ZymoGenetics (ZGEN)

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ZymoGenetics Presents Positive Interim Phase 1 Results for IL-21 in Combination with Rituxan(R) in B Cell Lymphoma
Monday December 10, 6:00 am ET
Good Safety Profile and Anti-Lymphoma Activity Observed

SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today presented interim results from a Phase 1 clinical trial of Interleukin 21 (IL-21) in combination with Rituxan® (rituximab) in patients with relapsed low-grade B Cell lymphoma at the American Society of Hematology (ASH) 2007 Annual Meeting. The Phase 1 study is part of a larger clinical program examining the use of IL-21 both as a single agent and in combination with approved cancer therapeutics.

“The Phase 1 data show that the combination of IL-21 with rituximab was well tolerated and resulted in anti-lymphoma activity,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “IL-21 may increase the ability of approved therapies like rituximab to target and kill cancer cells.”

The ASH poster presentation, “Recombinant Interleukin-21 Plus Rituximab: Clinical Activity in a Phase 1, Dose-Finding Trial in Relapsed Low-Grade B Cell Lymphoma,” reviewed results from 15 subjects from the two-part open label multi-center study. Part 1 of the study included 9 patients and consisted of dose-escalation portion to identify a dose of IL-21 that can be safely combined with rituximab. Part 2 of the study is evaluating the safety and anti-tumor effects of the combination in an expanded cohort of 12 additional patients to be treated at the dose identified in Part 1. Results from 6 subjects in Part 2 were reported at ASH.

The study evaluated three dose levels of IL-21 (30, 100 and 150 mcg/kg), given intravenously once per week in combination with a standard dose of rituximab (375 mg/m2) for four weeks. While no dose limiting toxicities were seen at any dose level, a dose of 100 mcg/kg of IL-21 in combination with rituximab was selected for cohort expansion as re-treatment at 150 mcg/kg was associated with increased toxicity. The majority of adverse events and lab abnormalities at all dose levels were Grade 1 or 2 and included flu-like symptoms, headache, fatigue and nausea. One subject with a prior history of cardiac disease who experienced chest pain during the study died of complications after a stenting procedure and was not evaluable for response. Evidence of anti-tumor activity was seen in this heavily pretreated group of patients, most of whom had previously received rituximab. Best response during the study, per investigator assessment, included 2 complete responses, 4 partial responses, 7 stable disease and 1 progressive disease. Final data from the study will provide more information about the overall safety and anti-tumor effects of this combination therapy.
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