Zinger Key Points
- Over 70% of early-stage CTCL patients (5 of 6 completing 18 weeks) achieved "Treatment Success" with HyBryte in the IIS study.
- HyBryte treatment showed safety, tolerability, and early complete responses in two patients by 18 weeks of therapy.
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On Tuesday, Soligenix Inc. SNGX announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL), a type of cancer that starts in the T-lymphocytes, a type of white blood cell that fights infection.
Cutaneous T-cell lymphoma is a group of rare blood cancers that affects the skin.
Nine patients have been enrolled and treated with HyBryte over up to 54 weeks.
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Patients have responded positively to HyBryte therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving "Treatment Success."
Treatment Success is predefined in the study's protocol as a greater than or equal to 50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to the baseline.
Three of the five Treatment Successes were achieved within the first 12 weeks of treatment, with two patients achieving a "complete response" by 18 weeks.
Of the remaining patients, two have recently started the study, and two had to drop out for logistical reasons. One showed a substantial improvement (>30%) by their Week 18 visit. In addition, HyBryte appears to be safe and well-tolerated in all patients.
In December, Soligenix announced that patient enrollment had opened for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) for CTCL.
The confirmatory Phase 3 study, FLASH2, builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study, each further supporting the design of the FLASH2 clinical trial.
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.
Price Action: SNGX stock closed at $3.13 on Monday.
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