pleased that the safety profile we witnessed in our preclinical experience with IDCT is being reflected now that the therapy is being used in human patients.”
About the IDCT Trial
The IDCT trial is a prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical study to evaluate the safety and preliminary efficacy of IDCT in subjects with single-level, symptomatic lumbar intervertebral disc degeneration. The trial is underway in more than 10 centers across the U.S. and will enroll 60 subjects. Those subjects who meet all eligibility criteria are being randomized to one of four treatment cohorts: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and placebo (n=10). Each subject receives a single intradiscal injection of his or her assigned treatment into the target symptomatic lumbar intervertebral disc. Following treatment, subjects will be observed and evaluated for a period of one year, with a one-year extension period.
Through this study, IDCT is being evaluated under an investigational new drug (IND) allowance by the U.S. Food and Drug Administration (FDA) and will be regulated as a drug-biologic through a therapeutics biologics application (BLA).
For more information, please visit: clinicaltrials.gov.
DiscGenics is a privately held, clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics is harnessing the restorative potential of cells native to the intervertebral disc to develop what we hope will be a profound therapeutic option for millions of patients suffering from the debilitating effects of back pain. DiscGenics’ first product candidate, an injectable disc cell therapy, or IDCT, is a homologous, allogeneic cell therapy that utilizes proprietary Discogenic Cells to offer a non-surgical, potentially regenerative solution for the treatment of patients with mild to moderate degenerative disc disease.