Positive top-line results for pivotal phase III FLASH trial in CTCL
The treatment options for cutaneous T-cell lymphoma (CTCL) are currently limited, with research ongoing in several clinical trials. SGX301 (synthetic hypericin) presents one potential treatment option for CTCL, with top-line positive results recently reported from the phase III FLASH (Fluorescent Light Activated Synthetic Hypericin) trial (NCT02448381).1
In total, 169 patients with Stage IA, IB or IIA CTCL were randomized 2:1 to receive SGX301 or placebo. Preliminary results report that a statistically significant treatment response (p=0.04) was observed in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment following Cycle 1.
The trial consists of three treatment cycles (each eight weeks long) and in a preliminary assessment of the results from the open-label Cycle 2, a significantly more robust response after 12 weeks of treatment was indicated (data anticipated June 2020).
Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study noted that “This is an important outcome for patients suffering from CTCL. SGX301 has successfully demonstrated efficacy in this challenging chronic cancer, with no safety concerns, making it a potentially preferred first-line option for the treatment of early stage CTCL, which is the large majority of patients suffering from this disease”.
Reference
- Soligenix Announces Positive Top-line Results for its Pivotal Phase 3 FLASH Trial Evaluating SGX301 in Treatment of Cutaneous T-Cell Lymphoma. Available at: http://ir.soligenix.com/2020-03-19-Soligenix-Announces-Positive-Top-line-Results-for-its-Pivotal-Phase-3-FLASH-Trial-Evaluating-SGX301-in-Treatment-of-Cutaneous-T-Cell-Lymphoma (Last accessed 01/04/2020).
