OncBioMune Pharmaceuticals has submitted the protocol for a proposed Phase II clinical trial of ProscaVax vaccine for advanced prostate cancer to the US Food and Drug Administration (FDA).
If approved, OncBioMune will be able to begin the trial, which is expected to be held at Urology Clinics of North Texas (UCNT) in the US.
Following the approval, the trial aims to treat its first patient before December this year.
OncBioMune Pharmaceuticals CEO Dr Jonathan Head said: “Combined with the initiation of the world’s first ever study of a vaccine in early stage prostate cancer patients in ‘active surveillance’ at a teaching hospital of Harvard University, we are steadily building our position as a leader in immunotherapy with a novel approach to prostate cancer.
“As we grow this footprint, we believe that there will be an increase in our market valuation followed by potential partnering opportunities.”
The Phase II trial will build up on a successfully completed Phase la study of ProscaVax to treat those patients suffering with advanced prostate cancer who have failed earlier therapy with rising prostate specific antigen (PSA).
The Phase Ia trial enrolled a total of 20 patients and ProscaVax was observed to be safe and well-tolerated.
At 19 weeks of the trial, 80% of patients showed stable disease or no prostate cancer progression.
From these patients, 12 completed additional follow-up evaluation at 43 weeks post-therapy.
The trial demonstrated full overall survival rate for all the patients, while 12 of the 17 evaluable patients continued to live in either a stable condition or progression-free disease.
ProscaVax features a combination of prostate cancer associated prostate-specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).