HedgePath Pharmaceuticals, Inc., a pharmaceutical development company focused on discovering, developing and ultimately commercializing innovative therapeutics to inhibit the progression of cancerous and non-cancerous proliferation disorders, announced that the U.S. Patent and Trademark Office (USPTO) has notified HedgePath that new claims have been allowed regarding the use of the anti-fungal drug itraconazole, and specifically the patented formulation of SUBA-Itraconazole in patients with prostate cancer. SUBA-Itraconazole is HedgePath’s proprietary formulation of itraconazole and is designed to enable improved bioavailability compared to conventional itraconazole. HedgePath is the exclusive U.S. licensee of SUBA-Itraconazole in certain fields.

In the coming months, HedgePath intends to submit an IND (Investigational New Drug application) to the U.S. Food and Drug Administration (FDA) to study SUBA-Itraconazole treatment in patients with late-stage, advanced prostate cancer, and thereafter initiate a clinical trial once the IND is cleared.

This new patent, for which 20 claims have been allowed, relates to methods for treating both non-metastatic prostate cancer and metastatic castrate-resistant prostate cancer (mCRPC) by orally administering SUBA-Itraconazole. The claims also include the use of itraconazole in combination with chemotherapy regimens, which are the standard of care for late-stage prostate cancer patients. Additionally, the newly allowed claims cover techniques for prognosticating an outcome of prostate cancer treatment with itraconazole therapy and for determining the efficacy of the therapy, based on post-therapy prostate-specific antigen (PSA) levels.

Nicholas J. Virca, HedgePath’s President and Chief Executive Officer, stated, “Our clinical development program for prostate cancer will test SUBA-Itraconazole in conjunction with standard of care chemotherapy to assess whether the combination regimen could be of clinical benefit for the approximately 23,000 men in the United States each year who are diagnosed with late-stage prostate cancer. These patients appear to become resistant to androgen deprivation therapy (ADT) due to up-regulation of the Hedgehog (Hh) pathway, a major regulator of many fundamental cellular processes. The issuance of this new patent for treatment of prostate cancer with SUBA-Itraconazole, and our planned IND submission in the coming months, represent meaningful progress toward the human testing of our proposed therapy for these patients.”

In late-stage prostate cancer, up-regulation of the Hedgehog pathway may result in oncogene expression which interferes with the binding of ADT drugs to the androgen receptor (AR), thus causing biochemical resistance leading to mCRPC. Based on human testing, as well as in vitro studies, itraconazole appears to bind to the essential Hedgehog signaling pathway component in human cells called Smoothened (SMO) in a manner that is different than the FDA-approved drug vismodegib by preventing the ciliary accumulation of SMO normally caused by Hedgehog stimulation. Based on pre-IND discussions with FDA to date, HedgePath believes that following IND clearance, the company will look to initiate a multi-center Phase 2b clinical trial seeking to demonstrate that the addition of SUBA-Itraconazole to standard of care chemotherapy can improve rPFS (radiographic progression free survival) in late-stage mCRPC patients.