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Genzyme Transgenics Completes Successful Phase II Clinical Trial for Recombinant Human Antithrombin III
FRAMINGHAM, Mass., Sept. 4 /PRNewswire/ -- Genzyme Transgenics Corp. (Nasdaq:GZTC) announced today that it has successfully completed a phase II clinical trial for its lead product candidate, recombinant human antithrombin III (rhATIII), which is produced in the milk of transgenic goats.
Analysis of the results of the trial, which involved patients undergoing coronary artery bypass grafting (CABG) at Emory University, Atlanta, support rhATIII's safety claims and have helped to define an appropriate dose range for a planned pivotal trial. The phase II data has been presented to the U.S. Food and Drug Administration and the design of the phase III trial, scheduled to begin early next year, is currently under discussion. An abstract summarizing the rhATIII phase II clinical trial results has been submitted for presentation at a major scientific meeting early this fall.
A previous phase I study conducted in the United Kingdom had demonstrated the safety of rhATIII in healthy volunteers. The phase I study was the first clinical trial in which patients had been treated with a transgenically produced therapeutic protein.
``We are pleased that this study appears to confirm the results of our phase I ATIII study in healthy individuals and extends its safety profile to CABG patients,'' said James A. Geraghty, Genzyme Transgenics' president and chief executive officer. ``The satisfactory completion of this phase II study is a significant step toward commercialization of this first transgenically produced therapeutic protein. These findings also bring us closer to our goal of providing a superior, potentially more economical version of ATIII than the plasma-derived product on the market today.''
A blood plasma protein, ATIII helps regulate blood clotting. ATIII deficiency is associated with liver diseases, disseminated intravascular coagulation, septicemia, shock, burns, multiple trauma, bone marrow and other organ transplantation, hip and knee replacement, and other surgical procedures.
Currently ATIII is extracted from blood plasma, and is on the market in the United States for hereditary deficiency. In Europe and Japan, it is on the market for a number of acquired ATIII deficiency indications.
Transgenic proteins are produced by inserting human DNA into animals' cells so that the targeted protein, or drug, is secreted in the milk of female offspring. Genzyme Transgenics produces rhATIII in the milk of transgenic goats at its 168-acre commercial production facility in central Massachusetts. Genzyme Transgenics is collaborating with Genzyme General (Nasdaq:GENZ) to develop rhATIII. The companies believe new uses of the drug can increase its potential market.
Genzyme Transgenics is a biotechnology company focused on biopharmaceutical development through transgenic production of genetically engineered therapeutic products; specialized contract research services for pharmaceutical, biotechnology, medical device, and other companies; and the production of cancer vaccines. Genzyme General owns approximately 43 percent of the outstanding stock of Genzyme Transgenics.
This news release contains forward-looking information about the regulatory review of the company's rhATIII phase II clinical trial, commencement of an rhATIII pivotal clinical trial, and the potential broader therapeutic utility of rhATIII. Actual results may differ materially from these projections depending on the company's ability to complete clinical trials, the timing and content of decisions made by the FDA, the competitive environment, the efficacy of rhATIII for new uses, and market acceptance of transgenically produced rhATIII.
Genzyme's releases are on the World Wide Web at genzyme.com. They are also available from Genzyme's fax-on-demand service at 1
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