FDA Allows IND for DiscGenics’ Clinical Study

By Julie A. Vetalice

FDA accepted DiscGenics' Investigational New Drug Application for a clinical study of its cell therapy product candidate to treat degenerative disc disease (DDD).

In 4Q17, the company will begin U.S. enrollment of 60 patients in a prospective, randomized, double-blinded, vehicle- and placebo-controlled multicenter clinical study to evaluate IDCT in subjects with single-level, symptomatic lumbar intervertebral disc degeneration.

IDCT homologous, allogeneic, injectable cell therapy uses Discogenic Cells to yield a potentially regenerative DDD treatment. Preclinical studies have shown that IDCT normalized disc architecture and restored disc height in animal models. If the same can be shown in humans, it could present an alternative to non-restorative, late-stage surgeries.

Last month, the company closed a US $14MM Series B financing, bringing total funding to $21.7MM.

Sources: DiscGenics; ORTHOWORLD Inc.

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: Regulatory