, /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 an interim update on the open-label, investigator-initiated study (IIS) evaluating extended treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). The trial is sponsored by , MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the who was a leading enroller in the for the treatment of early-stage CTCL.
To date six patients have been enrolled and treated with HyBryteTM over a time period ranging up to 44 weeks. Patients have responded positively to HyBryteTM therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving "Treatment Success", as predefined in the study's protocol as ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks.
Of the remaining three patients, two have only recently started HyBryteTM therapy and have not yet reached their first efficacy evaluation visit (i.e., at Week 6) and the other had a substantial improvement documented at the Week 18 visit, but .
