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ZymoGenetics Reports Positive Phase 1 Results for IL-21 With Nexavar(R)
Date:10/23/2007

isease or better per RECIST are eligible to receive repeat treatment.

Overall, the majority of adverse events and lab abnormalities have been mild to moderate and consistent with the known safety profiles of IL-21 and sorafenib. Dose limiting toxicities consisting of skin-related events have occurred in a total of two patients, including one in the 10 mcg/kg cohort (hand-foot syndrome), and one in the 50 mcg/kg cohort (rash).

11 patients have completed at least one 6-week treatment course, all of whom have gone on to receive repeat treatment, which has not been associated with increased toxicity. 10 of these 11 patients have had measurable disease per RECIST criteria, and all 10 have had a decrease in tumor mass as their best response on study, ranging from 18 to 33% per investigator assessment. Four patients had unconfirmed Partial Responses, with at least 30% decrease in tumor measurements per investigator assessment and 3 of these are still on treatment. Of the 11 patients who finished the first treatment course, nine continue to receive therapy on study, and two patients discontinued therapy due to disease progression.

Renal Cell Cancer

There will be an estimated 51,190 new cases of renal cell carcinoma in the U.S. in 2007. It is estimated that renal cell carcinoma will result in approximately 19,600 deaths in the U.S. in 2007. Renal cell carcinoma accounts for approximately 2% of cancers worldwide. There is a clear need for new and improved therapies for renal cell cancer.

IL-21 in Combination with Tyrosine Kinase Inhibitors

Because tyrosine kinase inhibitors (TKIs) such as Nexavar and Sutent(R) 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
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SOURCE ZymoGenetics, Inc.
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