Prostvac extends survival in severe prostate cancer: Bavarian Nordic

Prostvac improves survival rate in metastatic prostate cancer, according to the developer of the anti-cancer drug Bavarian Nordic A/S.

Prostvac (Vaccinia-PSA-TRICOM and Fowlpox-PSA-TRICOM) is a therapeutic vaccine for advanced prostate cancer is being developed through a collaboration with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement with Bavarian Nordic’s U.S.-based subsidiary, BN ImmunoTherapeutics.

Prostvac is a viral vector-based immunotherapy, utilizing pox virus vectors that express prostate specific antigen (PSA) and three T cell costimulatory molecules are administered subcutaneously.

Prostvac induces a specific, targeted immune response that attacks prostate cancer cells.

Prostvac has improved the survival time in patients compared to a placebo, says data presented by bavarian Nordic at the European Cancer Organisation (ECCO), ECCO 15 – 34th ESMO Congress in Berlin, Germany.

Bavarian Nordic presented data from 125 patients with metastatic prostate cancer in a Phase II double-blind, prospective randomized placebo-controlled study of was presented at the meet.

Prostvac patients had a significantly longer median overall survival by 8.5 months compared to the control group. The hazard ratio estimate for overall survival from the study is 0.56 (95% CI 0.37-0.85). The statistical significance in the final data set is (p=0.006).

Prostvac also demonstrated a very favourable safety and tolerability profile, a press statement from Bavarian Nordic stated.

Conventional chemotherapy currently used to treat prostate cancer has limited survival rates and is often associated with numerous side effects.

Bavarian Nordic’s new statistical analysis of the data set showed that patients receiving Prostvac benefitted from the treatment regardless of their general condition or their median predicted survival, determined by the Halabi score.

Similarly, when grouped by a number of relevant parameters, e.g. PSA level, Prostvac patients benefitted from treatment as compared to the control group. This data indicates that Prostvac is universally applicable to a wide range of prostate cancer patients. This confirms Prostvac’s potential to address a significant medical need and market opportunity, the company statement said.

Bavarian Nordic expects to start confirmatory Phase III studies for Prostvac together with NCI in 2010.

Bavarian Nordic A/S is a leading industrial biotechnology company developing and producing novel vaccines for the treatment and prevention of diseases. Bavarian Nordic focuses mainly in three areas; biodefence, cancer and infectious diseases.

Currently, Bavarian Nordic has two programmes ready for Phase III: Imvamune, a third-generation smallpox vaccine is being developed under a contract with the US government and Prostvac.

In the first half of 2009 — for the period 1 January to 30 June 2009 — Bavarian Nordic generated revenue of DKK 33 million and recorded a loss before tax of DKK 188 million. As of 30 June 2009 the Group’s net free liquidity was DKK 489 million.

What is Metastatic Prostate Cancer?

In prostate cancer metastasis cancer cells are transported through the lymphatic system and the bloodstream to other parts of the body, where they lodge and grow secondary tumors.

Generally, prostate cancer is a relatively slow-growing cancer. Prostate cancer typically takes a number of years to become large enough to be detectable, and even longer to spread beyond the prostate.

However, a small percentage of patients experience more rapidly growing, aggressive forms of prostate cancer.

Prostate cancer is the most common non-skin cancer in America, affecting 1 in 6 men. A non-smoking man is more likely to develop prostate cancer than he is to develop colon, bladder, melanoma, lymphoma and kidney cancers combined. In fact, a man is 35% more likely to be diagnosed with prostate cancer than a woman is to be diagnosed with breast cancer.

In 2009, more than 192,000 men will be diagnosed with prostate cancer, and more than 27,000 men will die from the disease. One new case occurs every 2.7 minutes and a man dies from prostate cancer every 19 minutes.

It is estimated that there are more than 2 million American men currently living with prostate cancer.