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Kansas University Medical Center and Baylor Scott & White Research Institute Become the Latest Investigation Sites for Nativis, Inc. Recurrent Glioblastoma (rGBM) Clinical Trial

2016年09月07日 PM10:00
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SEATTLE

Nativis, Inc., a clinical stage life sciences bio-electronics company developing non-invasive, medical device treatments for cancers and other serious diseases, today announced its latest clinical trial sites. Kansas University Medical Center (KUMC) and Baylor Scott & White Research Institute have become the seventh and eighth sites in the U.S. evaluating and enrolling patients in its NAT-101 clinical trial for the treatment of recurrent glioblastoma multiforme (rGBM). A concurrent study (NAT-105) is being conducted in Australia at St. Vincent’s Hospital in Melbourne.

KUMC and Baylor Scott & White join John Wayne Cancer Institute in Santa Monica, CA; Virginia Mason Medical Center in Seattle, WA; California Cancer Care Associates in San Diego, CA; Seton Brain and Spine Institute in Austin, TX; Boca Raton Regional Hospital in Boca Raton, FL; and the University of Alabama Birmingham in Birmingham, AL as current sites enrolling patients in the clinical study.

NAT-101, a first in-human study, will evaluate a total of 64 patients, 32 receiving Nativis’ Voyager treatment as monotherapy and 32 patients receiving Voyager in combination with chemotherapy. The primary outcome is safety assessed by the incidence and evaluation of any serious adverse events through follow-up. Clinical utility will also be assessed by progression free survival at six months as the primary endpoint and by overall survival as a secondary endpoint. The study is currently more than 50 percent enrolled.

“We continue to make good progress in understanding the potential benefits of Voyager for patients with rGBM from this clinical trial and other pre-clinical experiments that are being conducted,” stated Dr. Santosh Kesari, Chairman of Neurosciences and Neurotherapeutics at the John Wayne Cancer Institute. “These results are promising, but still early for patients with this deadly disease. There have not been any new treatments for patients with rGBM in several decades that have dramatically improved survival, so any treatment that is safe and has the potential to improve outcomes is encouraging.”

“We are very pleased with the progress of NAT-101’s enrollment and the world-class research institutes that are participating in the study,” stated Chris Rivera, Nativis’ Chief Executive Officer. “This is an important clinical trial for the company and for a better understanding of the potential of Voyager. We look forward to completing enrollment of the study, analyzing the results and moving the technology forward to help patients with this terrible disease.”

Nativis has been accepted to present pre-clinical results at the upcoming Society of Neuro-Oncology Conference this November in Scottsdale, AZ.

For more information, please go to https://clinicaltrials.gov/ct2/show/NCT02296580 in the United States, and https://www.clinicaltrials.gov/ct2/show/NCT02507102 in Australia.

About Nativis, Inc.

Nativis is a clinical stage bioelectronics company developing non-invasive therapies for cancers and other serious diseases. It utilizes a proprietary ultra-low Radio Frequency Energy (ulRFE) platform technology, which regulates defined bioactive targets by specific modulation of charge pathways. ulRFE-modulated charge pathways have the potential to significantly change the way cancer and other serious diseases are treated.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160907005664/en/

CONTACT

For Nativis
Media Contact:
Nandi (Thorn) Butcher,
206-343-1543
nbutcher@feareygroup.com
or
Investor
Relations Contact:

Lee Roth, 646-536-7012
lroth@theruthgroup.com
or
Tram
Bui, 646-536-7035
tbui@theruthgroup.com

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