ISTO Technologies, Inc. Announces FDA Approval to Initiate a Clinical Trial for a Novel Treatment for Disc Nucleus Regeneration
Apr 28, 2009
April 28, 2009 (St. Louis, MO) – ISTO Technologies, Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) allowing the company to proceed with a Phase I clinical study for NuQu™, a cell-based injectable formulation of juvenile chondrocytes designed to regenerate cartilage, restore disc function and relieve discogenic back pain. Research studies have shown that juvenile cartilage cells regenerate cartilage in both in vitro and in vivo environments. NuQu is intended as an early intervention treatment for patients suffering from low back pain by potentially repairing cell biology in a damaged disc, restoring health and improving function.
“The disc environment is only conducive to specialized cells. Our research demonstrates that juvenile chondrocytes may be a good substitute for the nucleus cells that are lost to chronic degeneration,” said Jeffery Lotz, Ph.D. Director of the Orthopaedic Bioengineering Laboratory at University of California, San Francisco, a research collaborator on the NuQu program.
“Disc nucleus regeneration and repair represent an important area of ongoing spine research because it offers the promise of a minimally invasive intervention that treats a patient’s symptoms while potentially restoring function to the disc,” said Dom Coric, M.D. Chief, Department of Neurosurgery, Carolinas Medical Center.
Discogenic back pain impacts about 4 million patients annually in the United States with approximately 500,000 individuals not responding to conservative treatments, such as bed rest, non-steroidal anti-inflammatory pain medication and physical therapy. It is anticipated that treatment with NuQu may offer pain relief to those suffering from chronic back pain by repairing and regenerating cartilage in the spine. In addition to the physical pain endured by those afflicted by chronic back pain, there are significant economic and social costs to the U.S. healthcare system and the overall economy. Conservative estimates place the economic cost of back pain in the United States to be $100 billion annually, with approximately $26 billion of that amount directly attributable to treating the back pain.
Mitchell Seyedin Ph.D., President & CEO of ISTO, commented, “Moving the NuQu program into clinical evaluation represents an important achievement for ISTO and a notable milestone for those individuals suffering from chronic back pain. We believe that our cell-based therapy utilizing juvenile chondrocytes represents the future of spine care.”
In conjunction with the FDA approval to initiate the Phase I trial, ISTO also announced that it is seeking a corporate partner for the NuQu program to ensure that the full potential of the program is realized. Concerning the Company’s interest in a collaborative arrangement for the program, Dr. Seyedin said, “We are carefully evaluating corporate partnership opportunities for our NuQu program by seeking partnerships that have significant potential to build value and create returns for our investors. We are very interested in an arrangement that will complement ISTO’s development and manufacturing capabilities to potentially move NuQu to the market faster.”
ISTO Technologies, Inc., a privately-held orthobiologics company based in St. Louis, MO, is developing and marketing solutions for the repair and regeneration of damaged or injured cartilage and bone. ISTO’s mix of clinical stage, development stage and marketed products includes: DeNovo® ET, engineered cartilage to repair and restore joint function in the knee; NuQu™, a cell-based injectable formulation of juvenile chondrocytes for disc nucleus regeneration; and InQu®, an osteobiologic bone graft extender and substitute. For additional information on ISTO, please visit www.istobiologics.com or contact Scott Gill, Chief Financial Officer, at 314-995-6049.