New and interesting PROSTVAC(TM) data indicate broad therapeutic use
in metastatic prostate cancer
(Thomson Reuters ONE) - Kvistgaard, Denmark, September 21, 2009 - Bavarian Nordic A/S (OMX:BAVA) today presented further detailed PROSTVAC(TM) data at theEuropean CanCer Organisation (ECCO), ECCO 15 - 34th ESMO Congress inBerlin, Germany.Further data from a Phase II double-blind, prospective randomizedplacebo-controlled study of 125 patients with metastatic prostatecancer was presented by Dr. Wayne Godfrey, Senior Medical Director,BN ImmunoTherapeutics.The headline data as previously reported showed that patients in thePROSTVAC(TM) group had a significantly longer median overall survivalby 8.5 months compared to the control group. The hazard ratioestimate for overall survival from the study is 0.56 (95% CI0.37-0.85). The statistical significance in the final data set is(p=0.006). PROSTVAC(TM) also demonstrated a very favourable safetyand tolerability profile.A new statistical analysis of the data set showed that patientsreceiving PROSTVAC(TM) benefitted from the treatment regardless oftheir general condition or their median predicted survival,determined by the Halabi score. Similarly, when grouped by a numberof relevant parameters, e.g. PSA level, PROSTVAC(TM) patientsbenefitted from treatment as compared to the control group. This dataindicates that PROSTVAC(TM) is universally applicable to a wide rangeof prostate cancer patients. This confirms PROSTVAC(TM)'s potentialto address a significant medical need and market opportunity.Furthermore, it will be useful in further defining the patientpopulation for the pivotal phase III program.An abstract from Dr. Godfrey's presentation is now available onlineathttp://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 metastaticcastration-resistant prostate cancer (mCRPC)"As part of Bavarian Nordic's continued communication strategy onPROSTVAC(TM), the company will participate in the 16th AnnualProstate Cancer Foundation Scientific Retreat on September 24-26 atLake Tahoe, Nevada, where a PROSTVAC(TM) poster has been accepted forpresentation.Anders Hedegaard, President & CEO of Bavarian Nordic said: "As wecontinue to analyse our PROSTVAC(TM) data, we gain new insight in thepositive features of the vaccine and important information tofacilitate the future clinical development of PROSTVAC(TM). Withtoday's presentation at the ECCO congress along with our recentpresentation at ASCO and other cancer congresses, we continue tobroaden the awareness of PROSTVAC(TM) among leading cancer experts."Asger AamundChairmanContactAnders Hedegaard, President & CEO. Phone +45 23 20 30 64http://hugin.info/100065/R/1342695/321481.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 21.09.2009 - 21:33 Uhr
Sprache: Deutsch
News-ID 6039
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