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Biotech / Medical : GZTC -- Ignore unavailable to you. Want to Upgrade?

To: Exacctnt who wrote (709)	9/7/2000 11:22:19 AM
From: Exacctnt	Read Replies (1) \| Respond to of 752

Anybody willing to interpret this. biz.yahoo.com Genzyme Transgenics and Genzyme General Announce rhATIII Phase III Study Results FRAMINGHAM, Mass., Sept. 7 /PRNewswire/ -- Genzyme Transgenics Corporation (``GTC'') (Nasdaq: GZTC - news) and Genzyme General (Nasdaq: GENZ - news) announced today the primary endpoint results of a second phase III trial evaluating the ability of their recombinant human antithrombin III (rhATIII) to restore heparin sensitivity and assist in managing coagulation during cardiopulmonary bypass surgery. The primary endpoint of reduction in the use of fresh frozen plasma was met and was statistically significant (p=<0.001). The primary endpoint results of the second phase III trial were also consistent with the results of the identically designed first phase III trial announced in January. ``This second set of phase III data confirms that rhATIII has the potential to reliably support the management of anticoagulation in cardiopulmonary bypass patients who are resistant to heparin,'' said Jerrold Levy, M.D., director of cardiothoracic anesthesiology, Emory University School of Medicine. ``The prospect of using this reliable source of antithrombin III may enable physicians to reduce use of donor blood products.'' Patients undergoing cardiopulmonary bypass typically receive heparin to prevent clotting when their blood comes into contact with the surfaces of the heart-lung machine during surgery. Treatment of heparin-resistant patients with fresh frozen plasma is one option available to attempt to address heparin sensitivity and achieve adequate anticoagulation to permit initiation of cardiopulmonary bypass. ``Our rhATIII is the first transgenically produced medicine to successfully complete phase III studies,'' stated Sandra Nusinoff Lehrman, M.D., President and Chief Executive Officer of GTC. ``We anticipate discussions with the U.S. Food and Drug Administration to determine what information may be necessary in addition to the results of these clinical studies to ensure the strongest possible filing for approval.'' The primary endpoint results of the second phase III study demonstrated that of the patients not initially demonstrating adequate heparin response, only 19%, or 5 out of 26 of the patients in the rhATIII treated group, required fresh frozen plasma to extend coagulation times. In the placebo group 81%, or 22 out of 27 patients, required fresh frozen plasma. This double-blinded, randomized, placebo-controlled study evaluated 53 patients in medical centers in the U.S. and Europe. The degree of anticoagulation activity found during the study was measured by the activated clotting time (ACT), a point of care standard monitor used to assess coagulation status during cardiac surgery. In this study, an ACT of 480 seconds or greater reflects adequate anticoagulation for initiation and maintenance of CPB. Patients whose ACT was still less than 480 seconds after receiving a total of 400 U/kg of heparin were randomized into either a placebo or rhATIII group. Fresh frozen plasma was given to those patients whose ACT remained below 480 seconds after receiving either a placebo or rhATIII. The trial's secondary endpoints included maintenance of antithrombin levels in the patient's blood and examined changes in two biochemical markers of coagulation: D-dimer and fibrin monomer. Antithrombin III blood levels in patients provided rhATIII increased to an average of 123% of normal 30 minutes after the start of cardiopulmonary bypass, and were 114% of normal at the end of surgery. Antithrombin III blood levels in placebo patients that received fresh frozen plasma were 51% of normal 30 minutes after the start of bypass, and were 52% of normal at the end of surgery. There were no significant differences in D-dimer or fibrin monomer between groups. GTC and Genzyme General have established a joint venture, ATIII LLC, for the development, marketing, and distribution of rhATIII in the US and Europe. The companies believe that rhATIII may have significant advantages over plasma ATIII, including a consistent and reliable supply, and the ability to economically increase production, as additional patient needs are identified. The joint venture expects to file for FDA approval of rhATIII early in 2001. Genzyme Transgenics Corporation is a leader in developing medicines from the milk of specially bred animals, primarily goats. Many of the medicines under development are monoclonal antibodies and immunoglobulin fusion proteins or other therapeutic proteins. To date, GTC has formed more than a dozen collaboration agreements which provide for production of specific proteins. Additional information is available on the GTC web site, trangenics.com. Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of therapeutic products in development focused primarily on the treatment of rare genetic diseases. A division of the biotechnology company Genzyme Corporation, Genzyme General has its own common stock intended to reflect its value and track its economic performance. This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements about the potential benefits of rhATIII, anticipated advantages of rhATIII over plasma for the indication studied, and an expected submission to the FDA. 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 Genzyme Transgenics Corporation's and Genzyme Corporation's prospectuses and 1999 Annual Reports on Form 10-K, as filed with the Securities and Exchange Commission, including the uncertainties associated with additional safety studies, the risk of identifying and developing additional indications for rhATIII, the risks and uncertainties associated with dependence upon the actions of government and regulatory agencies, and market acceptance of rhATIII. SOURCE: Genzyme Transgenics Corporation