Autonomix Medical, Inc. has announced promising results from the initial phase of its first-in-human proof-of-concept trial evaluating a novel transvascular nerve ablation technique for severe pancreatic cancer pain. The trial demonstrated significant pain reduction and improved quality of life in patients, with many able to eliminate opioid use entirely.
The study enrolled 20 patients with unresectable pancreatic cancer experiencing severe abdominal pain. Nineteen patients received treatment via catheter placement in the celiac trunk, with 16 patients treated using femoral access and three using brachial access.
Significant Pain Reduction and Quality of Life Improvements
Among the 16 responding patients who received femoral access (84% of treated patients), results showed a mean pain reduction of 4.16 points on the Visual Analog Scale (VAS) at 7 days post-procedure, representing a 53.3% improvement from baseline. This improvement increased to 59.2% at the 4-6 week follow-up.
"We continue to be encouraged by the compelling results demonstrated in our PoC 1 phase, reinforced by consistent positive clinical outcomes observed at both the 7-day and 4-6 week post-procedure follow-ups," said Brad Hauser, CEO of Autonomix. "These findings provided a strong rationale for ceasing enrollment of this initial PoC 1 phase of the study and redirecting our clinical spending to additional targets."
The procedure's impact extended beyond pain relief. At 7 days post-procedure, responding patients reported a 76% improvement in global quality of health, a 33% improvement in functional quality of life, and a 37% improvement in symptomatic quality of life. These benefits were sustained at the 4-6 week follow-up.
Opioid Reduction and Safety Profile
Perhaps most notably, 100% of responding patients were able to eliminate opioid use at 7 days post-procedure, with 73% remaining opioid-free at the 4-6 week follow-up. This represents a significant advancement in pain management for pancreatic cancer patients, who often rely heavily on opioids for pain control.
The procedure demonstrated a strong safety profile with no device or procedure-related serious adverse events. As expected in a seriously ill patient population, there were eight serious adverse events unrelated to the procedure, including six patients who succumbed to their disease before the 4-6 week follow-up.
A recently released patient testimonial video further highlights the real-world impact of the technology. "Testimonials like this provide meaningful insight into the real-world impact our technology can have, particularly in improving quality of life and reducing dependence on pain medication," Hauser noted.
Key Procedural Learnings and Market Expansion
The trial revealed important procedural insights, particularly regarding access routes. All 16 patients treated via femoral access responded to treatment, while the three patients with brachial access showed no improvement in pain scores.
Based on these positive outcomes, Autonomix is expanding its clinical program to include a follow-on phase (PoC 2) that will evaluate the technology in additional visceral cancers that signal pain through the Celiac Plexus, as well as earlier-stage pancreatic cancers with moderate to severe pain.
"These results offer valuable insights that will guide future clinical studies, including our planned U.S. trials in 2025, bringing us closer to potential regulatory clearance," Hauser added.
Technology Platform with Broader Applications
Autonomix's technology constitutes a platform with potential applications across dozens of indications. While the current proof-of-concept trial focused on radiofrequency (RF) ablation for pain reduction, the company's proprietary technology also includes a catheter-based microchip sensing array designed to detect and differentiate neural signaling with greater sensitivity than currently available technologies.
"The initial PoC 1 phase of the trial was a pivotal step in validating our approach that radiofrequency ablation can effectively block pain signals," explained Hauser. "With our proprietary sensing technology, we believe we can more precisely target overactive nerves, potentially improving response rates."
Beyond pancreatic cancer pain, the company sees potential applications in cardiology, hypertension, and chronic pain management across a wide disease spectrum. The expanded PoC 2 phase will focus on interventional cancer pain management applications in pancreatic, gallbladder, liver, and bile duct cancers.
Trial Design and Methodology
The primary objective of the trial's initial phase was to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer pain using RF ablation in a transvascular approach. Secondary objectives included assessing adverse events, estimating pain level changes, and evaluating quality of life improvements.
All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and had a life expectancy of 3 months or more. Patients with successful procedures were evaluated at 7 days, 4-6 weeks, and 3 months post-procedure.
The company's catheter-based microchip sensing array was not used in this initial trial and will be evaluated in future studies as part of Autonomix's broader strategy to revolutionize how diseases involving the nervous system are diagnosed and treated.
For pancreatic cancer patients facing debilitating pain with few reliable solutions, these early results represent a promising advancement in pain management that could significantly improve quality of life during end-stage disease.
