September 27, 2012--Dendreon Corporation (NASDAQ: DNDN) today announced the first patient enrollment and initiation of treatment for the sipuleucel-T European Union (EU) open-label study. The open-label study is being conducted in European men with metastatic castrate-resistant prostate cancer (mCRPC) to describe product release parameters and report on safety in a European population. The study may enroll up to 45 patients in four sites across the EU. Dendreon has submitted a marketing authorization application (MAA) for sipuleucel-T which is currently under review by the European Medicines Agency (EMA). Sipuleucel-T is not approved for use outside the U.S. Sipuleucel-T is approved by the Food and Drug Administration (FDA) in the U.S. for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. It is marketed under the name PROVENGE ®.
"We are extremely pleased with the progress of this new study and that the first patient has begun his treatment," said Thomas Powles MD, MRCP, Barts Cancer Institute, St. Bartholomew's Hospital, London. "We are also excited about the potential study outcomes and look forward to a successful program with the support of our committed clinical team and dedicated patients."
In addition to the current EU open-label study, the following data presentations are taking place at the ESMO 2012 Congress in Vienna, Austria, 28 September –2 October:
- Saturday, September 29, 13:00-14:00 CEST – Abstract #939P: “Neoadjuvant Sipuleucel-T in Localized Prostate Cancer: Effects on Immune Cells within the Prostate Tumor Microenvironment.” Poster presentation.
- Saturday, September 29, 13:00-14:00 CEST – Abstract #940P: “Overall Survival Benefit with Sipuleucel-T by Baseline PSA: An Exploratory Analysis from Three Phase 3 Trials.” Poster presentation.
- Saturday, September 29, 13:00-14:00 CEST – Abstract #941P: “Impact of Salvage Therapy with AC8015F on the Overall Survival Benefit Achieved with Sipuleucel-T in Three Phase III Studies of Metastatic Castrate-Resistant Prostate Cancer. Poster presentation.
- Saturday, September 29, 13:00-14:00 CEST – Abstract #943P: “OpenACT: Phase II, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (mCRPC).” Poster presentation.
- Saturday, September 29, 13:00-14:00 CEST – Abstract #942P: “Antigen Presenting Cell (APC) Activation in Sipuleucel-T: Is Activation Increased in Earlier Prostate Cancer Disease States?” Poster presentation.
Indication and Important Safety InformationApproved for use in the U.S. only.
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