SEATTLE, Nov. 14 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. today announced highlights from a presentation given by clinical investigator John A. Thompson, M.D., of the University of Washington at the International Society for Biological Therapy of Cancer (ISBTc) annual meeting in Alexandria, Virginia. Dr. Thompson’s presentation reviewed findings from Part A of a Phase 1 clinical study with IL-21 in patients with advanced metastatic melanoma and renal cell carcinoma. The primary purpose of the study was to determine a maximum tolerated dose of IL-21.
A total of 15 patients were treated in this portion of the study at five different dose levels. There were several important observations that support further study of IL-21 as an anti-cancer agent:
-- dose dependent activation of the immune system as measured by increases in soluble CD25 serum levels; -- side effects were generally mild to moderate in intensity with the most common effects constituting “flu-like” symptoms and rash, consistent with stimulation of the immune system; and -- evidence of anti-tumor activity, with 2 patients achieving partial response (PR) and 8 exhibiting stable disease.
Based on findings in Part A of the study, ZymoGenetics and the study investigators concluded that a dosing regimen consisting of 2 cycles of 30mcg/kg/day x 5 days separated by a 9-day rest interval would be appropriate for further study. Accordingly, ZymoGenetics is conducting Part B of the study to enroll up to 24 additional patients (12 patients each with metastatic melanoma and renal cell carcinoma). The Part B study will characterize the safety of this outpatient regimen and estimate overall response rate for each form of cancer. The company is also in the process of planning additional studies with IL-21.
The presentation slides will be available at www.zymogenetics.com in the “What’s New” section of the home page.
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.
Contact Investor Relations John Calhoun, MD, MBA Director, Corporate Communications & Investor Relations 206-442-6744 Media Relations Susan W. Specht, MBA Corporate Communications Manager 206-442-6592 Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Doug Williams, Ph.D. http://profnet.prnewswire.com/ud_public.jsp?userid=10007095
ZymoGenetics, Inc.
CONTACT: investors, John Calhoun, MD, MBA, Director, CorporateCommunications & Investor Relations, +1-206-442-6744, or media, Susan W.Specht, MBA, Corporate Communications Manager, +1-206-442-6592, both ofZymoGenetics, Inc.
Web site: http://www.zymogenetics.com/
