Soligenix, Inc. (SNGX) Receives European Patent for Therapeutic Use of Synthetic Hypericin to Treat Cutaneous T-Cell Lymphoma

April 6, 2020 7:05 AM EDT
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Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European patent office has granted the divisional patent application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 2932973). The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL). Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the Company's photodynamic therapy, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of CTCL were recently announced (available here). This new patent expands on Soligenix's comprehensive patent estate, which includes protection on the composition of the purified synthetic hypericin, methods of synthesis and therapeutic methods of use in both CTCL and psoriasis, and is being pursued worldwide.

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. In the double-blind, placebo-controlled Phase 3 "FLASH" (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 demonstrated a statistically significant improvement (p=0.04) in its primary endpoint after just 6 weeks of therapy (Cycle 1). The open-label extended treatment (Cycles 2 and 3) and 6–month safety follow-up remain ongoing, with data from Cycle 2 expected to be available in June 2020. Preliminary assessment of the blinded Cycle 2 results suggest a more robust response rate after 12 weeks of SGX301 treatment.

"This recently issued patent continues to expand, strengthen and protect our synthetic hypericin patent estate," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the support of the National Cancer Institute (NCI), most recently providing $1.5 million of non-dilutive 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 pivotal Phase 3 CTCL study to potentially address the unmet medical need that currently exists in this orphan disease.

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