Bavarian Nordic Agrees on Interim Analysis with the FDA and Provides an Update on its PROSPECT Phase 3 Trial
(Thomson Reuters ONE) -
KVISTGAARD, Denmark, April 8, 2013 - Bavarian Nordic A/S (OMX: BAVA) today
announced that the Company plans to conduct an interim analysis of the on-going
PROSPECT Phase 3 trial of PROSTVAC® in prostate cancer patients with metastatic
disease. The updated statistical analysis plan for the trial, which was recently
accepted by the FDA, now includes pre-specified interim analyses of data that
will be performed to evaluate whether the trial should continue as planned or
potentially be stopped early for efficacy. In such case, a Biologics License
Application may be filed at an earlier stage, potentially shortening the overall
development time.
Enrollment in the trial is currently ongoing at almost 100 sites in 10
countries, and continues to expand into new countries and sites. As previously
communicated, the initiation of new sites has been delayed due to a lengthier
and more arduous regulatory process than anticipated in certain countries.
Bavarian Nordic has responded to this delay by implementing a number of
measures, aimed at completing enrollment within approximately one year.
Dr. James Breitmeyer, who was recently appointed President of BN
Immunotherapeutics, Inc. said, "Enrollment in the PROSPECT study has been my
first priority since I joined the company in February. Several enhancements to
study conduct have been made to catch up on enrollment. Specifically, we have
refocused our efforts towards high-performing clinical trial sites, an awareness
program has been implemented, and we have hired additional internal and external
resources to allow for a closer dialogue with the increasing number of clinical
trial sites."
Two abstracts have been accepted for the American Society of Clinical Oncology
(ASCO) Annual Meeting on May 31-June 4, 2013 in Chicago, Illinois, covering
clinical safety data for PROSTVAC®, and the rationale for and design of two new
studies of PROSTVAC® given in combination with enzalutamide. In connection with
the conference, Bavarian Nordic will also be hosting a PROSTVAC® update and
reception. Further information will follow shortly.
Asger Aamund
Chairman of the Board
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About PROSTVAC®
PROSTVAC® (PSA-TRICOM) is an off-the-shelf product candidate for the treatment
of prostate cancer. In 19 ongoing and completed clinical Phase 1 and Phase 2
trials, more than 600 patients have been treated with the immunotherapy
candidate, which has been well-tolerated. PROSTVAC® is a 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. The data from a larger Phase 2 trial
demonstrated PROSTVAC®'s ability to extend the median overall survival of
patients with advanced prostate cancer by 8.5 months, a nearly 50% increase
compared to the placebo group. This promising data led to the initiation of a
confirmatory Phase 3 trial (PROSPECT).
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, Inc.
About the PROSPECT Phase 3 Program
PROSPECT is a single global, randomized, double-blind, placebo-controlled Phase
3 trial and is expected to enroll 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 but who have not yet received other treatment options
such as chemotherapy will be eligible to enroll 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 demonstrate a better overall survival
than placebo.
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, 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
more than 600 patients. In infectious diseases, the company's lead program is
IMVAMUNE®, a non-replicating 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.
201308uk:
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Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1690946]
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Datum: 08.04.2013 - 07:01 Uhr
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