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Positive Preliminary Results Demonstrate Autonomix's Proprietary RF Ablation Technology's Ability to Reduce Opioid Use in Ongoing Human Clinical Trial
Globe Newswire 28-Oct-2024 8:00 AM
100% of the responder group went to zero opioid use at 4-6 weeks post-procedure
Up to 75% of late-stage pancreatic cancer patients are prescribed opioids and data suggests 20% are at risk for abuse and misuse1
Data from the initial "lead-in" cohort show responders experienced a reduction in pain assessed by VAS from 8.0 pre-procedure to 1.33 at 4-6 weeks post-procedure
THE WOODLANDS, TX, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ:AMIX) ("Autonomix" or the "Company"), a medical device company focused on advancing precision nerve-targeted treatments, today highlighted positive preliminary results from the first five "lead-in" patients in the Company's ongoing proof-of-concept human clinical trial (the "Trial") evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate pain in patients with pancreatic cancer pain. Three patients were treated with femoral access and two were treated with brachial access. Patients treated with brachial access showed no improvement in their pain scores (or worsened) while all patients treated with femoral access positively responded to treatment. The results presented here reflect the three patients in the responder group. Data, as previously reported, show a reduction in pain assessed using the Visual Analog Scale ("VAS") from a mean pre-procedure score of 8.0 to a mean score of 1.33 at 4-6 weeks post-procedure. Additionally, all responding patients were able to completely eliminate their opioid use at 4-6 weeks post-procedure. The Trial is expected to complete enrollment by year-end 2024.
"Late-stage pancreatic cancer patients with chronic pain are often dependent on opioids, resulting in significant side effects with risk of addiction and opioid overdose," commented Brad Hauser, Chief Executive Officer of Autonomix. "Preliminary data from responding subjects in our ongoing first-in-human trial have demonstrated a substantial, sustained reduction in pain scores that eliminated the need for opioid drugs for these patients. This underscores a potential breakthrough in interventional pain management, and we look forward to continuing evaluations of our differentiated approach and providing meaningful benefit to patients."
Opioid-based pharmacotherapy is currently the primary strategy used to manage moderate and severe pain for patients with progressive and advanced pancreatic cancer.2 Additionally, as sited in the manuscript titled "Pancreas Cancer-Associated Pain Management"3, several reports have established that cancer-related pain affects patient survival in pancreatic and other cancers.4,5,6,7 Inadequately treated pain can significantly affect a patient's eligibility and tolerance for chemotherapy. Conversely, patients with less pain intensity and pain of shorter duration are reported to have a better quality of life and longer survival.8,9
The Company's first-in-class technology platform utilizes a catheter-based microchip sensing array antenna that has the ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than currently available technologies. Once target nerves are identified, Autonomix uses its proprietary radio frequency (RF) ablation technology to kill targeted nerves, enabling a precision guided sense, treat and verify approach to addressing a number of disease categories from chronic pain management to hypertension and cardiology. 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 the Trial
The goal of the Trial is to assess pain reduction via radiofrequency (RF) ablation. The Company's catheter-based microchip sensing array used to detect and differentiate neural signaling was not used in this trial and will be evaluated in future studies.
The first five patients were enrolled and treated according to protocol in the beginning of the trial to familiarize the Principal Investigator ("PI") with the procedure and will not be included in the analysis of the trial objectives. These first five "lead-in" patients successfully completed the procedure per protocol with no immediate procedural-related complications or significant adverse events. The Company has reported positive preliminary results at 7-Day post procedure and for the 4-6 week follow-up.
The primary objective of the Trial is to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region. Secondary objectives include assessing the incidence of device- and procedure-related adverse events up to 4-6 weeks post-procedure; estimating the change in pain levels from pre- to post-procedure; and estimating the change in quality of life from pre- to post-procedure. All patients who have had a successful procedure will be evaluated at 7 days, 4–6 weeks and at 3 months post-procedure. All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and a life expectancy of 3 months or less. Following the successful completion of the procedure, two patients have since succumbed to their disease. Both events were expected outcomes and not related to the trial procedure.
As previously announced, Autonomix has amended the Trial 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. A total of twenty (20) additional patients will be enrolled in the Trial that will be formally included in the Trial data results and analysis of Trial objectives. Suitability is determined by the primary oncologist caring for the patients with the treating PI confirming eligibility for the Trial. Autonomix commenced patient screening under the amended protocol in May 2024 and remains on track to complete enrollment in the Trial by year-end.
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 platform system technology includes a catheter-based microchip sensing array that may have 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 this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.
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.
1https://pmc.ncbi.nlm.nih.gov/articles/PMC9160802/ 2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9160802/pdf/CAM4-11-2296.pdf 3https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176967/#:~:text=Conversely%2C%20patients%20with%20less%20pain,complementary%20and%20alternative%20medicine%20therapies 4 Michalski CW, Oti FE, Erkan M et al. Cannabinoids in pancreatic cancer: Correlation with survival and pain. Int J Cancer 2008;122:742–750. 5 Muller MW, Friess H, Koninger J et al. Factors influencing survival after bypass procedures in patients with advanced pancreatic adenocarcinomas. Am J Surg 2008;195:221–228. 6 Scarborough BM, Smith CB. Optimal pain management for patients with cancer in the modern era. CA Cancer J Clin 2018;68:182–196. 7 D'Haese JG, Hartel M, Demir IE et al. Pain sensation in pancreatic diseases is not uniform: The different facets of pancreatic pain. World J Gastroenterol 2014;20:9154–9161. 8 Staats PS, Hekmat H, Sauter P et al. The effects of alcohol celiac plexus block, pain, and mood on longevity in patients with unresectable pancreatic cancer: A double-blind, randomized, placebo-controlled study. Pain Med 2001;2:28–34. 9 Hameed M, Hameed H, Erdek M. Pain management in pancreatic cancer. Cancers (Basel) 2010;3:43–60.
