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Dendreon Announces Presentation of PROVENGE Data at the 2011 Genitourinary Cancers Symposium Annual Meeting
Date:2/17/2011

s who did not receive APC8015F (HR=0.52 [95% CI: 0.37, 0.73]; P=0.0001).  While baseline prognostic factors tended to be more favorable in patients who received APC8015F, treatment with APC8015F remained associated with improved survival after adjusting for these factors (HR=0.55 [95% CI: 0.39, 0.78]; P<0.001).  The safety profile of APC8015F was consistent with that observed in the PROVENGE Phase 3 clinical trials.

Abstract #155: Characterization of Antigen-Specific T cell Activation and Cytokine Expression Induced by Sipuleucel-T

In PROVENGE (sipuleucel-T) Phase 2 and 3 clinical trials, patients underwent leukaphereses to collect peripheral blood mononuclear cells (PBMCs).  For the patients randomized to receive sipuleucel-T, the patient's PBMCs were cultured with PA2024, a recombinant fusion protein consisting of prostatic acid phosphatase (PAP) and granulocyte-macrophage colony-stimulating factor (GM-CSF), to generate the treatment (sipuleucel-T), which is then infused into the patient.

This presentation examined the role of GM-CSF in T cell activation and cytokine production in patients in the sipuleucel-T Phase 2 and 3 clinical trials (P07-2 ProACT and D9902B IMPACT).  For this analysis, a portion of PBMCs from each leukapheresis were cultured with GM-CSF and compared to sipuleucel-T (PBMCs cultured with PA2024) to evaluate T cell activation, cytokine production, and upregulation of the costimulatory molecules, CD54 and CD86.

The study showed a statistically significant increase in the production of a number of cytokines, including IL-2 (P<0.0001) and IFNγ (P=0.0019), from cells cultured with PA2024 compared to those cultured with GM-CSF.  Furthermore, CD54 upregulation was enhanced at week 2 in response to PA2024 but not GM-CSF.  The increased T cell activation and enhanced cytokine expression which occurred after the first infusion of sipuleucel-T also appeared to be PA2024-specific
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