HedgePath Pharmaceuticals Announces Commencement of Patient Treatment in its Phase II(b) Clinical Trial

TAMPA, Fla. and SAN DIEGO, Sept. 29, 2015 /PRNewswire/ -- 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 initial patients have received base-line screening and the first of those patients has begun dosing in HPPI's Phase II(b) clinical trial examining SUBA™ Itraconazole Capsules as a potential therapy for basal cell carcinoma (BCC) in patients with basal cell carcinoma nevus syndrome (BCCNS), also known as Gorlin's Syndrome.

Today's announcement follows HPPI's August 2015 announcement of the commencement of enrollment in this trial, known as the SCORING trial (SUBA Cap Objective Response in Gorlin's).

Nicholas J. Virca, HPPI's President and CEO, commented that, "I am pleased to report that we continue to make progress with our SUBA-Itraconazole development program at our clinical trial sites in Florida, Michigan and California.  Based upon our on-going pre-screening program, which we implemented last month, we have now begun the process of treating our initial patients and scheduling additional patient visits to carry out base-line screening for subsequent enrollment into the first sixteen week phase of testing. (For more information, visit ClinicalTrials.gov, study identifier NCT02354261).

HPPI separately announced that it has entered into a sublicense with its commercial partner and licensor Mayne Pharma for exclusive rights in the U.S. to two additional patents regarding the use of itraconazole for treatment of cancer, namely US patent No 8,980,930 entitled "Angiogenesis Inhibitors", issued on March 17, 2015 and US patent No 8,653,083 entitled "Hedgehog Pathway Antagonists to Treat Disease", issued on February 18, 2014.

Mr. Virca commented, "We believe that our progress in the clinic and continued positive collaboration with our partner Mayne Pharma continue to demonstrate our commitment to the clinical development and eventual commercialization of SUBA-Itraconazole as an anti-cancer therapy in the U.S. should we gain FDA approvals for our proposed therapies."

About HedgePath Pharmaceuticals

HedgePath Pharmaceuticals, Inc. (OTCQB: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 and San Diego, California.  For more information, please visit www.hedgepathpharma.com.

Cautionary Note Regarding Forward Looking Statements

This press release 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, [email protected] 

Investor Relations Contact:
HedgePath Pharmaceuticals, Inc., Garrison Hasara, CFO & Treasurer, [email protected]

© 2015 HedgePath Pharmaceuticals, Inc.  All rights reserved.

Logo - http://photos.prnewswire.com/prnh/20150928/271412LOGO

SOURCE HedgePath Pharmaceuticals, Inc.

Related Links

http://www.hedgepathpharma.com