New And Interesting PROSTVAC(TM) Data Indicate Broad Therapeutic Use In Metastatic Prostate Cancer

Main Category: Prostate / Prostate Cancer
Also Included In: Clinical Trials / Drug Trials;  Conferences
Article Date: 23 Sep 2009 - 2:00 PDT

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Bavarian Nordic A/S (OMX: BAVA) yesterday presented further detailed PROSTVAC(TM) data at the European Cancer Organisation (ECCO), ECCO 15 - 34th ESMO Congress in Berlin, Germany.

Further data from a Phase II double-blind, prospective randomized placebo-controlled study of 125 patients with metastatic prostate cancer was presented by Dr. Wayne Godfrey, Senior Medical Director, BN ImmunoTherapeutics.

The headline data as previously reported showed that 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). PROSTVAC(TM) also demonstrated a very favourable safety and tolerability profile.

A new statistical analysis of the data set showed that patients receiving PROSTVAC(TM) benefitted from the treatment regardless of their general condition or their median predicted survival, determined by the Halabi score. Similarly, when grouped by a number of relevant parameters, e.g. PSA level, PROSTVAC(TM) patients benefitted from treatment as compared to the control group. This data indicates that PROSTVAC(TM) is universally applicable to a wide range of prostate cancer patients. This confirms PROSTVAC(TM)'s potential to address a significant medical need and market opportunity. Furthermore, it will be useful in further defining the patient population for the pivotal phase III program.

Abstract no. O-7002.

Title: "Further analysis of a Phase II randomized controlled trial (RCT) of a poxviral-based PSA targeted immunotherapy in metastatic castration-resistant prostate cancer (mCRPC)"

As part of Bavarian Nordic's continued communication strategy on PROSTVAC(TM), the company will participate in the 16th Annual Prostate Cancer Foundation Scientific Retreat on September 24-26 at Lake Tahoe, Nevada, where a PROSTVAC(TM) poster has been accepted for presentation.

Anders Hedegaard, President & CEO of Bavarian Nordic said: "As we continue to analyse our PROSTVAC(TM) data, we gain new insight in the positive features of the vaccine and important information to facilitate the future clinical development of PROSTVAC(TM). With today's presentation at the ECCO congress along with our recent presentation at ASCO and other cancer congresses, we continue to broaden the awareness of PROSTVAC(TM) among leading cancer experts."

Forward-looking statements

This announcement includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

About Bavarian Nordic

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 pipeline is focused in the three areas; biodefence, cancer and infectious diseases, and includes seven development programmes. Two programmes are ready for Phase III: IMVAMUNE(R), a third-generation smallpox vaccine is being developed under a contract with the US government, and PROSTVAC(TM), a therapeutic vaccine for advanced prostate cancer is being developed under a collaboration agreement with the National Cancer Institute.

Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.

Source: Bavarian Nordic A/S

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