Aethlon Medical, Inc. has announced that the independent Data Safety Monitoring Board overseeing its ongoing clinical trial, AEMD-2022-06, has completed a scheduled safety review. The board has recommended advancing to the next patient cohort without any modifications. This trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab," is assessing the Hemopurifier's safety, feasibility, and optimal dosing. The primary endpoint is the incidence of adverse events and clinically significant changes in safety laboratory tests. Aethlon Medical aims to use the findings to inform the design of a future efficacy and safety study required for regulatory approval. Enrollment for Cohort 2 is now open, with participants set to receive two Hemopurifier treatments over a one-week period at three clinical sites in Australia. The trial intends to enroll approximately 9 to 18 patients. Results from this study will be presented in the future as the trial progresses.
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