Medicus Pharma Advances In Cancer Care With Updated Phase 2 Protocol For Non-Invasive Treatment

Medicus Pharma Ltd.,  announced that it has submitted a comprehensive and updated Phase 2 Investigational New Drug (IND) clinical protocol (SKNJCT-003) to the U.S. Food and Drug Administration (FDA). This protocol aims to treat basal cell carcinoma (BCC) of the skin non-invasively using micro-needle arrays containing doxorubicin (D-MNA), developed by its wholly owned subsidiary, Skinject, Inc. The submission includes revisions to the clinical protocol, along with supporting documents on Chemistry, Manufacturing, and Controls (CMC), stability, and sterility.

It also addresses the clinical non-hold comments from the FDA received on March 21, 2024. Additionally, the Company provided the requested safety data from the Phase 1 safety and tolerability study completed in March 2021 (SKNJCT-001) to support the proposed doses of 100μg and 200μg of D-MNA. An updated investigator brochure, featuring safety information from both the SKNJCT-001 and SKNJCT-002 clinical trials, was also included.

Earlier this year, the Company submitted a Phase 2 IND clinical protocol (SKNJCT-003) to the FDA for a non-invasive treatment of basal cell carcinoma (BCC) of the skin using micro-array needles containing doxorubicin (D-MNA). This clinical study, SKNJCT-003, is designed as a randomized, double-blinded, placebo-controlled (P-MNA), multi-center trial, aiming to enroll up to 60 subjects with nodular type BCC of the skin.

The study will assess the efficacy of two dose levels of D-MNA. Participants will be randomized into one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The high-dose of 200μg D-MNA proposed in this study is the maximum dose previously used in Skinject’s Phase 1 safety and tolerability study (SKNJCT-001), completed in March 2021.

SKNJCT-001 successfully achieved its primary goal of ensuring safety and tolerability. The investigational product, D-MNA, demonstrated excellent tolerability across all dose levels in the thirteen (13) participants enrolled, with no dose-limiting toxicities (DLTs) or serious adverse events (SAEs) reported. Additionally, there were no systemic effects or clinically significant abnormalities observed in laboratory parameters, vital signs, ECGs, or physical examinations.

The study also highlighted the efficacy of D-MNA, with six participants achieving complete responses, defined as the histological disappearance of BCC upon final excision at the end of the study visit. Notably, all six participants demonstrating complete responses had the nodular subtype of BCC. The updated Phase 2 clinical protocol (SKNJCT-003) now incorporates artificial intelligence (AI) and confocal microscopy as supplementary endpoints at one of the clinical sites

Dr. Raza Bokhari, Executive Chairman & CEO, said in a statement, “This Phase 2 clinical protocol, in its final form, is a comprehensive design, well positioned to get the nod from the FDA to commence randomizing participants hopefully before the end of this quarter. We are very excited to incorporate artificial intelligence (AI) powered software and confocal microscopy as supplemental endpoints in one of the clinical site to improve the assessment accuracy of the clinical program and hopefully also eliminate any invasive intervention even at the diagnostic stage, making our treatment regimen completely non-invasive from start to finish.”