BATON ROUGE, LA--(Marketwired - May 09, 2017) - OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) ("OncBioMune" or the "Company"), a clinical stage biopharmaceutical company engaged in the development of targeted cancer therapies and a proprietary vaccine technology, is pleased to provide a corporate update on corporate and clinical developments thus far in the first half of 2017.
When OncBioMune chose to enter the public markets in late in September 2015, management was charged with two primary directives to build shareholder value. One was to advance ProscaVax through a phase 1 study into mid-stage trials with the ultimate goal of late-stage research and commercialization as the world's first therapeutic prostate cancer vaccine. The second was to employ an aggressive acquisition strategy for a variety of purposes, including generating revenue to fund R&D activity and additional acquisitions. Approximately one and a half year later, the Company continues to effectively execute on this business model. Since the start of 2017, OncBioMune has announced:
- Completing the acquisition of Vitel Laboratorios S.A. de C.V. ("Vitel"), establishing OncBioMune Mexico S.A. de C.V. as a wholly-owned Mexico City-based subsidiary of OncBioMune as it integrates Vitel's operations into a component of the Company. The acquisition transitioned OncBioMune into a revenue-generating company with two recently commercialized drugs and a portfolio of others either already licensed or in negotiations for licensing or acquisition.
- Sales in Mexico from September 16, 2016 to April 17, 2017 for Bekunis® for constipation and Cirkused® for stress were approximately US$350,000, exceeding projections for US$155,000 initially forecast for the first seven months at product launch during the third quarter of 2016. The Company anticipates that sales efforts will continue to accelerate and anticipates combined sales in the range of US$750,000 to US$850,000 for the products in 2017.
- Completing enrollment in the Phase 1 study of ProscaVax evaluating the novel therapeutic cancer vaccine in the treatment of prostate specific antigen (PSA) recurrent prostate cancer in hormone-naïve and hormone-independent patients.
- Presenting an abstract illustrating research on ProscaVax at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C. Data to date from the trial supports the strong safety profile of ProscaVax while also providing evidence of efficacy with respect to slowing tumor growth and increasing an immune response.
- Receiving authorization to perform the protocol proposed for the Phase 2/3 clinical trial of ProscaVax from the Department of Urology of the High Specialty Hospital IMSS Siglo XXI ("HSH IMSS") in Mexico. This approval followed that of Department of Oncology, meaning that the two departments both offered their support to the Phase 2/3 study of ProscaVax set to commence in Mexico for the treatment of in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients.
- Acquiring tretinoin, also known as all-trans retinoic acid (ATRA), an oral drug for the treatment of Acute Promyelocytic Leukemia (APL) for commercialization throughout Mexico, Central America and Latin America. This was originally announced as a license agreement.
- Submitting to COFEPRIS, Mexico's equivalent of the U.S. Food and Drug Administration, requisite documentation seeking marketing authorization of the Anti-D immunoglobulin product marketed as KamRho® and licensed by OncBioMune for the Mexican market. Anti-D immunoglobulin is listed on the World Health Organization's List of Essential Medicines.
- Partnering with AqVida GmbH, a Germany-based FDF manufacturer specializing in the development, registration, manufacturing and distribution of generic pharmaceutical products, for the purpose commercializing AqVida's portfolio of products in Mexico. AqVida and OncBioMune are further negotiating AqVida's interest to spearhead clinical trials and development of ProscaVax for the European markets.
- The signing of a non-binding term sheet to develop mid-stage GPX-150 compound (5-imino-13-deoxydoxorubicin) in the Mexico, Central and Latin America markets for several hard-to-treat diseases and conditions. The partner has successfully completed a Phase 2 trial in the United States that met safety goals and demonstrated a therapeutic benefit in adult patients with metastatic and nonresectable soft tissue sarcoma.
- The signing of a non-binding term sheet with the world's biggest generic drug manufacturer regarding licensing Norepinefrine as indicated for the treatment of low blood pressure and heart failure for commercialization in the Mexican and other Central and Latin American countries.
- The signing of a non-binding term sheet with for the purpose of development and commercialization of telatinib in 34 countries across Mexico, Central and Latin America. More specifically, the term sheet identified the clinical development of the potent oral VEGFR2/3 inhibitor telatinib for the treatment of gastric cancer.
- The decision, based upon the guidance of Glenn J. Bubley, M.D., Associate Professor, Medicine Harvard Medical School and Director, Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center and the Principal Investigator for the planned Phase 2 study of ProscaVax for early-stage prostate cancer patients in the "active surveillance" category to be hosted at a major Northeast U.S. university cancer center, to submit the study to the Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute. CTEP coordinates the clinical therapeutics development program of the Division of Cancer Treatment and Diagnosis (DCTD) by reviewing clinical trials and evaluating their merits for collaboration and funding.
"We're very proud of all that we have accomplished in a very short period of time so far in 2017," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We're are hitting on all cylinders, but really feel like we are only beginning to hit our stride. As final preparations transpire to commence the two trials of ProscaVax, we're extremely active in discussions to acquire, license or partner for drugs in Mexico and neighboring markets. At this moment, there are a total of 48 drugs/drug candidates that are already under our control for specific markets or are the subject of negotiations. There is a lot of work in front of us to finalize agreements and bring products to market, but all is going according to design with revenue coming in and deals in the works that can bolster revenue many fold in the coming years as ProscaVax moves down the clinical path. We're more confident than ever that we'll look back on 2017 as a transformational year for our company by maintaining our course and continuing to successfully meet milestones."
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About OncBioMune Pharmaceuticals, Inc.
OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.
Forward-Looking Statements
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.
