SGX301 is poised to enter pivotal Phase 3 clinical testing for the treatment of cutaneous T-cell lymphoma (CTCL) and is highly synergistic with the company’s existing development pipeline. As part of the acquisition, Soligenix acquired all rights for synthetic hypericin, including intellectual property, and preclinical and clinical data.
SGX301 is a novel, first-in-class, photodynamic therapy utilizing safe visible light for activation. The active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by fluorescent light. 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 A (UVA) exposure.
Topical hypericin has demonstrated safety in a Phase 1 clinical study in healthy volunteers. In a Phase 2, placebo-controlled, clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3% of the CTCL patients responding to topical hypericin treatment compared to only 8.3% receiving placebo (p = 0.04).
These clinical data fully support advancing this therapy to a pivotal Phase 3 clinical trial in CTCL. The Phase 3 clinical protocol of SGX301 for the treatment of CTCL is currently in final review with the US Food and Drug Administration (FDA).
SGX301 has received orphan drug designation by the FDA for the treatment of CTCL, which provides for 7 years of market exclusivity upon approval in the US. SGX301 is being developed pursuant to discoveries made at New York University Medical Center together with the Yeda Research and Development Company, Ltd., which is the commercial arm of the Weizmann Institute of Science in Rehovot, Israel.
In addition to SGX301, the acquired technology package includes preclinical and clinical data supporting other potential indications for hypericin photodynamic therapy, such as psoriasis. Psoriasis is an autoimmune inflammatory disease that is similarly characterized by cutaneous accumulation of T-cell lymphocytes but without cancerous transformation.
It is a common disease that affects over 7 million adults in the US. Photodynamic therapy is a frequently employed initial therapy for psoriasis, despite the need for ultraviolet light exposure and its attendant risk of melanoma and non-melanoma skin cancer. The Phase 2 clinical study has shown that hypericin and visible light phototherapy is also effective in treating these lesions.
"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," stated Christopher J Schaber, PhD, President & Chief Executive Officer of Soligenix.
"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."