FDA greenlights study of breakthrough device to treat aggressive pancreatic cancer
- New York-based oncology and vascular technologies company AngioDynamics this week said it received FDA approval to begin a clinical study of its NanoKnife technology in Stage 3 pancreatic cancer patients under an investigational device exemption.
- The NanoKnife system received a breakthrough device designation from FDA in January 2018, giving the company an expedited pathway to develop treatment for the aggressive cancer. Use of the technology, which gained 510(k) clearance in 2008 for the surgical ablation of soft tissue, has been documented in the treatment of more than 800 patients with Stage 3 pancreatic cancer from 2012 to 2019, the company said.
- The FDA go-ahead was a talking point as the company reported quarterly earnings Tuesday of $86.3 million, up about 3% over last year.
The NanoKnife uses low energy electrical pulses to permanently open pores in target cell membranes, resulting in cell death. The body’s natural processes then remove the treated tissue within weeks.
AngioDynamics said its DIRECT clinical study of the NanoKnife will support a proposed expanded indication for the device to treat Stage 3 pancreatic cancer and facilitate reimbursement for hospitals and physicians.
The DIRECT study will have a randomized controlled trial at up to 15 sites and a real-world evidence registry at up to 30 sites. Each site will have a NanoKnife treatment arm and a control arm. The company expects to enroll about 250 patients in each arm. The primary endpoint of the study is overall survival.
Pancreatic cancer has the lowest survival rate of any cancer, due to its aggressive nature, lack of early warning signs and limited treatment options for Stage 3 and 4 disease. Chemotherapy and radiotherapy are considered the standard of care.
Speaking on the company’s third quarter earnings call this week, AngioDynamics CEO Jim Clemmer noted that pancreatic cancer affects about 57,000 people each year in the United States, with about 25% of those patients at Stage 3, making them good candidates for the DIRECT study.
Robert Martin, co-principal investigator of the DIRECT study and surgical oncologist at the University of Louisville, said evidence that has accumulated over the past 10 years has shown that the device’s irreversible electroporation technology is an effective adjunctive treatment for patients with locally advanced pancreatic cancer.
AngioDynamics reported third-quarter net sales rose 3% to $86.3 million, as strong sales of its Solero microwave tissue ablation system offset weaker-than-expected NanoKnife capital sales during the period. Net income fell to $800,000, or 2 cents a share, from $14 million, or 37 cents a share, a year ago.