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Stem Cell Buzz May Help Industry

Advanced Cell said Wednesday it plans to hold a conference for investors on Friday to "to discuss recent progress and events with respect to the company's initiatives to develop stem cell-based therapies for a range of diseases and conditions."
by Steve Mitchell
UPI Senior Medical Correspondent
Washington (UPI) Jan 17, 2007
Stem cell companies may benefit from the buzz surrounding the field generated by the anticipated clash between Congress and President Bush and increased regulatory attention being given to adult stem cell products. Companies focused on embryonic stem cell therapeutics have issued releases about their research recently in an apparent attempt to capitalize on the increased attention on the field after the House passed legislation last week that would relax restrictions on federal funding for the research.

Both chambers of Congress passed a similar bill last year, but Bush vetoed it and is expected to continue his opposition this year. House Democrats last week were hopeful they could garner enough votes to override a veto, but they fell short of the votes they would need to do so.

Advanced Cell said Wednesday it plans to hold a conference for investors on Friday to "to discuss recent progress and events with respect to the company's initiatives to develop stem cell-based therapies for a range of diseases and conditions."

The firm also announced earlier this week that it was awarded a federal grant from the National Institutes of Health for research focused on gaining a better understanding of how embryonic stem cells develop and differentiation into specific types of cells and complex tissues.

Geron said Wednesday new research indicates GRNOPC1, a potential human embryonic stem cell-based therapeutic for spinal cord injury, produces multiple nerve growth factors that stimulate survival and regeneration of damaged neurons in animal models.

Ivan Feinseth, an analyst with Matrix Research, told United Press International he thinks Geron's stock is currently overpriced.

"Based on the current revenue stream and other factors, the stock is overvalued," Feinseth said. He currently rates Geron as a strong sale.

"Of course, current legislation could change that," Feinseth added. But he does not follow Congress and said he did not feel qualified to comment on what might happen on the political front.

Michael Werner, president of the Werner Group, a biotech consulting firm in Washington, told UPI the support for the legislation being considered in Congress will help companies attract funding and investors.

"The clear demonstration of broad bipartisan support for this legislation shows this research has got a lot of promise and credibility and that means the private markets are going to be more willing to fund companies that are in this space," Werner said.

The Food and Drug Administration Tuesday took a step that will make it easier for cord blood stem cell products to reach the market and also may have implications for other stem cell products.

The FDA issued a draft guidance for a streamlined path to licensure for cord blood products for certain medical conditions, such as replenishing the bone marrow in patients with leukemia.

"Cord blood hematopoietic stem/progenitor cells offer the potential for tremendous therapeutic benefit," said Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "In this draft guidance, FDA provides recommendations on a streamlined path to licensure for these promising products that also ensures their safety and effectiveness."

Under the draft guidance, cord blood banks can cite existing data in the docket to support licensure for certain indications rather than having to provide their own clinical data. The FDA said it was proposing this strategy because it has determined cord blood hematopoietic stem/progenitor cells are safe and effective for certain indications based on data submitted to the public docket and published scientific research.

Werner said the FDA's action also may boost investor support for the field and make it easier for companies developing products based on cord blood stem cells to move forward.

"It will certainly help cord blood companies by streamlining the development process and it could help the regenerative medicine field more broadly," he said.

The fact that it comes from a federal agency also "demonstrates this is a field that is no longer way out there," Werner said. "It shows this is the real deal. We are able to use these technologies and we're getting closer and closer to getting products in the clinic and treating patients."

Advanced Cell said during its Friday conference call William Caldwell IV, its chairman and chief executive officer, will provide an overview of the company's activities and will comment on the effect the political climate is having on stem cell research.

This includes not only the federal debate, but favorable legislation for the research passed by certain states, such as California and New Jersey. Advanced Cell also noted that Eliot Spitzer, who was recently elected governor of New York, called for passage of a research-and-development bond that would provide $2 billion over a 10-year period, at least half of which would go towards stem cell work.

Geron, which published its new research in Stem Cells and Development, said the findings emphasize the therapeutic potential of GRNOPC1.

"The work extends our knowledge of the multiple biological activities of GRNOPC1," said Thomas Okarma, Geron's president and CEO. "The multiple functions of GRNOPC1 affirm the potential therapeutic utility of our cell-based approach to the repair of spinal cord injury and provide multiple mechanisms within a single therapy to achieve functional recovery."

Source: United Press International

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Researchers First To Map Gene That Regulates Adult Stem Cell Growth
Lexington KY (SPX) Jan 16, 2007
A new discovery in stem cell research may mean big things for cancer patients in the future. Gary Van Zant, Ph.D., and a research team at the University of Kentucky published their findings today in Nature Genetics, an international scientific journal. The researchers genetically mapped a stem cell gene and its protein product, Laxetin, and building on that effort, carried the investigation all the way through to the identification of the gene itself.







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