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
PROSTVAC(TM) data presented at the ASCO Meeting demonstrates the potential for significant increases in life expectancy in late-stage prostate cancer
| Source: Bavarian Nordic A/S