PROSTVAC(TM) Data Presented at the ASCO Meeting Demonstrates the Potential for Significant Increases in Life Expectancy in Late-
02 Junio 2009 - 10:27AM
PR Newswire (US)
KVISTGARD, Denmark, June 2 /PRNewswire-FirstCall/ -- Detailed data
from a randomized Phase 2 study with PROSTVAC(TM) were presented at
the ASCO Annual Meeting in Orlando. The presentation was made by
Philip Kantoff MD, Professor of Medicine, Harvard Medical School,
and the Dana-Farber Cancer Institute who is also the principal
investigator of the study. The more detailed analysis supports the
headline data that were reported in October 2008. In the Phase 2
prospective randomized placebo-controlled study of 125 patients
with advanced prostate cancer, 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). There
were no major clinically meaningful imbalances in baseline
characteristics in the PROSTVAC(TM) and control vector treated
arms. PROSTVAC(TM) immunotherapy was well tolerated, with some
patients having injection site reactions (40-60%), and systemic
symptoms of fatigue, fevers, and chills (10-30%) reported. PROSTVAC
is an 'off-the-shelf' viral vector-based immunotherapy, utilizing
pox virus vectors that express PSA and three T cell costimulatory
molecules are administered subcutaneously. An abstract from
Professor Kantoff's presentation is now available on ASCO's
website: http://www.abstract.asco.org/AbstView_65_33254.html Slides
from the presentation will be available within one week at:
http://www.asco.org/ASCOv2/MultiMedia/Virtual+Meeting Philip
Kantoff MD, Professor of Medicine, Harvard Medical School, the
principal investigator of the study, said: "There are few available
treatments for advanced prostate cancer. To see this extent of
improvement in overall survival is very encouraging. These phase II
data with PROSTVAC(TM) warrant confirmation with a phase III study
and when confirmed this product has the potential to fulfil an
unmet medical need for these patients." Reiner Laus, President
& CEO of BN ImmunoTherapeutics said: "We are delighted that the
data presented at the ASCO Annual Meeting confirms the excellent
headline data with our prostate cancer vaccine candidate,
PROSTVAC(TM), ready to start Phase 3 in 2010." Located in Mountain
View, California, BN ImmunoTherapeutics is a subsidiary of Bavarian
Nordic, headquartered in Denmark. 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 business
strategy is focused in three areas: biodefence, cancer and
infectious diseases. Bavarian Nordic's proprietary and patented
technology, MVA-BN(R), has been demonstrated in clinical trials to
be one of the world's safest, multivalent vaccine vectors. Bavarian
Nordic has ongoing contracts with the US government for the
late-stage development and procurement of the company's
third-generation smallpox vaccine, IMVAMUNE(R). Bavarian Nordic is
listed on the OMX NASDAQ under the symbol BAVA. For more
information, please visit: http://www.bavarian-nordic.com/ "Safe
Harbour" Statement under the Private Securities Litigation Reform
Act of 1995: Except for the historical information contained
herein, this release contains "forward-looking statements" within
the meaning of the Private Securities Reform Act of 1995. No
"forward-looking statement" can be guaranteed, and actual results
may differ materially from those projected. Bavarian Nordic
undertakes no obligation to publicly update any "forward-looking
statement", whether as a result of new information, future events,
or otherwise. Additional information regarding risks and
uncertainties is set forth in the current Annual Report and in
Bavarian Nordic's periodic reports, if any, which we incorporate by
reference. DATASOURCE: Bavarian Nordic A/S CONTACT: Contact (media
only): Reiner Laus, President & CEO, BN ImmunoTherapeutics,
Inc., +1-650-681-4660
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