Late-stage biopharmaceutical company, Soligenix, Inc., known for developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced the European Commission, based on the recommendation of the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted synthetic hypericin (SGX301’s active pharmaceutical ingredient) orphan drug designation as a treatment for cutaneous T-cell lymphoma (CTCL). This new designation follows SGX301’s previously granted orphan and fast track designations from the US Food and Drug Administration as a first-line treatment for CTCL.
The Company has been busy collaborating with some of the most prominent CTCL centers, together with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to launch a crucial Phase III clinical study with SGX301 involving 120 patients. The study is expected to begin in the second half of 2015, and will be testing this novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation.
SGX301’s active ingredient, synthetic hypericin, is a strong photosensitizer which when topically applied to lesions fluoresces and reduces the risk of secondary malignancies commonly associated with chemotherapy and other methods of photo therapy. SGX301 produced favorable safety profiles in previous Phase I studies in healthy volunteers, and favorable tolerability in a Phase II, double-blind, placebo-controlled study in CTCL patients. With the new orphan drug designation, Soligenix can expect 10 years of marketing exclusivity in the European Union upon SGX301’s final approval, along with incentives for protocol assistance during the rest of product development.
“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.”
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