The Food and Drug Administration (FDA) has granted Fast Track designation for IDCT (DiscGenics, Inc.), an investigational cell therapy for the reduction in pain and disability associated with degenerative disc disease (DDD).
IDCT is a homologous, allogeneic, injectable cell therapy that utilizes patented progenitor cells, known as Discogenic Cells. The cells are derived from adult human intervertebral disc tissue and are injected into the target disc. The Company believes IDCT has two potential therapeutic effects for the treatment of mild to moderate DDD; a regenerative capacity to create new intervertebral disc tissue and an anti-inflammatory effect.
The FDA designation is based on preclinical studies of IDCT that have demonstrated significant improvement of disc height, normalization of disc architecture, and overall no safety concerns. The treatment is currently being evaluated in two phase 1/2 multicenter trials in adults with lumbar DDD in the US and Japan.
The FDA is evaluating IDCT under an investigational new drug (IND) allowance and will be regulating it as a drug-biologic through a biologics license application (BLA).
“We are thrilled to receive Fast Track designation for IDCT as it recognizes the extremely compelling preclinical and safety data we have generated for IDCT through our robust research and development and clinical programs, and underscores FDA’s acknowledgement of low back pain as a serious medical condition with a profound lack of treatment options,” said Flagg Flanagan, Chairman and CEO of DiscGenics, Inc.
For more information visit DiscGenics.com.