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StemCells grows federal grant

Armed with a federal grant, StemCells Inc. of Palo Alto hopes to revolutionize the treatment of severe spinal cord injuries with its stem-cell technology.

The 8-year-old company recently received a $342,000 Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke to continue animal experiments using its patented human neural stem-cell technology.

StemCells is developing a cell-based therapy made from human neural stem cells, which promises to repair or repopulate neural tissue that has been damaged or lost as the result of disease or injury. For example, a neural stem cell could repair a person's damaged central nervous system.

The company (Nasdaq: STEM) harvests stem cells from donated tissue from aborted fetuses, obtained through a nonprofit California organization that the company declined to name. The company's approach has helped it discover rare stem cells, which are preprogrammed to become the mature cells of the organ from which they are derived, unlike embryonic stem cells, says president and CEO Martin McGlynn. Embryonic stem cells are the "starter set" that later differentiate into all the different kinds of cells needed to grow a body. If cells are harvested at the embryonic stage, they are not preprogrammed to form any particular organ.

And, unlike some embryonic stem-cell research, research that uses fetal stem cells is eligible to receive grants from the federal government, says Michael Werner, vice president of bioethics for the Biotechnology Industry Organization, based in Washington, D.C. Research using embryonic stem cells can only receive federal funding if the stems cells were derived from embryos prior to Aug. 9, 2001, the day President Bush outlined the federal research funding policy, Werner explains.

Earlier this year, StemCells announced that mice inflicted with spinal-cord injuries showed improved motor function after the company transplanted its neural stem-cells into the animals. The company plans to use its federal grant to expand the experiment to a greater number of mice and use more refined transplantation techniques, McGlynn says.

"This is the first time, to our knowledge, that transplanted and engrafted human neural stem cells have been directly correlated with improved function recovery in a mouse spinal-cord injury model," McGlynn says. "Previously É injured rats have been given stem cells from other rats or mice, but not stem cells from a human source."

While the potential to treat disease and injury with stem-cell technology is something investors are excited about, fundamental research and regulatory issues need to be addressed before the commercialization of stem-cell products, says Matt Kaplan, senior biotech analyst with Punk Ziegel & Co. of< New York, which has no investment banking relationship with StemCells.

"This has more of a 10-year horizon," Kaplan says of stem-cell products. Kaplan owns no StemCells shares.

At press time, StemCells' stock was trading at $1.91, down from its 52-week high of $2.85.

McGlynn says the company has begun discussions with the U.S. Food and Drug Administration to begin clinical trails, but he declined to provide further details.

But if StemCells' therapy does make it to the market, the upside would be significant.

The National Spinal Cord Injury Statistical Center estimates there are about 1,000 new cases of spinal-cord injuries in the United States per year, in addition to 20,000 Americans already living with a spinal-cord injury. fty-five percent of those inflicted with a spinal-cord injury are between 16 and 30 years old.

The National Institutes of Health estimates it costs more than $10 billion in specialized care per year for paralyzed patients in the United States.

StemCells' neural stem cell therapy also may be used to repair neurodegenerative disease, stroke and genetic disorders. The 30-employee company has liver and pancreas stem cell-based therapies in its pipeline, which are in pre-clinical development.

It will be years before the company can offer hope to thousands of Americans with spinal-cord injuries. But thanks to the federal government, StemCells is one step closer.

Rhonda Ascierto is a Biz Ink reporter.

You can reach her at rascierto@svbizink.com.

 

posted @ Friday, September 19, 2003 12:00 AM by host

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