On November 8, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported its upcoming Phase 2 clinical trials of ProscaVax for prostate cancer and other corporate developments (Press release, Oncbiomune, NOV 8, 2018, http://oncbiomune.com/2018/11/08/oncbiomune-phase-2-clinical-trial-to-begin-enrollment-company-announces-other-development-and-corporate-milestones/ [SID1234531154]).

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Phase 2 Trial, Early-Stage Prostate Cancer

The Company’s lead Phase 2 trial of ProscaVax for prostate cancer (View Source) is being hosted by Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University, and its affiliate hospital. The Company reported that the trial will commence on or about December 17, 2018. Enrollment is scheduled for 120 patients (80 in the ProscaVax arm, 40 in active surveillance arm).

This study will evaluate the safety and efficacy of ProscaVax, OncBioMune’s prostate cancer vaccine (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)) in patients with low-risk localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. Active surveillance is a frequently used disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy that are often accompanied by unpleasant side effects, including impotence and urinary incontinence.

In the ProscaVax arm of the study, during the first 4 months of induction treatment, 6 doses of the Proscavax vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months.

Primary outcomes for the study are:

Prostate cancer progression measured by PSA test (Time Frame: At pre-study, every 3 months until 2 years starting at week 7 for the ProscaVax arm and at study entry for the active surveillance arm)
Prostate cancer progression measured by digital rectal examination (Time Frame: At pre-study and then every 6 months for 2 years)
Prostate cancer progression measured by prostate biopsy (Time Frame: At pre-study and then every 12-months for 2 years)
Secondary Outcomes for the study are:

PSA doubling time (Time Frame: At pre-study, and then every 3 months until 2 years, starting at week 7 for ProscaVax arm and at study entry for active surveillance arm)
Assessment of Adverse Events (Time Frame: From first injection until 30 days past the 24-month assessments)
Management anticipates providing interim results throughout the trial as they are available, tentatively beginning during the second quarter of 2019.

Phase 2 Trial, Late-Stage Prostate Cancer

This study, which is expected to get the FDA green light in the coming weeks, is being hosted by Urology Clinics of North Texas, a preeminent 10-center urology group in Texas serving the Dallas, Fort Worth, Collin, Rockwall and Tarrant County areas. The trial is similar in design to and builds upon the successfully completed Phase 1a trial of ProscaVax and will treat hormone-naïve recurrent prostate cancer patients with increasing PSA that have failed previous conventional therapies. Per protocol, following FDA approval, the trial is scheduled to enroll 30 biochemically progressing prostate cancer patients. The study is anticipated to take three years to complete.

As previously announced, OncBioMune has signed a work order with the leading Contract Research Organization Theradex Oncology for its services throughout this clinical trial. An independent Institutional Review Board (IRB) is being used for this trial, which is expected to reduce IRB review times. Once approved by the FDA and IRB, the clinical trial information will be submitted to clinicaltrials.gov, where the summary of the clinical trial will then be publicly available.

In the completed Phase 1a clinical trial, at 19 weeks post-therapy, 80 percent of the patients (n=20) treated with ProscaVax demonstrated stable disease/no prostate cancer progression. At 43 weeks post-therapy, overall survival was 100% for all 20 patients and 12 of the 17 evaluable patients (70.6%) continued to live with stable, progression-free disease.

As with the BIDMC Phase 2 trial, OncBioMune anticipates releasing interim data as available detailing the safety and efficacy data from ProscaVax therapy.

Corporate Developments

Dr. Jonathan Head, Chief Executive Officer and Chairman at OncBioMune, last week spoke about the development of ProscaVax at Oncology Meeting Innovations’ 2018 Global Summit on Genitourinary Malignancies in Banff, Alberta, Canada. Dr. Head’s presentation was well received and sparked interest in ProscaVax as a compelling experimental immunotherapeutic vaccine targeting prostate cancer at the earliest stage, where no current therapies exist, and in the late stage, where the limited number of FDA-approved therapies frequently fail. Dr. Head’s presentation will be available this week on the Company’s website on the "Investors" > "Events and Presentations" tab.

The Company recently made a significant improvement to its balance sheet with the retirement of $900,000 in debt. The Company continues to focus on improving its liquidity and strengthening its balance sheet in support of the clinical trials and additional continued development of ProscaVax. In furtherance of these efforts, OncBioMune reported that it is planning to host a shareholder conference call in December 2018. The Company expects to disclose details on the call in connection with the filing of its Form 10-Q for the quarter ended September 30, 2018.

"Our team and stakeholders have worked vigilantly to make 2018 a milestone year at OncBioMune. We believe that our concerted efforts have built considerable momentum as we look ahead to 2019," commented Dr. Head. "There is still much work to be done to meet our goal of developing the world’s first therapeutic prostate cancer vaccine, but all that we have accomplished so far this year with positioning for two significant clinical trials certainly gives us reason to be very optimistic about where we are heading for our company, our shareholders and the oncology community."

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About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.