- Patient enrollment to begin in fourth quarter -
SEATTLE, Oct. 4 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (Nasdaq: ZGEN) today announced that, together with its collaborator Merck Serono, it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) to conduct a pivotal clinical trial with the investigational new drug atacicept for the treatment of patients with lupus nephritis. This is one of two clinical studies intended to form part of the application for marketing authorization.
The randomized, double-blind placebo-controlled multi-center clinical trial will be conducted at sites in North America, Europe, Latin America, and Asia. Approximately 200 patients with active lupus nephritis will be enrolled in this trial, aimed at demonstrating the efficacy and safety of atacicept as compared to placebo.
"Together with Merck Serono, we concluded that an SPA provided the clearest path to ensure that this trial will support the application for atacicept marketing authorization," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer. "We're pleased to have reached agreement with the FDA about the design of this study and plan to begin enrolling patients in the fourth quarter of 2007."
In the SPA process, the FDA evaluates the design of clinical trials intended to form the basis of an efficacy claim to support a new drug application. The SPA provides a binding agreement between the FDA and a company that the study design, trial size, endpoints and data analyses plan, are acceptable to the FDA and are adequate to support a license application for marketing in the U.S.
ZymoGenetics and Merck Serono are developing atacicept as a potential
treatment for autoimmune diseases and B-cell malignancies. Merck Serono is
the study sponsor, however ZymoGenetics will operationally conduct the
lupus nephritis study. The companies plan to conduct a second study in
|SOURCE ZymoGenetics, Inc.|
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