OncBioMune Pharmaceuticals submitted the outline for its proposed Phase 2 clinical trial of ProscaVax as a vaccine against early stage prostate cancer to the US Food and Drug Administration.
OncBioMune Pharmaceuticals (OTCQB:OBMP) submitted the protocol for its proposed Phase 2 clinical trial of ProscaVax as a vaccine against early stage prostate cancer to the US Food and Drug Administration.
As quoted in the press release:
In the trial, ProscaVax will be evaluated for safety, tolerability and efficacy as a treatment for patients at disease presentation who, in collaboration with their oncologist, chose to forego standard approved therapies in favor of careful monitoring for disease progression, a process known more commonly as “active surveillance.”
ProscaVax is an immunotherapeutic cancer vaccine consisting of a combination of the tumor-associated antigen PSA (prostate specific antigen) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
There are currently no FDA-approved treatments for patients in active surveillance. Today’s approved therapies for early-stage prostate cancer include surgery to remove the prostate and some surrounding tissue (radical prostatectomy), radiation and brachytherapy, all of which are well documented to have unpleasant side effects, including impotence and urinary incontinence.