OncBioMune Pharmaceuticals has reported an ongoing review of its Phase II clinical trial protocol by the regulatory committee at Beth Israel Deaconess Medical Centre / Harvard Medical School in the US for evaluation of ProscaVax to treat early stage prostate cancer.
ProscaVax is being developed by the firm as a therapeutic vaccine to potentially become the standard-of-care treatment for prostate cancer.
The immunotherapeutic cancer vaccine combines tumour-associated prostate specific antigen (PSA) with biological adjuvants, interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
Designed to assess the safety, tolerability and efficacy of ProscaVax, the Phase II trial will enrol newly diagnosed, treatment-naïve patients who have agreed to avoid standard approved therapies such as radical prostatectomy, radiation or brachytherapy.
OncBioMune CEO Dr Jonathan Head said: “The regulatory committee is a component of the Institutional Review Board and integral to the protocol approval process to commence the study.
“I interpret the protocol now being in their hands as a signal that we are getting close to conducting the first ever trial of ProscaVax as a front-line treatment for prostate cancer.”
The firm has already obtained data from a Phase I/II trial of ProscaVax conducted in 12 prostate cancer patients administered initially with six vaccinations.
Upon measurement of serum PSA concentrations after three to four weeks following the sixth vaccination, it was found that two-thirds of the patients experienced decreased PSAs.
In addition to the Phase II trial for early stage prostate cancer, the firm plans to commence a Phase II/III trial for patients with late-stage prostate cancer in Mexico.