PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) reported additional data from its Phase 2 SKNJCT-003 clinical study evaluating the SkinJect microneedle delivery system for the treatment of basal cell carcinoma, the company said.
The study tested microneedle delivery of D-MNA and P-MNA treatments and found that the 200-microgram treatment cohort achieved 73 percent clinical clearance and 40 percent histological clearance at Day 57.
Clinical clearance refers to the visible disappearance of the treated lesion, while histological clearance indicates the absence of tumor cells on biopsy.
The study also showed a separation in treatment response between the D-MNA cohort and the placebo microneedle cohort.
Patients receiving the active treatment achieved 73 percent clinical clearance compared with 38 percent in the placebo microneedle group, according to the company.
Researchers said microneedle insertion itself may trigger biological responses such as tumor disruption, immune signaling and wound-healing processes, which may contribute to some responses observed in placebo groups in device-drug combination studies.
Basal cell carcinoma is the most common cancer worldwide, with millions of lesions treated annually.
The company said the treatment approach may offer a non-surgical option for some patients if confirmed in future studies.
“We believe the SKNJCT-003 dataset reinforces the premise of SkinJect as a potential new treatment modality for basal cell carcinoma,” Medicus Executive Chairman and Chief Executive Officer Dr. Raza Bokhari said.
Medicus said the dataset supports plans to seek regulatory guidance from the U.S. Food and Drug Administration through an End-of-Phase-2 meeting.
The company said it also plans to pursue potential partnerships with pharmaceutical companies for later-stage development and commercialization of the treatment.
Medicus Pharma is a biotechnology company focused on developing therapies for dermatologic and oncology conditions.
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