ZymoGenetics Begins Phase 1/2 Clinical Trial With IL-21 And Nexavar In Patients With Renal Cell Cancer

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 18 Oct 2006 - 0:00 PDT

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ZymoGenetics, Inc. (Nasdaq: ZGEN) today announced the start of a Phase 1/2 clinical study of Interleukin 21 (IL-21) in combination with Nexavar(R) (sorafenib) in patients with advanced renal cell cancer. The study will evaluate the safety and preliminary anti-tumor activity of IL-21 in combination with Nexavar.

"Our preclinical data have demonstrated that IL-21 can be additive, or even synergistic, when used in combination with Nexavar and other tyrosine kinase inhibitors," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "This study will be the first step to demonstrate whether the combination of IL-21 with approved cancer therapies for solid tumors can improve patient outcomes."

The open-label, dose-escalation multi-center U.S. trial is expected to enroll 48 patients with metastatic stage IV renal cell cancer. The Phase 1 part of the study will establish the maximum tolerated dose of IL-21 given for one treatment course, consisting of two 5-day cycles of IL-21 in combination with a standard dose of Nexavar administered over a 6-week period. The Phase 2 part of the study will further evaluate the safety and preliminary anti-tumor activity of IL-21 at the dose established in Phase 1 in combination with Nexavar.

Because tyrosine kinase inhibitors (TKIs) such as Nexavar and Sutent inhibit the growth of tumor cells, and IL-21 activates the immune system to target killing of tumor cells, the two therapies may provide additive or synergistic effects. Treatment with a TKI may make cancer cells more sensitive to natural killer or T cell mediated killing after activation with IL-21. Preclinical research conducted by ZymoGenetics of TKIs and IL-21 found that IL-21 had additive anti-tumor effects when combined with a TKI in a renal cell cancer model. These preclinical results will be presented at upcoming oncology meetings in October and November of this year.

About Interleukin 21 (IL-21)

IL-21 has potent biological activity in regulating key classes of immune cells, including cytotoxic T cells and natural killer cells. These cell types play key roles in surveillance of the body to eliminate malignant and infected cells. Based upon the ability of IL-21 to inhibit tumor growth in a number of animal models, ZymoGenetics is developing IL-21 for the treatment of cancer, initially in metastatic melanoma and renal cell carcinoma, and has retained commercialization rights for IL-21 in North America. The company licensed commercialization rights outside of North America to Novo Nordisk A/S.

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 http://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.

ZymoGenetics, Inc
http://www.zymogenetics.com

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