D-MNA Displays Potential as Noninvasive Therapy in Basal Cell Carcinoma of the Skin

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Treatment with micro-array needles containing doxorubicin (D-MNA) showed potential as a noninvasive treatment for patients with basal cell carcinoma (BCC) of the skin, according to data from the phase 2 SKNJCT-003 trial (NCT06608238).1

Findings from an interim analysis of the study announced by Medicus Pharma demonstrated that no dose-limiting toxicities (DLTs) or serious adverse effects (AEs) were reported in patients treated with D-MNA at 100 µg or 200 µg.

Additionally, a proportion of patients treated with D-MNA experienced a complete clinical clearance of more than 60%.

Data from the interim analysis will be submitted to the FDA in an effort to arrange a Type C meeting with the regulatory agency, where Medicus Pharma aims to align with the FDA regarding a clinical pathway for D-MNA in BCC.

“We are immensely encouraged by the positively trending interim analysis,” Raza Bokhari, MD, executive chairman and chief executive officer of Medicus Pharma, stated in a news release. "The interim analysis brings us one step closer to delivering a novel, noninvasive treatment for BCC.”

The novel MNA delivery system was developed by SkinJect with the goal of delivering topical doxorubicin directly to a lesion. In doing so, doxorubicin concentrations are below the standard systemic dosing levels, potentially reducing the toxicities associated with systemic delivery of doxorubicin.2

The ongoing SKNJCT-003 trial is a double-blind, placebo-controlled study enrolling patients 18 to 85 years of age with histologically confirmed, previously untreated nodular BCC suitable for excision at the end of the study that is between 0.5 cm and 1.3 cm in diameter at the time of biopsy.3

Investigators are excluding patients with nodular BCC located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation, and those with recurrence of a nodular BCC lesion or basal cell nevus syndrome are also excluded. The trial is also excluded patients who are immunocompromised; those with an active malignancy other than nonmetastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix; patients who received systemic chemotherapy within 12 months of baseline; and those with inadequate laboratory values at baseline.

The study will enroll approximately 60 patients in total who are being randomly assigned 1:1:1 to receive D-MNA at 100 µg; D-MNA at 200 µg; or placebo given as an intradermal patch once per week for 2 weeks.

The study’s primary end point is the proportion of patients to experienced histological clearance of the target lesion. Clinical clearance of the target lesion is a secondary end point.

Notably, the previously completed phase 1 SKNJCT-001 trial (NCT03646188) evaluating D-MNA in patients with BCC met its primary end point of tolerability and safety.1 No DLTs or serious AEs were reported, and patients did not experience any systemic effects or clinically significant abnormal laboratory findings, vital signs, ECGs, or physical examinations.

Among evaluable patients (n = 13), 6 achieved complete responses (CRs), defined as the disappearance of BCC in the final excision at the end-of-study visit. All 6 patients to achieve a CR had nodular BCC.

SKNJCT-001, which was completed in March 2021, included patients at least 40 years of age with superficial or nodular primary BCC who received no prior treatment.2

The study evaluated D-MNA at doses of 25 µg, 50 µg ,100 µg, and 200 µg. The rate of DLTs served as the trial’s primary end point, and the proportion of patients to achieve a CR was the trial’s key secondary end point.

References

1. Medicus Pharma Ltd announces positively trending interim analysis for SKNJCT-003 phase 2 clinical study to non-invasively treat basal cell carcinoma of the skin (BCC). News release. Medicus Pharma. March 6, 2025. Accessed March 14, 2025. https://medicuspharma.com/medicus-pharma-ltd-announces-positively-trending-interim-analysis-for-sknjct-003-phase-2-clinical-study-to-non-invasively-treat-basal-cell-carcinoma-of-the-skin-bcc/
2. Dose escalation trial to evaluate dose limiting toxicity/​maximum tolerated dose of microneedle arrays containing doxorubicin (D-MNA) in basal cell carcinoma (BCC). ClincialTrials.gov. Updated March 12, 2024. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT03646188
3. The purpose of this study is to evaluate the safety and efficacy of D-MNA in adult patients with nodular basal cell carcinoma. ClinicalTrials.gov. Updated September 23, 2024. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT06608238