If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ATIII Safe in Clinical Trial, IND Filed for Phase II Trial FRAMINGHAM, Mass., Oct. 21, 1996 -- Genzyme Transgenics Corp. (Nasdaq: GZTC) announced today that results from a phase I trial conducted in the United Kingdom showed that the transgenic form of antithrombin III (ATIII), a plasma protein that helps prevent harmful blood clotting in many serious medical conditions, raised no safety issues in healthy subjects. The company also announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for a phase II trial in the United States later this year. The phase II trial will be aimed at a reduction in bleeding and in the amount of donor blood needed by patients undergoing coronary artery bypass surgery. In the phase I trial, which was conducted by Guy's Drug Research Unit Ltd. (G.D.R.U.) of London, 20 healthy male volunteers between the ages of 18 and 35 were divided into five groups of four subjects. Within each group, three subjects received ATIII intravenously and one received saline as a placebo control. Each group received different dosage levels of ATIII. The dosage range in the study was 10 IU/kg to 200 IU/kg. The maximum dose used in the study was well above the expected clinical dosage levels that could be effective. A review of all safety parameters of the study -- including tests of blood, urine, and vital signs -- showed no clinically significant changes in any group and no differences between subjects who received ATIII and those who received the placebo. "We are very pleased with these positive results in this first human trial ever of a transgenically produced drug," said James A. Geraghty, president and chief executive officer of Genzyme Transgenics. "The study is another milestone in our continuing path toward launching this and other important products." 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 ATIII in the milk of transgenic goats at its 168-acre commercial production facility in central Massachusetts. It has achieved clinical-grade purity and scaled up its proprietary purification and production processes in preparation for human clinical trials. Plasma-derived ATIII is currently on the market for a number of acquired ATIII deficiency indications in Europe and Japan. The transgenic form of the protein is being developed to expand the available indications and ultimately could replace the plasma version. Genzyme Transgenics believes the transgenic form of the drug will be safer and more cost-effective than the current plasma-derived drug. In addition to treating both acquired and hereditary ATIII deficiencies, Genzyme Transgenics believes new uses may increase the potential market for the product well beyond the current market of more than $200 million worldwide. Examples of conditions where an acquired ATIII deficiency can occur include liver diseases, disseminated intravascular coagulation, septicemia, shock, burns, multiple trauma, bone marrow and other organ transplantation, hip and knee replacement, and other surgical procedures. Genzyme Transgenics is engaged in the application of transgenic technology to enable the development and production of recombinant proteins and monoclonal antibodies for medical uses. The company's contract research organization (CRO) businesses provide non-clinical development and testing services to pharmaceutical, biotechnology, medical device, and other companies. Genzyme Corp.'s General Division (Nasdaq: GENZ) owns approximately 44.8 percent of the outstanding stock of Genzyme Transgenics. This news release contains forward-looking information, including statements about when a phase II clinical trial on ATIII will begin, the product's cost-effectiveness, and the potential market size. Actual results may differ materially from these projections depending on decisions made by the FDA and the accuracy of the company's research on the market and new potential indications.
|
