Medicus Pharma (TSX-V:MDCX) announced that it has submitted a Phase 2 Investigational New Drug (IND) clinical protocol to non-invasively treat basal cell carcinoma (BCC) of the skin using micro-array needles containing doxorubicin (D-MNA) developed by its portfolio company SkinJect to the United States Food and Drug Administration (FDA).
The company said it is seeking feedback from the FDA on the IND to finalize the protocol.
It said the study, SKNJCT-003, will enroll up to 60 patients presenting with nodular type BCC of the skin and will evaluate the efficacy of two dose levels of D-MNA when compared with a placebo.
The low-dose group will receive 100μg of D-MNA and the high-dose group 200μg of D-MNA, the maximum tolerated dose established in SkinJect’s Phase 1 safety and tolerability trial carried out in March 2021.
“Our Phase 2 study is designed to position the company to gain regulatory alignment and fast track the clinical development program," Medicus Pharma (TSX-V:MDCX) CEO Dr. Raza Bokhari said in a statement.
"BCC is perhaps the most common and fast-growing cancer across the globe with over 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 first in class, novel therapeutic alternative to treat this unmet medical need."
Medicus Pharma (TSX-V:MDCX) is a clinical-stage, multi-strategy holding company focused on investing in and accelerating novel life sciences and biotechnology companies through FDA-approved clinical trials.