New and Interesting PROSTVAC(TM) Data Indicate Broad Therapeutic Use in Metastatic Prostate Cancer
September 22 2009 - 8:00AM
PR Newswire (US)
KVISTGAARD, Denmark, September 22 /PRNewswire-FirstCall/ --
Bavarian Nordic A/S (OMX: BAVA) yesterday presented further
detailed PROSTVAC(TM) data at the European Cancer Organisation
(ECCO), ECCO 15 - 34th ESMO Congress in Berlin, Germany. Further
data from a Phase II double-blind, prospective randomized
placebo-controlled study of 125 patients with metastatic prostate
cancer was presented by Dr. Wayne Godfrey, Senior Medical Director,
BN ImmunoTherapeutics. The headline data as previously reported
showed that patients in the PROSTVAC(TM) group had a significantly
longer median overall survival by 8.5 months compared to the
control group. The hazard ratio estimate for overall survival from
the study is 0.56 (95% CI 0.37-0.85). The statistical significance
in the final data set is (p=0.006). PROSTVAC(TM) also demonstrated
a very favourable safety and tolerability profile. A new
statistical analysis of the data set showed that patients receiving
PROSTVAC(TM) benefitted from the treatment regardless of their
general condition or their median predicted survival, determined by
the Halabi score. Similarly, when grouped by a number of relevant
parameters, e.g. PSA level, PROSTVAC(TM) patients benefitted from
treatment as compared to the control group. This data indicates
that PROSTVAC(TM) is universally applicable to a wide range of
prostate cancer patients. This confirms PROSTVAC(TM)'s potential to
address a significant medical need and market opportunity.
Furthermore, it will be useful in further defining the patient
population for the pivotal phase III program. An abstract from Dr.
Godfrey's presentation is now available online at
http://ex2.excerptamedica.com/CIW-09ecco/ Abstract no. O-7002.
Title: "Further analysis of a Phase II randomized controlled trial
(RCT) of a poxviral-based PSA targeted immunotherapy in metastatic
castration-resistant prostate cancer (mCRPC)" As part of Bavarian
Nordic's continued communication strategy on PROSTVAC(TM), the
company will participate in the 16th Annual Prostate Cancer
Foundation Scientific Retreat on September 24-26 at Lake Tahoe,
Nevada, where a PROSTVAC(TM) poster has been accepted for
presentation. Anders Hedegaard, President & CEO of Bavarian
Nordic said: "As we continue to analyse our PROSTVAC(TM) data, we
gain new insight in the positive features of the vaccine and
important information to facilitate the future clinical development
of PROSTVAC(TM). With today's presentation at the ECCO congress
along with our recent presentation at ASCO and other cancer
congresses, we continue to broaden the awareness of PROSTVAC(TM)
among leading cancer experts." 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. About Bavarian Nordic Bavarian Nordic
A/S is a leading industrial 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 is focused in the three areas; biodefence,
cancer and infectious diseases, and includes seven development
programmes. Two programmes are ready for Phase III: IMVAMUNE(R), a
third-generation smallpox vaccine is being developed under a
contract with the US government, and PROSTVAC(TM), a therapeutic
vaccine for advanced prostate cancer is being developed under a
collaboration agreement with the National Cancer Institute.
Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol
BAVA. For more information please visit
http://www.bavarian-nordic.com/ DATASOURCE: Bavarian Nordic A/S
CONTACT: Contact: Anders Hedegaard, President & CEO, Bavarian
Nordic, +45-23-20-30-64
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