Soligenix CEO Chrisopher Schaber joined Steve Darling from Proactive to announce an interim update on the open-label, investigator-initiated study evaluating extended HyBryte™ treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma. To date, six patients have been enrolled and treated with HyBryte™ over a time period ranging up to 44 weeks. Patients have responded positively to HyBryte™ therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving "Treatment Success," as predefined in the study's protocol as ≥50% improvement in their cumulative mCAILS score compared to Baseline.
Schaber also told Proactive that of the three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks. Of the remaining three patients, two have only recently started HyBryte™ therapy and have not yet reached their first efficacy evaluation visit, and the other had a substantial improvement documented at the Week 18 visit but has not yet achieved the success threshold.
Patients have the potential to be treated for up to 12 months with twice-a-week dosing (visible light activation following ointment application by 24 ± 6 hours). The study also allows for potential transition to a "real-world" setting with home-use.
Another vertical from the company is for public health solutions, which include heat-stable vaccines for emerging infectious diseases and biodefense. The latter segment has received over $60 million in non-dilutive funding from the US government.Soligenix's vaccines are notable for their heat stability, allowing them to be stored outside refrigerators for over two years at temperatures exceeding 100°F. This makes them particularly valuable in regions like Sudan, where cold chain distribution is challenging.
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