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GTC Biotherapeutics Completes Enrollment in European Efficacy Study; Recombinant Human Antithrombin III to be Named ATryn(R).

GTC Biotherapeutics, Inc. (Nasdaq: GTCB; "GTC") announced today that enrollment into the efficacy study for recombinant human antithrombin III (rhATIII) has been completed. The results of the efficacy study will be included in a filing requesting marketing authorization in Europe. A total of 14 patients have been enrolled and treated in this study. The efficacy study was designed to assess the ability of rhATIII to prevent blood clots in patients that have a hereditary antithrombin deficiency and are giving birth or undergoing a major surgical procedure. GTC expects to file for marketing authorization in Europe by February 2004. The product will be sold under the name ATryn(R) after the appropriate regulatory review and approvals of the application are obtained.

"Completing enrollment in the efficacy study is an important milestone in obtaining the first regulatory review of our lead product, ATryn(R)," stated Geoffrey F. Cox, Ph.D., GTC's Chairman and CEO. "We look forward to completing evaluation of the data from this study and disclosing the results in an appropriate forum."

Patients with a hereditary antithrombin deficiency are prone to developing blood clots, especially during high-risk medical procedures. These patients are normally treated with an orally available anticoagulant. However, this maintenance therapy often must be discontinued during events such as childbirth or surgery. Human plasma derived antithrombin is often given to cover the period of high risk for the development of blood clots.

The clinical study evaluates the safety and efficacy of ATryn(R) administered by a continuous intravenous infusion with maintenance throughout the procedure and a few days after the procedure. The study includes blood samples that check for the formation of antibodies to ATryn(R) and ultrasound readings that look for the formation of blood clots in the legs. The clinical study was conducted in accordance with scientific advice received from the European Medicines Evaluation Agency (EMEA).

Antithrombin is a blood protein with anticoagulant and anti-inflammatory properties. This protein has been difficult to express using conventional recombinant protein production methods. GTC expresses this protein in the milk of goats that have the human antithrombin gene linked to a milk-protein promoting gene. This approach provides the opportunity to produce highly purified antithrombin in a well-characterized recombinant form as ATryn(R). A recombinant antithrombin may also help reduce the supply constraints that can occur with antithrombin that is derived from human blood.

GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. GTC has more than a dozen programs in development, including its internal proprietary products. In addition to the ATryn(R) program, GTC is developing a recombinant human serum albumin and a malaria vaccine. In GTC's external programs, GTC's technology is used to develop transgenic production of the partners' proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant protein production systems. GTC's external program collaborations are developing transgenic versions of products such as monoclonal antibodies and immunoglobulin fusion proteins for conditions such as rheumatoid arthritis, HIV/AIDS and cancer. One of the external programs recently entered clinical trials with a transgenically produced product. Additional information is available on the GTC web site, .

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the future plans to file for market authorization for ATryn(R) with the EMEA and GTC's intention to present clinical data in appropriate forums. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports as filed with the Securities and Exchange Commission, including the risks and uncertainties associated with conducting clinical studies, and the risks and uncertainties associated with dependence upon the actions of regulatory agencies. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.

CONTACT: Thomas E. Newberry, Vice President, Corporate Communications of GTC Biotherapeutics, Inc., +1-508-370-5374; or Investors - E. Blair Schoeb, or Media - Kathy Jones, Ph.D., both of Burns McClellan, Inc., +1-212-213-0006, for GTC Biotherapeutics

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Geographic Code:1USA
Date:Dec 17, 2003
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