Medicus Pharma (TSX-V:MDCX) announced the enrollment of the first patient in its Phase 2 clinical trial of its investigational therapy D-MNA in adults with nodular basal cell carcinoma (BCC).
The company said the multi-center study, SKNJCT-003, will enrol up to 60 patients across six trial sites in the United States.
It will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. Subjects will be split into three groups, a placebo-controlled group receiving P-MNA, a low-dose group receiving 100 micrograms (μg) of D-MNA, and a high-dose group receiving 200μg of D-MNA.
The company highlighted that the high dose, 200μg D-MNA, proposed is the maximum dose that was used in its SkinJect's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021.
SKNJCT-001 met its primary objective of safety and tolerability, and also demonstrated the efficacy of the product with six patients achieving complete responses.
Medicus Pharma (TSX-V:MDCX) CEO Dr Raza Bokhari said that randomizing the first patient in SKNJCT-003 was an important milestone for the company.
"Our Artificial intelligence powered Phase 2 study protocol, supported by Confocal microscopy, is designed to position the company to gain regulatory alignment with the FDA and fast track the clinical development program,” Bokhari said.
“BCC is the most common cancer across the globe with estimated 5 million cases diagnosed in the US each year. There is no effective non-invasive treatment regimen available to treat BCC; we aspire to deliver both first in class and best in class novel therapeutic alternative to fulfill this unmet medical need.”