Medicus Pharma Ltd (TSX-V:MDCX) has unveiled some early encouraging results from its phase I study, the most eye-catching of which was a complete response to treatment from six of the 13 skin cancer patients taking part in the trial.
Known as SKNJCT-001, the clinical evaluation was designed as an open-label, dose-escalation study aimed at assessing the safety, tolerability, and efficacy of a new therapeutic approach using dissolvable microneedle arrays loaded with the chemotherapeutic agent doxorubicin (D-MNA).
To do this it recruited a small cohort of people (13) with basal cell carcinoma (BCC) and assessed responses across various dosage levels including 25 ug, 50 ug, 100 ug, 200 ug, and a placebo control with no medicinal value. A placebo provides a benchmark against which researchers can assess their results.
The primary goal of the phase I study was to determine the treatment's safety and maximum tolerated dose (MTD).
Results showed the investigational product, D-MNA, demonstrated a high level of safety and was well-tolerated by all participants, with no reported dose-limiting toxicities, serious adverse events, or reasons for discontinuation of the study.
Additionally, there were no systemic effects or clinically significant abnormalities observed in laboratory tests, vital signs, ECGs, or physical examinations. The maximum tolerated dose was identified as 200 ug.
Another significant outcome from the study was the efficacy of D-MNA, with six subjects showing complete responses, meaning the total disappearance of BCC as confirmed histologically at the study's conclusion.
This response rate is particularly noteworthy as all participants with complete responses had the nodular subtype of BCC, indicating a potential targeted treatment pathway for this common cancer variant.
Following the success of the trial, Medicus has already taken steps towards the next phase of research by submitting a phase II investigational new drug (IND) clinical protocol to the US Food and Drug Administration (FDA).
This upcoming study, named SKINJCT-003, aims to further explore the non-invasive treatment of BCC using micro-array needles containing doxorubicin. The company is currently awaiting feedback from the FDA to make any necessary revisions and finalize the study protocol.