Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce that the company has received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical trial evaluating its Doxorubicin Microneedle Array technology for the non-invasive treatment of basal cell carcinoma of the skin. The study, known as SKNJCT-003, is already underway across nine clinical sites in the United States and will now broaden to include additional sites in the U.K., following this latest approval milestone. Dr. Bokhari explained that approvals were issued by the Medicines and Healthcare products Regulatory Agency , the Health Research Authority (HRA), and the Wales Research Ethics Committee. The MHRA’s authorization came after a comprehensive scientific review of the Investigational Medicinal Product Dossier and clinical protocol, while WREC issued a favorable ethical opinion. The HRA subsequently granted study-wide governance approval, confirming full compliance with U.K. Good Clinical Practice (GCP) and National Health Service (NHS) capacity and capability standards. The Phase 2 trial is designed as a randomized, double-blind, placebo-controlled, multi-center study enrolling up to 90 patients with BCC. It aims to evaluate the efficacy and safety of two dose levels of D-MNA compared to a placebo control. Participants will be randomized into three groups in a 1:1:1 ratio, a placebo-controlled group, a low-dose group, and a high-dose group. Dr. Bokhari highlighted that the 200 μg high-dose level represents the maximum dose previously tested in Medicus Pharma’s Phase 1 safety and tolerability study, which was successfully completed in March 2021. The company views the U.K. expansion as a significant step toward advancing its novel microneedle drug delivery platform and potentially transforming the treatment landscape for non-melanoma skin cancers through a minimally invasive, localized therapy that may reduce the need for surgery and improve patient outcomes. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #Biotech #CancerTreatment #ClinicalTrials #FDAApproval #SkinCancer #HealthcareInnovation #Investing #MedicalResearch #SkinCancer #BasalCellCarcinoma #BiotechNews #CancerResearch #GorlinSyndrome #BasalCellCarcinoma #CompassionateUse #FDAApproval #RareDiseaseTreatment #NoninvasiveTherapy #BiotechNews