Phase III FLASH trial of SGX 301 shows increased efficacy in T-cell lymphoma.- Soligenix

Soligenix announced that continued treatment with SGX 301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% in the open-label treatment cycle (referred to as Cycle 2) of its pivotal Phase III FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). These highly statistically significant results confirm the benefit of continued SGX 301 treatment in CTCL patients.

Soligenix previously announced positive top-line results when the study achieved statistical significance (p=0.04) in its primary endpoint over the first 6 week double-blind treatment cycle (referred to as Cycle 1) (available here). The study enrolled 169 patients randomized 2:1 to receive either SGX 301 or placebo in Cycle 1. After the subsequent additional 6-week treatment in the open-label Cycle 2, the response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold. Treatment responses for each cycle were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment). A positive response was defined as an improvement of at least 50% in the Composite Assessment of Index Lesion Score (CAILS) for three index lesions evaluated in both Cycles 1 and 2. The data continues to indicate that SGX 301 is safe and well tolerated.

In the third (optional) treatment cycle (Cycle 3), all subjects could receive SGX 301 treatment of all their lesions. Of note, the majority of patients enrolled have elected to continue with this optional cycle of the study. Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX 301 is not systemically available, consistent with the general safety of this topical product observed to date. Results from Cycle 3 and the subsequent 6-month follow-up after completion of treatment will be further announced as the final patients continue to complete their designated visits.