Medicus Pharma says U.S. FDA has provided comments on Phase 2 Clinical Protocol of SKNJCT-003
Vancouver, Canada
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March 28, 2024 08:21 AM Eastern Daylight Time
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma joined Steve Darling from Proactive to share significant updates regarding the company's interaction with the U.S Food and Drug Administration (FDA). Medicus Pharma has received comments from the FDA, pertaining to its recent study findings and regulatory submissions.
The FDA's feedback regarding the study results is considered exploratory, with specific requests directed towards providing additional data from clinical studies to support the doses of 100μg and 200μg of micro-array needles containing doxorubicin. Additionally, the FDA has requested an updated investigator brochure, incorporating insights from the clinical studies SKNJCT-001 and SKNJCT-002, focusing particularly on adverse events and dose-limiting toxicities at each dose level.
Dr. Bokhari conveyed to Proactive that the SKNJCT-001 study successfully met its primary objective of assessing safety and tolerability. The investigational product, D-MNA, demonstrated favorable safety profiles across all dose levels among the thirteen participants enrolled in the study. This encouraging outcome underscores the potential of D-MNA as a safe and well-tolerated therapeutic option.
In response to the FDA's requests, Medicus Pharma is committed to making a comprehensive submission in the second quarter of 2024. This submission will include the requested data and an updated investigator brochure, meticulously incorporating insights from the SKNJCT-001 and SKNJCT-002 studies. Furthermore, the submission will encompass Chemistry, Manufacturing, and Controls (CMC) stability data, ensuring a comprehensive and robust dossier.
Dr. Bokhari reiterated Medicus Pharma's dedication to adhering to regulatory guidelines and fostering transparent communication with regulatory authorities. By addressing the FDA's queries and providing comprehensive data, the company aims to facilitate the regulatory review process and advance the development of D-MNA towards potential regulatory approval.
In summary, Medicus Pharma remains steadfast in its commitment to advancing innovative therapies while upholding the highest standards of safety and efficacy. The company's proactive engagement with regulatory agencies reflects its dedication to bringing impactful treatments to patients in need.
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