Preliminary data from long-term Phase II STAND study to be presented
at 29th Annual European Association of Urology
(EAU) Congress
Company Website:
http://www.dendreon.com
SEATTLE -- (Business Wire)
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)
Contacts:
Dendreon Corporation
Lindsay Rocco, 862-596-1304
Corporate
Communications
media@dendreon.com
Source: Dendreon Corporation
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