The European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, granted orphan drug designation to synthetic hypericin, the active pharmaceutical ingredient in SGX301, for the treatment of cutaneous T-cell lymphoma, a rare disease and a class of non-Hodgkin’s lymphoma.
SGX301 has previously been granted both orphan drug and fast track designations from the FDA for the first-line treatment of CTCL.
Soligenix Inc., the drug’s sponsor, is currently working with leading CTCL centers, as well as with the National Organization for Rare Disorders and the Cutaneous Lymphoma Foundation to begin a 120 subject pivotal phase III clinical trial with SGX301 in the second half of 2015.
SGX301 is a novel, first-in-class, photodynamic therapy utilizing visible light for activation. Synthetic hypericin is a potent photosensitizer which is topically applied to skin lesions and activated by visible fluorescent light.
In a phase II, double-blind, placebo-controlled clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3 percent of the CTCL patients responding to SGX301 treatment compared to only 8.3 percent receiving placebo (p <= 0.04).
