BN sees positive Ph II results for Prostvac
Denmark's Bavarian Nordic has now evaluated the mature Phase II data from the therapeutic prostate cancer vaccine candidate Prostvac that had been obtained as part of the recently entered partnership with the National Cancer Institute in the USA.
The results from the prospective, randomized placebo-controlled study of 125 patients with advanced prostate cancer after four years of follow-up show that patients receiving Prostvac had a statistically-significantly longer median overall survival by 8.5 months (p=0.015) compared to the control group. Currently the only approved treatment for advanced prostate cancer extends median overall survival by an average of approximately two months. In addition, the vaccine had a favorable safety and tolerability profile.
Based on these promising results, BN expects to initiate confirmatory Phase III studies for Prostvac together with the NCI in the first half of 2010 that will form the basis of a potential submission for this therapy.
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