BN ImmunoTherapeutics Reports Further Data on PROSTVAC(TM)
ImmunoTherapeutics, Inc. announced today that the first detailed data on
PROSTVAC(TM) since the vaccine was licensed 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
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: http://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
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
Reiner Laus, MD, President & CEO of BN ImmunoTherapeutics, 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.”
subsidiary of Bavarian Nordic, headquartered in
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: www.bavarian-nordic.com
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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
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Nordic’s periodic reports, if any, which we incorporate by reference.
SOURCE BN ImmunoTherapeutics