NEWARK, Calif., July 26, 2012 (GLOBE NEWSWIRE) — StemCells, Inc. (Nasdaq:STEM) today announced that the California Institute for Regenerative Medicine (CIRM) has approved an award to the Company and its collaborators for up to $20 million under CIRM’s Disease Team Therapy Development Award program (RFA 10-05). The award is to fund preclinical development of StemCells’ proprietary HuCNS-SC® product candidate (purified human neural stem cells) as a potential treatment for cervical spinal cord injury. The award will provide funding over a maximum four-year period, with the goal of filing an investigational new drug (IND) application to begin clinical testing in that time.
“We understand that this was a very competitive process and we are extremely grateful to CIRM for its support,” commented Martin McGlynn, President and CEO of StemCells, Inc. “We view this decision by CIRM as a strong vote of confidence in our neural stem cell technology and the world class team of scientists and clinicians who will be collaborating to translate this exciting research into potential treatments and cures for patients with spinal cord injury. We are currently conducting a Phase I/II trial in thoracic spinal cord injury. This funding now allows us the opportunity to expand testing of our cells for cervical spinal cord injury, the most common form of spinal cord injury.”
StemCells will evaluate its HuCNS-SC cells as a potential treatment for cervical spinal cord injury in collaboration with a team led by Aileen Anderson, Ph.D., Associate Professor in the Departments of Physical Medicine and Rehabilitation, and Anatomy and Neurobiology at University of California, Irvine. Dr. Anderson’s laboratory has a long history of collaboration with StemCells in spinal cord injury, including the studies which led to the world’s first clinical trial for a neural stem cell therapeutic in chronic spinal cord injury. This Phase I/II clinical trial, currently underway in Zurich, Switzerland, recently reported positive safety data from the first cohort of treated patients, and continues to enroll patients from Europe, the United States and Canada.
The state’s stem-cell institute has awarded $20 million to UC Irvine researchers, along with a private company, to prepare the way for human testing of a treatment for spinal-cord injuries in the neck region — one that could restore movement and independence for some of the 1.3 million spinal-cord injury sufferers in the United States.
The treatment, developed by the husband and wife research team, Aileen Anderson and Brian Cummings, along with StemCells Inc. of Newark, Ca., would involve injecting versatile human neural stem cells into the neck area.
The cells, capable of transforming themselves based on cues from the body, could then migrate to the injured area and perhaps repair the protective sheaths, known as myelin, around nerve cells. If the treatment works as expected, it would restore movement and body control for patients with debilitating injuries.
While the treatment has the potential to allow the paralyzed to walk again, more modest gains are more likely — and well worth the effort, Anderson said Friday.
UC Irvine husband-wife research team, Brian Cummings and Aileen Anderson. Courtesy UC Irvine.
“Obviously that would be, of course, what we in our wildest dreams would see in a clinical trial,” she said. “But likely what you’re going to see for any spinal cord injury is much more incremental improvement in function. For people with spinal cord injuries, that could be a huge thing. It could help with health care costs, the ability to function independently. If you can type on a computer, versus not, or write with a pen — it changes an awful lot.”
The $20 million was among $150 million authorized on Thursday by the board of the California Institute for Regenerative Medicine, a stem-cell funding body created by a California voter initiative in 2004.
Anderson and Cummings are among a cadre of stem-cell scientists at UCI’s Sue & Bill Gross Stem Cell Research Center, and have already pushed the field forward.
A treatment they developed for chronic spinal cord injury, along with StemCells Inc., is now being tested on patients in Switzerland, and was recently shown to be safe for the first group of patients to receive it.
And StemCells Inc., which grows the human neural stem cells from donated brain tissue of surgically aborted fetuses, helped score another recent success involving UCI researchers including Frank LaFerla of UCI MIND.
In that case, the cells were used to restore memory and brain function in mice bred to model the effects of Alzheimer’s disease. That achievement, announced just last week, also eventually could be translated into treatments for humans with the disease.
The $20 million, Anderson said, will allow her and Cummings over the next four years to gather the large amount of data needed before human trials can begin.
That includes determining how long after a spinal cord injury the treatment might be effective, along with collecting data on the safety of the proposed treatment.
The ultimate goal would be the filing of an application to begin human trials of the treatment.