Soligenix Receives Patent for Improved Production of Synthetic Hypericin

Soligenix announced the United States Patent Office (USPTO) has granted the patent titled "Systems and Methods for Producing Synthetic Hypericin." The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. 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 with an interim analysis anticipated in the October 2018 timeframe. This new patent (No. 10,053,413), expected to expire in 2036, broadens the protection around synthetic hypericin, in addition to the previously granted 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 avoids 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 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 120 evaluable 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 80 subjects will receive SGX301 treatment and 40 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.

A blinded interim analysis for the study is anticipated in the October 2018 timeframe, with final topline results for the trial targeted for the first half of 2019.

"This recently issued patent continues to expand, strengthen and protect our synthetic hypericin patent estate," Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix said. "With the support of the National Cancer Institute (NCI), most recently providing $1.5 million of funding under a two year Small Business Innovative Research (SBIR) grant, as well as important contributions from key patient advocacy organizations, such as the Cutaneous Lymphoma Foundation, we look forward to completing the ongoing Phase 3 CTCL study to potentially address the unmet medical need that currently exists in this orphan disease."

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