Medical Device Daily

AngioDynamics (Queensbury, New York) is seeking an additional indication for its NanoKnife application, for the treatment of locally advanced unreselectable pancreatic cancer. The firm reported that it was conducting a company-sponsored trial to evaluate the safety and feasibility of the NanoKnife system to treat patients suffering from pancreatic cancer.

The company said last week that it had completed patient enrollment in its European prospective NanoKnife System trial (ONC-208).

Ten subjects at Policlinico G.B. Rossi, University of Verona (Verona, Italy), have been treated in the study, titled, “NanoKnife Low Energy Direct Current (LEDC) System in Subjects with Locally Advanced Unresectable Pancreatic Cancer.“ It is being conducted by Professor Claudio Bassi, Policlinico G.B. Rossi, University of Verona, Department of Surgery, in Verona, Italy.

“Through this, and other studies, we are building a body of evidence that helps us better understand the NanoKnife system's capabilities,“ said Joseph DeVivo president/CEO of AngioDynamics in a news release. “We look forward to seeing published scientific results from this European pancreas trial in the next six to nine months.“

AngioDynamics' trial, more specifically, is a single-arm safety pilot study of patients who have locally advanced unreselectable pancreatic cancer and who have failed chemotherapy.“ Eligibility for the trial was based on subjects having tumors of a size no greater than 4 cm and their being unresponsive to chemotherapy as demonstrated with either computed tomography (CT) or magnetic resonance (MR) imaging, and having not taken any chemotherapy agents within 14 days of treatment with the NanoKnife system.

The primary endpoint is safety determined at 90-days post treatment, with efficacy as a secondary endpoint, also determined at 90-days, through tumor response assessment with imaging.

During an October earnings call, DeVivo told listeners that “this protocol also is the exact protocol we have in front of the FDA for the U.S. IDE pancreas submission and with intent to pool this data to increase the power of that submission.“

Securing approval for this indication could be a tremendous win for the company and could eventually open up an even bigger market opportunity for the device, which already has 510(k) clearance for use in the surgical ablation of soft tissue.

It is estimated that in 2011, 44,030 new cases will occur in the U.S. as well as 37,660 deaths. The overall five-year relative survival for 2001-07 was 5.5% in 17 geographic areas covered by the National Cancer Institute's Surveillance Epidemilogy and End Results program.

But DeVivo, during the earnings call, said that the potential for the device to fully realize its market isn't going to happen at a rapid pace.

“Regarding NanoKnife, we're still early in [ the device] even though we've been talking about it for sometime. Capital sales are a big part of the revenue,“ DeVivo said during the earnings call. “And the capital sales are going to be lumpy. We're going to see a little bit of ups and downs. The reason why[the company] displayed this clinical data is for you to see we're investing heavily in clinical data because we know that this clinical data is going to move this market.“

He added, “We have bucketfuls of anecdotal information which inspire and excite thought leaders. But no one's ever made a market on thought leaders. You make the market by getting into the core users, and you don't get to the core users until you get a large amount of data... in my view regardless it's still going to take some time to develop this market.“

NanoKnife is a technology that AngioDynamics received when it acquired a privately held company called Oncobionic for $25 million (Medical Device Daily, Oct. 19, 2006). The device incorporates irreversible electroporation (IRE), a non-thermal tissue ablation technique in which electrical fields are used to create nano-scale defects in cell membranes, leading to the demise of the cell.

IRE is a physiologic — rather than thermal — change at the cellular level that may have advantages of more precise excision without any damage at all to healthy structures around it. Research is being conducted at select sites in the U.S. using irreversible electroporation for treatment of tumors.