FDA granted DiscGenics a Fast Track designation for its investigational injectable disc cell therapy, IDCT, currently undergoing clinical trials in the U.S. and Japan for the reduction in pain and disability associated with degenerative disc disease. Companies can apply for Fast Track once they have sufficient preclinical and clinical evidence that a product may be able to treat an unmet medical need for a serious medical condition.
Enrollment is ongoing in the two clinical trials. IDCT is being evaluated in the U.S. under an investigational new drug allowance by FDA, and will be regulated as a drug/biologic through a biologics license application. In Japan, the trial is supported by a Clinical Trial Notification approved by the Japanese Pharmaceuticals and Medical Devices Agency. The U.S. study has shown safety in the first cohort of patients.