New Study Opens Window for OncBioMune Cancer Vaccine in Early and Advanced Prostate Cancer Patients

BATON ROUGE, LA, Sept. 27, 2016 /PRNewswire/ – Treatment for newly diagnosed prostate cancer remains controversial, largely due to the fact that the disease typically progresses very slowly, so selecting which therapy and when is a topic of debate.  Today, early-stage prostate cancer patients have minimal options, mainly comprised to choosing between radiation, a prostatectomy (surgical removal of the prostate) or “active surveillance.”  Surgery and radiation are known to have side effects that can include incontinence and impotence, sometimes for prolonged periods of time.  Designed to monitor for disease progression, active surveillance involves routine doctor visits for physical prostate exams, periodic biopsies, and blood tests to measure the level of prostate specific antigens (PSA).
A new study, published in the New England Journal of Medicine last week, followed 1,643 localized-prostate cancer (meaning the cancer was confined to the prostate) patients in Britain (median age of 62) for a decade to evaluate outcomes of the different treatment regimens to provide some clarity on benefits.  Patients in the study were randomized equally into groups for radiation, surgery or active surveillance.  If disease progression was observed in patients in the active surveillance group, those patients had the option of surgery or radiation treatment.
In line with survival data from the American Cancer Society, study results showed that the 10-year survival rate was almost 99 percent, regardless of treatment plan.  The patients are still being followed to analyze mortality rates beyond 10 years.  204 men experienced disease progression, with 112 of those patients in the monitoring group, versus 46 in each of the surgery and radiotherapy groups.  54 percent (291 out of 545) of the patients in surveillance group ended up having radical treatment (surgery, radiotherapy, brachytherapy or high-intensity focused ultrasound therapy), including 56 patients within nine months of starting the trial.
“This first-of-its-kind study is particularly important to our efforts, as it provided comparable information on outcomes and the value of the different treatment options,” commented Dr. Jonathan Head, CEO at Baton Rouge-based OncBioMune Pharmaceuticals (OTCMKTS:OBMP), who was not involved with the study, in a phone conversation.  OncBioMune is developing an immunotherapy cancer vaccine called ProscaVax that combines PSA with adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF) to treat prostate cancer at various stages.
“Our goal is to provide a safe, effective therapeutic option for prostate cancer patients at any stage of disease, whether as a first-line therapy or in advanced disease,” said Dr. Head.  “In addition to over half of the active surveillance patients requiring radical treatment, the U.K. study data showed that about 6 percent of patients in the surgery and radiotherapy groups still required additional therapies and 14 percent of radiotherapy patients had rising PSA levels following therapy.   Start extrapolating that data into the 1.1 million prostate cancer cases recorded globally in 2012 and you begin to realize the necessity and potential for new therapies to help these patients.”
ProscaVax is designed to keep PSA levels in check.  As noted in a recent patient testimonial video by Steve Karalekas, the vaccine did just that for him.  Diagnosed with prostate cancer in 2005, Karalekas, a former White House staffer of President Richard Nixon, underwent a radical prostatectomy.  Despite the surgery, his PSA levels continued to rise steadily and, on consult of a friend, turned to OncBioMune and ProscaVax.  In the video, Karalekas explains the surprise of doctors at the National Cancer Institute that his PSA levels returned to normal following ProscaVax treatments.
“I am happy to say that 11 years later, I’m sitting before you in excellent health, no side effects, no issues, no problems and I’m in perfect health,” said Karalekas in the video.
According to Dr. Head, about 40 prostate cancer patients have been treated with ProscaVax in clinical studies to date without any serious adverse events being reported as attributed to the vaccine.
Looking to the market opportunity in early-stage prostate cancer goes without mentioning patients with advanced, relapsed or refractory disease for which ProscaVax could be utilized as well.  Like other cancers, as the disease progresses, chemotherapy often is the recommended course of treatment.  Johnson & Johnson’s oral drug Zytiga, which is approved for treating metastatic, castration-resistant prostate cancer in combination with prednisone for pancreatic cancer patients that have failed chemotherapy using docetaxel, was the seventh best selling cancer drug in the world in 2015, with sales of $2.23 billion.
Funded in part through a grant from the U.S. Department of Defense, ProscaVax is currently being evaluated in hormone-independent and hormone-naïve prostate cancer patients with rising PSA levels in a Phase 1 clinical trial at theUniversity of California-San Diego’s Moores Cancer Center and Veterans Hospital in La Jolla, California.  A Phase 2 trial for prostate cancer patients in the active surveillance category is being prepared for commencement in the Beth Israel Deaconess Medical Center network of hospitals.  South of the U.S. border, OncBioMune has partnered with Vitel Laboratorios, S.A. de C.V. for a Phase 2/3 study in Mexico in the same patient population as the UCSD study.
With the potential for the Mexican trial to serve as a registration study, OncBioMune is considering a merger with Vitel, disclosing this month that it is in discussions to acquire Vitel and its portfolio of drugs, some of which are approved or near commercialization in the Mexican market.
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