Medicus Pharma (NASDAQ:MDCX) said on Thursday it has received full regulatory and ethical approvals in the UK to expand its ongoing Phase 2 clinical trial evaluating its Doxorubicin Microneedle Array (D-MNA) treatment for basal cell carcinoma (BCC), a common form of skin cancer.
The UK’s Medicines and Healthcare products Regulatory Agency, Health Research Authority and Wales Research Ethics Committee granted the approvals, allowing Medicus to add clinical sites in the country to its ongoing study (SKNJCT-003), which is already underway across nine sites in the US.
“The United Kingdom regulatory and ethical approval is another major step forward in establishing a global footprint of our novel, non-invasive treatment for BCC of the skin, which we believe represents more than $2 billion in potential market opportunity,” said CEO Dr Raza Bokhari.
The SKNJCT-003 Phase 2 study is enrolling up to 90 participants to evaluate Medicus Pharma’s Doxorubicin Microneedle Array (D-MNA), a dissolvable microneedle therapy designed to deliver chemotherapy directly to BCC tumors and potentially eliminate the need for surgery.
A Phase 1 trial completed in 2021 found the treatment was well tolerated with no serious side effects, and six of 13 patients achieved complete lesion clearance. An interim analysis of the current trial earlier this year showed over 60% clinical clearance among participants.
Medicus has expanded its clinical program globally, including a related study in the United Arab Emirates, and in August acquired UK-based Antev, which is developing Teverelix, a next-generation therapy for advanced prostate cancer. The company also partnered with the Gorlin Syndrome Alliance in October to provide compassionate access to SKINJECT for patients with the rare genetic condition that causes multiple or recurrent BCCs.