#United States #Princeton #Soligenix #HyBryte #Cutaneous T-Cell Lymphoma

Soligenix Updates Its Medical Advisory Board for HyBryte™ Development

Soligenix, Inc., a biopharmaceutical company with a focus on rare diseases, recently announced significant changes to its United States Medical Advisory Board (MAB) for the treatment of cutaneous T-cell lymphoma (CTCL). This update is part of the company's strategic initiative to enhance clinical development and regulatory engagements related to its promising drug candidate, HyBryte™ (synthetic hypericin).

The Role of the Medical Advisory Board

Consisting of specialists in dermatology and oncology, the MAB provides invaluable expertise and guidance for clinical programs. Their contributions are crucial in navigating the regulatory landscape, particularly during the ongoing Phase 3 clinical trial known as FLASH2 for HyBryte™.

Given recent member retirements, Soligenix proudly announces the addition of leading experts in CTCL as principal investigators for the HyBryte™ program. This diverse group will continue offering insights into clinical strategies and opportunities for incorporating home-use applications of the therapy, which could significantly benefit CTCL patients facing treatment challenges.

Key Members of the Advisory Board

Among the newly appointed MAB members is Dr. Jennifer DeSimone, an Associate Professor of Dermatology at the University of Virginia. Dr. DeSimone is an authority in cutaneous oncology and has been involved in numerous clinical trials, making her insights particularly valuable for advancing the clinical applications of HyBryte™.

Another esteemed member, Dr. Youn Kim from Stanford University, brings extensive experience in multidisciplinary research for cutaneous lymphoma. Her leadership and publication record, with over 350 contributions to the field, amplify the board's capability to offer strategic clinical guidance.

Dr. Aaron Mangold, recognized for his research in complex medical dermatology, will also play a pivotal role in the ongoing development of HyBryte™, facilitating valuable research operations. As the chair of Dermatology Research at the Mayo Clinic, he aims to maximize patient outcomes with HyBryte™ treatments.

Finally, Dr. Brian Poligone, who has been at the forefront of lymphoma research, has played a crucial role in the HyBryte™ trials, treating numerous patients. His extensive expertise will steer the board's strategic direction.

Advancements in HyBryte™ Clinical Development

HyBryte™ represents a first-in-class, photodynamic therapy that utilizes visible light for activation alongside synthetic hypericin, a photosensitizer that effectively targets malignant T-cells in the skin. This novel approach not only ensures enhanced safety by avoiding DNA-damaging agents often associated with severe side effects but also provides targeted treatment for deeper skin lesions, which are common in CTCL patients.

Clinical studies have already demonstrated promising efficacy, with significant enhancements in patient conditions observed in the initial stages of current trials. Continuous monitoring by the MAB ensures that patient needs resonate with the therapy outcomes.

Future Expectations

Upcoming development plans include the second Phase 3 trial, FLASH2, anticipated to solidify HyBryte™’s efficacy in treating early-stage CTCL. This multi-center study intends to enroll approximately 80 subjects, emphasizing extended treatment duration to replicate real-world scenarios. Soligenix aims to streamline patient recruitment through active engagement with the CTCL community, supported by ongoing dialogues with regulatory bodies.

As Soligenix establishes this enhanced framework through the updated Medical Advisory Board, the company remains committed to addressing the unmet medical needs faced by CTCL patients globally. By employing innovative clinical strategies under expert guidance, Soligenix seeks to bring viable therapies to market that could redefine the landscape of rare disease treatment.