Bavarian Nordic Reports Further Data On PROSTVAC(TM)

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Cancer / Oncology
Article Date: 02 Mar 2009 - 4:00 PDT

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Bavarian Nordic announced 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.

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."

Forward-looking statements

This announcement includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

About Bavarian Nordic

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) is 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

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