Phase III FLASH trial of SGX 301 shows statistical significant response in cutaneous T-cell lymphoma.- Soligenix

Soligenix announced positive preliminary top-line results for its pivotal Phase III FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX 301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04). SGX301 treatment in the first cycle was safe and well tolerated. In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment. Comment: Of note, preliminary results from blinded data to date suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment. Further independent review of lesion photographs may be conducted to provide for a more uniform confirmation of response. Results from Cycle 2 are expected to be announced in June 2020.