About 165,000 American men will be diagnosed with prostate cancer in 2018, according to estimates from the American Cancer Society. Many of these men will be learning about their disease in the early stage, where there are no drugs and limited treatment options listed by the Food and Drug Administration (FDA).
For the most part, patients opt for either surgery or radiation therapy to try and kill the tumor cells. Some will elect for what is called "active surveillance," a strategy involving working with a doctor to regularly check for the disease getting worse before deciding that surgery or radiation is mandatory to try and slow the cancer.
OncBioMune Pharmaceuticals (OTCQB:OBMP) is hoping to bring a new option to the table with its novel therapeutic prostate cancer vaccine called ProscaVax.
After successfully completing a phase 1a study funded in part by the Department of Defense in patients with advanced prostate cancer, the Baton Rouge-based company decided to forego the 1b portion of that study in favor of two phase 2 trials: one in the same advanced-stage recurrent or relapsed prostate cancer group and the other addressing the active surveillance group.
ProscaVax, the lead drug built on OncBioMune's immuno-oncology platform has steadily been shown to be safe and well tolerated in humans. ProscaVax is a combination of prostate specific antigen with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).
The company is looking to make history with the first trial of a therapeutic vaccine for patients in active surveillance. Management has previously announced signing Theradex Oncology as the Contract Research Organization for the study and receiving all necessary approvals from the FDA and host hospital (Beth Israel Deaconess Medical Center, a teaching hospital of Harvard's vaunted Dana-Farber Cancer Institute) to commence the trial.
On Monday, OncBioMune said that ClinicalTrials.gov has now been updated to list the study and detail all the parameters and endpoints.
Could we be looking at a new front-line treatment for prostate cancer, the most common type of cancer in men behind only skin cancer?
It's far too early to tell, but Dr. Jonathan Head, chief executive and chairman at OncBioMune is optimistic about an alternative for patients in great need.
"For the first time ever, prostate cancer patients in the trial will have a therapeutic vaccine as an option rather than waiting for disease progression or jumping into more invasive treatments options that frequently are accompanied by very unpleasant side effects, such as urinary incontinence and impotence," said Dr. Head in today's press release.
Shares of OBMP, which were trading as low as a penny in March have been rising as the start of the trials draws near, including touching 4.5 cents in May and June. Shares pulled back some to a recent low of 2.4 cents and were on the rise again on Monday, gaining 15% to 2.99 cents at the lunch hour in New York.
