Expanded HyBryte treatment demonstrates positive outcomes in early-stage cutaneous T-cell lymphoma

The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase III FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage CTCL. To date six patients have been enrolled and treated with HyBryte over a time period ranging up to 44 weeks. Patients have responded positively to HyBryte 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 HyBryte 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 has not yet achieved the success threshold. In addition, HyBryte appears to be safe and well tolerated in all patients, with no treatment-related adverse events reported to date.

"In the Phase III FLASH study, HyBryte was shown to be efficacious with a promising safety profile. With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments. In our FDA-funded study, initial results evaluating the expanded use of HyBryte in a 'real world' treatment setting are promising, further supporting and extending results from the previous positive Phase II and III clinical trials," noted Dr. Kim, Principal Investigator of the IIS. "We look forward to continuing to work with the FDA to complete this study and to participating in the upcoming confirmatory Phase III placebo-controlled study."

"We are pleased with the initial study results and with the FDA's support of the IIS that provides CTCL patients an opportunity to access HyBryte in an open-label setting," stated Christopher J. Schaber, President and CEO of Soligenix, Inc. "CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. Following the initial Phase III FLASH study which demonstrated the safety and efficacy of shorter courses of HyBryte therapy, we are pleased to see that continuing treatment for longer time periods is resulting in the anticipated improved outcomes for patients. As the body of compelling data continues to grow in support of this novel therapy, we look forward to working with Dr. Kim on this important study as well as embarking on our confirmatory Phase III replication study later this year. We will continue to provide additional updates on the III as data becomes available."