Soligenix Acquires Phase III Clinical Oncology Candidate SGX301
By Cyndi Root
Soligenix announced in a press release that it has acquired SGX301 (synthetic hypericin), currently entering phase III trials. The photodynamic therapy is a Food and Drug Administration (FDA) designated Orphan Drug for the treatment of cutaneous T-cell lymphoma (CTCL). The drug was developed at New York University Medical Center with the Yeda Research and Development Company, the commercial arm of the Weizmann Institute of Science in Rehovot, Israel. Solgenix acquired all Intellectual Property (IP) right, preclinical data, and clinical data supporting other indications, such as psoriasis.
Christopher J. Schaber, PhD, President and CEO of Soligenix, 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.”
SGX301
SGX301 is a robust photosensitizer with hypericin as the active ingredient. Applied topically to skin lesions, fluorescent light activates the agent, in contrast to treatments that use ultraviolet A (UVA), which could lead to a secondary malignancy. In a Phase I trial, topical hypericin demonstrated safety. In a Phase II trial, 58 percent of participants responded to treatment, compared to 8 percent in the placebo group. That study also showed that the drug was well tolerated and safe. The FDA is currently reviewing the Phase III clinical protocol.
Included in the acquired rights are preclinical and clinical data that support SGX301 usage in other indications. Conditions such as psoriasis may respond to hypericin photodynamic therapy. Psoriasis is a cutaneous accumulation of T-cell lymphocytes that do not transform to cancer. A disease that affects over seven million people in the U.S., standard psoriasis care is UVA light exposure, which exposes the patient to the risk of melanoma and non-melanoma skin cancer.
About Soligenix
Soligenix develops products for inflammation, oncology, and biodefense. The company is developing oral BDP (beclomethasone 17, 21-dipropionate) for gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease, acute radiation enteritis, and chronic Graft-versus-Host disease. Soligenix works with Biomedical Advanced Research and Development Authority (BARDA) on biodefense countermeasures, such as RiVax for ricin toxin and VeloThrax for anthrax exposure.