Florida’s HedgePath Pharmaceuticals heralded a positive midstage study for its oral capsules designed to treat a complication associated with basal cell carcinoma. The oral regimen demonstrated effectiveness in reducing tumor size, delaying or eliminating the need for surgery.
Basal cell carcinoma nevus syndrome (BCCNS) is the result of a genetic mutation that causes a major regulatory process to malfunction. This process, the Hedgehog pathway, controls cell development in healthy embryos, but in patients with the disease, it causes disfiguring lesions on the face.
Normally, BCCNS would require surgery. But the capsule SUBA-itraconazole gives patients the option to control the symptoms of the disease without an invasive removal, which can cause massive scarring. The FDA orphan drug-designated antifungal candidate is a formulation with improved bioavailability to be administered orally.
In 8 of 13 subjects, tumor burden decreased by more than 30%, according to a release, and the patients had an average reduction of 60% over at least 16 weeks of dosing. Patients had significant basal cell carcinoma and a minimum of 10 surgically eligible lesions, as well as a history of surgical removal. None of the patients showed an increased tumor burden.
HedgePath is the sole patent owner of SUBA-itraconazole.
- here's the release