DiscGenics has been notified by the US Food and Drug Administration (FDA) that an Investigational New Drug (IND) application for a clinical study of its first product candidate, IDCT, may proceed.
IDCT is a homologous, allogeneic, injectable cell therapy that utilises proprietary Discogenic Cells. The company hopes it could offer a potentially regenerative solution for the treatment of mild to moderate degenerative disc disease (DDD).
The company can now initiate a prospective, randomised, double-blinded, vehicle- and placebo-controlled, multicentre clinical study to evaluate the safety and preliminary efficacy of IDCT in subjects with single-level, symptomatic lumbar intervertebral disc degeneration.
The 60-subject trial is expected to begin enrolling in the US in the fourth quarter of 2017.
“I am very excited to be participating in the clinical development of this possibly game-changing regenerative therapy for patients with chronic low back pain,” says Domagoj Coric, principal investigator for the study and a practicing neurosurgeon at Carolina Neurosurgery and Spine Associates in Charlotte, USA.
“Preclinical studies indicate that IDCT can safely normalise disc architecture and restore disc height in several animal models. If IDCT demonstrates similar results in human subjects, the outcome could be reduced pain and disability, potentially revolutionising the way we treat patients with DDD by bypassing many mid-stage treatments and potentially eliminating non-restorative, late-stage surgeries,” he adds.
Flagg Flanagan, chief executive officer and chairman of the Board of Directors for DiscGenics, says, “We have worked closely with FDA over the past several years to design our preclinical studies to support our eventual IND filing, so receiving the go-ahead from the agency to begin in-human trials is a critical step forward for our clinical program.”
The IND was filed electronically with the FDA Center for Biologics Evaluation and Research (CBER) – Office of Tissues and Advanced Therapies (OTAT).