PROSTVAC(TM) Data Presented at the ASCO Meeting Demonstrates the Potential for Significant...

PROSTVAC(TM) Data Presented at the ASCO Meeting Demonstrates the Potential for
Significant Increases in Life Expectancy in Late-Stage Prostate Cancer

KVISTGAARD, Denmark, June 1 /PRNewswire-FirstCall/ -- Detailed data from
a randomized Phase 2 study with PROSTVAC(TM) were presented Saturday 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(TM) 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."
Anders Hedegaard, President & CEO of Bavarian Nordic 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."
About PROSTVAC(TM)
PROSTVAC(TM) is a therapeutic vaccine moving into late stage clinical
development that has the potential to extend the lives of people with
advanced prostate cancer. Administered subcutaneously, it induces a specific,
targeted immune response that attacks prostate cancer cells. Conventional
chemotherapy currently used to treat prostate cancer has limited survival
rates and is often associated with numerous side effects. In contrast,
PROSTVAC(TM) has the potential to extend survival with improved quality of
life. PROSTVAC(TM) 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.
In clinical trials to date PROSTVAC(TM) and related PSA containing
poxviral vaccines have been investigated and optimised in more than 500
patients for 10 years.
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
business strategy is focused in three areas: biodefence, cancer and
infectious diseases. Bavarian Nordic's proprietary and patented technology
MVA-BN(R) is 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 NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please visit http://www.bavarian-nordic.com
SOURCE Bavarian Nordic A/S

Contact: Anders Hedegaard, President & CEO, Bavarian Nordic, +45-23-20-30-64