Sirnaomics has dosed the first subject in the Phase I/II clinical trial of its RNAi therapeutic, STP705, to treat facial squamous cell skin cancer in situ (isSCC) patients.
The open-label, dose-escalation trial will assess the safety, tolerability, and efficacy of varying intralesional doses of STP705.
It will also aid in detecting the recommended drug dose.
The biomarkers linked to isSCC formation pathways, including TGF-β1 and COX-2, will be assessed in the trial.
The trial will enrol a total of 30 subjects into three trial cohorts. They will receive the drug once every week for a total of six weeks.
Cohort A will be given a 30μg dose while Cohort B and C will receive 60μg and 90μg doses, respectively.
Determining the number of subjects with histological clearance (HC) of facial isSCC lesions following STP705 treatment is the trial’s primary endpoint.
The company anticipates concluding the trial and reporting data in the first quarter of next year.
A lead candidate of the company, STP705 is a small interfering RNA (siRNA) drug.
Leveraging dual-targeted inhibitory properties and polypeptide nanoparticle-boosted delivery, it targets both TGF-β1 and COX2 gene expression.
Sirnaomics founder, board chairman, executive director, president, and CEO Dr Patrick Lu said: “We expect that the study of STP705 as a treatment for facial isSCC to yield positive results, given previous studies of STP705 that have shown to be safe and effective as a cancer treatment.
“Our drug has the potential to offer millions of patients with these non-melanoma facial lesions a non-surgical, non-invasive alternative to traditional lesion removal.”
In May this year, the company began a Phase I trial of STP705 in adult patients who undergo abdominoplasty for submental fat reduction.
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