CAMBRIDGE, Mass., Aug. 31 /PRNewswire-FirstCall/ -- ViaCell, Inc. announced today the publication of results of a preclinical study demonstrating that administration of stem cells sourced from umbilical cord blood and using ViaCell's proprietary process significantly improved heart function in an in vivo model of myocardial infarction (heart attack). The results of the preclinical study, sponsored by ViaCell and conducted in association with the Toronto General Research Institute at Toronto General Hospital under the supervision of Dr. Ren Ke-Li, have been published in the August 30,2005 Cardiovascular Surgery Supplement of Circulation: Journal of the American Heart Association.
As described in the publication, four weeks after cell transplantation, engrafted human unrestricted somatic stem cells (USSCs) were detected in the infarct region of the heart, and the implanted cells were shown to improve regional perfusion (p<0.05) and wall motion (p<0.05) of the infarct region compared to controls. In addition, ejection fraction, a measure of global heart function, increased in the transplant group compared to a decrease in controls (p<0.01).
Nicolas Chronos, M.D., chief medical and scientific officer of American Cardiovascular Research Institute, Atlanta, GA, and interventional cardiologist at the Atlanta cardiology group at St. Joseph's Hospital, stated, "Stem cell therapy offers tremendous promise, and I believe that acute myocardial infarction and congestive heart failure are among the diseases that will be the first to benefit from this approach. The research being described in the Circulation article is particularly significant, lending further support to the rationale for the use of stem cells from both related and unrelated donors. Allogeneic sources, a type of 'off-the-shelf' therapy, have the potential to greatly expand the number of patients who may one day be candidates for cell-based therapy."
Stephan Wnendt, Ph.D., ViaCell's Senior Vice President, Research and Development, stated, "We believe that unrestricted somatic stem cells from human umbilical cord blood have a great potential for the treatment of cardiovascular disease. Although not yet demonstrated in humans, USSCs have been found to engraft to the site of the infarct and significantly improve heart function in in vivo models. Additionally, USSCs are uniquely sourced from controversy-free umbilical cord blood."
The journal article from Kim et al. entitled, "Cell Transplantation Improves Ventricular Function After a Myocardial Infarction: A Pre-Clinical Study of Human Unrestricted Somatic Stem Cells in a Porcine Model" and full publication are available online at http://www.circ.ahajournals.org/.
Stem Cell Program in Cardiac Disease
Acute myocardial infarction (AMI), or heart attack, occurs when the blood supply to part of the heart muscle is severely reduced or stopped. This occurs when one of the heart's arteries is blocked by an obstruction, such as a blood clot that has formed on a plaque formed by arteriosclerosis. If the blood supply is cut off drastically or for a long time, heart muscle cells suffer irreversible injury and die. According to a study by the National Heart, Lung and Blood Institute, there are approximately 1.2 million cases of myocardial infarction each year in the United States, with a fatal outcome in about 42% of cases. Many patients who survive develop a chronic form of heart disease called congestive heart failure (CHF) which is associated with a progressive deterioration of the heart muscle. According to the National Heart, Lung and Blood Institute, about 5 million patients suffer from CHF in the United States.
Although patient survival rates have been improved by using catheters or drugs to remove thrombotic occlusions (blood vessel blockages), there is no proven therapy for repairing or regenerating damaged heart tissue. Recent clinical data obtained by other companies with stem cells isolated from the patient's own bone marrow, however, indicate that cardiac function may be able to be improved by the application of stem cells. Based on these clinical studies and its own preclinical investigations, ViaCell believes that USSCs could regenerate damaged heart tissue in humans and could be an effective, standardized product for heart repair, although this technology is at an early stage of development and, to date, the safety and efficacy of this therapy has not been demonstrated in humans.
About ViaCell
ViaCell, Inc. is a clinical-stage biotechnology company dedicated to enabling the widespread application of human cells as medicine. The Company is developing a pipeline of proprietary product candidates intended to address cancer, cardiac disease, diabetes and infertility. ViaCell's portfolio of proprietary technologies includes Selective Amplification technology and USSCs. The Company's lead cord-blood derived stem cell therapy product candidate, CB001, is currently in a Phase I clinical trial. ViaCell also offers expecting families the option of preserving their baby's cord blood stem cells through its Viacord business.
This press release may contain forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 and it is the Company's intent that such statements be protected by the safe harbor created thereby. Examples of such statements include, but are not limited to, statements relating to: the purpose of a pre-clinical study of a cardiac cell therapy product candidate for generating data supporting the filing of an IND, the conduct of research to improve production and characterization of islet stem cells, the potential for NIPs-derived pancreatic islet stem cells to produce certain insulin, and the potential benefits of the Company's product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to: uncertainties inherent in anticipating the results of pre-clinical and clinical studies; adverse effects on revenues related to litigation, competition and public perception regarding the Company's product; difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates that could slow or prevent product approval or market acceptance; and the Company's ability to obtain additional financing if necessary to support development and commercialization activities or unanticipated research and development costs. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission, including the matters discussed under the heading "Risk Factors That May Affect Results" in the Company's report on form 10-K filed via EDGAR with the Commission on March 31, 2005 and in subsequent quarterly filings. ViaCell does not undertake any obligation to update forward-looking statements.
CONTACT: Stephen G. Dance of ViaCell, Inc., +1-617-914-3535,
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