MOUNTAIN VIEW, California, February 25 /PRNewswire/ -- BN 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 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: 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 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.
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."
Located in Mountain View, California, BN ImmunoTherapeutics is a subsidiary of Bavarian Nordic, headquartered in Denmark.
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
"Safe Harbour" Statement under the Private Securities Litigation Reform 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 uncertainties is set forth in the current Annual Report and in Bavarian Nordic's periodic reports, if any, which we incorporate by reference.
|SOURCE BN ImmunoTherapeutics|
Copyright©2009 PR Newswire.
All rights reserved