CAMBRIDGE, Mass., June 26 /PRNewswire-FirstCall/ -. ViaCell, Inc. announced today the United States Food and Drug Administration (FDA) has conditionally approved its Investigational Device Exemption (IDE) to evaluate its ViaCyte(SM) investigational product offering for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology. The Company intends to conduct a single, pivotal clinical trial to study the safety and efficacy of ViaCyte. Enrollment is expected to commence in late 2006. If the results of the study are positive, ViaCell expects to seek marketing clearance under the FDA's 510(k) pathway. There is currently no FDA-cleared product for oocyte cryopreservation.
"Although there is evidence that oocyte cryopreservation has resulted in pregnancies and births, there is not an FDA-cleared product available today. Our goal is to conduct a well-controlled, regulated clinical trial in order to generate data to support FDA clearance of our product for cryopreservation of oocytes," said Marc D. Beer, President and Chief Executive Officer of ViaCell. "If cleared by the FDA, we believe ViaCyte will offer new fertility options to women."
The primary objective of the study is to determine the efficacy of ViaCyte for the cryopreserving and thawing of human oocytes. The open-label study will also evaluate safety and will be conducted at multiple sites in the United States, Spain and Argentina. The trial will seek to enroll approximately 300 healthy women, age twenty-one to thirty-five, who are currently seeking fertility treatment. The primary efficacy endpoint is live birth rate. Participants in the study will undergo traditional in vitro fertilization (IVF). After the eggs are retrieved, oocyte cryopreservation will be performed using ViaCyte. The oocytes will be thawed following storage in liquid nitrogen and subsequently inseminated. Embryos will be transferred to the subject's uterus using a non-surgical procedure. A summary of the ViaCyte study protocol will be available online at http://www.clinicaltrials.gov.
The FDA's conditional approval to begin enrolling patients in the ViaCyte clinical trial requires ViaCell to provide additional information within 45 days of the FDA's request. ViaCell anticipates it will satisfy the conditions within that time period.
"If solid clinical evidence is generated through this clinical trial, we believe we can advance the acceptance of egg-freezing from experimental into general clinical practice," said Dr. David Adamson, a nationally known infertility specialist and Director of Fertility Physicians of Northern California (FPNC).
ViaCyte is an investigational product offering intended to broaden reproductive options for women through the cryopreservation and thawing of human oocytes. The oocyte is a large cell with a high content of water, historically making it difficult to freeze. ViaCell has proprietary technology to cryopreserve and thaw human oocytes using a choline chloride- based media to protect the cells from damage during the freezing process.
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 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 offering intended to broaden reproductive choices for women through the cryopreservation of human eggs. ViaCell is headquartered in Cambridge, Massachusetts with a processing and storage facility in Kentucky and additional research and development operations in Singapore. Additional information about ViaCell is available online at http://www.viacellinc.com.
This press release contains forward-looking statements regarding the clinical development and potential of ViaCyte. Such statements are based on management's current expectations. Successful completion of the ViaCyte clinical trial and the potential for ViaCyte are subject to a number of risks and uncertainties which could cause actual results to differ materially from the Company's current expectations. For example, there is no assurance that the results of the clinical trial will show that ViaCyte is safe and effective in the preservation and storage of oocytes. We may not be able to enroll a sufficient number of patients in the clinical trial. We may not be able to generate a sufficient number of live births. We may encounter safety issues. Even if the data is positive, there is no assurance that the FDA will agree that we meet the standards for 510(k) clearance. The FDA could at any time determine that ViaCyte will require pre-marketing authorization, which may involve additional trials, time and expense. There is no assurance that the FDA will ever approve the product. Even if approved, there is no assurance that ViaCyte will achieve commercial success or be able to successfully compete with other oocyte cryopreservation products. Product development involves a high degree of risk. 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" in the Company's report on Form 10-Q for the quarter ending March 31, 2006, 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: Investors Media Justine E. Koenigsberg Justin Jackson ViaCell, Inc. Burns McClellan (617) 914-3494 (212) 213-0006 x327 jkoenigsberg@viacellinc.comjjackson@burnsmc.com
Photo: http://www.newscom.com/cgi-bin/prnh/20060303/VIACELLLOGOViaCell, Inc.CONTACT: Investors, Justine E. Koenigsberg of ViaCell, Inc.,+1-617-914-3494, jkoenigsberg@viacellinc.com; or Media, Justin Jackson ofBurns McClellan, +1-212-213-0006 x327, jjackson@burnsmc.com
Web site: http://www.viacellinc.com/
