Earlier this week Medicus Pharma (NASDAQ:MDCX, TSX-V:MDCX) announced that its innovative skin patch treatment has received Minor Use and Minor Species (MUMS) designation from the FDA.
The patch, which uses a cellulose-based, doxorubicin-loaded design, is aimed at treating squamous cell carcinoma in horses.
The company explained that this designation, comparable to orphan drug status in human medicine, extends exclusive marketing rights for seven years and reduces the scale of required clinical trials.
Medicus Pharma (NASDAQ:MDCX, TSX-V:MDCX) CEO Dr Raza Bokhari highlighted the importance of this approval, saying, "It validates our aspirations and confirms the paradigm-shifting potential of this treatment."
The patch was initially developed for basal cell carcinoma in humans, with patents from Carnegie Mellon and the University of Pittsburgh. However, the company expanded its focus to address a similar condition in equine species, where surgical intervention has been the standard treatment.
The FDA’s approval is seen as a validation of the patch’s potential to offer a safer, non-surgical alternative.
Bokhari noted that clinical trials, involving fewer than 50 horses, are planned for 2024, with commercialization possible as early as 2026. The treatment targets a significant market, with up to 7.25 million horses affected by squamous cell carcinoma.
Medicus believes this breakthrough could transform treatment options for both human and animal skin cancers.