SEATTLE, Sept. 5 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (Nasdaq: ZGEN - News) announced today that a Phase 3 clinical study of recombinant human Thrombin (rhThrombin) met its primary endpoint. Treatment with rhThrombin and bovine thrombin resulted in comparable incidence of hemostasis at 10 minutes in the four surgical settings tested.
The rate of antibody formation was 1.5% in response to treatment with rhThrombin, versus 22% for those treated with the bovine thrombin product (p < 0.0001). Of patients in the bovine thrombin group who had pre-existing antibodies to the bovine thrombin product, eight of ten showed a ten-fold or greater increase in antibody levels over baseline measurements. The overall antibody generation rate for the bovine thrombin product was within the range that has been reported in recent scientific literature. The rates of adverse events and serious adverse events between the two treatment arms of the study were comparable.
“We are very pleased with these positive results, which are in line with our expectations. In this study, recombinant human thrombin showed a superior immunogenicity profile to bovine thrombin and was highly effective in treating acute surgical bleeding,” said Bruce L.A. Carter, Ph.D., President and Chief Executive Officer of ZymoGenetics. “We remain on schedule for the filing of a Biologics License Application with the FDA before the end of this year.”
The rhThrombin pivotal Phase 3 trial was conducted at 34 sites in the U.S. Of the 411 treated surgical patients, 205 were randomized to receive rhThrombin and 206 received bovine thrombin. The double-blinded Phase 3 clinical trial evaluated the same four types of surgery examined in the Phase 2 studies: spinal surgery, liver resection, peripheral artery bypass and arteriovenous graft construction. The study was designed to support broad product labeling for the use of rhThrombin as an aid to controlling bleeding during surgery. The primary objective of the trial was to assess efficacy by comparing the effectiveness of rhThrombin as a surgical hemostat to the currently approved bovine-derived thrombin, as measured by the incidence of hemostasis within 10 minutes. The secondary objective was to evaluate safety, including testing for the formation of antibodies against rhThrombin or the bovine thrombin product.
The rhThrombin Phase 3 trial results will be presented on Sunday, September 17 at the Society for the Advancement of Blood Management (SABM) annual meeting in Jersey City, New Jersey during the 8:15 a.m. - 9:15 a.m. Plenary Session, “Emerging Recombinant Clotting Factors: What’s New”.
A conference call with ZymoGenetics senior management will be held today at 5:00 p.m. Eastern Time. The call may be accessed by dialing 877-407-0782. The international dial in number is 201-689-8567. Participants should dial in to the call approximately 10 minutes prior to the scheduled start time in order to register. The conference call will be archived for 30 days. For replay, dial 877-660-6853. For international callers, the replay number is 201-612-7415. Replay passcodes required for playback are: Account #: 286 and Conference ID #: 213452.
ZymoGenetics will also review detailed results from the rhThrombin Phase 3 clinical trial at an analyst and investor briefing to be held on Monday, September 18, 2006 at 10:00 a.m. Eastern Time at the Grand Hyatt Hotel in New York City. To attend the meeting, RSVP to media@zgi.com. The meeting will be webcast and available at: www.zymogenetics.com. The webcast will be archived for 30 days.
About rhThrombin
ZymoGenetics is developing rhThrombin, a recombinant form of human thrombin that is not derived from animal or human blood, for the control of bleeding associated with surgical procedures. Thrombin is used in more than 1 million surgeries each year in the United States. Currently, only thrombin derived from bovine blood is available in the U.S. as a stand-alone thrombin product. Bovine-derived thrombin has been associated with the development of antibodies that may cross-react with human blood proteins and in some cases these antibodies appear to be related to serious bleeding complications. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled-up to meet market demand.
About ZymoGenetics
ZymoGenetics creates novel protein drugs with the potential to significantly help patients fight their diseases. The Company is developing a diverse pipeline of potential proprietary product candidates that are moving into and through clinical development. These span a wide array of clinical opportunities that include bleeding, autoimmune diseases and cancer. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics’ actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven discovery strategy, preclinical and clinical development, regulatory oversight, intellectual property claims and litigation and other risks detailed in the company’s public filings with the Securities and Exchange Commission, including the company’s Annual Report on Form 10-K for the year ended December 31, 2005. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.
Contact Investor Relations John Calhoun, MD, MBA Director, Corporate Communications & Investor Relations (206) 442-6744
Media Relations Susan W. Specht, MBA Associate Director, Corporate Communications (206) 442-6592
Source: ZymoGenetics, Inc.
