Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce news that the company's Investigational New Animal Drug (INAD), featuring a dissolvable doxorubicin-containing microneedle array, has been granted Minor Use in Major Species Designation or MUMS by the U.S. Food and Drug Administration. This designation marks a significant step forward for Medicus Pharma’s mission to revolutionize veterinary oncology.
The FDA's MUMS designation is a pivotal milestone, akin to the Orphan Drug status for human medicines. It offers Medicus Pharma an extended 7-year period of exclusive marketing rights following approval or conditional approval, provided the company fulfills all regulatory requirements for maintaining the designation. This exclusivity positions the company to make a profound impact on treating external squamous cell carcinoma (SCC) in horses.
The innovative doxorubicin-containing microneedle array is a patent-protected, dissolvable transdermal patch designed with cellulose-based microneedles. These microneedles are tip-loaded with doxorubicin, a potent chemotherapy agent. When applied, the microneedles penetrate the stratum corneum layer of the skin, creating temporary microchannels. This allows the microneedles to reach the tumor, dissolve, and release doxorubicin directly into the targeted area, effectively eradicating cancer cells while minimizing systemic side effects.
Squamous cell carcinoma is a significant concern in horses, particularly in adult or aged animals with white or partially white coats. Breeds such as Appaloosa, Belgian, American Paint, and Pinto are especially susceptible. SCC typically develops in areas with minimal pigmentation and sparse hair, often around mucous membranes. Commonly affected areas include the eyes, lips, nose, anus, and external genitalia. With an overall incidence rate of 2-3%, this condition impacts a notable portion of the U.S. horse population, estimated to be between 6.6 and 7.25 million horses.
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