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news.US-based 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) to treat cutaneous T-cell lymphoma (CTCL).
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SGX301 is a first-in-class, photodynamic therapy using safe visible light for activation and its active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by visible fluorescent light.
The company said that topical hypericin has showed safety in a Phase I clinical trial carried out in healthy volunteers.
While in a double-blind, placebo-controlled Phase II trial in CTCL patients, the drug was seen safe and well tolerated, with 58.3% of the CTCL patients responding to SGX301 treatment compared to only 8.3% receiving placebo.
Hospital of the University of Pennsylvania director of Cutaneous Lymphoma Program Alain Rook said the university supports Soligenix in their efforts to improve outcomes for patients with CTCL, affecting up to 50,000 patients in the US.
"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," Rook said.
"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 upcoming Phase III protocol will be a highly powered, double-blind, randomized, placebo-controlled, multicenter trial.
Around 120 patients will be enrolled in the trial which will consist of three treatment cycles, each of eight weeks duration.