Nexia receives GTC technology for Protexia development
2004-09-23 08:55 ET - News Release
Mr. Jeffrey Turner reports
GTC BIOTHERAPEUTICS GRANTS LICENSE TO TECHNOLOGY TO SUPPORT NEXIA BIOTECHNOLOGIES' PROTEXIA(R)
GTC Biotherapeutics, Inc. and Nexia Biotechnologies Inc. have signed an exclusive agreement for GTC to license its transgenic technology for Nexia to continue the development, manufacture and sale of Protexia. This licensing agreement includes access to GTC's beta casein promoter and an option to license its filtration technology, which has been demonstrated to have utility for initial purification of Protexia. Protexia is a recombinant form of butyrylcholinesterase (BChE) produced in the milk of Nexia's transgenic goats. BChE is a naturally occurring enzyme found in the circulatory system of humans and acts as a bioscavenger which may be used to prevent the toxic effects of nerve agents and other organophosphate compounds. Protexia is being developed by Nexia jointly with the U.S. Army Medical Research Material Command (USAMRMC) and with Defence R&D Canada Suffield (DRDC Suffield), for therapeutic and prophylactic applications. The financial terms of the licensing agreement were not disclosed.
"Protexia has the potential to be an important biodefence product," stated Geoffrey F. Cox, PhD, GTC's chairman of the board and chief executive officer. "We are pleased to be able to license our intellectual property for the development of Protexia."
"GTC's casein promoter and filtration technology are important and a proven component of Nexia's manufacturing process for Protexia," commented Jeffrey D. Turner, PhD, president and chief executive officer of Nexia. "The technology GTC and Nexia are putting together enables the development of this innovative biotech-based medicine to counter a significant chemical weapons threat globally and at home." Nexia is working with the USAMRMC under the broad agency announcement contract, and a co-operative research and development agreement. Research and testing of Protexia are also being developed under a three-year, financed development and testing agreement with DRDC Suffield. Nexia has reported that Protexia has delivered broad spectrum protection against multiple lethal doses of nerve agents in animal models. In addition, Nexia has reported that in animal models a single injection of Protexia delivers sustained elevation of BChE levels in the blood, where it neutralizes the deleterious toxic effects of nerve agents.
The Protexia program has begun the stages of herd scale-up, purification process development and preclinical studies to support the filing of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA).
About GTC
GTC Biotherapeutics is a leader in the development, production and commercialization of therapeutic proteins through transgenic animal technology. GTC's ATryn, a recombinant form of human anti-thrombin, is undergoing review for market authorization in Europe. Subject to satisfactory approval, GTC will be the first company to commercially offer a transgenically produced product, which is projected for mid-2005. In addition to the ATryn program, GTC is developing a recombinant human serum albumin, a malaria vaccine, and a CD137 antibody to solid tumours. In its external programs, GTC's technology is used to develop transgenic production of its partners' proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant 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 is in clinical trials with a transgenically produced product. Additional information is available on the GTC website, http://www.gtc-bio.com.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
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