HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage CTCL
“The complete response rate, consistent treatment response and safety profile across multiple clinical studies to date with HyBryte™ has been exciting to see,” noted Dr. Kim, Principal Investigator of the IIS and Lead Investigator of the FLASH2 study. “In the first Phase 3 FLASH study, HyBryte™ was shown to be efficacious with a benign safety profile compared to the current therapies of steroids, chemotherapeutics and ultraviolet light in this chronic orphan disease. With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments. In our U.S. Food and Drug Administration (FDA)-funded study, initial results evaluating the expanded use of HyBryte™ in a “real world” treatment setting remain very promising, further supporting and extending results from the previous positive Phase 2 and 3 clinical trials. We look forward to continuing to work with the FDA to complete this study while we participate in the confirmatory Phase 3 placebo-controlled FLASH2 study.”
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