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Soligenix Inc (NASDAQ: SNGX) shares surged on Tuesday on a heavy volume of 23.6 million as per data from Benzinga Pro.
The Princeton, New Jersey-based company announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended Hybryte treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL).
To date, six patients have been enrolled and treated with HyBryte for up to 44 weeks.
Patients have responded positively to HyBryte therapy. Three of the four subjects who have completed at least 12 weeks of therapy already achieved “Treatment Success.”
Two of the three Treatment Successes were achieved within the first 12 weeks of treatment, and the third within 18 weeks.
Two of the remaining three patients have only recently started HyBryte therapy. They have not yet reached their first efficacy evaluation visit (i.e., at Week 6). The other had a substantial improvement documented at the Week 18 visit but has not achieved the success threshold yet.
In addition, HyBryte appears to be safe and well tolerated in all patients, with no treatment-related adverse events.
“In the Phase 3 FLASH study, HyBryte was shown to be efficacious with a promising safety profile. With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments.
Initial results evaluating the expanded use of HyBryte in a “real world” treatment setting were “promising.” This supports and extends results from the previous positive Phase 2 and 3 clinical trials.
“We look forward to continuing to work with the FDA to complete this study and to participating in the upcoming confirmatory Phase 3 placebo-controlled study,” noted a principal investigator of the IIS.
Recently, Soligenix released clinical results from a comparability study evaluating HyBryte versus Valchlor (mechlorethamine gel).
The open-label study (protocol HPN-CTCL-04) enrolled ten patients.
The study revealed that HyBryte treatment resulted in 60% of patients achieving a 50% or better improvement in their mCAILS score versus 20% of Valchlor patients. HyBryte has a more favorable safety profile.
Price Action: SNGX shares are up 221.5% at $6.43 at last check Tuesday.
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Posted In: SNGX