Interim results presented for first-in-human study in first of 2-stage study
Nativis, Inc., today announced the release of an abstract on its Nativis Voyager® system for use in patients with recurrent glioblastoma multiforme (rGBM). The abstract will be published online during the American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 2-6, 2017, in Chicago, IL. Abstracts can be found here.
The Nativis Voyager system is a non-invasive investigational device that delivers ultra-low radio frequency energy (ulRFE™) profiles to the brain. The ulRFE profiles are derived from changes in molecular electrostatic surface potential. The Voyager system is being studied in a first-in-human study to assess the safety and feasibility of treatment for recurrent glioblastoma multiforme.
In the publication entitled “A Feasibility Study of the Nativis Voyager™ System in Patients with Recurrent Glioblastoma Multiforme (GBM): Interim results of first-in-human study,” the authors, Garni Barkhoudarian, Charles Cobbs, Edward McClay, Brian Vaillant, J. Paul Duic, L. Burt Nabors, Benjamin M. Ellingson, Deborah Sheffield, Santosh Kesari, highlighted the interim results of the first part of a 2-stage study. This first study enrolled 14 patients at four clinical trial sites across the United States, in which 11 subjects were followed per protocol, with 3 subjects dropping out for reasons not associated with the study. In the first two months of treatment, 2 of the 11 subjects were Avastin-naïve and exhibited a partial response. After 6 cycles (24 weeks) of treatment, the local sites reported 2 patients were progression free. No serious adverse events associated with the investigational therapy were reported.
“We are honored to have our first-in-human study recognized by ASCO as we continue to pioneer our novel ulRFE technology,” commented Chris Rivera, Nativis President and Chief Executive Officer. “The interim data from this feasibility study provide an encouraging outlook for the Voyager system, which appears to be feasible and safe for the treatment of recurrent GBM. With these data in hand, we look forward to moving forward into the second and final stage of the study.”