ZymoGenetics Begins Phase 2 Clinical Studies with Recombinant Human Thrombin; Phase 1 Patient Treatment Completed with Innovative Surgical Hemostatic Agent.To download high-resolution, print-ready JPEG JPEG in full Joint Photographic Experts Group Standard computer file format for storing graphic images in a compressed form for general use. JPEG images are compressed using a mathematical algorithm. images, click on the thumbnail image above. WARNING: these images are very large (800K+) Click here for caption Business Editors & Health/Medical Writers MULTIMEDIA AVAILABLE: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=4617404 SEATTLE--(BUSINESS WIRE)--April 19, 2004 ZymoGenetics (Nasdaq:ZGEN) today announced that it has begun a multi-center Phase 2 clinical study of recombinant human Thrombin thrombin: see blood clotting. (rhThrombin) in patients undergoing liver resection Liver resection refers to the removal of the whole liver (which would be fatal in a living person) or one or more of its vascular segments. It is commonly done as a treatment for malignant tumors, such as hepatoma (liver cancer) or metastases from other cancers. . rhThrombin is being developed by ZymoGenetics for the control of bleeding associated with surgical procedures. The company recently completed enrollment in an open-label Phase 1 study, which provided the basis for moving into the Phase 2 study. ZymoGenetics expects to begin treating patients shortly in three additional multi-center Phase 2 clinical studies in lumbar spine Lumbar spine The segment of the human spine above the pelvis that is involved in low back pain. There are five vertebrae, or bones, in the lumbar spine. Mentioned in: Low Back Pain surgery, lower extremity lower extremity n. The hip, thigh, leg, ankle, or foot. Also called inferior limb, pelvic limb. peripheral artery bypass surgery Bypass surgery A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis). , and formation of vascular access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing grafts for dialysis. The company's goal is to obtain a broad label for use of the product as an aid to controlling blood loss in surgery. The four placebo-controlled and double-blind Phase 2 studies will be conducted in a total of 160 patients (40 per study), half with rhThrombin and half with placebo. The endpoints will be safety and time-to-hemostasis, with a 28-day follow-up to test for development of antibodies to rhThrombin. "We are extremely pleased with our progress to date in the clinical development of rhThrombin," commented Bruce L. A. Carter, Ph.D., President and Chief Executive Officer of ZymoGenetics. "We are encouraged by the early safety data from the Phase 1 study and remain confident as to our ability to move the program forward rapidly. We expect to complete the Phase 2 studies later this year, with the goal of beginning Phase 3 pivotal studies in early 2005." Walter F. Krengel, III, M.D., Bellevue Orthopaedic Associates and a lead investigator in the open-label Phase 1 clinical study in spinal surgery, said, "My recent experience in the Phase 1 study was very positive. We saw some instances of really dramatic hemostatic hemostatic /he·mo·stat·ic/ (he?mo-stat´ik) 1. causing hemostasis, or an agent that so acts. 2. due to or characterized by stasis of the blood. he·mo·stat·ic adj. response with rhThrombin for problematic epidural epidural /epi·du·ral/ (-dur´il) situated upon or outside the dura mater. ep·i·du·ral adj. Located on or over the dura mater. n. bleeding." About rhThrombin Thrombin is used in over 500,000 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 donors or cattle herds 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. 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 Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2003. 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. MULTIMEDIA AVAILABLE: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=4617404 |
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