PROSTVAC™ (Vaccinia-PSA-TRICOM and Fowlpox-PSA-TRICOM) is a therapeutic vaccine moving into late stage clinical development that has the potential to extend the lives of people with advanced prostate cancer. The vaccine induces a specific, targeted immune response that attacks metastatic cells in the prostate. Conventional chemotherapy currently used to treat prostate cancer has limited survival rates and is often associated with numerous side effects. In contrast, PROSTVAC™ has the potential to extend survival with improved quality of life.
In clinical trials to date PROSTVAC™ has been investigated in 464 patients.
PROSTVAC™ - promising Phase II results leads to Phase III in 2010 In October, after evaluating new data from a prospectively randomized, placebo-controlled study, Bavarian Nordic reported the resulting positive mature Phase II data with PROSTVAC™ that showed statistically significant improved overall survival.
The results from this study of 125 patients with metastatic prostate cancer after 4 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 2 months. In addition, PROSTVAC™ also had a favourable safety and tolerability profile.
Preparing for Phase III Based on the promising results, Bavarian Nordic expects to initiate confirmatory Phase III studies for PROSTVAC™ together with NCI in the first half of 2010 when the clinical product is ready. This will form the basis of approval for this therapy.
The Company expects to be able to leverage existing production facilities in the clinical and launch production of PROSTVAC™. This will require limited investments. Currently, the transfer and validation of the production process is ongoing, and if successful it is expected that the clinical product will be ready for the planned initiation of Phase III trials in the first half of 2010.
