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FDA grants fast track status to SGX301 for cutaneous T-cell lymphoma
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The FDA granted fast track status to SGX301 for the treatment of cutaneous T-cell lymphoma, the drug’s manufacturer announced today.
SGX301 (Soligenix) is a novel first-in-class photodynamic therapy.
The active ingredient — synthetic hypericin, a potent photosensitizer — is applied topically to skin lesions that is activated by fluorescent light 16 to 24 hours later.
The FDA’s Fast Track program is intended to facilitate the development and expedite the review of new drugs intended to treat serious conditions, as well as agents that would fill unmet medical needs.
Results of a phase 2 study showed SGX301 combined with photoactivation demonstrated considerable anti-proliferative effects on activated normal human lymphoid cells. SGX301, which previously received orphan drug designation from the FDA, also inhibited growth of cancerous T-cells from patients with cutaneous T-cell lymphoma.
Researchers reported statistically significant improvement with topical hypericin treatment compared with placebo (58.3% vs. 8.3%; P<.04). A phase 3 study is expected to begin in the first half of this year.
“We are very pleased to have been granted fast track designation from the FDA,” Christopher J. Schaber, PhD, president and CEO of Soligenix, said in a press release. “We believe that the FDA’s action in granting fast track designation validates the unmet medical need that currently exists for first-line treatment of cutaneous T-cell lymphoma and for the potential key role SGX301 can serve as a first-line therapy in this rare, life-threatening disease.”