HedgePath Pharma seeks FDA guidance on its SUBA-Cap trial

Thirty-seven percent of patients in the Phase 2(b) trial have demonstrated an equal to or greater than 30 percent reduction in target tumor burden.
Thirty-seven percent of patients in the Phase 2(b) trial have demonstrated an equal to or greater than 30 percent reduction in target tumor burden. | File image

HedgePath Pharmaceuticals Inc. (HPPI) recently announced that the U.S. Food and Drug Administration (FDA) granted the company’s Type-C Guidance Meeting Request for further guidance on HPPI’s Phase 2(b) clinical trial analyzing SUBA-Itraconazole (SUBA-Cap) oral capsule usage in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome.

“We reported to FDA that 37 percent of our patients in our Phase 2(b) trial have demonstrated an equal to or greater than 30 percent reduction in target tumor burden and there has been a complete disappearance of 28 percent of all target lesions across all subjects,” HPPI President and CEO Nicholas Virca said in a statement. “We are testing SUBA-Cap therapy in BCCNS patients with a significant history of BCC surgeries and intend to further note in our background package that, for the 35 patients being dosed in our trial, the mean number of prior BCCs removed by surgery was 195 per patient, yet 97 percent of our study group have avoided surgery while on SUBA-Cap therapy. We are very pleased with these results and look forward to FDA’s feedback as we move towards the conclusion and reporting of the results of this trial.”

HPPI is a clinical stage biopharmaceutical company; it seeks to commercialize new and innovative therapeutics for treating cancer patients.

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HedgePath Pharmaceuticals, Inc. 324 S Hyde Park Ave Tampa, FL - 33606