OncBioMune Pharmaceuticals will soon start a Phase 2 clinical trial of its investigational vaccine ProscaVax in men with early-stage prostate cancer under “active surveillance”. ProscaVax consists of a combination of the PSA protein produced by the prostate gland with the cytokines interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF). [Cytokines are molecules that participate in immune responses.] This will be the first time that prostate patients will be treated with a vaccine rather than waiting for disease progression or being exposed to more invasive treatment options that frequently are accompanied by unpleasant side effects such as incontinence and/or impotence. Scientists will evaluate whether the vaccine leads to a change in prostate cancer progression compared to patients on “active surveillance” in which disease progression is monitored before other strategies such as surgery or radiation therapy are considered. PSA doubling time and adverse effects will also be assessed.
Treatment arm-patients will start with a 4-month induction period, being given six (6) doses of ProscaVax at weeks 1, 2, 3, 7, 11, and 15. This period will be followed by maintenance injections once every month and alternating between low-dose IL-2 alone and the ProscaVax vaccine for six months.
OncBioMune reported results of a Phase 1a/1b study in January, 2018 showing that ProscaVax reduced tumor growth in 70% of recurrent prostate cancer patients after a minimum of 31 weeks of treatment. This result added to previously reported positive safety data. Trial results at 19 weeks of treatment also found that ProscaVax stopped disease progression in 80% of patients.
The single-site trial is expected to finish in August, 2022. It will be conducted at Beth Israel Deaconess Medical Center in Boston, MA and includes the Dana-Farber Cancer Institute. Information about this trial was published in the July 16th, on-line edition of Prostate Cancer News Today to which readers of this website are urged to subscribe.