Bavarian Nordic Announces Presentation of PROSTVAC® Data at the 2011 ASCO Annual Meeting

Kvistgård, Denmark, June 1, 2011 - Bavarian Nordic A/S (OMX: BAVA) today announced that investigators from the National Cancer Institute are presenting at the 2011 ASCO Annual Meeting in Chicago data from a study with PROSTVAC® entitled "Intraprostatic PSA-TRICOM vaccine administration in patients with locally recurrent prostate cancer".

In this study 21 patients with locally recurrent prostate cancer after primary radiation therapy were enrolled and received initial vaccination with subcutaneous injection of PROSTVAC® and booster intraprostatic injection of PROSTVAC®. The vaccine was well tolerated with only one grade 3 adverse event (fever). 18 of 21 patients had stable or improved PSA on study. 16 of 21 patients had stable or improved PSA doubling time. A paired t-test of 13 biopsies pre- and post-vaccination showed increases in tumor immunologic infiltrates. CD3+ cells increased from 12.3 → 21.3/high power field (hpf) (p=0.0079). CD4+ cells increased from 1.3 →13.1/hpf (p=0.0002). CD8+ cells rose from 6.4 →14/hpf (p=0.0002). Intraprostatic administration of PROSTVAC® appears safe, feasible and can generate a substantial immune response. Improved PSA kinetics and intense post-vaccination immune infiltrates were seen in the majority of patients.

An abstract of the presentation can be found here:

This study suggests that PROSTVAC® is active in stages of prostate cancer as early as locally recurrent disease. Further studies evaluating the efficacy of PROSTVAC® in this setting are thus promising and warranted.

The DCTD/NCI-sponsored study was conducted under the cooperative research and development agreement (CRADA) that Bavarian Nordic has with the NCI for further development of PROSTVAC®.

Anders Hedegaard, President & CEO of Bavarian Nordic said: "While the pivotal Phase 3 trials with PROSTVAC®that are set to start later this year are designed to verify the vaccine's potential to improve survival in metastatic disease, we are delighted to again present convincing data that support the use of PROSTVAC® in earlier disease settings, suggesting a potential for broader usage of the vaccine in prostate cancer."