ZymoGenetics has begun a phase I clinical trial using its investigational anticancer drug IL-21 in combination with Genentech and Biogen Idec's monoclonal antibody Rituxan in patients with advanced non-Hodgkin's lymphoma.
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According to the company, preclinical research into this combination offers compelling evidence for entering clinical trials, largely because IL-21 (Interleukin 21) appears to enhance a principal mechanism by which Rituxan is thought to work.
In the multi-center trial 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.
“We believe IL-21 in combination with Rituxan could offer an improvement over current therapies because in preclinical studies, IL-21 enhanced natural killer cell activity and improved monoclonal antibody anti-tumor activity,” said Dr Bruce Carter, president and CEO of ZymoGenetics.
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.
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