Recombinant Human Thrombin Phase 2 Studies Show Favorable Results
Aug 11, 2005, 00:42, Reviewed by: Dr.
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The combined Phase 2 study results showed that rhThrombin, a product candidate in development to control bleeding during surgery, appeared to be safe and well tolerated, with a favorable immunogenicity profile.
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By ZymoGenetics,
ZymoGenetics (Nasdaq:ZGEN) today presented the aggregate results of four Phase 2 clinical studies of recombinant human Thrombin (rhThrombin) at The International Society on Thrombosis and Haemostasis annual meeting in Sydney, Australia. The poster presentation is available at www.zymogenetics.com on the home page in the "What's New" section.
The combined Phase 2 study results showed that rhThrombin, a product candidate in development to control bleeding during surgery, appeared to be safe and well tolerated, with a favorable immunogenicity profile. A total of 130 patients undergoing spinal surgery, liver resection, peripheral artery bypass, or arteriovenous graft construction were evaluated.
ZymoGenetics is currently finalizing plans for the rhThrombin Phase 3 pivotal trial. The company expects to start treating patients in the Phase 3 trial later this year.
About rhThrombin
ZymoGenetics is developing rhThrombin for the control of bleeding associated with surgical procedures. Thrombin is used in over 700,000 surgeries per 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. In some cases, these antibodies lead to serious bleeding complications. Recombinant proteins, such as rhThrombin, can be manufactured to higher levels of purity and consistency than proteins purified from human or animal blood. Furthermore, the production of recombinant proteins is not dependent on the availability of blood from human or animal donors and can be scaled-up to meet market demands. For these reasons, ZymoGenetics believes that rhThrombin represents a potential preferred alternative to the bovine-derived product. 
- The study results were presented at The International Society on Thrombosis and Haemostasis annual meeting in Sydney, Australia.
www.zymogenetics.com
About ZymoGenetics
ZymoGenetics is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic proteins for the prevention or treatment of human 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, 2004. 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.
Contacts
Investor Relations:
John Calhoun, 206-442-6744
or
Media Relations:
Susan W. Specht, 206-442-6592
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