News Release
Final Phase 2 Results for IL-21 in Renal Cell Cancer Show Tolerability and Enhanced Efficacy of Nexavar Combination
May 14, 2009
"We see encouraging anti-tumor activity with IL-21 combined with Nexavar. The ASCO abstract, available today, reports a 26 percent response rate in 2nd- or 3rd-line renal cell carcinoma patients," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "The final poster presentation will also include progression-free survival results. We believe the combination of IL-21 and Nexavar could be more effective than Nexavar alone."
The multi-center Phase 2 clinical trial was conducted at 14 sites in the U.S. and Canada and enrolled 33 patients. Efficacy endpoints included overall response rate and progression-free survival per RECIST (Response Evaluation Criteria In Solid Tumors). Response was assessed by the investigator and by independent radiologic review.
ASCO Poster
| Title: Phase II study of recombinant IL-21 (rIL-21) plus sorafenib as second- or third-line therapy for metastatic renal cell cancer (mRCC): Final results. |
| Abstract: 3023 |
| Presenter: Shailender Bhatia, MD, Medical Oncology, UWMC/FHCRC/SCCA |
| Date: Sunday, May 31, 2009 |
| Time: 2:00 PM - 6:00 PM |
| Presentation Order: 18 |
| Poster Board: 15 |
| Location: Level 3, W315A |
About Interleukin 21 (IL-21)
Despite the positive impact of targeted therapies on treatment for renal cell cancer, the efficacy of these agents appears to decrease beyond the first-line setting. There is an unmet need for novel therapies after failure of the targeted agents. IL-21, a cytokine that enhances CD8+ T cell and NK cell activity, has single-agent anti-tumor activity (J Clin Oncol 26:2034, 2008). ZymoGenetics has worldwide rights to IL-21 and is developing IL-21 for the treatment of renal cell carcinoma and metastatic melanoma.
About ZymoGenetics
ZymoGenetics creates novel protein drugs that help patients fight disease. The Company developed and markets RECOTHROM(R) Thrombin, topical (Recombinant). Other product candidates are focused on cancer, autoimmune and viral diseases. ZymoGenetics intends to commercialize 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 preclinical and clinical development, product sales and marketing abilities, discovery strategy, strategic partnering, 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, 2008, and subsequent Quarterly Report on Form 10-Q. 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.
Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.
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"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding ZymoGenetics Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.