ISTO Technologies Initiates Phase II Trial of NuQu®: Novel Cell-based Therapy for the Treatment of Painful Spinal Discs
Oct 22, 2012
St. Louis, MO – October 22, 2012 – ISTO Technologies, Inc. announced today that it is initiating a Phase II trial to further evaluate the efficacy and safety of its NuQu® cell-based therapy for the treatment of pain and disability associated with degenerated spinal discs. The company expects to commence enrollment in the randomized, double-blinded, placebo-controlled trial in the fourth quarter of 2012. Interim results are expected by the end of 2013.
“I am very excited to be participating in the clinical development of this potentially ground-breaking technology,” commented Dr. Domagoj Coric, Lead Clinical Investigator for the project and a practicing neurosurgeon at Carolina Neurosurgery and Spine Associates in Charlotte, NC. “Data from 15 patients treated in the Phase I trial shows considerable promise in safety, with the potential of offering patients relief with little or no recovery time. NuQu could become a preferred alternative for those patients with chronic low back pain, who do not respond to traditional, nonsurgical care such as physical therapy or epidural steroid injections. Currently, the only options for these patients are to either live in pain or to undergo a major surgical procedure.”
ISTO estimates that each year in the U.S. there are approximately 500,000 patients presenting with discogenic back pain who do not respond to conservative treatment. This significant group of pain sufferers, who either refuse or are not medical candidates for surgery, represents a chronically disabled population of patients, which ISTO is targeting as initial beneficiaries of the NuQu program. There are currently no FDA approved disc nucleus regeneration or repair products in the market.
“We are hopeful that early treatment of lower back pain with this regenerative product could be potentially transformational for a very large patient population, enabling pain relief without the need for an invasive surgical procedure,” stated Dr. Mitchell Seyedin, President & CEO of ISTO. “We are thrilled with our progress in the development of this exciting product through clinical trials.”
The economic and social impact of back pain places a tremendous burden on patients suffering from the condition, as well as on the U.S. healthcare system and overall economy. It is estimated that, on average, 297 million restricted workdays and 87 million disability days are lost each year due to back pain, the leading source of which is intervertebral disc disease or degeneration. In a study released in 2004 mined from data from the Medical Expenditure Panel Survey, Duke University Medical Center researchers found that patients in the U.S. suffering from back pain consume more than $90 billion annually in health-care expenses, with approximately $26 billion of that amount directly attributable to the treatment of back pain.
For more information on ISTO and its NuQu therapy, please visit www.istobiologics.com.
About ISTO Technologies
ISTO is an orthobiologics company based in St Louis Missouri, which has developed initial research conducted at Washington University into a unique platform technology for cartilage regeneration. Cartilage, in addition to being an integral component of the spinal disc, also covers the surfaces of all joints in the body, including the knee, hip and shoulder. Cartilage ages over time, and is commonly damaged through injury. It does not normally heal in adults; and therefore leads to conditions such as osteoarthritis and back pain, two of the largest causes of disability in the U.S. ISTO’s platform technology is based upon the expansion of juvenile cartilage cells, which possess a significantly higher capacity to regenerate and restore healthy tissue when compared to adult cells. This expansion technology offers a platform for healing cartilage tissue, accessible to a large population, with “off-the-shelf” economy of scale.