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ViaCell Receives IDE Supplement Approval to Advance ViaCyte Pivotal Trial

ViaCell, Inc. (Nasdaq: VIAC) announced today that it has received FDA approval of its investigational device exemption (IDE) supplement for its ViaCyteSM pivotal clinical trial. The pivotal study will evaluate ViaCyte, an investigational product being studied for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology. FDA approval of the IDE supplement allows the Company to enroll women into the study and commence in vitro fertilization treatment, or IVF. Previously, the FDA disapproved the IDE supplement. In doing so, the FDA asked ViaCell to respond to questions related to the specifications and sourcing of certain raw materials used in the manufacturing of the ViaCyte media. All questions have been addressed and no conditions are outstanding.

“We are extremely pleased we resolved this issue with the FDA,” said Karen Nichols, Vice President, Regulatory Affairs and Quality Systems at ViaCell. “We can now begin treatment of women previously consented to participate in the ViaCyte pivotal trial and we expect our U.S. sites to advance enrollment. We continue to expect to complete the trial in 2009.”

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 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. 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.

About ViaCyte

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.

About ViaCell

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 ViaCell’s expectations as to the completion of the ViaCyte clinical trial. Such statements are based on management's current expectations. Successful and timely completion of the ViaCyte clinical trial 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 it expects. ViaCell may not be able to generate a sufficient number of live births. ViaCell may encounter safety issues. Manufacturing the ViaCyte media is a complex process. ViaCell may be unable to have the ViaCyte media consistently manufactured to specifications. Even if the data from the clinical trial is positive, there is no assurance that the FDA will agree that ViaCell has met the standards for 510(k) clearance, ViaCell’s specified regulatory pathway for ViaCyte. 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. Drug and device 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, 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 federally registered trademarks and ViaCyteSM is a service mark of ViaCell, Inc.

ViaCell, Inc.
Justine E. Koenigsberg, 617-914-3494
Senior Director, Corporate Communications


Source: Business Wire (July 9, 2007 - 7:31 AM EDT)