November 7, 2017
Nativis Research Partners to Present at the Society for Neuro-Oncology Annual Meeting in San Francisco
SEATTLE – November 7, 2017 – Nativis, Inc., a clinical stage therapeutic device company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, today announced further encouraging data supporting the use of ultra-low radio frequency energy (ulRFE®) in patients with recurrent glioblastoma (rGBM). Abstracts with the data will be presented at the 22nd Annual Meeting of the Society for Neuro-Oncology (SNO) in San Francisco, Saturday, November 18 at the Marriott Marquis Hotel. Dr. Garni Barkhoudarian of the John Wayne Cancer Institute and Pacific Neuroscience Institute at Saint John’s Health Center will present interim data from the NAT-101 clinical trial using the Nativis Voyager system, and Dr. Michael Salacz of The University of Kansas Cancer Center will present data on a case study of treatment using the Nativis Voyager system in a patient with diffuse midline glioma (DMG).
The Nativis Voyager system, a non-invasive investigational device, was studied at 12 investigational sites across the US. Fifty-nine patients were enrolled and treated to assess safety and feasibility of the treatment for rGBM. Barkoudarian’s presentation concludes that the Nativis Voyager system appears to be safe for the treatment of rGBM, as no serious device-related adverse events were reported. Additionally, the presentation suggests the Nativis Voyager system might have clinical utility for the treatment of rGBM, as approximately 40% of patients were progression free for at least 6 months and approximately 33% of patients survived for at least 12 months.
The case study to be presented by Salacz involved a young adult with rapidly progressing brain lesions determined to be H3 K27M mutation positive – i.e., DMG, WHO Grade IV. The patient was treated with active anti-cancer treatment using non-cytotoxic, repurposed drugs (modified CUSP/MTZ) along with the Nativis Voyager system.
“We believe this to be the first report of successful treatment of a patient with DMG using non-cytotoxic chemotherapy along with radiofrequency therapy. Toxicity has been minimal. We are planning a pilot study with this approach for patients with H3 K27M mutated tumors, a patient population which includes diffuse pontine gliomas in the pediatric population as well,” said Salacz.
“The Nativis Voyager technology is unique in its approach in the treatment of patients with rGBM. It is a simple device that is easy and comfortable for the patient to wear. Our work with the Nativis Voyager system has produced results that are promising, and we are planning further clinical trials with Nativis to produce additional data,” Barkhoudarian stated.
“The encouraging data from these and other studies demonstrate that ulRFE can be used to knock down specific key pathways associated with cancer signaling,” stated Chris E. Rivera, Nativis Chief Executive Officer. “Our novel technology has the potential to transform the way we treat cancer. With this encouraging data in hand, we will continue to develop the Nativis Voyager system for the treatment of GBM and rGBM with the aim to expand to additional indications in the future.” Nativis has an additional trial ongoing for newly diagnosed GBM in the US and for rGBM in the US and Australia (www.clinicaltrials.gov).
Nativis recently announced the expansion of its current Phase 1/2 feasibility study in rGBM, NAT-101 and will enroll up to 32 more patients in the combination therapy arm – i.e., Nativis Voyager® plus a standard chemotherapy drug. This study will be conducted at 10 or more clinical sites in the US and Australia. In addition, a Phase 1/2 feasibility study in up to 11 patients newly diagnosed with GBM, NAT-109, is enrolling patients at sites in the US. In this new feasibility study, patients will be treated with Nativis Voyager and standard of care – i.e., temozolomide and radiotherapy – following surgical resection. The primary endpoint in both studies is safety, and secondary endpoints include assessment of overall survival and progression-free survival.
Earlier this year, Nativis announced an exclusive license agreement with Teijin Limited of Japan for the development and commercialization of Nativis’ proprietary technology for the potential treatment of GBM in the Japanese market. Teijin Limited is a comprehensive Japanese company expanding businesses in high-performance materials, pharmaceuticals, home healthcare, product converting and information technology.
About Nativis, Inc.
Founded in 2002 and headquartered in Seattle, WA, Nativis is a clinical stage therapeutic device company. Nativis has invented and patented a groundbreaking technology that utilizes precisely targeted, ultra-low radio frequency energy (ulRFE®) to specifically regulate metabolic pathways on the molecular and genetic levels – without chemicals, radiation or drugs – delivered via a simple-to-use non-invasive investigational device called Nativis Voyager®. The company’s goal is to transform disease treatment on a global scale with ulRFE, which can potentially be applied to a wide range of human health conditions and to non‑human health needs (including agriculture, bio-fuels and veterinary medicine, to name a few). Nativis’ initial focus is on the treatment of patients with brain cancer (initially, glioblastoma), who are not well served by conventional standard of care therapies, which often result in poor outcomes and devastating side effects. Additional pre-clinical work is being undertaken for lung cancer, pancreatic cancer, inflammatory disease and chronic pain. Nativis Voyager® ulRFE® system for GBM is an investigational medical device, limited by United States law to investigational use only.
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