Medicus Pharma provides additional Phase 2 data for SkinJect Cancer therapy

Описание: Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to provide additional details from the company’s Phase 2 clinical study (SKNJCT-003) evaluating the safety and efficacy of its Doxorubicin Microneedle Array (D-MNA) for the non-invasive treatment of Basal Cell Carcinoma.

The data showed the strongest treatment response in the 200-microgram cohort, which achieved 73% clinical clearance and 40% histological clearance at Day 57. The results highlight the therapeutic potential of the company’s SkinJect platform, which uses microneedle technology to deliver chemotherapy directly into skin lesions without surgery.

According to Medicus Pharma, the findings are particularly notable given the device-based mechanism of SkinJect. The microneedle delivery process itself may produce biological activity, which can contribute to responses even in the placebo arm of the trial. In this study, the placebo microneedle array (P-MNA) was not tip-loaded with the chemotherapeutic agent but could still stimulate a biological response due to the mechanical action of the device.

The company noted that active placebo arms are not uncommon in device-drug combination trials and can be considered an acceptable regulatory data point. Importantly, the results demonstrated a clear separation in treatment response between the D-MNA therapy arm and the placebo microneedle arm in the 200-µg cohort, with clinical clearance rates of 73% and 38% respectively.

Management believes the dataset represents decision-grade evidence supporting the continued advancement of the SkinJect program as a potential non-surgical treatment option for patients with basal cell carcinoma. The company plans to move forward with an End-of-Phase-2 meeting with the U.S. Food and Drug Administration to determine the optimal registrational development pathway and explore.

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