PROSTVAC(TM) data presented at the ASCO Meeting demonstrates the potential for significant increases in life expectancy in late-stage prostate cancer


Today, 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(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."



Asger Aamund
Chairman


Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64

Attachments

17-09_uk.pdf