Medicus Pharma (NASDAQ:MDCX) said on Monday that new analysis of data from a mid-stage clinical trial of its SkinJect microneedle therapy showed encouraging results in treating basal cell carcinoma, the most common form of skin cancer.
The Medicus Pharma Ltd said the Phase 2 SKNJCT-003 study evaluating its SkinJect microneedle delivery system achieved 73% clinical clearance and 40% histological clearance in patients treated with a 200-microgram dose by Day 57, the strongest treatment response seen in the trial.
Clinical clearance refers to the visible disappearance of the tumor, while histological clearance indicates the absence of cancer cells on biopsy.
The company said the results support further development of SkinJect as a potential non-surgical treatment option for Basal Cell Carcinoma, a condition that affects millions of patients worldwide each year.
“We believe the SKNJCT-003 dataset reinforces the premise of SkinJect as a potential new treatment modality for basal cell carcinoma,” said Dr Raza Bokhari, CEO of Medicus. “The separation observed in the 200-µg treatment cohort, combined with the known biological activity of microneedle-based delivery systems, provides a strong foundation for advancing the program toward regulatory discussions and potential strategic partnerships.”
In the trial, the active treatment arm showed a higher clinical response rate than a placebo microneedle group, with 73% clearance compared with 38%, suggesting the drug delivered through the device contributed additional therapeutic benefit.
Medicus said the placebo group used a microneedle patch without the chemotherapy agent, but noted that microneedle insertion itself can trigger biological responses such as localized immune signaling and wound-healing processes that may contribute to tumor regression.
The company said this type of biological activity has been observed in previous studies of microneedle-based delivery systems and was also seen in earlier trials of the SkinJect platform.
Basal cell carcinoma is widely treated with surgical procedures such as Mohs surgery, but Medicus said the SkinJect approach could offer a minimally invasive alternative if future studies confirm the results.
The treatment could also benefit patients with Gorlin Syndrome, a rare genetic condition that can cause individuals to develop dozens or even hundreds of basal cell carcinomas during their lifetime, making repeated surgery challenging.
Medicus said it plans to use the trial data to support discussions with the US Food and Drug Administration about the next phase of development, including a potential registrational study.
The company added that it will continue talks with potential strategic partners in dermatology and oncology as it advances the SkinJect program toward later-stage development.