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Soligenix Earns Orphan Status in Europe
Late-stage biopharmaceutical company Soligenix has announced that the European Commission, acting on a positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation to synthetic hypericin (which is the active pharmaceutical ingredient in the company's SGX301 product) for the treatment of cutaneous T-cell lymphoma (CTCL).
Soligenix is currently working on a large, phase III clinical trial for SGX301, a novel, first-in-class, photodynamic therapy that uses safe, visible light instead of DMA-damaging ultraviolet light or radiation. Synthetic hypericin, a photosensitizer, is applied to skin lesions and activated by visible fluorescent light.
A phase II trial has confirmed the safety of SGX301 and patients had good responses to the treatment; 58 percent of patients in the phase II trial had responses compared to just over eight percent with placebo.
"We are extremely pleased to have received European orphan drug designation for the SGX301 program," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix, Inc. "This EU orphan designation, combined with our US orphan and fast track designations, positions SGX301 for an accelerated global regulatory product development pathway to address the significant unmet need that exists for this important indication. We look forward to aggressively advancing our pivotal Phase 3 study of SGX301 in CTCL."
Source: PR Newswire