FDA Approves DIRECT Study of AngioDynamics' NanoKnife to Treat Stage 3 Pancreatic Cancer
April 3, 2019—AngioDynamics, Inc. announced FDA approval of an investigational device exemption (IDE) application for the DIRECT clinical study of the company's NanoKnife irreversible electroporation direct cancer treatment. The DIRECT study supports a proposed expanded indication for the NanoKnife system for the treatment of stage 3 pancreatic cancer. In January 2018, the FDA granted the company’s NanoKnife system a Breakthrough Device Designation.
According to the company, the NanoKnife system is a next-generation ablative technology for the treatment of pancreatic cancer. In 2008, the device received 510(k) clearance from the FDA for the surgical ablation of soft tissue. The NanoKnife system utilizes low-energy, direct-current electrical pulses to permanently open pores in target cell membranes and does not rely on thermal effects. The treated tissue is then removed by the body's natural processes in a matter of weeks, mimicking natural cell death.
AngioDynamics’ DIRECT study will feature a comprehensive data collection strategy that will provide meaningful clinical information to health care professionals, support a regulatory indication for the treatment of stage 3 pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians. The next-generation study is classified as a Category B IDE by the FDA, allowing participating sites to obtain coverage for procedures performed as well as related routine costs.
The DIRECT study includes a randomized controlled trial (RCT) at up to 15 sites and a next-generation real-world evidence (REW) registry at up to 30 sites, each with a NanoKnife system treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival.
The RCT component will evaluate the NanoKnife system by isolating variables in a controlled setting. Recognizing that results from a hypercontrolled setting do not always translate to clinical practice, the RWE registry component will provide clinicians, patients, and payors with data generated in a real-world setting.
AngioDynamics advised that it is launching the a website, AngioDIRECT.com, to facilitate the enrollment of participants in the study. The online platform will provide patients and their families with information about pancreatic cancer and details about the study. It will also feature a physician locator to help prospective participants and referring health care professionals identify clinical study locations.
In the company announcement, the DIRECT study's Coprincipal Investigator, Robert C.G. Martin, MD, commented, “Existing evidence that has accumulated over the last 10 years has shown that irreversible electroporation is an effective adjunctive treatment for patients with locally advanced pancreatic cancer. We anticipate that this trial will demonstrate how the NanoKnife system can be utilized to enhance the quality of life for patients with stage 3 pancreatic cancer.” Dr. Martin is a surgical oncologist at the University of Louisville in Louisville, Kentucky.
DIRECT Coprincipal Investigator Govindarajan Narayanan, MD, added, “I’ve had promising experience utilizing irreversible electroporation as a treatment option for pancreatic cancer patients. We expect that the results of this trial will lead to a widely available alternative treatment option for advanced pancreatic cancer patients.” Dr. Narayanan is Chief of Interventional Oncology at the Miami Cancer Institute in Miami, Florida.