The DSMC completed a third and final planned mid-trial safety review following treatment of the first six subjects in the high dose study cohort, each of whom was treated based on random assignment into one of three arms: high dose IDCT study treatment, vehicle or placebo.
The DSMC reported there were no safety issues and recommended that the study proceed with completion of patient enrollment with no changes to the protocol.
This news closely follows a recent company announcement that the second planned safety review of the first 30-subject low dose study cohort revealed no safety issues.
"We are delighted to commence the final enrollment stage in our U.S. study of IDCT for DDD and are thrilled that the first 36 patients have now been safely treated," said Flagg Flanagan, CEO and board chairman of DiscGenics. "This is a blinded, first-in-human study where neither the treating clinicians nor the patients know what treatment is being administered. As a result, performance of periodic safety checks by an unblinded and independent body was essential to ensuring the ongoing safety of IDCT in a clinical setting. The members of the DSMC played a critical role in this process and we would like to sincerely thank them for their time and thoughtful review of the blinded safety data."
Patient enrollment in this U.S. study will now continue through completion of 60 total subjects.
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 14 centers across 12 states in the United States 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. Primary outcome measures include safety and reduction in pain. Secondary outcome measures include reduction in disability and radiographic improvement.
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 license application (BLA). Importantly, DiscGenics announced in August that the FDA granted Fast Track designation for IDCT as a potential treatment option for chronic low back pain. For more information on the U.S. study, click here.
IDCT is also being evaluated in a multicenter safety study in Japan, which is supported by a Clinical Trial Notification (CTN) approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). For more information on the Japanese study, click here.
DiscGenics is a privately held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. As the only company in the world to develop an allogeneic cell therapy derived from intervertebral disc cells to treat diseases of the disc, DiscGenics believes it has a unique opportunity to harness the restorative potential of the human body to heal millions of patients suffering from the debilitating effects of back pain. DiscGenics' first product candidate, IDCT, is a homologous, allogeneic, injectable cell therapy that utilizes biomedically engineered progenitor cells derived from intervertebral disc tissue, known as Discogenic Cells, to offer a non-surgical, potentially regenerative solution for the treatment of patients with mild to moderate degenerative disc disease.