Healthcare Industry News: cord blood
News Release - March 20, 2007
ViaCell Announces Commencement of ViaCyte Pivotal TrialStudy Aimed at Broadening Reproductive Choices for Women by Preserving Fertility
CAMBRIDGE, Mass.--(HSMN NewsFeed)--ViaCell, Inc. (Nasdaq: VIAC ) today announced it has initiated a clinical trial to evaluate the safety and efficacy of ViaCyteSM, an investigational product being studied for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology. Approximately three hundred healthy women, age twenty-one to thirty-five, who are currently seeking fertility treatment, are expected to enroll at multiple sites and countries, including in the United States. ViaCell expects the trial to be completed in 2009 and, if the results are positive, the Company expects to file for regulatory clearance in the United States. There is currently no FDA-cleared product for oocyte cryopreservation.
"This clinical trial is intended to build on existing oocyte cryopreservation data generated by academia. If successful, we believe data generated from this trial will be sufficient to support FDA clearance of ViaCyte. Our goal is to significantly broaden reproductive options for women by introducing the first FDA-cleared product offering," said Marc D. Beer, President and Chief Executive Officer of ViaCell.
"I am excited to be part of an innovative trial in the area of fertility preservation," stated Dr. Michael M. Alper, Medical Director and co-founder of Boston IVF and investigator of the ViaCyte clinical trial. "I believe ViaCyte has the potential to address a significant unmet medical need by supporting women's lifestyle choices to start a family later in life."
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 50 live births. 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 will be available on 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.
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 to investigate other potential therapeutic uses of umbilical cord blood-derived and adult 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, ViaCell's expectations as to the potential results of the ViaCyte study and the possibility of FDA clearance if the results are positive and ViaCell's belief as to the potential of ViaCyte. Such statements are based on management's current expectations. Successful completion of the ViaCyte clinical trial, ViaCell's ability to pursue the specified regulatory pathway 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. 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-K for the year ending December 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® and ViaCord® are federally registered trademarks and ViaCyteSM is a service mark of ViaCell, Inc.
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