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,
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,
SOURCE Bavarian Nordic A/S
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