Clinical Trials

Date: 2015-12-14

Type of information: Initiation of patient enrollment

phase: 3

Announcement: initiation of patient enrollment

Company: Soligenix (USA - NJ)

Product: SGX301 (synthetic hypericin)

Action mechanism:

photodynamic therapy. 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 which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. 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. SGX301 has received orphan drug and fast track designations from the FDA

Disease: cutaneous T-cell lymphoma

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

This phase 3 multicenter, randomized, double-blind, placebo controlled study will evaluate the efficacy of topical SGX301 (Synthetic Hypericin) and fluorescent bulb-light irradiation for the treatment of patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides). (NCT02448381 )

Latest news:

• On December 14, 2015, Soligenix announced that patient enrollment has been opened for its Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating SGX301 (synthetic hypericin), as a treatment for cutaneous T-cell lymphoma (CTCL). Soligenix has been working with leading CTCL centers, as well as with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to initiate this pivotal Phase 3 clinical trial with SGX301, referred to as the FLASH study (Fluorescent Light Activated Synthetic Hypericin), that will enroll 120 evaluable subjects. Based on the positive results demonstrated in the Phase 2 study of SGX301, the Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multicenter trial and will seek to enroll 120 evaluable subjects. The trial will consist of three treatment cycles, each of 8 weeks duration. Treatments will be administered twice weekly for the first 6 weeks and treatment response will be determined at the end of Week 8. In the first treatment cycle, approximately 80 subjects will receive SGX301 and 40 will receive placebo treatment of their index lesions. In the second cycle, all subjects will receive SGX301 treatment of their index lesions and in the third cycle all subjects will receive SGX301 treatment of all their lesions. Subjects will be followed for an additional 6 months after the completion of treatment. The primary efficacy endpoint will be assessed on the percent of patients in each of the two treatment groups achieving a Partial or Complete Response (yes/no) of the treated lesions defined as a ? 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (CAILS) score for 3 index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Other secondary measures will assess treatment response (including duration), degree of improvement, time to relapse and safety. The study is anticipated to complete enrollment with primary data available in the second half of 2016.
• On June 23, 2015, Soligenix announced that it will be working with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to educate and recruit patients for its pivotal Phase 3 clinical study of SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma. SGX301 has previously been granted both orphan drug and fast track designations from the FDA for the first-line treatment of cutaneous T-cell lymphoma. NORD, the leading, independent nonprofit organization committed to the identification, treatment and cures of rare diseases, and CLF, an independent, nonprofit patient advocacy organization whose mission is to support patients with cutaneous lymphoma, will assist the Company in educating patients and raising awareness of the Phase 3 clinical trial among patients who are eligible for participation.

Based on the positive results demonstrated in the Phase 2 study of SGX301, the upcoming Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multicenter trial and will seek to enroll approximately 120 subjects. The trial will consist of three treatment cycles, each of 8 weeks duration. Treatments will be administered twice weekly for the first 6 weeks and treatment response will be determined at the end of Week 8. In the first treatment cycle, approximately 80 subjects will receive SGX301 and 40 will receive placebo treatment of their index lesions. In the second cycle, all subjects will receive SGX301 treatment of their index lesions and in the third cycle all subjects will receive SGX301 treatment of all their lesions. Subjects will be followed for an additional 6 months after the completion of treatment. The primary clinical efficacy endpoint is treatment response assessed using the CAILS (Composite Assessment of Index Lesion Severity) score evaluating the three index lesions at the end of Cycle 1 (Week 8). The trial is anticipated to begin in the second half of 2015 with primary data available in the second half of 2016.

• On May 5, 2015, Soligenix announced that the company is currently working with leading CTCL centers, as well as with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to begin this 120 subject pivotal Phase 3 clinical trial with SGX301 in the second half of 2015.

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