The first detailed data on PROSTVAC(TM) since the vaccine was
licensed by Bavarian Nordic from the National Institutes of Health
(NIH) is now available. The data, that once again confirms the
excellent safety and efficacy results previously reported, will be
presented at the 2009 Genitourinary Cancers Symposium (GU) on
February 26-28, 2009 in Orlando, Florida.
Abstracts from three different studies, where PROSTVAC(TM) has been
evaluated as monotherapy or in combination with other therapies, are
presented at the conference. The results from the studies support the
further investigation in patients suffering from advanced prostate
cancer.
The abstracts can be seen in full at ASCO's website: www.asco.org.
Study I (Abstract no. 108)
Study title: "A Phase II study of PROSTVAC-V (Vaccinia)/TRICOM and
PROSTVAC-F (Fowlpox)/TRICOM with GM-CSF in Patients with PSA
Progression After Local Therapy for Prostate Cancer"
In a study run by the Eastern Cooperative Oncology Group, the effect
of PROSTVAC(TM) vaccination in patients with early stage recurrent
prostate cancer was evaluated.
Results from the study demonstrate that by using PROSTVAC(TM) in an
earlier disease setting, the vaccine has the ability to decrease the
rate of rise in PSA levels indicating a potential delay in disease
progression. In addition, the vaccine can be safely administered in a
patient population with early stage prostate cancer.
Study II (Abstract no. 210)
Study title: "Comparing the Overall Survival of Metastatic
Castration-Resistant Prostate Cancer Patients Treated with Docetaxel,
a Vaccine Admixed with one Costimulatory Molecule, and a Vaccine with
Three Costimulatory Molecules."
In this National Cancer Institute (NCI) conducted study comparing the
overall survival in patients with advanced prostate cancer, where
patients were treated with chemotherapy (docetaxel), chemotherapy in
combination with a pox-based vaccine, or PROSTVAC(TM). The study
compared the predicted overall survival (as determined by the Halabi
score), with the observed overall survival. The patient groups
receiving vaccine therapy had improvements in overall survival versus
what was predicted, by approximately 6 and 9 months. The group
receiving PROSTVAC(TM) had an improvement in overall survival
consistent with the previously reported efficacy data.
Study III (Abstract no. 184)
Study title: "Phase I Trial of Targeted Therapy with PSA-TRICOM
Vaccine (V) and Ipilimumab (ipi) in Patients (Pts) with Metastatic
Castration-Resistant Prostate Cancer (mCRPC)."
This NCI conducted study in patients with advanced prostate cancer
evaluated a combination of PROSTVAC(TM) vaccination with an
anti-CTLA4 antibody (Ipilimumab, provided under an National Cancer
Institute Clinical Trials Agreement with Bristol-Myers Squibb, Inc.)
The study confirms activity of this regimen on PSA responses in
advanced disease patients, and was associated with manageable side
effects. No > grade 2 adverse events were attributed to vaccine.
Further detailed results on PROSTVAC(TM) will be presented at the
2009 ASCO Annual Meeting on May 29 -June 2, 2009 in Orlando, Florida.
Anders Hedegaard, President & CEO of Bavarian Nordic, said: "We are
proud that for the first time since obtaining an exclusive license
from the NIH, detailed study results with PROSTVAC(TM) are being
presented at a major conference. These data, although early stage,
confirms the unique profile of our leading cancer vaccine candidate,
ready for Phase III. We are looking forward to present further
detailed PROSTVAC(TM) data throughout 2009."
Asger Aamund
Chairman
Contact
Anders Hedegaard, President & CEO
Phone +45 23 20 30 64
