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Autonomix Announces Approval of Protocol Amendment by Ethics Committee Upon Completion of All Lead-In Patients in Ongoing Human Clinical Trial
Company plans to release topline results from “lead-in” patients (n=5) imminently THE WOODLANDS, TX, June 03, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc.
About this update from Autonomix Medical, Inc.
[{"type":"text","content":"Company plans to release topline results from “lead-in” patients (n=5) imminently THE WOODLANDS, TX, June 03, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced it has received Ethics Committee approval of the protocol amendment for its ongoing proof-of-concept (PoC) human clinical trial evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate pain in patients with pancreatic cancer pain. The primary objective of the PoC human clinical trial is to successfully ablate relevant nerves and mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region. As previously announced, a total of twenty-five (25) subjects will be treated in the trial, with the first five patients treated acting as “lead-in” patients to be treated according to protocol to ensure the physician’s familiarity with the procedure before enrolling the twenty (20) subjects that will be formally included in the study data results and analysis of trial objectives. Confirmation of suitability is determined by the primary oncologist caring for the patients with the treating Principal Investigator confirming eligibility for the study. Following the completion of treatment for the first five “lead-in” patients, Autonomix has amended the study protocol to include the gathering of additional information on tumor encroachment on the vessels, as well as other key bio-measurements that may correlate with effective nerve ablation. Additionally, the Company has further defined severe pain for inclusion criteria as a 7 or above on the VAS scale as indicated by the patient rather than physician determination. Lori Bisson, Chief Executive Officer of Autonomix, commented, “We are pleased with the progress of the trial and the valuable insight received to date. We believe this amended protocol positions us to better assess the successful placement of the catheter adjacent to nerves targeted for ablation, establish its safety and efficacy against an unmet need, and perfect procedural techniques that will inform the best way to conduct ...