Which UAE hospitals are participating in the skin cancer study?

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Cleveland Clinic Abu Dhabi, Sheikh Shakbout Medical City, Burjeel Medical City, and American Hospital of Dubai are participating in the skin cancer study.

The clinical study, designated SKNJCT-004, will involve thirty-six patients across four sites in the United Arab Emirates. These participating institutions include Cleveland Clinic Abu Dhabi (CCAD), Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), and the American Hospital of Dubai (AHD). Insights Research Organization and Solutions (IROS), a UAE-based contract research organization and an M42 portfolio company, is managing the coordination of this clinical trial for Medicus Pharma Ltd.
Study Design and Patient Randomization

The SKNJCT-004 study is designed as a randomized, double-blind, placebo-controlled, multi-center trial, aiming to enroll up to 36 subjects diagnosed with basal cell carcinoma (BCC) of the skin. Participants will be randomly assigned in a 1:1:1 ratio to one of three treatment groups. These groups will receive either a placebo control (P-MNA), a low dose of D-MNA (100μg), or a high dose of D-MNA (200μg) to evaluate the efficacy of the investigational product at different dosage levels.
D-MNA Dosage and Previous Safety Data

The high-dose group in this study will receive 200μg of D-MNA, which represents the maximum dose administered in the Company's prior Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021. The earlier study successfully met its primary objectives for safety and tolerability, with the investigational product D-MNA being well-tolerated across all dose levels among the 13 participants. No dose-limiting toxicities or serious adverse events were reported, and no systemic effects or significant abnormal findings were observed in laboratory parameters, vital signs, ECGs, or physical examinations.
Efficacy Observations from Phase 1 and Ongoing US Study

The Phase 1 study (SKNJCT-001) also provided preliminary efficacy data, with six participants achieving complete responses, defined as the histological disappearance of BCC in the final excision at the study's conclusion. These participants with complete responses all had the nodular subtype of BCC. Medicus Pharma Ltd. is also conducting another Phase 2 clinical study, SKNJCT-003, in the United States across nine sites, which is expected to randomize 60 patients. Patient recruitment for SKNJCT-003 began in August 2024, and over half of the expected patients have already been randomized. The company anticipates completing an interim data analysis for SKNJCT-003 by the end of the first quarter of 2025 and plans to submit these findings to the United States Food and Drug Administration (FDA) in the second quarter of 2025 to support a Type C meeting.

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Which UAE hospitals are participating in the skin cancer study?

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