ST. LOUIS, MO--(Marketwire - April 28, 2009) -
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
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.istotech.com or contact Scott Gill, Chief Financial Officer, at