Medicus initiates phase 2 trial of D-MNA for basal cell carcinoma

Key takeaways:

• The first patient has been enrolled in a phase 2 trial of D-MNA.
• D-MNA is a micro-array of doxorubicin.

The first patient has been enrolled in a phase 2 clinical trial of D-MNA for the treatment of basal cell carcinoma, Medicus Pharma announced in a press release.

A randomized, double blind, placebo-controlled, multicenter study, SKNJCT-003 will enroll up to 60 patients with nodular basal cell carcinoma (BCC) in the U.S. Patients will be randomly assigned to receive 100 g or 200 g of D-MNA or placebo (P-MNA).

D-MNA is noninvasive treatment consisting of a micro-array of needles containing doxorubicin.

A phase 1 trial found D-MNA was well tolerated across all dose levels with no systemic effects or abnormal findings in laboratory parameters, vital signs, ECGs or physical examinations, according to the release.

Complete efficacy response in the trial is defined as the disappearance of BCC histologically in the final excision.

“BCC is the most common cancer across the globe with estimated 5 million cases diagnosed in the U.S. each year,” Raza Bokhari, MD, MBA, Medicus executive chairman and CEO, said in the release. “There is no effective noninvasive 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.”

Reference:

• Medicus Pharma Ltd. receives FDA comments on phase 2 clinical protocol to non-invasively treat basal cell carcinoma of the skin. https://medicuspharma.com/medicus-pharma-ltd-receives-fda-comments-on-phase-2-clinical-protocol-to-non-invasively-treat-basal-cell-carcinoma-of-the-skin/. Posted March 21, 2024. Accessed Aug. 27, 2024.