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ZymoGenetics begins phase 1 trial with IL-21 and Rituxan in non-Hodgkin's lymphoma patients
By E. Janene Geiss
Philadelphia, July 12 - ZymoGenetics, Inc. said Wednesday that a phase 1 clinical trial is underway using Interleukin 21 (IL-21) in combination with the monoclonal antibody Rituxan.
The open label dose-escalation trial is enrolling patients with advanced non-Hodgkin's lymphoma in a multi-site study conducted in the United States, according to a company news release.
Patients will be treated with Rituxan and IL-21 once weekly for four weeks. Responding patients will be offered the combination regimen for four additional weeks, officials said.
The primary objective of the study is to evaluate the safety and tolerability of IL-21 when administered with Rituxan. Secondary objectives are to characterize the pharmacokinetics, immunogenicity and preliminary evidence of tumor activity of this combination, officials said.
Preclinical research into this combination offers compelling evidence for entering clinical trials, largely because IL-21 appears to enhance a principal mechanism by which Rituxan is thought to work, officials said.
At a recent medical conference, ZymoGenetics presented the results of preclinical research on IL-21's ability to enhance Rituxan-mediated killing of B-lymphoma cell lines.
In these studies, after 90 days of follow-up, a combination of IL-21 plus low-dose Rituxan enabled survival of 70% of mice injected with an aggressive non-Hodgkin's lymphoma cell line, compared with only 10% that were treated with the same dose of Rituxan alone, and none that were treated with IL-21 alone.
ZymoGenetics is developing IL-21 for the treatment of cancer and has retained commercialization rights for IL-21 in North America. The company has licensed commercialization rights outside of North America to Novo Nordisk A/S, officials said.
ZymoGenetics is a Seattle biopharmaceutical company.
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