New and interesting PROSTVAC™ data indicate broad therapeutic use in metastatic prostate cancer
21 September 2009
Download pdf
Kvistgaard, Denmark, September 21, 2009- Bavarian
Nordic A/S (OMX: BAVA) today presented further detailed
PROSTVAC™ 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™ 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™ also demonstrated a very favourable
safety and tolerability profile.
A new statistical analysis of the data set showed that patients
receiving PROSTVAC™ 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™ patients
benefitted from treatment as compared to the control group. This
data indicates that PROSTVAC™ is universally applicable to a
wide range of prostate cancer patients. This confirms
PROSTVAC™'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.
An abstract from Dr. Godfrey's presentation is now available online
at http://ex2.excerptamedica.com/CIW-09ecco/
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™, the company will participate in the 16th Annual
Prostate Cancer Foundation Scientific Retreat on September 24-26 at
Lake Tahoe, Nevada, where a PROSTVAC™ poster has been
accepted for presentation.
Anders Hedegaard, President & CEO of Bavarian Nordic said:
"As we continue to analyse our PROSTVAC™ data, we gain
new insight in the positive features of the vaccine and important
information to facilitate the future clinical development of
PROSTVAC™. 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™
among leading cancer experts."
Contact:
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64