NEW YORK – Sirnaomics said Friday that it dosed the first patient in a Phase I/II trial of its siRNA drug candidate STP705 for the treatment of facial squamous cell skin cancer in situ (isSCC).
In addition to evaluating safety, tolerability, and efficacy of STP705, researchers will also look for biomarkers involved in the formation of isSCC, including in the TGF-B1 and COX-2 genes. Gaithersburg, Maryland-based Sirnaomics aims to enroll 30 patients who will receive one of three doses of STP705 — 30 μg, 60 μg, or 90 μg — by intralesional injection. The primary endpoint of the trial is determining the number of patients whose lesions are histologically cleared after STP705 treatment.
STP705 silences TGF-B1 and COX-2, the overexpression of which are commonly associated with development of SCC. In a previous Phase II trial of STP705 in isSCC, 19 out of 25 patients, or 76 percent, achieved histological clearance of their lesions.
"With surgical removal being the only available treatment for isSCC currently, patients have normally found the results to be painful and aesthetically unpleasing on the face. By dosing our first patient in this Phase I/II study, we can begin to evaluate the safety and effectiveness of STP705 in eradicating these cancerous lesions," Michael Molyneaux, chief medical officer of Sirnaomics, said in a statement. "Formulating this clinical trial as a dose escalation study also gives us the opportunity to determine which dose is the best suited in removing the cancer without adverse events."
Sirnaomics expects the trial to be completed in the first quarter of 2023. The company is also testing the drug in other trials in squamous cell, basal cell, and liver cancers as well as for keloid and hypertrophic scaring and as a medical cosmetology treatment.