Two Presentations Highlight HyBryte™ Therapy's Improved Response Rates with Extended Treatment and Increased Light Doses
PRINCETON, N.J., Oct. 7, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (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 today that two of its lead investigators are presenting findings from recent additional, supportive trials with HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The presentations will occur at the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumour Group Annual Meeting in Lausanne, Switzerland on October 9-11, 2024. Dr. Ellen Kim, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania, will present a poster with expanded preliminary results from the investigator-initiated study (RW-HPN-MF-01) she is leading at the University of Pennsylvania. Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Medical Group, will give an oral presentation on recent results from two expanded treatment studies (HPN-CTCL-02 and HPN-CTCL-04) conducted at the Rochester Skin Lymphoma Medical Group.
Oral Presentation:
Session Title: ORAL PRESENTATIONS – CLINICAL STUDIES 1. The official conference program can be found here.
Oral Presentation Title: Phase 2a Study of Topical 0.25% Hypericin in Mycosis Fungoides:Results and Review of the FLASH Study presented by Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group on October 9, 2024 at 5:54 pm.
Poster Presentation:
Topical hypericin ointment photodynamic therapy for early stage mycosis fungoides/CTCL – a Phase 2 real world investigator-initiated study presented on October 9th, 2024 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.
These presentations further elaborate on the Company's findings in these supportive studies which have demonstrated the utility of longer treatment times (Study RW-HPN-MF-01; investigator-initiated study), the lack of significant systemic exposure to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability compared to Valchlor® (Study HPN-CTCL-04).
About the EORTC CLTG Meeting
An annual meeting of the cutaneous lymphoma tumour group (CLTG), a division of the European Organisation for Research and Treatment of Cancer (EORTC), focuses this year on facilitating the convergence of experts, delegates, and sponsors from Europe and around the globe, all convened to deliberate upon the latest advancements in skin lymphoma as well as the common ground between malignant and benign skin inflammation's research, diagnostics and treatment. The meeting website is available here.
About HyBryte™
HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte™ has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).
The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte™ treatment in this cycle was safe and well tolerated.
In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p