Soligenix all set to begin FLASH clinical trial for SGX301 in CTCL

US biopharma company Soligenix has wrapped up enrolling patients for its phase 3 Fluorescent Light Activated Synthetic Hypericin clinical trial (FLASH clinical trial) for SGX301 (synthetic hypericin) in cutaneous T-cell lymphoma (CTCL).

The late-stage study enrolled 169 subjects in the FLASH clinical trial. This was after Soligenix secured positive interim analysis, which included a prospectively defined, unblinded evaluation of the primary efficacy endpoint of the FLASH clinical trial by an independent Data Monitoring Committee (DMC).

Soligenix expects to release top-line results in Q1 2020.

SGX301 is a photodynamic therapy that uses the photosensitizer synthetic hypericin that is applied as an ointment to the cancerous skin lesions and activated using a short and, safe, fluorescent light treatment.  This treatment approach is likely to minimize the risk of secondary malignancies, including melanoma, that is inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that depend on exposure to ultraviolet A and B light, said Soligenix.

Christopher J. Schaber – President and CEO of Soligenix said: “We are pleased to have completed enrollment and look forward to the top-line results in the first quarter of next year, particularly in light of the DMC recommendation at the interim analysis which observed a beneficial drug effect.

“We have invested a significant amount of the Company’s resources into the CTCL development program and continue to positively position this fast-tracked program for approval.  We believe SGX301 has the potential to be a valuable therapy in the front-line treatment of early stage CTCL, which is an orphan disease and area of unmet medical need.”