Medicus Pharma (TSX-V:MDCX) announced that it has received feedback from the US Food and Drug Administration (FDA) on its Phase 2 clinical protocol to non-invasively treat basal cell carcinoma, a type of skin cancer, using its microneedle technology.
Earlier in 2024, the company submitted to the FDA its Phase 2 Investigational New Drug clinical protocol to treat basal cell carcinoma using micro-array needles containing doxorubicin (D-MNA).
The proposed 60-patient, multi-center study will evaluate the efficacy of two dose levels of D-MNA compared to placebo in patients with a nodular type of basal cell carcinoma.
The patients will be randomized into 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.
Medicus noted that the high dose proposed was used in its wholly-owned subsidiary Skinject’s Phase 1 safety and tolerability study, SKNJCT-001, which was completed in March 2021.
The company said on Thursday that the FDA has responded to its submission with clinical non-hold comments and requested it provide data from SKNJCT-001 to support the dose of 100μg and 200μg of micro-array needles containing D-MNA.
It said the agency also asked it to provide an updated investigator brochure that includes information from the clinical studies SKNJCT-001 and SKNJCT-002; specifically, include data regarding any adverse events or dose-limiting toxicities at each dose level.
SKNJCT-001 was found to be safe and well tolerated across all dose levels in all 13 participants in the study with no dose-limiting toxicities, serious adverse events, or adverse events, Medicus noted.
"We are immensely encouraged by the feedback from the FDA," CEO Raza Bokhari commented.
"The clinical non-hold comments by the FDA bring us one step closer to delivering a game-changing novel, non-invasive alternative to treat basal cell carcinoma of the skin."
Medicus said it plans to make a full submission to the FDA during the second quarter and will provide the information requested by the agency. It said it will also include chemistry, manufacturing and controls (CMC) stability data.