KVISTGARD, Denmark — 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 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.”
Reiner Laus, President & CEO of BN ImmunoTherapeutics 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.”
Located in Mountain View, California, BN ImmunoTherapeutics is a subsidiary of Bavarian Nordic, headquartered in Denmark.
Bavarian Nordic A/S is a leading industrial biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company’s business strategy is focused in three areas: biodefence, cancer and infectious diseases. Bavarian Nordic’s proprietary and patented technology, MVA-BN(R), has been demonstrated in clinical trials to be one of the world’s safest, multivalent vaccine vectors. Bavarian Nordic has ongoing contracts with the US government for the late-stage development and procurement of the company’s third-generation smallpox vaccine, IMVAMUNE(R).
Bavarian Nordic is listed on the OMX NASDAQ under the symbol BAVA.
For more information, please visit: http://www.bavarian-nordic.com
“Safe Harbour” Statement under the Private Securities Litigation Reform Act of 1995:
Except for the historical information contained herein, this release contains “forward-looking statements” within the meaning of the Private Securities Reform Act of 1995. No “forward-looking statement” can be guaranteed, and actual results may differ materially from those projected. Bavarian Nordic undertakes no obligation to publicly update any “forward-looking statement”, whether as a result of new information, future events, or otherwise. Additional information regarding risks and uncertainties is set forth in the current Annual Report and in Bavarian Nordic’s periodic reports, if any, which we incorporate by reference.