Interim Analysis for Bavarian Nordic's Phase 2 PROSTVAC® Trial Presented at Annual ASCO Meeting
(Thomson Reuters ONE) -
KVISTGAARD, Denmark, June 2, 2012 - Bavarian Nordic A/S (OMX: BAVA) today
announces new interim data from an ongoing, Phase 2 randomized trial of the
Company's PROSTVAC® therapeutic prostate cancer vaccine being conducted by the
National Cancer Institute (NCI). This trial is evaluating PROSTVAC® when used in
combination with Quadramet® (samarium-153 EDTMP, or Sm-153), a commercially
available skeletal-targeted radiopharmaceutical. The interim data will be
presented as a poster during the 2012 American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago, Illinois.
According to the investigators from NCI, this interim analysis suggests that the
combination of PROSTVAC® and Sm-153 in patients with metastatic castration-
resistant prostate cancer (mCRPC) is well tolerated with similar toxicity
profile to Sm-153 alone. The early indication of improved time-to-tumor
progression (TTP) warrants continued study accrual.
"A randomized, placebo-controlled Phase 2 study of PROSTVAC® reported an 8.5-
month improvement in median overall survival in men with metastatic, castrate
resistant prostate cancer. Based upon these encouraging results, we recently
initiated our pivotal, global Phase 3 clinical study, PROSPECT," stated Anders
Hedegaard, President & CEO of Bavarian Nordic. "To learn more about the
potential usefulness of PROSTVAC® in other settings, PROSTVAC® is being studied
by the National Cancer Institute in combination with Sm-153, and we are
encouraged by these interim results," he added.
This Phase 2 multi-center trial is intended to randomize 68 patients to Sm-153
alone (Arm A) or with PROSTVAC® (Arm B). Of 37 patients enrolled to date, 3 were
not evaluable for progression-free survival (PFS). At four months, the PFS for
evaluable patients in Arm A was 11.8% compared to 29.4% in Arm B. Median PFS for
patients in Arm A was 60 days compared to 117 days in Arm B. The most common
side effects were grade 3 or 4 thrombocytopenia occurring in 22% and 26% of
treatment cycles on Arms A and B, respectively. "Interim analysis of a phase 2
randomized clinical trial of Samarium-153 (Sm-153) with or without PSA-TRICOM
vaccine in metastatic castration resistant prostate cancer (mCRPC) after
docetaxel" by Gulley, J. et al. (Abstract No. 2526, Poster Discussion Session,
Developmental Therapeutics - Clinical Pharmacology and Immunotherapy, 8:00 AM to
12:00 PM CT, Saturday June 2, 2012.)
On Sunday, June 3, 2012, Bavarian Nordic's PROSPECT clinical trial, a global,
randomized, double-blind, placebo-controlled Phase 3 trial of PROSTVAC® in
prostate cancer patients with asymptomatic or minimally symptomatic, castrate-
resistant, metastatic disease will be the subject of a "Trials in Progress"
abstract, which is designed to provide an opportunity for members of the
research community to present ongoing trials, foster collaboration, and discuss
correlatives and novel trial designs. "Prospect: A Randomized, Double-blind,
Phase 3 Efficacy Trial of PROSTVAC®" by Olga Bandman (Abstract No. TPS4699,
General Poster Session, Genitourinary Cancer, 8:00 AM to 12:00 PM CT, Sunday
June 3, 2012.
The abstracts can be accessed through the ASCO website, www.asco.org.
Bavarian Nordic also will be hosting a PROSTVAC® clinical update and reception
for investors on Monday, June 4, 2012 in Chicago, Illinois. The principal
investigators for the PROSPECT trial, 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 be joined by members of the Company's
senior management team to discuss plans for the ongoing clinical development of
PROSTVAC®. To register for this event, or for more information, please contact
Mette Buhl of Bavarian Nordic via email at mette.buhl(at)bavarian-nordic.com or by
phone at +45 33 28 83 00.
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
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 2012. With an
estimated more than 100,000 deaths in 2012, 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 a prime-boost vaccine that sequentially combines two different
poxviruses (vaccinia and fowlpox). Administered subcutaneously, it is designed
to induce a specific, targeted immune response that attacks prostate cancer
cells. In clinical studies to date, the most common side effects of PROSTVAC®
were injection site reactions and fatigue.
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 20 ongoing and completed
clinical trials involving more than 2,000 patients.
In April 2010, PROSTVAC® was granted Fast Track designation by the FDA for the
treatment of men with mCRPC.
About the PROSPECT Phase 3 Clinical Trial
This global, randomized, double-blind, placebo-controlled Phase 3 trial of
PROSTVAC® in men with asymptomatic or minimally symptomatic castrate-resistant,
metastatic prostate cancer (mCRPC) 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 are castrate resistant may 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
http://www.continueyourfight.com
About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and
producing novel vaccines for the treatment and prevention of life-threatening
diseases with a large unmet medical need. The company's pipeline targets cancer
and infectious diseases. In oncology, the company's lead program is PROSTVAC®, a
therapeutic vaccine candidate for advanced prostate cancer that is the subject
of an ongoing pivotal Phase 3 trial and is being developed under a collaboration
agreement with the National Cancer Institute. In infectious diseases, the
company's lead program is IMVAMUNE®, a third-generation smallpox vaccine
candidate that is being developed and supplied for emergency use to the U.S.
Strategic National Stockpile under a contract with the U.S. Government. For more
information, visit www.bavarian-nordic.com.
Forward-looking statements
This announcement includes "forward-looking statements" that involve risks,
uncertainties and other factors, many of which are outside of our control that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. We undertake no obligation to
publicly update or revise forward-looking statements to reflect subsequent
events or circumstances after the date made, except as required by law.
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Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1616939]
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Datum: 02.06.2012 - 15:01 Uhr
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