ZymoGenetics (ZGEN) Announces Promising Preliminary Results from Phase 2 Study of IL-21

May 13, 2009 8:45 AM EDT

ZymoGenetics, Inc. (NASDAQ: ZGEN) today announced that Interleukin 21 (IL-21) demonstrated an impressive overall response rate in the treatment of metastatic melanoma. In interim Phase 2 results from 24 patients, 29 percent showed a partial response, with an additional 33 percent of patients showing stable disease in this difficult to treat disease.

Results from the Phase 2 clinical trial in patients with metastatic melanoma were presented at the World Congress on Melanoma meeting in Vienna, Austria. The single-agent multi-center clinical trial is being conducted by the NCIC Clinical Trials Group in Canada and is evaluating three dosing regimens of IL-21 in patients with no prior systemic therapy for metastatic melanoma. The primary endpoint is efficacy, as measured by objective response or lack of early disease progression.

To date 7 of the 24 patients (29%) had a partial response (5 confirmed by RECIST criteria). Eight patients (33%) had stable disease. The most common adverse events were mild or moderate fatigue and rash.

Two schedules testing 50 mcg/kg were evaluated in a total of 10 patients but were poorly tolerated due to adverse events including neutropenia and skin rash. The trial will be completed with a full cohort of 30 patients to be treated at the 30 mcg/kg dose, which is tolerable for outpatient dosing and active as assessed by tumor response.

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