ISTO Technologies Completes Enrollment of NuQu Phase II Trial for Back Pain
Cell-Based Therapy Could Offer Minimally-Invasive Option for Patients Who Don't Respond to Conservative Therapy
ST. LOUIS, Oct. 7, 2013 (GLOBE NEWSWIRE) -- ISTO Technologies, Inc. today announced that it is has completed enrollment of its Phase 2 clinical trial, to further evaluate the efficacy and safety of NuQu(R), a novel, cell-based therapy for the treatment of pain and disability associated with degenerated spinal discs. The randomized, double-blinded trial completed enrollment of 44 patients from 9 active research sites across the United States, and is anticipated that ISTO will collect final data for primary outcome measures in Q4 2014.
Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates and principal investigator of the trial said, "As a cell-based technology, NuQu is very promising and is potentially transformational for a large patient population, enabling pain relief without an invasive surgical procedure. It is the goal of the therapeutically-diverse investigators involved in the trial to evaluate this potential therapy for patients who do not respond to conservative treatment."
Many patients with back pain show degeneration of cartilage in their intervertebral disc. Typically, therapeutic treatment begins with conservative measures, such as bed rest, chiropractic care, physical therapy, spinal injections and/or medications including opioids. All of these methodologies are geared toward facilitating movement and relieving pain, but none restore the biology of the disc, and in many patients, will not prevent advancement of disability and the eventual need for surgical correction.
Roger Härtl, M.D., of Weill Cornell Medical College and a NuQu clinical investigator, said, "As a regenerative therapy, NuQu marks the beginning of an exciting era. Because it is aimed at restoring cartilage in the disc, without altering the structure of the vertebral column, NuQu may not only heal degeneration, but may also prevent progression of spinal disease to multple levels."
ISTO's cell-platform technology harnesses the potency of juvenile cartilage cells, called chondrocytes. Scientific data has demonstrated that when compared to adult cells, cartilage produced by juvenile chondrocytes shows 100-fold higher content of proteoglycan, which is a type of protein critical for the development of cartilage connective tissue. This results in greater cartilage matrix production, and maximizes the opportunity to heal cartilage injuries in a variety of clinical settings.
Mitchell Seyedin, Ph.D., President and Chief Executive Officer of ISTO Technologies, said, "NuQu utilizes juvenile cartilage cells that are not only remarkably prolific, but are programmed to produce cartilage in the spinal disc, an environment with no vascular supply. This is not possible with other cell types."
Each year 12.5 million Americans experience chronic back pain.
Approximately 70 percent, or 8.5 million, of these individuals require surgery to correct disc herniation and/or relatively advanced vertebral deterioration. The remaining 30 percent, or 4 million people, experience less severe deterioration, and are not yet considered surgical candidates. Of these, 85 percent respond well to repetitive, continued conservative therapy, while the remainder, approximately
10-15 percent, do not respond to conservative therapy and are excellent candidates for NuQu.
NuQu is currently delivered in clinical trials in a single-use, minimally invasive, out-patient procedure, and it is anticipated that this will remain unchanged upon commercialization. ISTO Technologies believes that the potential regenerative characteristics of NuQu and its patient-friendly method of delivery will be viewed favorably by insurance payors as a viable and cost-effective alternative to surgical procedures for those suffering from chronic back pain.
For more information on ISTO and its NuQu therapy, please visit:
www.istotech.com or clintrials.gov/NuQu.
NuQu Phase 2 Clinical Investigators
Domagoj Coric MD-lead Goodman, MD Hyun Bae, MD
Charlotte, NC Birmingham, AL Santa Monica, CA
Conor O'Neill, MD Härtl, MD Brian Subach, MD
San Francisco, CA New York, NY Reston, VA
Scott Kitchell, MD Ryan Reeves, MD Jeshuran, MD
Eugene, OR Southlake, TX Macon, GA
About ISTO Technologies
ISTO Technologies, Inc. is a state-of-the-art regenerative medicine company developing innovative cartilage and bone products for spinal therapy, sports medicine and other orthopedic indications. ISTO's main strategic focus is advancing its allogeneic juvenile chondrocyte technology platform for cartilage regeneration. In addition, the company is marketing a novel biosynthetic product developed by ISTO that supports bone formation in a variety of surgical orthopedic applications, including spinal and ankle fusion procedures and trauma cases.
This press release contains forward-looking statements that are based upon management's current expectations and are inherently uncertain.
Actual results and timing of events could differ materially from current expectations and forward-looking statements.
CONTACT: ISTO Technologies, Inc.
Chief Financial Officer
The Ruth Group
Nick Laudico (investors)
Kirsten Thomas (media)
Posted: October 2013