Strong Ph II data for Biomira's Stimuvax

Canadian cancer vaccine specialist Biomira has reported Phase II study results from Stimuvax demonstrating that the BLP25 liposome vaccine could slow rising prostate specific antigen levels in some post-surgical prostate cancer patients, potentially delaying the need for initiation of androgen-deprivation therapy.

The findings from the open-label Phase II safety and efficacy trial, which was conducted at the Cross Cancer Institute in Edmonton, Alberta, Canada, and enrolled 16 post-radical prostatectomy patients, was published in the July 2006 issue of the Journal of Urology. Study participants underwent surgery at least six months prior to study entry, but experienced rising PSA levels post-surgery, final measurements having increased at least 50% above the lowest post-surgical level.

Biomira noted that, while no decreases in PSA occurred, stabilization was observed in 50% of subjects at the end of the primary treatment phase, and was maintained in one patient until the end of the study. Another interesting outcome was a noted increase in PSA doubling time, which was prolonged by more than 50% in six men at the end of the trial, compared with the doubling time prior to vaccine treatment. These observations, along with favorable safety data, led the study's authors to conclude that Stimuvax warrants further testing in larger controlled studies.