The Institutional Review Board (IRB) has approved an increase in number of patients to be included in Medicus Pharma’s Phase 2 clinical study of D-MNA for the Treatment of Nodular Basal Cell Carcinoma (BCC).
D-MNA is noninvasive treatment consisting of a micro-array of needles containing doxorubicin.
The Phase 2 clinical study (SKNJCT-003) which is currently underway in nine clinical sites in United States, will expand into additional sites in US, as well as two clinical trial sites in Europe, and will now include 90 patients, up from 60.
The Company also announced that it has randomized more the 45 participants in the study and is on track to submit the package seeking a Type C meeting with the United States Food and Drug Administration (FDA) before the end of Q2 2025.
“Increasing the number of participants in the study and expanding the clinical trial sites in Europe is very time appropriate,” says Dr. Raza Bokhari, Executive Chairman & CEO, in a news release. “With our study design awaiting approval by the Department of Health in Abu Dhabi, and exploring collaboration in the Asia-pacific region, we are making promising progress in securing global validation of our novel, non-invasive treatment for BCC.”
Trending Positively
Earlier in March 2025, the Company’s interim analysis showed that clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than 60%.
The analysis also showed the investigational product, D-MNA was well tolerated for both dose levels, a low-dose group receiving 100ug of D-MNA and a high-dose group receiving 200ug of D-MNA in all participants so far enrolled in the study, with no dose limiting toxicities (DLTs), or serious adverse events (SAEs).
In addition, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examination.
The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed.
