ISTO announces completion of enrollment in NuQu Phase I clinical study for discogenic back pain

ISTO Technologies, Inc. (ISTO), an  orthobiologics company with a cell-based platform for cartilage regeneration, announced today the completion of patient enrollment in the Phase I clinical study for NuQu™, an injectable formulation of juvenile chondrocytes designed for the treatment of discogenic back pain. The study included 15 patients enrolled at two clinical sites. All patients enrolled in the trial suffered from persistent discogenic back pain and disability despite undergoing previous traditional conservative therapy.

NuQu, a cell-based therapy derived from ISTO's platform technology for cartilage regeneration, is intended as an early intervention treatment for patients suffering from low back pain by potentially repairing, regenerating and restoring function to the disc. In preclinical studies, the juvenile chondrocytes used in the NuQu program have shown to have far greater regenerative potential than adult cartilage cells in both in vitro and in vivo environments.

"ISTO is excited about the completion of this clinical milestone that brings the promise of our novel spine therapy for patients suffering from chronic back pain one step closer to commercialization. The completion of patient enrollment for the Phase I trial is a major achievement for ISTO and our novel NuQu cell-based disc regeneration program. We look forward to analyzing the six-month interim results from the trial in early 2011 and moving NuQu to the next stage of clinical development," said Mitchell Seyedin, PhD, President and CEO of ISTO Technologies. "We wish to thank our investigators and their dedicated teams for their continued support of this innovative cell-based technology," continued Dr. Seyedin.

The principal investigators in this pilot study are Dr. Domagoj Coric of Carolina Neurosurgery and Spine Associates, Chief, Department of Neurosurgery, Carolinas Medical Center, and Dr. Kenneth Pettine, co-founder of the Spine Institute and an international leader in non-fusion spine research of Loveland, Colorado. "Disc nucleus regeneration and repair represent an important area of ongoing spine research. It offers the promise of a minimally invasive intervention that treats a patient's symptoms while potentially restoring function to the disc," said Dr. Coric. "This technology offers the promise of regeneration, repair and restoration of function for a very large patient population that suffers from chronic back pain," added Dr. Coric.

Dr. Pettine commented, "A tissue engineering approach and, in particular, a cell-based therapy to treat degenerative discs represents a new renaissance in spine treatment. This technology has enormous potential for filling a significant unmet medical need and may offer an important additional treatment option for our patients."

Discogenic back pain impacts about 4 million patients annually in the United States, with an estimated 500,000 individuals not responding to conservative treatments such as bed rest, non-steroidal anti-inflammatory pain medication and physical therapy. In addition to the physical pain endured by those afflicted by chronic back pain, these ailments add significant economic and social costs to the healthcare system and the overall economy. According to a recent study published in the August 15, 2010 issue of Spine and conducted by Annette Becker, M.D., of the University of Marburg in Germany and her colleagues, the costs (direct and indirect) of caring for patients with chronic low back pain were about twice that required to care for acutely ill patients.