Autonomix Announces Approval of Protocol Amendment by Ethics Committee Upon Completion of All Lead-In Patients in Ongoing Human Clinical Trial
Autonomix Medical (NASDAQ: AMIX) announced the approval of a protocol amendment by the Ethics Committee for its ongoing proof-of-concept human clinical trial. The trial evaluates the safety and efficacy of delivering transvascular energy to ablate nerves and mitigate pain in pancreatic cancer patients. Following the treatment of the first five 'lead-in' patients, the protocol was amended to gather additional data on tumor encroachment and other bio-measurements, and to refine inclusion criteria based on patient-reported pain levels. Autonomix plans to release topline results from the lead-in patients soon and aims to complete trial enrollment by year-end. The company's catheter-based technology seeks to offer a targeted, effective alternative to current pain management methods.
- Approval of protocol amendment by the Ethics Committee.
- Completion of treatment for the first five 'lead-in' patients.
- Additional data collection on tumor encroachment and bio-measurements.
- Refinement of inclusion criteria based on patient-reported pain levels.
- Plans to release topline results from 'lead-in' patients soon.
- On track to complete trial enrollment by year-end.
- Catheter-based technology potentially offering a targeted alternative to current pain management methods.
- No immediate data on the effectiveness or safety from the lead-in patients yet.
- Potential risks associated with the new procedural techniques.
Insights
The approval of the protocol amendment for Autonomix’s ongoing PoC human clinical trial is a significant development in the field of oncology, particularly for patients suffering from pancreatic cancer pain. The utilization of RF ablation to target specific nerves is innovative and holds potential for substantial improvement in pain management for these patients. Traditional approaches, such as systemic opioid treatment or blind ethanol injections, come with high risks and limited efficacy. By incorporating precise nerve targeting, this new protocol could offer a more effective and safer alternative. The additional gathering of tumor encroachment data and defining severe pain with patient input will enhance the accuracy and relevancy of the study outcomes. This step aligns with a growing trend in oncology to use patient-reported outcomes for more personalized treatments.
From a medical research perspective, the amendment and the imminent release of topline results from the lead-in patients could add valuable data to the existing literature on pain management in oncology. The strategic focus on bio-measurements and patient-reported pain scales ensures that the study will provide a comprehensive view of the treatment's efficacy and safety. This trial could set a new benchmark for subsequent studies and innovations in the field. Additionally, the success of this clinical trial could encourage further investment and interest in RF ablation technologies, potentially accelerating advancements in treatment options beyond pancreatic cancer.
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 the procedure moving forward.”
Autonomix commenced patient screening under the amended protocol in May 2024 and remains on track to complete enrollment in the PoC human clinical trial by year-end.
The Company’s catheter-based technology is being developed to do two things: sense neural signals associated with pain or disease and deliver targeted ablation to those nerves for treatment. Autonomix believes this technology is a better alternative to the current approaches commonly used today, where doctors either rely on systemic drugs like opioids that lose effectiveness and have unwanted side effects or treat suspected areas blindly in hopes of hitting the right nerves, an approach that is often inaccurate and can miss the target and even cause collateral damage to surrounding parts of the body.
The Company is initially developing its technology to address pancreatic cancer-related pain. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. For more information about the Company’s technology, please visit autonomix.com.
About Autonomix Medical, Inc.
Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.
We are initially developing technology for pancreatic cancer pain, a condition that causes debilitating pain and is without an effective solution. Our technology constitutes a platform to address dozens of indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum.
For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
Forward Looking Statements
Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward looking statements in this press release include, without limitation, the potential of the technology to treat pain associated with pancreatic cancer, to successfully enroll patients within the specific timeframe, and to complete its clinical study in pancreatic cancer pain. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”
Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on May 31, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
autonomix@jtcir.com
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