BATON ROUGE, La., Nov. 08, 2018 (GLOBE NEWSWIRE) — 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, today provides an update on its upcoming Phase 2 clinical trials of ProscaVax for prostate cancer and other corporate developments.<\/p>\n
Phase 2 Trial, Early-Stage Prostate Cancer<\/strong><\/p>\n The Company\u2019s lead Phase 2 trial of ProscaVax for prostate cancer (https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03579654<\/u><\/a>) is being hosted by Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University, and its affiliate hospital.\u00a0 \u00a0The Company today announced that the trial will commence on or about December 17, 2018.\u00a0 Enrollment is scheduled for 120 patients (80 in the ProscaVax arm, 40 in active surveillance arm).\u00a0<\/p>\n This study will evaluate the safety and efficacy of ProscaVax, OncBioMune\u2019s 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.\u00a0 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.<\/p>\n 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.<\/p>\n Primary outcomes for the study are:<\/p>\n Secondary Outcomes for the study are:<\/p>\n Management anticipates providing interim results throughout the trial as they are available, tentatively beginning during the second quarter of 2019.<\/p>\n Phase 2 Trial, Late-Stage Prostate Cancer<\/strong><\/p>\n This study, which is expected to get the FDA green light in the coming weeks, is being hosted by Urology Clinics of North Texas<\/u><\/a>, a preeminent 10-center urology group in Texas serving the Dallas, Fort Worth, Collin, Rockwall and Tarrant County areas.\u00a0 The trial is similar in design to and builds upon the successfully completed Phase 1a trial of ProscaVax and will treat hormone-na\u00efve recurrent prostate cancer patients with increasing PSA that have failed previous conventional therapies.\u00a0 Per protocol, following FDA approval, the trial is scheduled to enroll 30 biochemically progressing prostate cancer patients.\u00a0 The study is anticipated to take three years to complete.<\/p>\n As previously announced, OncBioMune has signed a work order with the leading Contract Research Organization Theradex Oncology for its services throughout this clinical trial.\u00a0 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.<\/p>\n 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. \u00a0At 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.<\/p>\n As with the BIDMC Phase 2 trial, OncBioMune anticipates releasing interim data as available detailing the safety and efficacy data from ProscaVax therapy.<\/p>\n Corporate Developments<\/strong><\/p>\n Dr. Jonathan Head, Chief Executive Officer and Chairman at OncBioMune, last week spoke about the development of ProscaVax at Oncology Meeting Innovations\u2019 2018 Global Summit on Genitourinary Malignancies in Banff, Alberta, Canada. Dr. Head\u2019s 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.\u00a0 Dr. Head\u2019s presentation will be available this week on the Company\u2019s website on the \u201cInvestors\u201d > \u201cEvents and Presentations\u201d tab.<\/p>\n The Company recently made a significant improvement to its balance sheet with the retirement of $900,000 in debt.\u00a0 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.\u00a0 In furtherance of these efforts, OncBioMune today announced that it is planning to host a shareholder conference call in December 2018.\u00a0 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.<\/p>\n \u201cOur 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,\u201d commented Dr. Head.\u00a0 \u201cThere is still much work to be done to meet our goal of developing the world\u2019s 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.\u201d<\/p>\n Sign up for OncBioMune email alerts at: http:\/\/oncbiomune.com\/email-alerts\/<\/u><\/a>.<\/p>\n About Prostate Cancer<\/strong><\/p>\n 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.\u00a0 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.\u00a0 Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer.\u00a0 Approximately 2.9 million men are living with prostate cancer today.\u00a0 The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.<\/p>\n About OncBioMune Pharmaceuticals, Inc.<\/strong><\/p>\n OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, based on their proprietary therapeutic cancer vaccine technology designed to stimulate the immune system to attack tumor cells without damaging healthy tissue. Our lead pipeline product, ProscaVax\u2122, has successfully completed enrollment and vaccination of the prostate cancer patients and is collecting long-term follow-up results for the 1a portion of their Phase 1a\/1b clinical trial.\u00a0 Due to the impressive results and proven safety profile of ProscaVax\u2122, OncBioMune is forgoing the 1b portion of the trial to advance ProscaVax\u2122 into Phase 2 clinical trials\u00a0 A Phase 2 clinical trial is scheduled to commence at Beth Israel Deaconess Medical Center a Harvard University teaching hospital evaluating ProscaVax as a front-line therapy in prostate cancer patients in the \u201cactive surveillance\u201d category, representing the first mid-stage trial of an immunotherapeutic vaccine in this patient population.\u00a0 OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars and generics to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.<\/p>\n Forward-Looking Statements<\/strong><\/p>\n This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause OncBioMune Pharmaceuticals’ actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. OncBioMune Pharmaceuticals has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are OncBioMune Pharmaceuticals’ need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that OncBioMune Pharmaceutical’s vaccines and therapeutics may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in OncBioMune Pharmaceutical’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. OncBioMune Pharmaceuticals undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.<\/p>\n Contact:<\/strong><\/p>\n OncBioMune Pharmaceuticals, Inc. \u00a0<\/p>\n","protected":false},"excerpt":{"rendered":" BATON ROUGE, La., Nov. 08, 2018 (GLOBE NEWSWIRE) — 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, today provides an update on its upcoming Phase 2 clinical trials of ProscaVax for prostate cancer and other corporate developments.<\/p>\n Phase 2 Trial, Early-Stage Prostate Cancer<\/strong><\/p>\n The Company’s lead Phase 2 trial of ProscaVax for prostate cancer (https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03579654<\/u><\/a>) is being hosted by Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University, and its affiliate hospital. The Company today announced 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). <\/p>\n 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.<\/p>\n 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.<\/p>\n Primary outcomes for the study are:<\/p>\n Secondary Outcomes for the study are:<\/p>\n Management anticipates providing interim results throughout the trial as they are available, tentatively beginning during the second quarter of 2019.<\/p>\n\n
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Jonathan F. Head, PhD
Chief Executive Officer and Chairman of the Board
Jhead@oncbiomune.com<\/p>\n\n
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