Medicus Pharma Ltd. announced the submission to the United States Food and Drug Administration (FDA) a Phase 2 Investigational New Drug (IND) clinical protocol (SKNJCT-003) to non-invasively treat basal cell Carcinoma (BCC) of the skin using micro-array needles containing doxorubicin (D-MNA), developed by its wholly-owned portfolio company, SkinJect Inc. The company is seeking comments from the FDA to revise and amend the IND and finalize the protocol. The clinical study, SKNJCT-003, is designed to be a randomized, double-blinded, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with nodular type BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to placebo in patients with nodular BCC.

The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100ug of D-MNA, and a high-dose group receiving 200ug of D-MNA. The high-dose to be used in the trial, 200ug D-MNA, is the maximum tolerated dose that was established in SkinJect's Phase 1 safety and tolerability trial completed in March 2021. This safety study, representing complete dissolution in six patients with BCC, also showed complete clinical response with no residual BCC and no relapse or recurrence across different dose levels and subject demographics.