New data from ongoing studies with PROSTVAC®, a vaccine in development for the treatment of prostate cancer, will be presented this weekend at the 2011 ASCO Annual Meeting in Chicago, USA. The data suggest that PROSTVAC® may be able to slow disease progression in early stage prostate cancer.

An estimated more than 780,000 new cases of prostate cancer are diagnosed worldwide every year and more than 250,000 people die each year from the condition.

Previously, a large, double-blind, randomized, placebo controlled Phase 2 trial in patients with metastatic castration-resistant prostate cancer showed that PROSTVAC® extended the median overall survival with 8.5 months compared to placebo. In addition, recent studies suggest that the vaccine's potential may be even greater if used in earlier disease settings, where it seems to slow disease progression.

PROSTVAC® is being developed in collaboration with the National Cancer Institute (NCI). The results that will be presented at ASCO by investigators from NCI were from a Phase 1 study in 21 patients with locally recurrent prostate cancer after primary radiation therapy. Patients received an initial vaccination with subcutaneous injection of PROSTVAC® and booster intraprostatic injection of PROSTVAC®. More than 80% of the patients had stable or improved PSA on study, thus suggesting that PROSTVAC® was able to control the disease progression.

This study is one of six ongoing studies, currently conducted by the NCI with PROSTVAC® as monotherapy or in combination with other therapies in different disease settings, including early stage disease.

- This is a small study. However, PROSTVAC® is currently being investigated in various clinical studies in nearly 400 patients, and preliminary results from several of these studies confirm the same positive trend. In time we hope to confirm these results in larger studies, as was the case with the Phase 2 study which showed an improved survival in patients with advanced prostate cancer, and thereby validate a therapeutic effect in both early and late stage disease, commented Anders Hedegaard, President & CEO of Bavarian Nordic.

With the ongoing studies, a total of nearly 900 patients will have participated in PROSTVAC® clinical trials and later this year, Bavarian Nordic expects to initiate the pivotal Phase 3 trials that are intended to form the basis of approval of the vaccine for metastatic disease. The study will include up to 1,200 patients.

Source:
Bavarian Nordic