New CTCL Treatment from Soligenix to Begin Phase III Clinical Trial

Biopharmaceutical firm Soligenix has entered into an agreement with the US Food and Drug Administration (FDA) on the design of a major Phase III clinical trial assessing its product SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).

SGX301 is described as a first-in-class, photodynamic therapy using safe visible light for activation. Its active ingredient, synthetic hypericin, is a potent photosensitizer topically applied to skin lesions and activated by visible fluorescent light.

A double-blind, placebo-controlled Phase II trial in CTCL patients demonstrated the drug's safety and tolerance, with 58.3 percent of the CTCL patients responding to SGX301 treatment compared to only 8.3 percent receiving placebo.

"I have had a lengthy scientific and clinical interest in hypericin and am pleased that the Soligenix team is advancing this product to a Phase 3 clinical study," said Alain Rook director of the Cutaneous Lymphoma Program at the University of Pennsylvania. "I believe that SGX301 has the potential to be a major step forward in the treatment of CTCL by providing a safer alternative therapy over the course of the patients' disease than is currently available."

Based on the positive results showed in the Phase II trial of SGX301,

The Phase III protocol for SGX301 will be a double-blind, randomized, placebo-controlled, multicenter trial enrolling 120 patients.

Source: PBR