First Patient In Dendreon EU Open-Label Study Begins Sipuleucel-T Infusion Treatment
Sipuleucel-T Data To Be Presented At The ESMO 2012 Congress (European
Society for Medical Oncology)
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
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
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
Indication and Important Safety Information
Approved for use in the U.S. only.
PROVENGE® (sipuleucel-T) is an autologous cellular
immunotherapy indicated for the treatment of asymptomatic or minimally
symptomatic metastatic castrate resistant (hormone refractory) prostate
PROVENGE is intended solely for autologous use and is not routinely
tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer
patients in four randomized clinical trials who underwent at least one
leukapheresis. The most common adverse events (incidence greater-than or
equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache,
and headache. Serious adverse events reported in the PROVENGE group
include acute infusion reactions (occurring within 1 day of infusion)
and cerebrovascular events. In controlled clinical trials, severe (Grade
3) acute infusion reactions were reported in 3.5% of patients in the
PROVENGE group. Reactions included chills, fever, fatigue, asthenia,
dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension,
muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion
reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's
ongoing commitment to patients, Dendreon will conduct a registry of
approximately 1500 patients to further evaluate a small potential safety
signal of cerebrovascular events. In four randomized clinical trials of
PROVENGE in prostate cancer patients, cerebrovascular events were
observed in 3.5% of patients in the PROVENGE group compared with 2.6% of
patients in the control group.
For the FDA approved full prescribing information, please visit http://www.provenge.com.
Dendreon Corporation is a biotechnology company whose mission is to
target cancer and transform lives through the discovery, development,
commercialization and manufacturing of novel therapeutics. The Company
applies its expertise in antigen identification, engineering and cell
processing to produce active cellular immunotherapy (ACI) product
candidates designed to stimulate an immune response in a variety of
tumor types. Dendreon's first product, PROVENGE®
(sipuleucel-T), was approved by the FDA in April 2010. Dendreon is
exploring the application of additional ACI product candidates and small
molecules for the potential treatment of a variety of cancers. The
Company is headquartered in Seattle, Washington and is traded on
the NASDAQ Global Market under the symbol DNDN. For more information
about the Company and its programs, visit http://www.dendreon.com.
Source: Dendreon Corporation
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