HedgePath Pharmaceuticals, a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today that it has entered into a definitive agreement with an affiliate of Mayne Pharma Group Limited under which Mayne Pharma will invest $2.5 million in HPPI in a private common stock and warrant financing. The closing of the financing is expected to occur within five business days.
HPPI will use this funding to immediately accelerate its development program, which is focused on the treatment of certain cancers using Mayne Pharma's patented oral formulation of the currently approval anti-fungal drug itraconazole, known as SUBA-Itraconazole, for which HPPI has exclusive U.S. rights in the field of cancer. In particular, HPPI will shortly be commencing a Phase II(b) clinical trial designed to determine the safety and effectiveness of SUBA-Itraconazole dosing on the reduction in individual patient tumor burden in patients with Basal Cell Carcinoma Nevus Syndrome (also known as Gorlin Syndrome). Preliminary results are expected to be available by early 2016.
Mayne Pharma's CEO, Mr. Scott Richards said, "We are excited about increasing our stake in HPPI and accelerating the development and commercialization of our patented SUBA-Itraconazole for the treatment of cancer. The body of evidence supporting the use of itraconazole in cancer is well established, and we believe our SUBA-Itraconazole product provides a number of advantages over conventional itraconazole, including improved bioavailability and more consistent blood levels to improve the therapeutic effect."
Nicholas J. Virca, HPPI's President and CEO, further commented that, "This investment by Mayne Pharma enables us to immediately begin efforts to open clinical trial sites during this quarter for our Phase II(b) study, following the protocols which were cleared by FDA in December 2014."
BCCNS results from a genetic mutation, which causes the Hedgehog pathway to function improperly leading to the chronic formation of basal cell tumors. Industry sources estimate that there are approximately 10,000 patients in the United States with BCCNS, which could potentially qualify for SUBA-Itraconazole under the FDA's Orphan Drug Designation Program for treatment of BCCNS in this patient population.
"Our Phase II(b) design is a single-arm, multi-center, open-label, non-placebo controlled study which will involve the recruiting of up to 40 patients where a meaningful response will be defined as a 30% or greater reduction in the cumulative size of target tumors, based upon the clinical evaluation of at least 33 of 40 patients. We plan to report preliminary results by early 2016, after assessing the effectiveness and safety of 16 weeks of dosing in these patients," commented Mr. Virca. He continued that, "If the results demonstrate we have achieved our primary endpoint, we will initiate further discussions with FDA to determine if our trial could potentially serve as the basis for accelerated approval and submission of a New Drug Application."
In the financing, for its $2.5 million investment, Mayne Pharma will receive 33,333,333 shares of HPPI common stock, bringing its position in HPPI to 49.5% of the currently outstanding common stock, and a 5-year warrant to purchase an additional 33,333,333 shares of HPPI common stock.
HPPI, Mayne Pharma and certain related parties have also entered into updated agreements covering HPPI and Mayne Pharma's joint development of SUBA-Itraconazole for the treatment of cancer as well as certain governance matters relating to HPPI given Mayne Pharma's increased ownership in the company.