ATLANTA, March 13 /PRNewswire-FirstCall/ -- ViaCell, Inc. announced today preclinical findings evaluating Unrestricted Somatic Stem Cells (USSCs), pluripotent stem cells cultivated from human cord blood, in a small animal model of myocardial infarction. In the study USSCs showed a dose-dependent response and result in functional recovery in an animal model of acute myocardial infarction four weeks post transplantation. These findings were presented today by Dr. Hiroto Iwasaki of Kobe Institute of Biomedical Research and Innovation/RIKEN Center for Developmental Biology in Isehara, Japan at the American College of Cardiology 55th Annual Scientific Session being held in Atlanta, Georgia.
“These data are very exciting as we’ve seen few examples of a dose- dependent effect of stem cells demonstrated in the cardiac field thus far. While further research is needed, we also demonstrated USSCs differentiate into both endothelial and cardiomyocytes,” said Dr. Takayuki Asahara of Kobe Institute of Biomedical Research and Innovation/RIKEN Center for Developmental Biology. “Through our work with ViaCell evaluating their proprietary USSCs, we are encouraged about the potential these cells may have to regenerate damaged heart tissue.”
The primary goal of this study was to determine if USSCs would lead to functional improvement after acute myocardial infarction in a small animal model. USSCs were implanted 20 minutes after an acute myocardial infarction was induced by ligating one of the coronary arteries. Key research findings showed engraftment of USSCs in the infarct region and a dose-dependent improvement of heart function conferred by USSCs whereby human skin fibroblasts did not induce any improvement.
“We are encouraged with these research findings and intend to advance this program further in preclinical testing to determine optimal dosing, delivery, and targeting of USSCs as a treatment for cardiac disease. With over 800,000 annual cases of patients surviving a myocardial infarction and 5 million people suffering from chronic heart failure and no proven therapy to repair or regenerate the heart, we believe our USSC program is an important initiative,” said Stephan Wnendt, Ph.D., Senior Vice President of Research and Development at ViaCell.
If the preclinical data support further development, ViaCell expects to file an Investigational New Drug Application (IND) to commence human clinical trials of its USSCs in the cardiac area in late 2006 or early 2007.
Unrestricted somatic stem cells are a pluripotent source of stem cells cultivated from human cord blood mononuclear cells. These cells have the ability to differentiate into many cell types including endothelial cells, fat, bone, cartilage and neuronal cells under specified in vitro culture conditions. Preclinical evidence suggests USSCs can differentiate in vivo in many tissue types as shown by distribution and function of human cells in the liver, bone, bone marrow, brain and heart of transplanted animals. The company believes USSCs may have potential in a number of indications.
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 or 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, approximately 5 million patients suffer from CHF in the United States.
About ViaCell
ViaCell is a biotechnology company focused on enabling the widespread use of human cells as medicine. The Company is developing a pipeline of proprietary stem cell product candidates intended to address cancer, cardiac disease, and diabetes. CB001, its lead cord blood derived stem cell therapy product candidate, is being developed for hematopoietic stem cell transplantation in patients affected by a variety of cancers. In addition to its therapeutic development programs, ViaCell’s Reproductive Health Business Unit commercializes ViaCord(R), a product that offers expecting families the option of preserving their baby’s umbilical cord blood. The Company is working to leverage its commercial infrastructure and product development capabilities by developing ViaCyte(SM), its investigational product intended to broaden reproductive choices for women through the cryopreservation of human unfertilized eggs. ViaCell is headquartered in Cambridge, Massachusetts with a processing and storage facility in Kentucky and additional research and development operations in Singapore.
This press release contains forward-looking statements regarding the Company’s plans for development of its USSC product candidate, including the timing as to a possible IND filing, and the Company’s views as to the potential for USSCs in the cardiac area and in other indications. Such statements are based on management’s current beliefs and expectations. Drug development involves a high degree of risk. There are a number of risks and uncertainties that could cause actual results to differ materially from management’s current beliefs and expectations. The Company’s USSC product candidate is at an early stage of development and has not completed preclinical testing or been tested in humans. Promising results in small animal studies may not be indicative of results that may be obtained in larger animal studies or in humans. Preclinical studies have yielded and may continue in the future to yield inconsistent results. We may not be able to find a way to successfully deliver and target cells to the damaged regions of the heart for trans-vascular delivery or other commercially viable route of administration. There is no assurance that we will be able to show effect in further animal models or that data will support filing the IND and starting clinical trials. Even if we are able to begin clinical trials, there is no assurance that we will be able to show that USSCs are safe and effective in the treatment of cardiac disease. We may encounter technical, regulatory, safety, manufacturing, delivery or intellectual property-related hurdles or issues as we develop this product candidate. For more information on the risks and uncertainties associated with the Company and its products and programs, see the factors set forth under the heading “Risk Factors That May Affect Results” in the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2005, which is on file with the Securities and Exchange Commission and which factors are incorporated herein by reference. ViaCell does not undertake any obligation to update forward-looking statements.
ViaCell(R) and ViaCord(R) are registered trademarks and ViaCyte(SM) is a service mark of ViaCell, Inc.
For More Information Contact: Justine E. Koenigsberg Senior Director, Corporate Communications (617) 914-3494
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CONTACT: Justine E. Koenigsberg, Senior Director, CorporateCommunications, +1-617- 914-3494
