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Stem Cell Faithful
By Steve Johnson
San Jose Mercury News
23 March 2006
Even with California's stem-cell research institute mired in legal challenges that block most of its financing, businesses in the Bay Area and elsewhere are betting their bottom lines that stem cells one day will yield staggering new medical cures and profits.
About 100 companies in the United States and an equal number in other countries are trying to develop stem cell-based therapies and other products, according to venture capitalist G. Steven Burrill, who hosted a stem-cell conference in San Francisco last week.
Coaxing commercial blockbusters from stem cells is costly and could take years. Even so, many of the executives and others drawn to the event sounded optimistic, given the progress they and others say is being made.
"Stem-cell therapeutics no longer are relegated to the realm of theory,'' said Randall Mills, chief executive of Osiris Therapeutics of Baltimore, which is conducting human tests to see if the cells can repair damaged hearts and arthritic knees, among other things. "They are coming and they will have a huge impact.''
Stem cells, the precursors to every tissue in the body, already are being used to treat people suffering from such things as cancer and blood disorders. Many scientists believe the cells also can be manipulated to provide cures for a wide variety of other ailments, from Parkinson's disease to diabetes.
Just this month, StemCells of Palo Alto announced that Oregon Health & Science University will begin testing the company's stem-cell based treatment for children with the fatal disorder called Batten disease, which is linked to a defective or missing brain enzyme.
Under the test, which federal regulators approved in October, six babies will be injected with neural stem cells derived from fetuses in hopes of prompting their brains to produce the enzyme and counteract the ailment.
"This is a very, very exciting development for our company,'' said Martin McGlynn, StemCells' chief executive. "We've never put these things in a human before. This is pioneering work.''
Advanced Cell Technology, which last month moved its headquarters from Massachusetts to Alameda, hopes to use stem cells to treat people with the eye disease macular degeneration and to regenerate skin to help heal wounds.
"We think that has important medical benefit,'' said Michael West, the company's president and chief scientific officer.
Meanwhile, Geron of Menlo Park hopes to get federal permission this year to test its theory that people paralyzed by spinal injuries can be healed by injecting them with human embryonic stem cells, which can form almost any type of tissue.
The concept, which already has enabled paralyzed rats to walk, would be the first human test of a human embryonic stem-cell treatment.
No drug or other therapeutic agent derived from stem cells has yet been approved for sale by the U.S. Food and Drug Administration, according to experts at the Burrill conference. But that will happen sooner than many people think, said Thomas Okarma, Geron's chief executive.
"We're optimistic that the time frame is much shorter than what you hear about in the newspapers,'' he said. Instead of taking 15 years, as is often reported, he envisions the FDA approving stem-cell products within five to seven years.
Studying stem cells isn't cheap. Mills of Osiris Therapeutics in Baltimore said his company already has spent more than $200 million on stem-cell studies and plans to spend $48 million more this year. But getting others to help foot such bills isn't easy.
Government money is tight. President Bush took action that severely restricted federal spending for embryonic stem-cell research in 2001 because early-stage embryos are destroyed when the cells are used in experiments.
Bush's restrictions prompted California voters in 2004 to pass Proposition 71, which allocates $3 billion in state money for stem-cell research, mostly using embryonic stem cells. But two lawsuits pending in Alameda County Superior Court have held up the bond sale to finance the state program, and appeals are expected to tie up the money into next year.
Until the political and legal uncertainties surrounding stem cells are resolved, many venture capitalists and other investors are reluctant to finance companies hoping to make commercial products from the cells, several of those at the convention complained.
"That's our No. 1 challenge, access to capital,'' said Ralph Snodgrass, chief executive of VistaGen Therapeutics of Burlingame, which is growing stem cells to help identify possible drugs for diabetes and other ailments.
Still, more companies are finding a way to do stem-cell research. Many are motivated by the chance to make big money someday. However, some executives at the conference said they also are driven by the hope that their efforts one day may significantly ease human suffering.
R. Douglas Armstrong, chief executive of Aastrom Biosciences in Michigan, showed slides of a patient who took part in a test of the company's stem-cell treatment for regenerating bone. Doctors considered the patient's severely fractured arm so untreatable they initially thought it should be amputated. But after the man was given Aastrom's stem-cell treatment, his arm healed, Armstrong said, .
"We were able to fix something that was not fixable,'' said Armstrong. "That's the excitement of stem-cell regeneration.''
Contact Steve Johnson at sjohnson@mercurynews.com or (408) 920-5043.
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