Bavarian Nordic: Positive Mature Phase II Results From Newly Acquired Prostate Cancer Vaccine
125 Patient, Prospective Randomized Placebo-Controlled Phase II Study
Bavarian Nordic has now evaluated the mature phase II data from the therapeutic prostate cancer vaccine candidate PROSTVAC(TM) that had been obtained as part of the recently entered partnership with the National Cancer Institute (NCI) in the US.
The results from the Phase II prospective randomized placebo-controlled study of 125 patients with advanced prostate cancer after 4 years of follow-up show that patients receiving PROSTVAC(TM) 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(TM) also had a favourable safety and tolerability profile.
Based on these promising results, Bavarian Nordic expects to initiate confirmatory Phase III studies for PROSTVAC(TM) together with NCI in the first half of 2010 that will form the basis of approval for this therapy.
Prostate cancer is the most common form of cancer with more than 500,000 new diagnosed patients globally per year and only limited treatment options. With estimated more than 140,000 related deaths annually, prostate cancer is the third leading cause of cancer related deaths in men.
Philip KantoffMD, 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 and Chief Executive Officer, Bavarian Nordic A/S, said "We are delighted with these promising results from this Phase II study, which will be published in full over the coming months. Based on these data we believe that PROSTVAC(TM) offers a potential breakthrough and real hope for patients suffering from advanced prostate cancer. Furthermore, unlike other current prostate cancer vaccines in development, PROSTVAC(TM) is an off-the shelf product that does not require complex individualised therapy. These results provide a full endorsement for our decision to strengthen our presence in cancer vaccine research, as announced earlier this year in connection with our newly launched strategy."
This announcement does not change Bavarian Nordic's previously announced financial guidance for 2008. The decision to take PROSTVAC(TM) into phase III trials will have a limited financial impact on year 2009, which will be covered by the company's net free liquidity.
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