Soligenix receives us patent for improved production of synthetic hypericin composition

Soligenix, inc. announced that the united states (us) patent office has allowed the divisional patent application titled "systems and methods for producing synthetic hypericin". the allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin. synthetic hypericin is the active pharmaceutical ingredient in sgx301, the company's photodynamic therapy for the treatment of cutaneous t-cell lymphoma (ctcl), currently the subject of an actively recruiting pivotal phase 3 clinical trial where final topline results are expected in the first quarter of 2020. this new divisional claim set expands on the previous issued claims in the parent us patent (no. 10,053,413) protecting the composition of the purified synthetic hypericin and is expected to expire in 2036. these patents broaden the patent protection conferred by earlier issued us patents covering methods of use (no. 7,122,518) and methods of synthesis (no. 8,629,302). sgx301 is a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a potent photosensitizer that is applied to the cancerous ctcl skin lesions and activated using a brief, safe, fluorescent light treatment. this treatment approach is expected to minimize the risk of secondary malignancies (including melanoma) inherent with the frequently employed dna-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet a and b exposure. based on the positive results demonstrated in the phase 2 study of sgx301, the phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial seeking to enroll 160 subjects. the phase 3 study is referred to as the flash (fluorescent light activated synthetic hypericin) trial. the trial consists of three treatment cycles, each of 8 weeks duration. treatments are administered twice weekly for the first 6 weeks and treatment response is determined at the end of week 8. in the first treatment cycle, approximately 107 subjects will receive sgx301 treatment and 53 will receive placebo treatment of their index lesions. in the second cycle, all subjects will receive sgx301 treatment of their index lesions and in the third (optional) cycle all subjects will receive sgx301 treatment of all their lesions. subjects will be followed for an additional 6 months after the completion of treatment. to date, the majority of patients enrolled have elected to continue on with the optional, open-label component of the study. an interim analysis completed in october 2018 identified a promising signal and adjusted the study sample size to maintain the rigorous 90% power of the study.
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