The late-stage biopharmaceutical company Soligenix announced that it has begun patient enrollment for the investigator-initiated RW-HPN-MF-01 study (ClinicalTrials.gov identifier NCT05872854) designed to evaluate the expanded treatment of synthetic hypericin in patients with early-stage cutaneous T-cell lymphoma (CTCL). Researchers plan to enroll 50 patients from select high-enrolling clinical centers that participated in the previous phase III FLASH study—which demonstrated that synthetic hypericin exhibited a positive safety profile and may be an effective therapy for this patient population. The patients who participate in the new study will receive up to 12 months of treatment with two doses per week of ointment application followed by visible light activation 24 ± 6 hours later. In addition, patients will have the opportunity to transition to the home-use setting. The researchers noted that the primary endpoint of the study will be the quantity of successful treatments, defined as ≥ 50% reduction in the cumulative Composite Assessment of Index Lesion Severity score from baseline to the end of the treatment. “This [study] has the potential to augment the expanding safety database for synthetic hypericin as well as provide further evidence into [its practical use] once commercially available,” concluded Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
August 21, 2023