Sirnaomics has reported interim data from part-one of the Phase IIb clinical trial of STP705 to treat cutaneous squamous cell carcinoma in situ (isSCC).
The double-blind, two-part, placebo-controlled, randomised trial underway is analysing the safety and efficacy of varying intralesional doses of STP705 in isSCC patients.
In part one, 32 subjects received either a 30µg/ml, 60µg/ml, or 90µg/ml dose of STP705 while 12 participants were given a placebo once a week.
According to the trial data from part one, 78% of those who received STP705 attained histological clearance.
The 30µg treatment arm, one among the three treatment groups, attained a histological clearance of 89%.
No treatment-associated adverse events (AEs) or serious AEs were reported in the trial.
In addition, Local Skin Response Scores were reported to be stable or enhanced across all treatment arms.
Based on these findings, part two of the trial will have 60 more participants.
Enrolled participants will be randomised to receive either STP705 or a placebo weekly for six weeks.
The lesion will be removed in the seventh week.
A small interfering ribonucleic acid (siRNA) therapeutic, STP705 is a lead product candidate of the company.
At present, STP705 is being analysed in seven clinical trials for isSCC including basal cell carcinoma (BCC), keloid scarring, hypertrophic scarring, facial isSCC, liver cancer, and as a medical aesthetics therapy.
Sirnaomics founder, board chairman, executive director, president and CEO Dr Patrick Lu said: “The positive clinical readouts of the part-one study of this Phase IIb trial provide further validation of our STP705 for treatment of non-melanoma skin cancers.
“With more clinical results from this study and the cutaneous basal cell carcinoma study, we feel more enthusiastic about this novel RNAi cancer therapeutics for the treatment of squamous cell carcinoma, addressing a broader unmet patient need.”
In August this year, the company reported that a cohort, which received a 180μg dose of STP705 in the Phase II trial, attained a 100% complete response for treating cutaneous BCC.
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