Advancing Real-World Solutions for Patients Suffering from Intractable Nerve-Driven Pain
Clinical Trials Targeting
Visceral Cancer Pain
Advancing Real-World Solutions for Patients Suffering from Intractable Nerve-Driven Pain
Autonomix is redefining the treatment of visceral cancer pain through the development of a novel, minimally invasive nerve ablation platform. Our first-in-human clinical trial is focused on validating this technology in patients suffering from severe pancreatic cancer pain – a condition notoriously difficult to manage with existing therapies.
Proof-of-Concept Study in Pancreatic Cancer Pain Demonstrates Positive Outcomes
Significant pain reduction achieved in initial phase of first-in-human study (PoC 1) using RF ablation via a transvascular approach
Autonomix’s lead clinical program has shown promising results in patients with pancreatic cancer, a disease frequently associated with severe, nerve-mediated pain. In the initial phase of our first-in-human Proof-of-Concept (PoC 1) study, patients experienced clinically meaningful reductions in pain intensity highlighting the platform’s ability to transform nerve-targeted interventions.
These early results offer important validation of our transvascular approach and reinforce the potential to address high-burden indications by enabling access to difficult-to-reach nerve bundles. Unlike traditional approaches that rely on open or percutaneous access, our catheter-based system allows for minimally invasive navigation through shared vasculature and reduces procedural complexity.
Autonomix’s pioneering approach opens the door to treating previously unreachable nerve structures and introduces a potential new standard of care for managing pain in cancer and other chronic conditions without the use of opioids.
Study Design
20
Subjects1
01
Clinical Site
Objective
Transvascular Ablation of Relevant Nerve Plexuses to Reduce Intractable Cancer Pain
Footnote
1. Subjects includes the first five lead-in subjects used for procedure optimization
Clinically Meaningful Pain Reduction Achieved and Maintained Through 6 Week Follow-Up in PoC 1 Phase
1. Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1. PMID: 16320034; PMCID: PMC3454549.
Notable Topline Statistics and Key Learnings from the PoC 1 Phase (N=20)
Study Details
- All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and a life expectancy of 3 months or more
- 19 of 20 enrolled patients were treated, and each assessed as successful catheter placement in the celiac trunk. One (1) patient was enrolled and not treated due to unsuccessful catheter placement because of an existing celiac trunk stenosis (narrowing of the vessel)
- There were no device or procedure-related serious adverse events. As to be expected with surgical procedures in seriously ill patient populations, there were 8 serious adverse events (6 subjects succumbed to their disease before the 4-6 week follow up, which were not related to the procedure, and 2 events resulting in hospitalization also unrelated to the procedure) and 14 adverse events (including 8 events of expected arterial constrictions due to spasms and temporary artery occlusion)
- 16 patients were treated using femoral access and three (3) patients using brachial access. 100% of patients (16) with femoral access responded to treatment, while the three (3) patients with brachial access showed no improvement in pain scores, representing a key procedural learning
- Across the total population (mITT – n=19), pain relief occurred as early as 24 hours post-procedure. At 7-days post-procedure, there was a mean pain reduction of 3.32 on the Visual Analog Scale (“VAS”) (baseline 7.61 to 4.29), or 43.6% improvement. At 4-6 weeks post-procedure, there was a mean pain reduction of 3.95 on the VAS pain scale (baseline of 7.95 to 4.00), or 49.7% improvement
- Responding femoral patients (n=16) represented 84% of treated patients with a mean pain reduction of 4.16 on the VAS pain scale (baseline of 7.81 to 3.65), or 53.3% improvement, at 7-days post-procedure. At 4-6 weeks post-procedure, there was a mean 4.67 reduction on the VAS pain scale (baseline of 7.89 to 3.22), or 59.2% improvement
- At 7-days post-procedure, responding femoral 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. At 4-6 weeks post-procedure, responding femoral patients reported a 42% improvement in global quality of health, a 28% improvement in functional quality of life and a 29% improvement in symptomatic quality of life
- 100% of responding patients were able to go to zero opioid use at 7-days post-procedure, while 73% of responding patients were at zero opioid use at 4-6 weeks post-procedure
- Three patient VAS scores were not reported at the 4-6 week post-procedure follow-up due to the inability to travel given the natural progression of their disease and will be recorded as missing data in the final report
Footnotes
- As to be expected in seriously ill patient populations, there were 8 serious adverse events not related to the device or procedure (6 subjects succumbed to their disease before the 4-6 week follow up and 2 events related to disease progression resulting in hospitalization)
- Three (3) patients with brachial access showed no improvement and one (1) patient was enrolled and not treated due to unsuccessful catheter placement because of an existing celiac trunk stenosis (narrowing of the vessel)
Proof-of-Concept Expansion (PoC 2): From Severe Cancer Pain to Broader Visceral Applications
Targeting pain in additional visceral cancers and earlier-stage pancreatic cancer
Based on the positive results demonstrated in the PoC 1 phase, Autonomix will initiate a follow-on PoC 2 phase in a market expansion opportunity that will double the potential addressable market beyond pancreatic cancer pain by evaluating additional visceral cancers that signal pain through the Celiac Plexus and earlier stage pancreatic cancers with moderate to severe pain. This follow-on phase of development is designed to validate the broader utility of our technology in interventional cancer pain management.
Study Design
20
Subjects
01
Clinical Site
Objective
Transvascular Ablation of Relevant Nerve Plexuses to Reduce Intractable Cancer Pain
- Visceral Cancer Pain Management: Focus on Interventional Cancer Pain Management in Visceral Cancers, including: Pancreatic | Gall Bladder | Liver | Bile Duct
- Earlier Stage Pancreatic Cancer: Expanding Treatment to Patients with Moderate to Severe Pain, Earlier in Disease Progression
- Market Impact: This Expansion Has the Potential to Double the Addressable Market Beyond Late-Stage Pancreatic Cancer Pain
Physician and Lead-In Patient Interviews from Initial Phase of Proof-of-Concept Study
Hear from the primary investigator and participating patients about their experience in the PoC trial and the potential impact of this breakthrough technology.
About Pain Associated with Pancreatic Cancer
A high-need, high-impact target
Pancreatic cancer pain management is a critical unmet need within a global pancreatic cancer market valued at $2.2 billion.* Pain associated with pancreatic cancer is often severe, persistent, and resistant to conventional therapies making it a key target for innovation.
Autonomix’s first-in-human proof-of-concept study is the first step toward regulatory approval for a novel approach to treating pancreatic cancer pain. Our platform combines a proprietary microchip and sensing antenna array to detect and ablate pain-generating nerves via a simple, safe transvascular procedure and represents a first-of-its-kind advancement in therapeutic electrophysiology.
A Major Unmet Medical Need
Impact on Survival and Quality of Life
Pancreatic cancer is one of the most aggressive and life-altering cancers, with widespread consequences beyond tumor progression:
- 11th most common cancer worldwide1
- 95% mortality rate1
- Over 50% of patients experience intractable pain2
- 80-90% present with unresectable or metastatic disease
These clinical realities result in:
- Malnutrition and reduced caloric intake
- Disrupted sleep
- Inability to work and socialize
- Poor tolerance to chemotherapy
- Pancreatic cancer statistics. WCRF International. (2024, June 26). https://www.wcrf.org/cancer-trends/pancreatic-cancer-statistics/;
- Rawla, P., Sunkara, T., Gaduputi, V.. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World Journal of Oncology, North America, 10, Feb. 2019.