SEATTLE, March 3 /PRNewswire-FirstCall/-- Dendreon Corporation (Nasdaq: DNDN) announced the publication of a manuscript titled, "CD54 is a surrogate marker of antigen presenting cell activation" in Cancer Immunology, Immunotherapy.
The manuscript describes and supports the use of CD54 as a surrogate marker of antigen presenting cell activation (APC) activation and validates its utility as a potency measure of PROVENGE(R) (sipuleucel-T). In particular, it describes how Dendreon researchers used CD54 and the upregulation of its expression on antigen presenting cells (APC) as a means by which human APC activation could be assessed and most importantly, how such measurements could be used to determine the potency of PROVENGE before its administration to patients with prostate cancer. The assessment of product potency is a key release measure required by the U.S. Food and Drug Administration (FDA).
The upregulation of CD54 has been used as part of the potency assay for PROVENGE since the initiation of the PROVENGE clinical development program. Data correlating CD54 upregulation to overall survival in patients from two Phase 3 trials, D9901 and D9902A have been presented at recent scientific meetings and at the FDA Cell Tissue and Gene Therapy Advisory Committee Meeting on March 29, 2007.
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In clinical studies, patients typically received three doses of PROVENGE over a one-month period as a complete course of therapy.
Dendreon Corporation is a biotechnology company whose mission is to
target cancer and transform lives through the discovery, development and
commercialization of novel therapeutics that
|SOURCE Dendreon Corporation|
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