Biopharmaceutical firm OncBioMune Pharmaceuticals has closed patient enrolment in the Phase I clinical trial of ProscaVax for the treatment of prostate cancer.
ProscaVax is an immunotherapeutic vaccine candidate that combines the prostate-specific antigen (PSA) with the interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
The open-label trial enrolled a total of 20 hormone-naïve and hormone-independent patients with a reportedly progressive disease.
The trial is designed to evaluate the vaccine's safety, tolerability and effects on survivability, time to measurable disease, level of PSA in the blood, and the body's immune response to the vaccine.
OncBioMune chief executive officer Dr Jonathan Head said: "The interim data to date has been extremely compelling, demonstrating the strong safety and tolerability profile of ProscaVax, as well as indications of efficacy with respect to slowing tumour progression and supporting an immune response to disease.
"Based upon the data and years of previous research, we remain optimistic that ProscaVax has a future as a meaningful therapeutic for the millions of people affected by prostate cancer."
The trial is being conducted at two US sites, University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, and has received funding from the US navy cancer vaccine programme.
The trial's primary objective is the measure of dose limiting adverse events from the first injection to 30 days after the last injection.
The firm has previously announced that it is avoiding the initially planned second stage of the trial due to the positive interim safety results achieved in the first stage.
Image: Histology of prostate cancer. Photo: courtesy of Otis Brawley/National Cancer Institute.