Bavarian Nordic Initiates Pivotal Phase 3 Trial of PROSTVAC® Prostate Cancer Immunotherapy
15 November 2011
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Kvistgaard, Denmark - November 15, 2011 - Bavarian Nordic A/S
(OMX: BAVA) today announced that its subsidiary, BN
ImmunoTherapeutics has initiated the pivotal Phase 3 trial of
PROSTVAC® for patients with asymptomatic or minimally
symptomatic metastatic castration-resistant prostate cancer. The
trial is being conducted under a Special Protocol Assessment
agreement with the FDA.
The first site in the U.S. has opened for enrolment of patients
into the study, with a number of other sites and countries to
follow soon.
"The trial represents the first-ever Phase 3 study in the
history of Bavarian Nordic, and we are extremely proud to have
achieved this significant milestone in our cancer vaccine division
in our efforts to advance novel vaccines for the treatment of
cancer," stated Anders Hedegaard, President & CEO of Bavarian
Nordic. "We are encouraged by the results we have seen to date with
PROSTVAC® and hope that this product may provide a more
effective and convenient therapy for patients with prostate
cancer."
PROSTVAC® is an "off-the-shelf" therapeutic vaccine
candidate that has the potential to extend the lives of people with
advanced prostate cancer. Administered subcutaneously, it induces a
specific, targeted immune response that attacks prostate cancer
cells.
James L. Gulley, M.D., Ph.D., Director of the Clinical Trials
Group at the Laboratory of Tumor Immunology and Biology at the
National Cancer Institute (NCI), and Philip Kantoff M.D., Professor
of Medicine at Harvard Medical School, will act as principal
investigators on the trial.
According to Dr. Gulley, the Phase 2 clinical trial data of
PROSTVAC® demonstrated a very promising 44% reduction in the
rate of death with an 8.5 month improvement in median overall
survival, a level of clinical benefit that compares favorably to
other currently approved agents for advanced prostate cancer. Dr.
Gulley hopes to confirm this improvement in survival in the
trial.
About the Phase 3 trial
The single global, randomized, double-blind, placebo-controlled
Phase 3 study is based on the promising findings from a previous
randomized, placebo-controlled Phase 2 trial of the vaccine in 125
patients with advanced prostate cancer and is expected to enrol
about 1,200 patients in three study arms. Patients in the two
active study arms will receive either PROSTVAC® alone or
PROSTVAC® with adjuvant doses of GM-CSF. Patients who have
metastatic disease and have failed hormone therapy will be eligible
to enrol in the study. The primary endpoint is overall survival
(OS). For the study outcome to be positive, either one or both of
the treatment arms must be superior to placebo. About 300 clinical
trial centers in more than 20 countries are expected to participate
in the trial. Patient enrolment in the trial is expected to take up
to twenty-four months.
For more information about the trial, visit: /prostvac.
About Prostate Cancer
Prostate cancer is the most frequently diagnosed cancer in men.
The disease affects approximately one in six men and an estimated
600,000 new cases of prostate cancer are expected in the U.S. and
Europe during 2011. With an estimated more than 100,000 deaths in
2011, prostate cancer is also the second-leading cause of cancer
death in men. Approximately 4 million men are living in the U.S.
and Europe today who have been diagnosed with prostate cancer.
Sources: American Cancer Society and Evaluate Pharma.
About PROSTVAC®
PROSTVAC® is an "off-the-shelf" prime-boost vaccine that
sequentially combines two different poxviruses (vaccinia and
fowlpox). Administered subcutaneously, it induces a specific,
targeted immune response that attacks prostate cancer cells.
Conventional chemotherapy currently used to treat prostate cancer
has shown limited improvement in OS and is often associated with
serious side effects. In contrast, PROSTVAC® has the potential
to extend survival with minimal toxicity.
In a large, prospective randomized, double-blind,
placebo-controlled Phase 2 study of 125 patients with metastatic
prostate cancer, patients in the PROSTVAC® group had a
significantly longer median overall survival by 8.5 months compared
to the control group (p=0.006). The hazard ratio estimate for
overall survival from the study is 0.56 (95% CI 0.37-0.85).
PROSTVAC® is being developed in collaboration with the
National Cancer Institute under a Cooperative Research and
Development Agreement with Bavarian Nordic's U.S.-based subsidiary,
BN ImmunoTherapeutics. To date, PROSTVAC® and related PSA
containing poxviral vaccines have been investigated in 19 ongoing
and completed clinical trials involving more than 850 patients.
PROSTVAC® is currently the subject of six NCI sponsored
clinical Phase 1 and 2 studies in different settings.
In April 2010, PROSTVAC® was granted Fast Track designation
by the FDA for the treatment of men with asymptomatic or minimally
symptomatic metastatic castration-resistant prostate cancer
(mCRPC).
About Poxviruses and Immunotherapy
Although increased expression of tumor associated antigens, such
as prostate-specific antigen (PSA), is associated with advanced
disease these they do not sufficiently activate the immune system
to attack cancer cells. To overcome this poor responsiveness,
recombinant poxvirus vectors, including vaccinia, fowlpox and
modified vaccinia Ankara (MVA), can be genetically engineered to
express one or more tumor-associated antigens to greatly enhance
the immune system's ability to recognize and destroy cancer cells
bearing any of the targeted antigens. Bavarian Nordic's vaccine
candidates containing vaccinia and fowlpox have been the subject of
over 30 clinical trials in more than 1,000 patients with prostate,
breast, lung, colorectal, gastric, pancreatic, ovarian, and other
cancers. These extensive clinical studies suggest a favorable
safety and tolerability profile along with immunologic responses
directed against the relevant tumor-associated antigens.
Contact:
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64
