ZymoGenetics Reports Positive Phase 1 Results for IL-21 With ... (

ZymoGenetics Reports Positive Phase 1 Results for IL-21 With Nexavar(R)

Date:10/23/2007

- Interim data shows promise as a potential treatment for kidney cancer -

SEATTLE, Oct. 23 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (Nasdaq: ZGEN) today presented positive Phase 1 interim data from a Phase 1/2 trial of Interleukin 21 (IL-21) in combination with Nexavar(R) (sorafenib) in patients with renal cell cancer. Preliminary data from the Phase 1 trial suggests that the combination of IL-21 and sorafenib is well tolerated, with a toxicity profile similar to known toxicities of each agent alone. This combination therapy has also shown promising anti-tumor activity.

"IL-21's unique mechanism of action makes it an ideal potential candidate for combination with approved targeted agents in renal cell cancer," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "We were very pleased to see that the combination of IL-21 and Nexavar can be safely administered for repeated courses, and that the majority of patients treated to date experience tumor shrinkage. The Phase 2 part of this trial should allow us to confirm these promising results."

Results were presented at the AACR-NCI-EORTC International Conference on "Molecular Targets and Cancer Therapeutics" held in San Francisco. ZymoGenetics is in the process of finishing the Phase 1 part of the study evaluating the combination therapy in patients with clear cell histology, which accounts for 85% of all renal cell tumors. The Phase 2 portion of the study is expected to begin before year end and will examine a larger patient group treated with the maximum tolerated dose of IL-21.

To date, a total of 13 evaluable patients have been enrolled in the Phase 1 portion of the study and treated at one of three dose levels (10, 30 and 50 mcg/kg of IL-21). Treatment consists of IL-21 administered IV on days 1-5 and 15-19 of a 6 week treatment course in combination with sorafenib administered at the recommended dose of 400 mg twice a day. Patients with Stable D
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SOURCE ZymoGenetics, Inc.
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ZymoGenetics Reports Positive Phase 1 Results for IL-21 With ...( - Interim data shows promise as a po...),Health