Onyvax begins Ph IIb trial of prostate cancer vacc

London, UK-based biotechnology firm Onyvax says that it has begun a new Phase IIb clinical trial of its immunostimulatory agent, Onyvax-P, which is being developed to treat prostate cancer.

The study, which is being conducted at the US National Cancer Institute in Bathesda, Maryland, is designed to assess the drug in 44 patients with rising prostate-specific antigen levels after receiving localized therapy for primary prostate cancer. Participants will receive three months of androgen deprivation therapy before being randomized to receive 15 administrations of either Onyvax-P, or placebo, over a 12-month period. The program will examine the vaccine's effect on PSA-defined disease progression, PSA doubling time, testosterone recovery and immunological response.

Onyvax said that the NCI study will run in parallel to its ongoing Phase IIb trial of Onyvax-P in non-metastatic hormone-refractory prostate cancer that is being carried out at centers in Europe.