, /PRNewswire/ -- Soligenix, Inc. (Nasdaq: ) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive clinical results from a comparability study evaluating HyBryteTM (synthetic hypericin) versus Valchlor (mechlorethamine gel) in the treatment of (CTCL). The open-label study (protocol HPN-CTCL-04) enrolled 10 patients (5 patients per group) with treatment success defined as a ≥50% improvement in a patient's cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score after 12 weeks of topical treatment compared to Baseline.
The study revealed that treatment resulted in 60% of patients achieving a 50% or better improvement in their mCAILS score versus 20% of Valchlor patients, with HyBryteTM having a more favorable safety profile. All subjects were enrolled by , MD, PhD, at the Rochester Skin Lymphoma Medical Group, . "Following the positive results from the previous Phase 2 and 3 studies where I previously participated in evaluating HyBryteTM, we were excited to support Soligenix's effort to conduct a prospective comparative assessment of HyBryteTM versus Valchlor ," stated Dr.
, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the comparability study. "Despite the small study sample size and a randomization that lead to the HyBryteTM group having patients with more extensiv.