The data, collected from three different studies confirm the excellent safety and efficacy results previously reported, and they support the further investigation in patients suffering from advanced prostate cancer. Also, the data indicate that PROSTVAC(TM) can be used in earlier disease settings and thus in a larger patient population.
In May 2009 detailed PROSTVAC(TM) data were presented at the 2009 ASCO
Annual Meeting in Orlando, Florida. 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 double-blind, prospective randomized placebo-controlled study of 125 patients with metastatic 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). These data were improved compared to the headline data presented in the fall in connection with the first announcement.
PROSTVAC(TM) immunotherapy was well tolerated, with some patients having injection site reactions (40-60%), and brief systemic symptoms of fatigue, fevers, and chills (10-30%) reported.
In July 2009, a review on PROSTVAC(TM) from key investigators from the National Cancer Institute (NCI) was published in the publication "Expert Opinion on Investigational Drugs", Volume 18, Issue 7 2009. This is the most comprehensive and updated review on PROSTVAC(TM) so far.
Quote from the article: "Preliminary clinical trials have indicated
negligible toxicity, a
|SOURCE Bavarian Nordic A/S|
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