Expert Opinion on Investigational Drugs is an international monthly peer-reviewed journal, evaluating drugs in preclinical and clinical development.  Authors are encouraged to express their Expert Opinion of the status of the research under review and its impact on clinical practice, rather than simply review the available data.  The audience consists of scientists, managers and decision-makers in the pharmaceutical industry, and others closely involved in research and development.

"Topical synthetic hypericin represents a paradigm shift in the skin-directed management of early-stage CTCL. Its unique mechanism, excellent safety profile, and robust clinical efficacy position it as a formidable potential new agent in the therapeutic armamentarium," stated Dr. Poligone, Director of the Rochester Skin Lymphoma Medical Group. "Following the positive results from the previous Phase 2 and 3 studies I participated in, as well as the ongoing confirmatory FLASH2 Phase 3 study, I was honored to be invited by Expert Opinion on Investigational Drugs to provide a definitive analysis of the HyBryte™ clinical data landscape. HyBryte™ has been demonstrated to have a non-mutagenic mechanism of action, uses a non-carcinogenic light source and appears to have improved tolerability relative to available therapies such as mechlorethamine. The rapid response rates and the efficacy demonstrated on thicker plaque lesions, combined with its activity in difficult to treat disease variants like folliculotropic mycosis fungoides, makes HyBryte™ a potential broad-spectrum, first-line option for patients with early-stage CTCL. We look forward to continuing our support of Soligenix in the development of HyBryte™."

"We are pleased to have Dr. Poligone and his team review the compelling data generated from the HyBryte™ clinical program, enabling the medical community to evaluate its safety, efficacy and utility in early-stage CTCL," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "We look forward to continuing our work with Dr. Poligone and all our principal investigators as we move towards completing patient enrollment in the FLASH2 Phase 3 study later this year, with an interim analysis of this study expected in 2Q 2026."