News Releases

TAMPA, FLORIDA – (September 12, 2016) – HedgePath Pharmaceuticals, Inc. (OTCQB:HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today that its President and Chief Executive Officer, Mr. Nicholas J. Virca, will present at the Rodman & Renshaw 18th Annual Global Investment Conference to be held in New York City. The presentation will occur on Tuesday, September 13, 2016 at 3pm EST in the Lotte New York Palace Hotel. 

Mr. Virca will provide an update on HPPI’s ongoing Phase II(b) clinical trial in subjects with BCCNS (basal cell carcinoma nevus syndrome) also known as Gorlin Syndrome, a genetic condition where individuals develop multiple basal cell carcinomas at an early age and continue to develop new tumors throughout their lifetime.  Previously announced positive interim data will be reviewed for the first 13 subjects who have completed at least 16 weeks of SUBA-Itraconazole oral dosing.   

SUBA-Itraconazole is a patented formulation of itraconazole which offers significantly improved bioavailability over existing formulations and has exhibited limited to no toxicity in subjects under study.  Mr. Virca will present trial data on reductions in target tumor burden in each subject and treatment results for individual primary target lesions across all subjects compared to baseline, which the company believes thus far demonstrates the clinical impact of its targeted molecular therapy for BCCNS. 

HPPI has an exclusive Supply and License Agreement with a wholly owned subsidiary of Mayne Pharma Group Limited, under which HPPI is pursuing clinical development of Mayne Pharma’s patented formulation of SUBA-Itraconazole for treatment of BCCNS and other cancers with a focus on seeking regulatory approvals and marketing in the United States.  

 

The presentation will be webcast live and can be accessed at www.hedgepathpharma.com.  For those who are not available to listen to the live broadcast, replay of the webcast will be available on the HPPI website. 

 

About HedgePath Pharmaceuticals 

 

HedgePath Pharmaceuticals, Inc. (“HPPI”) is a clinical stage biopharmaceutical company that is seeking to repurpose the FDA approved antifungal pharmaceutical itraconazole as a potential treatment for cancer.  HPPI is the exclusive U.S. licensee of a patented formulation of itraconazole, called SUBA-Itraconazole, which clinical studies have shown to have greater bioavailability than generic itraconazole.  

The Hedgehog signaling pathway is a major regulator of cellular processes in vertebrates, including cell differentiation, tissue polarity and cell proliferation.  Based on published research, HPPI believes that inhibiting the Hedgehog pathway could delay or possibly prevent the development of certain cancers in humans.  Leveraging research undertaken by key investigators in the field, HPPI plans to explore the effectiveness of SUBA-Itraconazole as an anti-cancer agent and to pursue its potential commercialization.  HPPI has offices in Tampa, Florida.  For more information, please visit www.hedgepathpharma.com.  

Cautionary Note Regarding Forward Looking Statements 

This press release, the presentation described herein, and any statements of representatives and partners of HedgePath Pharmaceuticals, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve significant risks and uncertainties.  Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions.  These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission.  Actual results (including, without limitation, the actual timing for, or actual results of, the Company’s clinical trial described herein or the FDA’s review of such results) may differ significantly from those set forth or implied in the forward-looking statements.  These forward-looking statements involve numerous risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control).  The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.  

 

For more information:  

 

Company Contact: 

HedgePath Pharmaceuticals, Inc., Nicholas J. Virca, President and CEO, 813-864-2559 nvirca@hedgepathpharma.com  

 

Investor Relations Contact: 

The Shoreham Group, LLC., Tim Ryan, Managing Director, 212-242-7777 tryan@shorehamgroupllc.com 

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