- Medicus Pharma (TSXV:MDCX), a life-sciences and biotech stock, has made a submission to the U.S. FDA to refine and finalize the protocol for its basal cell carcinoma treatment candidate’s approved phase-II clinical trial
- The company’s non-invasive treatment would be a first-mover in the skin cancer space, subject to approval
- Medicus Pharma is a clinical-stage holding company investing in and accelerating de-risked life-sciences and biotech assets
- Medicus Pharma stock (TSXV:MDCX) is up by 5.26 per cent since inception in October 2023
Medicus Pharma (TSXV:MDCX), a life-sciences and biotech stock, has made a submission to the U.S. FDA to refine and finalize the protocol for its basal cell carcinoma treatment candidate’s approved phase-II clinical trial.
The drug, doxorubicin (D-MNA), is delivered non-invasively through the skin using micro-array needles developed by SkinJect, Medicus’ wholly owned portfolio company.
The clinical trial, SKNJCT-003, will be a randomized, double-blinded, placebo-controlled (P-MNA), multi-center study including up to 60 subjects suffering from nodular-type basal cell carcinoma.
The company will evaluate the efficacy of two dose levels of D-MNA versus a placebo across 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 latter the maximum tolerated dose established during SkinJect’s phase-I safety and tolerability trial completed in March 2021.
The phase-I trial achieved complete needle dissolution in six patients with basal cell carcinoma, with no residual cancer and no relapse or recurrence across different dose levels and subject demographics.
“Our phase-II study is designed to position the company to gain regulatory alignment and fast-track the clinical development program,” Raza Bokhari, Medicus Pharma’s executive chairman and chief executive officer, said in a statement. “Basal cell carcinoma is perhaps the most common and fast-growing cancer across the globe with over 5 million cases diagnosed in the U.S. each year. There is no effective non-invasive treatment regimen available to treat basal cell carcinoma; we aspire to deliver a first-in-class, novel therapeutic alternative to treat this unmet medical need.”
Medicus Pharma is a clinical-stage holding company investing in and accelerating de-risked life-sciences and biotech assets through FDA-approval and commercialization.
Skinject, Medicus’ wholly owned subsidiary, is a development-stage, life-sciences company focused on non-invasive treatments for basal cell and squamous cell skin cancer using patented dissolvable microneedles.
Medicus Pharma stock (TSXV:MDCX) last traded at C$2 per share. The biotech stock is up by 5.26 per cent since inception in October 2023.
Join the discussion: Find out what everybody’s saying about this biotech stock on the Medicus Pharma Bullboard, and check out the rest of Stockhouse’s stock forums and message boards.
The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.