CAMBRIDGE, Mass.--(BUSINESS WIRE)--ViaCell, Inc. (Nasdaq: VIAC - News) today announced it expects to expand the number of U.S. clinical sites participating in its ViaCyte(SM) pivotal trial from three to eight. ViaCyte is an investigational product intended to broaden reproductive options for women through the freezing and thawing of human oocytes (eggs). The FDA has approved ViaCell's Investigational Device Exemption (IDE) supplement supporting the expansion of its U.S. clinical trial sites. The pivotal trial commenced in March 2007 and is expected to be completed in 2009.
"There is great enthusiasm behind this program through our clinical investigators and the reproductive endocrinologist community. By expanding the number of sites in the U.S. we increase access to our trial and gain broader insight from opinion leaders on the value of our egg freezing product candidate," said Marc D. Beer, President and Chief Executive Officer of ViaCell. "Egg freezing is an emerging area and we believe we are on the forefront of offering a technology to women who need to extend or protect their fertility."
The primary objective of the pivotal study is to determine the efficacy of the ViaCyte media for the cryopreserving and thawing of human oocytes. The open-label study will also evaluate safety. Women seeking in vitro fertilization (IVF), diagnosed with male factor infertility, are eligible to enroll. The primary efficacy endpoint is live birth rate and 50 live births must be achieved. Approximately 300 healthy women, age 21-35, who are currently seeking fertility treatment, are expected to enroll in the study. Participants in the study will undergo traditional 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. Additional information about the trial is available online at http://www.clinicaltrials.gov.
ViaCyte is an investigational product 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's proprietary technology to cryopreserve and thaw human oocytes uses a choline chloride-based media designed to protect the cells from damage during the freezing process with the goal of making it possible to successfully store and thaw oocytes for future use. There is currently no FDA-cleared product for oocyte cryopreservation.
ViaCell, Inc. is a biotechnology company dedicated to enabling the widespread application of human cells as medicine. The Company markets ViaCord®, a product offering through which families can preserve their baby's umbilical cord blood at the time of birth for possible future medical use in treating over 40 diseases including certain blood cancers and genetic diseases. ViaCell also conducts research and development primarily to investigate other potential therapeutic uses of umbilical cord blood-derived stem cells and on technology for expanding populations of these cells. ViaCell's pipeline is focused in the areas of cancer, cardiac disease, diabetes and fertility. For more information about ViaCell, visit our website at http://www.viacellinc.com.
This press release contains forward-looking statements regarding the clinical development of ViaCyte, including statements regarding the timing and size of its clinical trial. Such statements are based on management's current expectations. These statements 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. ViaCell may not be able to enroll a sufficient number of patients in the clinical trial or to enroll patients as rapidly as we expect. ViaCell may not be able to generate a sufficient number of live births. ViaCell may encounter safety issues. Even if the data is positive, there is no assurance that the FDA will agree that ViaCell has met the standards for 510(k) clearance. The FDA could at any time determine that ViaCyte will require pre-marketing authorization, which would 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 and IVF 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 June 30, 2007, 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® and ViaCord® are registered trademarks and
ViaCyte(SM) is a service mark of ViaCell, Inc.
Justine E. Koenigsberg, 617-914-3494
Senior Director, Corporate Communications
Source: ViaCell, Inc.