Preliminary data from long-term Phase II STAND
study to be presented at 29th Annual European Association of
Urology (EAU) Congress
April 11, 2014 – Dendreon Corporation (NASDAQ:DNDN) today
announced the presentation of preliminary data from a long-term
analysis of the Phase II STAND study demonstrating that
tumor-specific T-cell responses appear to be enhanced and sustained
when PROVENGE® (sipuleucel-T) is given after androgen deprivation
therapy (ADT) in patients with biochemically-recurrent prostate
cancer (BRPC) at high risk for metastases. These data will be
presented at the 29th Annual European Association of Urology (EAU)
Congress taking place from April 11-15, 2014 in Stockholm,
Sweden.1
“We are pleased with the preliminary STAND data, which show the
continued potential for sequencing PROVENGE with other treatments
and the impact that immunotherapy has on immune responses in
advanced prostate cancer patients,” said Andrew S. Sandler, M.D.,
executive vice president and chief medical officer at Dendreon.
“The presentation of these data at EAU highlights Dendreon’s
commitment to expanding awareness and understanding of
immunotherapy and PROVENGE in Europe as we prepare to make PROVENGE
available to advanced prostate cancer patients beyond the United
States.”
ADT is a standard treatment option for men with BRPC after
failure of local therapy. The STAND study is a randomized, Phase II
trial that consisted of two patient study groups, one completing
PROVENGE two weeks before ADT and the second receiving PROVENGE
three months after the start of ADT. Preliminary results suggest
enhanced cellular immune responses when PROVENGE was given after
ADT, and these responses were persistent for at least 12 months and
robust in both patient groups.
“The STAND study results are encouraging as they provide
additional evidence on how sipuleucel-T can be sequenced with other
treatments which will assist clinician decision-making upon whether
immune responses correlate with certain clinical parameters, such
as prostate specific antigen (PSA) recurrence,” said Neal Shore,
M.D., medical director at the Carolina Urologic Research
Center.
PROVENGE is approved in all 28 countries of the European Union
(EU) as well as Norway, Iceland and Liechtenstein for the
treatment of asymptomatic or minimally symptomatic metastatic
(non-visceral) castrate resistant prostate cancer in male adults in
whom chemotherapy is not yet clinically indicated. Dendreon plans
to make PROVENGE commercially available in Europe, beginning with
Germany and the United Kingdom, through Centers of Excellence.
Important Safety Information for PROVENGE
PROVENGE is intended solely for autologous use and should under
no circumstances be administered to other patients.
The safety evaluation of PROVENGE was based on data from 601
prostate cancer patients in four randomized clinical trials and
post-marketing surveillance.
PROVENGE should be delayed in patients with active systemic
infection until resolution and used with caution in patients with a
history of embolic and thrombotic events, including cerebrovascular
disease and cardiovascular disorders.
Serious adverse reactions reported include acute infusion
reactions (occurring within 1 day of infusion), catheter sepsis,
staphylococcal bacteremia, myocardial infarction and
cerebrovascular events.
The most commonly reported adverse reactions were chills,
fatigue, pyrexia (fever), nausea, arthralgia (joint ache),
headache, and vomiting.
About Dendreon
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 U.S. Food and Drug Administration (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/.
Statements in this press release that are not strictly
historical in nature constitute "forward-looking
statements." Such statements include, but are not limited to,
statements regarding the expected benefits of the recent and prior
restructurings, the timing and elements of the restructurings, the
timing and form of related charges, the expected annual operating
expense reductions, expectations and beliefs
regarding Dendreon's financial position, profitability
and Dendreon's ability to break even and achieve improved
performance as a result of the restructurings, statements regarding
sequencing studies, statements regarding studies to advance
understanding of immunotherapy and the treatment of advanced
prostate cancer, statements regarding biomarkers, expectations
about automation or the early detection study, expectations about
advancing our pipeline, expectations regarding reductions of cost
of goods sold, expectations regarding reimbursement approvals of
PROVENGE® in Europe or Dendreon's ability to launch and
commercialize PROVENGE in Europe, expectations regarding the
presentation of clinical data, developments
affecting Dendreon's U.S. and global business and
prospects, beliefs and expectations regarding potential revenue and
earnings from product sales, including beliefs
regarding Dendreon's ability to grow sales, expectations
regarding market size, target market, and market opportunity,
beliefs regarding the impact of our direct to consumer advertising,
expectations with respect to our sales force execution and
effectiveness, progress generally on commercialization efforts for
PROVENGE, and expectations about clinical trial enrollments. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors which may
cause Dendreon's actual results to be materially
different from historical results or from any results expressed or
implied by such forward-looking statements. These factors
include, but are not limited to, our inability to achieve and
sustain commercial success for PROVENGE; the identification of
efficacy, safety or other issues with PROVENGE; a slower than
anticipated adoption by treating physicians of PROVENGE for the
treatment of patients with advanced prostate cancer for a variety
of reasons, including competing therapies, instability in our
sales force, the risk that we cannot replace vacant sales positions
on a prompt basis, perceived difficulties in the treatment process,
delays in obtaining reimbursement or for other reasons; any
promotional limitations imposed by the FDA or the EU on
our ability to commercialize and market PROVENGE; unexpected
difficulties and costs associated with the rapid expansion of our
commercial operations to support the commercial launch of PROVENGE;
the impact of competing therapies on sales of PROVENGE, the failure
to achieve reimbursement approvals in Europe, manufacturing or
quality difficulties, the dilution or other effects resulting from
capital raising or debt restructuring transactions, disruptions or
delays and other factors discussed in the "Risk Factors" section of
Dendreon's Annual Report on Form 10-K for the year
ended December 31, 2013. All forward-looking statements are
qualified in their entirety by this cautionary
statement. Dendreon is providing this information as of
the date of this press release and does not undertake any
obligation to update any forward-looking statements contained in
this release as a result of new information, future events or
otherwise.
1 Results of this analysis from the randomized, open-label Phase
II study will be presented as follows: A randomized phase II study
evaluating the optimal sequencing of sipuleucel-T and androgen
deprivation therapy (ADT) in biochemically-recurrent prostate
cancer (BRPC): Immune results with a focus on humoral responses.
April 14, 14:00 – 15:30 CET, Androgen deprivation therapy, still
work to be done (Poster Session 79, Room A8)
Dendreon CorporationLindsay Rocco, 862-596-1304Corporate
Communicationsmedia@dendreon.com