On February 11, 2020 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, reported that Dr. Brian Poligone, clinical investigator and lead enroller in the pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating SGX301 in the treatment of early stage cutaneous T-cell lymphoma (CTCL), will present a patient case study from the trial (Press release, Soligenix, FEB 11, 2020, View Source [SID1234554174]). The presentation will be given at the upcoming 4th World Congress of Cutaneous Lymphomas on February 12-14, in Barcelona, Spain.
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Oral Presentation:
Response in a patient with refractory folliculotropic mycosis fungoides to a topical hypericin ointment activated with fluorescent light presented by Brian Poligone, MD, PhD, an Investigator in the FLASH study and Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, USA, on February 13th, 2020 at 8:00 AM CET. Abstract will be available on corporate website following the conference.
Folliculotropic mycosis fungoides (FMF) is a type of CTCL that is very difficult to treat. FMF is generally considered more severe and aggressive than other types of CTCL due to its greater risk of disease progression and worse prognosis. Treatment usually includes early consideration of systemic therapies, as topical therapies are often not beneficial. The presented case study focuses on a single patient with FMF who has completed the Phase 3 FLASH trial, including the open-label cycles and 6-month follow-up. The patient had previously failed at least five therapies, including topical treatments, oral medications and phototherapy. While in the study, the patient received at least 12 weeks of SGX301 treatment and experienced significant improvement, eventually leading to complete clearance of disease that has been sustained for at least 4 years.
"I’m happy to be presenting this important case study at the world congress," stated Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Group. "This patient community needs safe, skin directed therapies to treat this difficult lymphoma and I’m very excited that SGX301 may be one such therapy. I know I can speak for the other clinical study sites participating in the FLASH study, when I say, we are eager for the topline results this quarter."
About the 4th World Congress of Cutaneous Lymphomas
The 4th World Congress is designed to promote the exchange of scientific ideas and foster interactions between physicians, researchers and anyone engaged in the field of cutaneous lymphomas. The program will include discussions of basic, translational and clinical research and discuss new developments in the diagnosis, practice and management of cutaneous lymphomas. More information about the Congress is found here and the final programme is available here.
About SGX301
SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies 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: 58.3% compared to 8.3%, respectively.
The Phase 3 FLASH trial enrolled 169 patients with Stage IA, IB or IIA CTCL. Enrollment of the trial is completed and topline primary endpoint results are expected to be available in Q1 2020. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments are administered twice weekly for the first 6 weeks and treatment response is determined at the end of Week 8. In the first treatment cycle, approximately 107 subjects receive SGX301 treatment (0.25% synthetic hypericin) and 53 receive placebo treatment of their index lesions. In the second cycle, all subjects receive SGX301 treatment of their index lesions and in the third (optional) cycle all subjects receive SGX301 treatment of all their lesions. Subjects are followed for an additional 6 months after the completion of treatment. The majority of patients enrolled have elected to continue with the optional, open-label component of the study.
The Phase 3 CTCL clinical study was partially funded with this NCI Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.
SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).
About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.