PROSTVAC Vaccine for Prostate Cancer to Enter Phase III Clinical Trials
June 3, 2012 -- PROSTVAC, a virus-based vaccine, successful showed an average 8.5 month overall survival benefit and favorable side effects in Phase II clinical trials. Men enrolled in the study had asymptomatic to minimally symptomatic metastatic prostate cancer.
Phase II trial data supported the design of a Phase III protocol that will test the hypothesis of overall survival. The trial was introduced at the annual ASCO meeting by Olga Bandman with BN ImmunoTherapeutics in Mountain View, CA. The trial will expand researchers understanding of the immune system response to cancer vaccines and is set to include patients with asymptomatic of minimally symptomatic treatment-resistant metastatic prostate cancer. An expected 400 patients will enroll in the study for 12 months, with a primary endpoint of overall survival. Secondary endpoints will be proportion of event=free patients at six months compared to placebo.
“The thorough immune monitoring program would provide basis for future studies on the effects of cancer immunotherapy on immune system and facilitate a search for potential biomarkers of such effects,” said Bandman.
The trial is currently open for enrollment at www.clinicaltrials.gov, using registry number NCT00450463.
Read the abstract.