PROSTVAC® and Ipilimumab Phase 1 Study Supports Rationale for Combining Two Immunotherapies for Prostate Cancer
(Thomson Reuters ONE) -
KVISTGAARD, Denmark, February 23, 2012 - Bavarian Nordic A/S (OMX: BAVA)
announced today that a newly published study suggests potential synergy of the
Company's PROSTVAC(®) investigational therapeutic cancer vaccine when used in
combination with ipilimumab, another immune therapy. Results of the Phase 1
dose escalation study were published in the journal The Lancet Oncology. The
scientific findings of this Phase 1 potentially provide proof of concept that
the combination of an immune checkpoint inhibitor with a therapeutic cancer
vaccine is feasible and might enhance the clinical efficacy of the combination
treatment. Several other NCI-funded combination studies with PROSTVAC(®) are
currently ongoing.
According to 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), stated in the paper that although the Phase 1 trial was small
and non-randomized, the median overall survival of 34.4 months for the 30
patients treated raises the possibility that the combination ipilimumab and
PROSTVAC(®) might result in prolonged overall survival.
"In a randomized placebo-controlled Phase 2 study, PROSTVAC(®) demonstrated an
8.5-month improvement in median overall survival, in men with mCRPC. 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 further enhance the potential efficacy of PROSTVAC(®), we studied
PROSTVAC(®) in combination with ipilimumab and are encouraged by the observed
safety and efficacy profile of the immunotherapeutic combination."
Asger Aamund
Chairman of the Board
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About PROSTVAC(®)
PROSTVAC(®) is an investigational therapeutic cancer vaccine, subcutaneously
administrated in a prime-boost schedule to sequentially combine two different
poxviruses (vaccinia and fowlpox). PROSTVAC(®) induces a PSA-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.
About the PROSPECT Clinical Study Program
The global, randomized, double-blind, placebo-controlled Phase 3 study,
PROSPECT, is expected to enrol about 1,200 patients. For additional information
about PROSPECT, please visitwww.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, 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
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.
201201uk:
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Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1588442]
Unternehmensinformation / Kurzprofil:
Datum: 23.02.2012 - 08:12 Uhr
Sprache: Deutsch
News-ID 117692
Anzahl Zeichen: 5327
contact information:
Town:
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Kategorie:
Business News
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