International Stem Cell Corporation (OTCBB:ISCO) (www.intlstemcell.com), the company which pioneered the creation of human stem cells from unfertilized eggs (called "parthenogenetic stem cells"), provides the following comments regarding draft stem cell research guidelines issued by the National Institutes of Health (NIH) on April 17, 2009.
ISCO is surprised and disappointed that NIH draft guidelines favor federal financing for the study of embryonic stem cells, including those derived from surplus viable human embryos created for reproductive purposes and stored at fertility clinics, while denying government funds for the study of similar stem cells derived using other methods. These methods include parthenogenesis, which does not require the use or destruction of viable human embryos.
The important issues ISCO hopes the NIH will consider from a scientific, ethical, and competitive perspective prior to finalizing its human stem cell research guidelines include the following:
The draft guidelines effectively turn upside down an important ethical issue. The current proposal approves government funding for the study of stem cells derived from the destruction of viable human embryos while prohibiting funding for parthenogenesis, which does not destroy viable human embryos. In fact, the research use of ISCO's parthenogenetic stem cells has been approved by three independent Embryonic Stem Cell Research Oversight committees in the U.S. and by the California Institute for Regenerative Medicine. Parthenogenetic stem cells have also been approved for use in Germany, where the restrictions on embryonic stem cell research were even stronger than they were in the U.S. under the Bush administration.
Restricting U.S. funding to limited types of stem cells will limit opportunities for U.S. researchers and potentially lead to lost jobs and higher costs for American health care. Parthenogenetic stem cells are unique models for the study of immune rejection and DNA expression patterns. Another technology called "SCNT," excluded under the NIH draft guidelines and not pursued by ISCO, may also create stem cell lines useful in the study genetic diseases such as Parkinson's disease. U.S. companies developing parthenogenesis and SCNT technologies are receiving funding offers from the governments of Korea, India, and China. Without access to federal funding here in the U.S., technologies could migrate to other countries. When disease cures are ultimately developed and sought by the U.S. population, those cost-savings technologies and jobs will be located outside the U.S.
Fears exist that the study of certain types of stem cells will lead to women being exploited for their eggs, this fear is not applicable to parthenogenesis. A relatively small number of parthenogenetic stem cell lines stored in an "immune-matched parthenogenetic stem cell bank" could become a valuable resource from which therapeutic cells could be derived to treat large segments of the population. This level of efficiency is simply not available with any other source of stem cells. As a result, the total number of eggs ultimately needed to treat the population might be far fewer than if embryonic stem cells derived from fertility clinics were the only option available.
The proposed guidelines would create a de-facto monopoly on the economic benefits of stem cell research for two organizations that control most of the current patents for embryonic stem cells. At present, no one can produce cells from embryonic stem cells for human therapy in the U.S. without a license from one of these two organizations. Denying government funds for the study of similar cells derived using other methods limits competition in the licensing of patents. This will likely result in cures that are more expensive, take much longer to create, and/or be produced outside the U.S.
"Given the Obama Administration's commitment to the pursuit of objective scientific advances vs. rigid adherence to fixed political ideologies, we find the proposed NIH stem cell research guidelines vexing and all too narrowly focused," says International Stem Cell Corporation Chairman and CEO Kenneth Aldrich. "We believe these guidelines offer a strong opportunity to better educate the public about alternative stem cell research methods that exist beyond embryonic stem cells and hope that, upon further investigation and consideration, the NIH guidelines will be revised to take these worthy alternative methods into account. We appreciate this opportunity to make our comments public, make ourselves available to the Institute for consultation on issues relating to stem cell research, and look forward to a rigorous review process prior to the finalization of the Institute's guidelines."
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ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California biotechnology company focused on developing therapeutic and research products. ISCO's technology, Parthenogenesis, results in the creation of pluripotent human stem cell lines from unfertilized human eggs. ISCO scientists have created the first Parthenogenetic homozygous stem cell line (phSC-Hhom-4) that can be a source of therapeutic cells that will minimize immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. These advancements offer the potential to create the first true "Stem Cell Bank" and address ethical issues by eliminating the need to use or destroy fertilized embryos. ISCO also produces and markets specialized cells and growth media worldwide for therapeutic research through its subsidiary Lifeline Cell Technology. For more information, visit the ISCO website at: www.internationalstemcell.com.
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Key Words: Stem Cells, Biotechnology, Parthenogenesis
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman, CEO
Jeffrey Janus, President
The Investor Relations Group
Adam S. Holdsworth