FDA has given approval for AngioDynamics to undergo a pilot study of the NanoKnife for the ablation of prostate cancer tissue in low-risk patients. The IDE comes on the heels of the Latham, NY-based company making significant strides in its mission to obtain an indication for the treatment of pancreatic cancer.
“NanoKnife has been in the market for a general soft tissue claim for about eight or nine years,” Brent Boucher, AngioDynamics, Senior VP and General Manager of Oncology, told MD+DI. “On April 1 we received approval to pursue a pancreas indication for stage three pancreatic cancer. We enrolled our first patient about three weeks ago
There will be a total of six patients at three sites in the U.S. for the prostate pilot study. Boucher noted that the pilot study for prostate would give AngioDynamics the ability to engage in dialogue with FDA about what the pivotal study would be.
If the company can get approval, the NanoKnife could have tremendous implications for prostate cancer. AngioDynamics said as it stands now, prostate cancer is the second leading cause of cancer death in American men. Approximately one man out of every nine will be diagnosed with prostate cancer during his lifetime.
Traditional treatment options have focused on standard whole-gland therapies, such as active surveillance, radical prostatectomy, and external beam radiation. However, over the last decade, focal therapy has been evaluated as an alternative for select patients diagnosed with localized prostate cancer in order to minimize treatment-related toxicity.
The NanoKnife works a bit differently from traditional approaches, Boucher said.
“You insert these needles or probes that are positioned around the prostate,” he said. “[Then] you have an electrical current that’s transmitted between the probes. In short bursts [these currents] disrupt the cell membrane. They create these permanent holes in the cancer cell membrane and that ultimately destroys the cancer cell and subsequently the tumor in the prostate.”
Developments with the NanoKnife come a month after AngioDynamics announced it was selling its Namic fluid management portfolio to Medline Industries for about $167.5 million. The company said it would use proceeds from the divestiture to pay down all outstanding debt and support strategic investments in the company’s existing portfolio to drive enhanced growth and future profitability.