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A new designation for IDCT disc therapy
SALT LAKE CITY—DiscGenics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DiscGenics’ IDCT, an investigational cell therapy. IDCT is currently being evaluated in clinical trials in the U.S. and Japan for the reduction in pain and disability associated with degenerative disc disease (DDD), a major cause of chronic low back pain.
DDD is a painful, chronic and progressive disease characterized by inflammation and breakdown of extracellular matrix within the intervertebral disc. The condition is estimated to affect more than a million people. Current treatment options for DDD are limited to physical rehabilitation programs and pain management, in earlier stages. In more advanced stages, sometimes a patient’s only option is surgical intervention to remove the painful disc(s), fuse two or more vertebral bones together and/or replace bone or tissue altogether. But back surgeries often have limited success, and may result in subsequent adjacent level degeneration.
IDCT is a homologous, allogeneic, injectable cell therapy that utilizes biomedically engineered progenitor cells, known as Discogenic Cells, that have been derived from intervertebral disc tissue to offer a non-invasive, potentially regenerative solution for the treatment of mild to moderate DDD.
“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 the FDA’s acknowledgement of low back pain as a serious medical condition with a profound lack of treatment options. This Fast Track designation reinforces our commitment to working with regulators to identify ways to accelerate development and expedite approval of the therapy within existing regulatory frameworks to make IDCT available to patients as quickly as possible,” said Flagg Flanagan, CEO and chairman of the Board of Directors for DiscGenics.
As a manufactured allogeneic cell therapy, IDCT is regulated by the FDA’s Center for Biologics Evaluation and Research under Section 351 of the Public Health Service Act. As a result, DiscGenics is adhering to the rigors of a regulated drug pathway that requires not only proof that the product has a therapeutic effect through clinical evaluation, but also that it meets critical safety standards and is produced consistently from lot to lot through adherence to current good manufacturing practice (cGMP) standards for a cell therapy.
DiscGenics is conducting two parallel prospective, randomized, double-blinded, controlled, multicenter clinical trials of IDCT in the U.S. and Japan. IDCT is being evaluated in the U.S. under an investigational new drug allowance by the 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. Primary outcome measures include safety and reduction in pain. Secondary outcome measures include reduction in disability and radiographic improvement. The U.S. study has shown safety in the first cohort of patients, and enrollment is ongoing for both studies.
On August 7th, DiscGenics noted that the first patients have been treated in its Japanese safety study. The treatments took place at Tokai University School of Medicine in Kanagawa, led by Dr. Daisuke Sakai, associate professor at the department of Orthopedic Surgery and the study’s principal investigator.
“I am excited to be participating in the clinical evaluation of IDCT as a potential cell therapy to treat degenerative disc disease,” mentioned Dr. Sakai in a press release. “I am encouraged by my preclinical observations of IDCT’s human Discogenic Cells in a canine disc degeneration model that demonstrated the ability to stop disc height degeneration while improving the structure of the intervertebral disc. If we can achieve similar results in human subjects, the result could be reduced pain and disability associated with DDD.”
Initiation of this trial was supported by the Japanese Pharmaceuticals and Medical Devices Agency approval of a Clinical Trial Notification application for IDCT, announced in the fourth quarter of 2018.