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SNGX: Soligenix Acquires a Phase 3 Oncology Platform for the Treatment of Cutaneous T-Cell Lymphoma

By Anthony Schwartz, PhD


Soligenix (SNGX) is a clinical stage biopharmaceutical company focused on the development of therapeutics for the treatment of inflammatory diseases, cancer and biodefense applications. On September 5th, 2014, the company announced the acquisition of all intellectual property, preclinical and clinical data for SGX301 (synthetic hypericin), a novel drug poised to enter Phase 3 trials for the treatment of cutaneous T-cell lymphoma (CTCL).

SGX301, a topically applied photosensitizer, utilizes safe and visible light for activation and treatment of CTCL. Clinical data from a Phase 2 study showed a 58.3% response rate in patients with CTCL compared to 8.3% in patients receiving placebo (p = 0.04). The drug has received orphan drug designation with the FDA and data are in final review with the FDA with the intention of starting a pivotal Phase 3 trial in the near future. Currently, there are no approved therapies for the treatment of CTCL, which has a median survival of only 2.5 years in patients with advanced CTCL. Unapproved therapies such as Psoralen, a mutagenic chemical, is administrated with ultraviolet A light which is known to be carcinogenic and can lead to secondary skin cancers. Christopher J. Schaber, PhD, stated, “We are very excited by the acquisition of this late-stage technology which has the potential to be the first photodynamic therapy approved for CTCL.”

Soligenix acquired the rights for SGX301 from HY Biopharma, Inc for $14 million in cash and restricted securities. The orphan designation allows for 7 years of market exclusivity in the US if SGX301 is approved. In addition to CTCL, the SGX301 platform also includes data supporting other indications such as psoriasis. Dr. Schaber also said, "With SGX301 we will be able to leverage our clinical development expertise in cancer and cancer supportive care.  We also anticipate the potential for a number of federal funding opportunities for SGX301 in this orphan disease, as well as for expansion into other indications of unmet medical need."


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