PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) has entered a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SKINJECT™, its investigational doxorubicin-containing microneedle therapy for patients suffering from Gorlin Syndrome, a rare genetic disorder that causes recurring basal cell carcinomas (BCCs).
Through the partnership, Medicus and the GSA will jointly pursue an Expanded Access Investigational New Drug (IND) Program with the U.S. Food and Drug Administration. The initiative seeks to provide treatment options for patients with multiple, recurrent, or inoperable BCCs while collecting real-world safety and efficacy data to support future regulatory submissions.
Gorlin Syndrome affects roughly one in 31,000 people worldwide, often leading to hundreds of recurring skin cancers over a patient’s lifetime. Current treatment options rely heavily on repeated surgeries and topical therapies, which can be physically and emotionally burdensome.
“Patients with Gorlin Syndrome endure a lifelong burden of recurring skin cancers that often require repeated surgeries and disfiguring treatments,” said Dr. Raza Bokhari, Executive Chairman and CEO of Medicus. “By working together with the Gorlin Syndrome Alliance, we hope to unite clinical science, regulatory leadership, and advocacy to deliver hope for individuals facing lifelong burdens of Gorlin Syndrome.”
GSA Executive Director Meredith Weiss described the partnership as a bridge between “breakthroughs in skin cancer therapy and real-world needs,” emphasizing the importance of patient input in shaping access pathways for novel treatments.
SKINJECT™ is a localized, non-invasive immunogenic therapy designed to target non-melanoma skin cancers using dissolvable microneedle arrays. The company is currently conducting a Phase 2 proof-of-concept trial (SKNJCT-003) across nine U.S. sites, with more than 75% of its 90 participants already enrolled. Interim data released earlier this year showed more than 60% clinical clearance in treated lesions. The FDA has provided positive feedback supporting a 505(b)(2) regulatory pathway for SKINJECT.
In parallel, Medicus is running a clinical study in the United Arab Emirates (SKNJCT-004), coordinated by Insights Research Organization and Solutions, with Cleveland Clinic Abu Dhabi serving as the principal investigator.
The collaboration follows Medicus’ recent acquisition of Antev, a U.K.-based biotech firm developing Teverelix, a next-generation GnRH antagonist for advanced prostate cancer and acute urinary retention. The move broadens Medicus’ clinical portfolio, which now spans oncology, dermatology, and endocrine disorders.
With the Gorlin partnership and expanding global trials, Medicus continues to advance its mission of developing non-invasive, precision therapies aimed at improving patient outcomes in complex and underserved disease areas.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.