Soligenix announced continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH (Fluorescent Light Activated Synthetic Hypericin) study. This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients electing to receive SGX301 for a total of 18 weeks demonstrating a 50% or greater reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients demonstrating such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046). In addition, continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study has revealed that 12 weeks of treatment (Cycle 2) with SGX301 is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions of cutaneous T-cell lymphoma (CTCL) when compared to Cycle 1 placebo lesion responses, further demonstrating the unique benefits of the more deeply penetrating visible light activation of hypericin. SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the blood stream after targeted topical application to the lesions, as well as the use of visible light.
"Along with SGX301's rapid response time and safety profile, the patch and plaque data from the study are extremely compelling," said Brian Poligone, MD, PhD, Lead Enrolling Investigator in the FLASH study and Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, USA. "Current treatments for CTCL are generally less effective against plaques and deeper lesions, very similar to the problem observed in psoriasis. The ability of SGX301 to target both patches and thicker plaques in CTCL is an important feature for this therapy and, if approved, will be of benefit to patients, regardless of their presentation. These results are consistent with the positive findings highlighted in a recently reported case study of folliculotropic mycosis fungoides, a hard to treat variant of CTCL where lesions are associated with the hair follicles deep in the skin and more resistant to phototherapy."
"On behalf of everyone at Soligenix, I would like to extend my sincere thanks to the patients, families, investigators, and advisors involved in the pivotal Phase 3 FLASH study," said Richard Straube, MD, Chief Medical Officer of Soligenix. "In treating CTCL, which is a chronic cancer with no cure, long-term safety is of paramount concern. SGX301 treatment continues to demonstrate strong efficacy and a very benign safety profile, which is of significant benefit to patients living with this difficult disease. Although the focus of the additional optional cycle was safety, we continue to see improvement in CTCL lesions with extended SGX301 treatment, building upon the robust efficacy signal in previous cycles. The efficacy against both patch and plaque lesions, for example, is particularly encouraging and we believe provides another important differentiating feature from other therapies currently being used to treat early stage disease."
Soligenix previously announced positive top-line results when the FLASH study achieved statistical significance (p=0.04) in its primary endpoint over the first 6-week double-blind treatment cycle (Cycle 1) (available here). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo in Cycle 1. After the subsequent additional 6-week treatment in the open-label Cycle 2, the response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold (40% with p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment). These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients (press release available here). Treatment responses were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment). A positive response was defined as an improvement of ...
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