Bavarian Nordic to Report New PROSTVAC® Clinical Data at the American Society of Clinical Oncology Annual Meeting
(Thomson Reuters ONE) -
KVISTGAARD, Denmark, May 18, 2012 - Bavarian Nordic A/S (OMX: BAVA) today
announced that new interim data from an ongoing, Phase 2 randomized trial of the
Company's PROSTVAC® therapeutic cancer vaccine when used in combination with
Quadramet® (samarium-153 EDTMP), a commercially available skeletal-targeted
radiopharmaceutical, will be presented as a poster during the 2012 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois on June
2, 2012.
Bavarian Nordic's PROSPECT, a single global, randomized, double-blind, placebo-
controlled Phase 3 study of PROSTVAC® in prostate cancer patients with
metastatic disease who have failed hormone therapy is also 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.
Abstract titles and presentation times are provided below.
* "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", abstract number 2526,
Poster Discussion Session, Developmental Therapeutics - Clinical
Pharmacology and Immunotherapy from 8:00 AM to 12:00 PM CT on Saturday June
2, 2012.
* "Prospect: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC®",
abstract number TPS4699, General Poster Session, Genitourinary Cancer from
8:00 AM to 12:00 PM CT on Sunday June 3, 2012.
Bavarian Nordic will also be hosting a PROSTVAC® update and reception 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
this next-generation prostate cancer vaccine. 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 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, and includes ten development programs. 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 clinical Phase 1 and Phase 2 trials, PROSTVAC® has been tested in
nearly 600 patients. 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
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 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 five NCI sponsored clinical Phase 1 and 2 studies in different
settings.
About the PROSPECT Phase 3 Program
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 http://www.continueyourfight.com
2012-05-18-uk:
http://hugin.info/100065/R/1613191/513655.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via Thomson Reuters ONE
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