HedgePath Pharma receives expanded US patent coverage

TAMPA, FloridaWednesday, May 16, 2018, 17:00 Hrs  [IST]

HedgePath Pharmaceuticals, Inc. (HPPI), a clinical stage bio-pharmaceutical company that discovers, develops and plans to commercialise innovative therapeutics for patients with cancer, announced that the US Patent and Trademark Office (USPTO) has issued a new patent to HPPI which expands the company's patent portfolio.

The new patent is entitled "Treatment and Prognostic Monitoring of Cancerous Proliferation Disorders Using Hedgehog Pathway Inhibitors." The claims covered by the patent relate to the use of the already FDA-approved anti-fungal drug itraconazole being re-purposed by HPPI to treat cancer. A patented formulation of itraconazole is being studied by HPPI as a product candidate for the treatment of cancer.

Nicholas Virca, HPPI's president and chief executive officer, stated, "This new patent, which has 21 claims, relates to methods for treating cancer by orally administering a formulation of itraconazole that confers superior bio availability compared to conventional formulations of itraconazole. The patent covers treatment of hematologic cancers, such as leukemia or lymphoma, as well as non-hematologic cancers including lung, ovarian, breast, brain and pancreatic cancers. The patent claims also cover treatment of prostate cancer, basal cell carcinoma, and other cancers, and monitoring subjects undergoing such treatments based on biomarkers and other criteria predictive of efficacy. Issuance of this patent strengthens and expands the scope of patent protection provided by our first patent, US Patent No. 9,192,609, which issued on November 24, 2015."

The basic premise behind HPPI's proposed therapy is that in certain cancers, the Hedgehog pathway, a major regulator of many fundamental cellular processes, malfunctions, thus leading to the formation of cancerous cells. Itraconazole appears to act on the essential Hedgehog pathway component 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. Itraconazole also has a much shorter half-life than vismodegib, which may be the reason it has less side effects than vismodegib.

The new patent's claims also cover techniques for prognosticating an outcome of prostate cancer treatment with the itraconazole therapy, and for determining the efficacy of the therapy, based on post-therapy prostate-specific antigen levels. Unlike the majority of prostate cancer drugs, which target androgens in order to lower testosterone levels, the effect of itraconazole for treatment of prostate cancer is androgen-independent.

This expanded IP coverage supports HPPI's efforts in exploiting the many potential opportunities regarding Hedgehog pathway modulation as a "molecular indication" as opposed to narrower, cancer specific approvals.