Medicus Pharma Ltd. (MDCX) has received Minor Use in Major Species (MUMS) designation from the U.S. FDA for its Doxorubicin-containing microneedle array (D-MNA) patch, intended to treat external squamous cell carcinoma (SCC) in horses.
The announcement on December 9, 2024, marks a significant achievement for Medicus as it works to develop a non-invasive treatment for this severe skin cancer in horses.
SCC is a common form of skin cancer in horses, especially those with white or partially white coats. This form of cancer is primarily found in areas with minimal pigmentation, like around the eyes, lips, and genital areas.
The D-MNA patch offers a promising alternative. This dissolvable microneedle patch, which is tip-loaded with doxorubicin, delivers the chemotherapy agent directly to the tumor site.
The microneedles penetrate the skin and tumor, dissolve, and release the drug, potentially eliminating cancer cells in a targeted, non-invasive way.
The MUMS designation is a huge win for Medicus. Similar to Orphan Drug status, it gives the company the opportunity to secure 7 years of exclusive marketing for the D-MNA patch, assuming it meets all regulatory requirements. This could provide the company with a significant competitive edge in a market where effective treatments for equine SCC are lacking.
Raza Bokhari, Executive Chairman and CEO of Medicus, expressed that "Receiving the MUMS designation is a critical step forward in the development of our D-MNA patch. It gives us a first-mover advantage in treating equine SCC, and we are hopeful that we can bring this product to market as early as 2026."
Medicus Pharma's development of the D-MNA patch is part of its broader focus on advancing novel therapeutics in both the veterinary and human oncology spaces.
The company is also working on human skin cancer treatments through its subsidiary, SkinJect Inc., which has already completed Phase 1 studies of the D-MNA patch in basal cell carcinoma (BCC) patients.
If the D-MNA patch is successfully developed and approved for use in horses, it could represent a breakthrough in the treatment of equine SCC, offering an effective, non-invasive treatment option for a population with few alternatives.
MDCX closed Thursday (Dec.12. 2024) trading at $2.75, down 1.79%.
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