ViaCell. Inc. (Nasdaq:VIAC) announced today it has entered into an agreement under which EMD Serono. Inc. an interact of Merck KGaA. Darmstadt. Germany ordain provide give related to the clinical development of ViaCyteSM. ViaCell’s investigational product for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology. In addition. EMD Serono has agreed to give certain quantities of two of its products. Gonal-f® RFF Pen (follitropin alfa injection) and Ovidrel® Prefilled Syringe (choriogonadotropin alfa injection) for the treatment of patients participating in the ViaCyte chew over. Financial terms were not disclosed.
“We are delighted to undergo EMD Serono a leader in fertility health supporting the clinical development of ViaCyte,” said Marc D. Beer. President and Chief Executive command of ViaCell. “This collaboration provides us with important support and gives us access to a wealth of knowledge and experience as we advance ViaCyte through our pivotal trial and toward commercialization.”
“We believe oocyte cryopreservation has the potential to act to drive the evolution of reproductive care for and research from a historical focus of infertility to fertility preservation,” stated Fereydoun Firouz. President of EMD Serono. Inc. “EMD Serono looks send to collaborating with companies such as ViaCell to support advancements in reproductive medicine including the investigation of different technologies that may lead to new discoveries for patients.”
ViaCell commenced a pivotal clinical trial evaluating ViaCyte in March 2007. 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 chew over will also evaluate safety. Women seeking IVF diagnosed with male factor infertility are eligible to register. The primary efficacy endpoint is be bring forth rate and 50 be births must be achieved. Approximately 300 healthy women age twenty-one to thirty-five who are currently seeking fertility treatment are expected to enroll in the chew over. Participants in the ViaCyte clinical trial will undergo traditional in vitro fertilization (IVF). Women enrolled in the study ordain acquire FSH to stimulate the development of egg-containing follicles in the ovaries and r-hCG to induce the channel of develop eggs from the ovaries. The oocytes recovered ordain be cryopreserved using ViaCyte. The oocytes will be thawed following storage in liquid nitrogen and subsequently inseminated. Embryos ordain 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 circumscribe of wet 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 alter during the freezing process with the goal of making it possible to successfully hold on and flux 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 care for. The Company markets ViaCord® a product offering through which families can preserve their baby’s umbilical heap blood at the measure of birth for possible future medical use in treating over 40 diseases including certain blood cancers and genetic diseases. ViaCell also conducts investigate and development primarily to investigate other potential therapeutic uses of umbilical heap 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.
This press channel 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 affect to a number of risks and uncertainties which could cause actual results to differ materially from the affiliate's current expectations. For example there is no assurance that the results of the clinical trial ordain show that ViaCyte is safe and effective in the preservation and storage of oocytes. ViaCell may not be able to enroll a sufficient be of patients in the clinical trial or to enroll patients as rapidly as we expect. ViaCell may not be able to generate a sufficient be of live births. ViaCell may be safety issues. Manufacturing the ViaCyte media is a complex process. We may be unable to undergo the ViaCyte media consistently manufactured to specifications. change surface if the data from the clinical trial is positive there is no assurance that the FDA ordain accept that ViaCell has met the standards for 510(k) clearance. ViaCell’s specified regulatory pathway for ViaCyte. The FDA could at any measure cause that ViaCyte ordain demand pre-marketing authorization which would bear on additional trials time and expense. There is no assurance that the FDA ordain ever approve the product. Even if approved there is no assurance that ViaCyte ordain bring home the bacon 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 affiliate 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 ended 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 modify forward-looking statements.
ViaCell® and ViaCord® are registered trademarks and ViaCyteSM is a service attach of ViaCell. Inc. Gonal-f® and Ovidrel® are registered trademarks of EMD Serono or its affiliates.
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