StemCells Comments on Passage of California Proposition 71; Company Supports Stem Cell Research and Cures Initiative.PALO ALTO, Calif. -- StemCells, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :STEM) today commented on the passage of California State Proposition 71 (Prop. 71), the California Stem Cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. Research and Cures Initiative, praising the Initiative's intention to encourage stem cell research in the State of California, and to finance such research with State funds of approximately $295 million annually for 10 years beginning with 2005. "The passage of Proposition 71 is an important event both for California academic institutions and researchers engaged in or looking to play a role in stem cell science, and for California companies undertaking stem cell research. It is our understanding that the California Institute for Regenerative Medicine The California Institute for Regenerative Medicine (CIRM) was created by California's Proposition 71 (2004), which authorized it to issue $3 billion in grants, funded by bonds, over ten years for embryonic stem cell and other biomedical research. , to be created under the Initiative, will provide grants to advance embryonic stem cell Embryonic stem cells (ES cells) are stem cells derived from the inner cell mass of an early stage embryo known as a blastocyst. Human embryos reach the blastocyst stage 4-5 days post fertilization, at which time they consist of 50-150 cells. ES cells are pluripotent. research as well as adult stem cell Adult stem cells are undifferentiated cells found throughout the body that divide to replenish dying cells and regenerate damaged tissues. Also known as somatic (from Greek Σωματικóς, of the body research, which is the current and exclusive focus at StemCells, Inc.," said Martin McGlynn, President and Chief Executive Officer of StemCells. "Certainly, much work remains to be done to unlock the therapeutic value of stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young , and the funds generated by this Initiative will be a shot in the arm for stem cell research not supported by the federal government. Not only will Prop. 71 help California build upon its leadership in the field, but we believe it will encourage young scientists to pursue careers in stem cell biology and related fields in California, which is critical to the future health of our industry. The State's commitment to supporting stem cell research also may attract leading scientists in the field to California," he added. The Company noted that details are not yet final regarding the formation of the California Institute for Regenerative Medicine or the process for applying for grants. "The process will be a competitive one. As a company operating in California since 1995 and as a leader in tissue-derived stem cells, we intend to compete for our fair share," said Mr. McGlynn. Current White House restrictions on use of federal funds Federal Funds Funds deposited to regional Federal Reserve Banks by commercial banks, including funds in excess of reserve requirements. Notes: These non-interest bearing deposits are lent out at the Fed funds rate to other banks unable to meet overnight reserve to support embryonic stem cell research does not change the work StemCells, Inc. is doing with adult stem cells, and it is "business as usual" for the Company with the continuation of the current Administration. StemCells, Inc. remains eligible for federal government support due to its focus on adult stem cells, as well as for funds under Prop. 71. "Our R&D programs, all of which concentrate on diseases of, or injury to, the central nervous system, the liver and the pancreas, have been funded primarily by our shareholders, rather than by the public sector. We appreciate the National Institute of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ) grants that assist research in the use of our cells for various diseases and conditions such as Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. and spinal cord injuries, but we do not rely on them," commented Mr. McGlynn. "As a publicly traded company publicly traded company A company whose shares of common stock are held by the public and are available for purchase by investors. The shares of publicly traded firms are bought and sold on the organized exchanges or in the over-the-counter market. that recently raised additional capital, we expect to complete our first clinical trial without dependence on state or federal funds." As previously announced, StemCells has sufficient cash to take the planned Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I for Batten disease Batten disease see ceroid lipofuscinosis. through trial recruitment, study monitoring, data analysis and patient follow-up, as well as support the planned filing in 2005 of a second Investigational New Drug (IND) application for another central nervous system indication. The commencement of the Batten's trial remains subject to U.S. Food and Drug Administration approval of StemCells' first IND, which the Company plans to file by the first quarter of 2005. Assuming approval, the trial will investigate the safety of transplanting the Company's patented human neural stem cells (HuCNS-SC) in neuronal ceroid lipofuscinoses patients, and determine if the transplanted cells secrete the missing lysosomal lysosomal pertaining to or emanating from lysosomes. lysosomal enzymes enzymes located in the lysosomes. lysosomal phospholipidosis enzymes in the brain and alter some characteristics and clinical course of the disease. About Batten Disease The neuronal ceroid lipofuscinoses (NCLs) are a group of rare genetic disorders affecting children, generally known as Batten disease. In patients with Batten disease, particular housekeeping enzymes normally secreted in the brain are either defective or missing, as a result of gene mutations. Lack of the enzyme causes a buildup of toxic waste toxic waste is waste material, often in chemical form, that can cause death or injury to living creatures. It usually is the product of industry or commerce, but comes also from residential use, agriculture, the military, medical facilities, radioactive sources, and (aggregates of lipids and proteins called lipofuscin) primarily in the brain and leads to the death of neurons. Children with Batten disease suffer seizures and the progressive loss of motor skills, sight and mental capacity, eventually becoming blind, bedridden bed·rid·den or bed·rid adj. Confined to bed because of illness or infirmity. and unable to communicate. Today, Batten disease is always fatal. About StemCells, Inc. StemCells, Inc. is a development stage biotechnology company focused on the discovery, development and commercialization of stem cell-based therapies to treat diseases of the nervous system, liver, and pancreas. The Company's stem cell programs seek to repair or repopulate neural or other tissue that has been damaged or lost as a result of disease or injury. StemCells is the first company to directly identify and isolate human neural stem cells from normal brain tissue. These stem cells are expandable into cell banks for therapeutic use, which demonstrates the feasibility of using normal, non-genetically modified cells as cell-based therapies. StemCells is the only publicly traded company solely focused on stem cell research and development and has approximately 39 U.S. and 100 non-U.S. patents, as well as 100 patent applications pending worldwide. Further information about the Company is available on its web site at: www.stemcellsinc.com. Apart from statements of historical facts, the text of this press release constitutes forward-looking statements regarding, among other things, the future business operations of StemCells, Inc. ("the Company"). The forward-looking statements speak only as of the date of this news release. StemCells does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in the forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainties regarding the Company's ability to obtain the capital resources needed to continue its current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; the fact that the Company's stem cell technology is at the pre-clinical stage and has not yet led to the development of any proposed product; the uncertainty whether the Company will be able to file an IND in the time it projects and whether the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. will permit it to proceed to clinical testing; the uncertainty regarding the validity and enforceability of issued patents; the uncertainty whether any products that may be generated in the future in the Company's stem cell programs will prove clinically effective and not cause tumors or other side effects Side effects Effects of a proposed project on other parts of the firm. ; the uncertainty whether the Company will achieve revenues from product sales or become profitable; uncertainties regarding the Company's obligations in regard to its former encapsulated cell therapy encapsulated cell therapy Therapeutics The enclosing of cells capable of producing a desired substance, in a semipermeable nonimmunogenic sheath, to restore a lost function facilities in Rhode Island; and other factors that are described in Exhibit 99 to the Company's Annual Report on Form 10-K titled "Cautionary Factors Relevant to Forward-Looking Statements." |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion