SEATTLE--(BUSINESS WIRE)--Nativis, Inc., a clinical stage life science bio-electronics company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, today announced expansion of its clinical program in Glioblastoma Multiforme (GBM).
Chris Rivera, Nativis President and Chief Executive Officer, announced that based on encouraging safety and survival data, the current feasibility study in recurrent GBM, NAT-101, will be expanded to 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. In addition, a feasibility study in up to 11 patients newly diagnosed with GBM, NAT-109, will begin enrolling patients at multiple 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. Previously, 58 patients were enrolled and treated in NAT-101; 21 patients received Nativis Voyager treatment alone, and 37 patients received Nativis Voyager treatment plus standard of care. Data collected from NAT-101 suggest that the Nativis Voyager is safe and well-tolerated – i.e., no device-related serious adverse events were reported – and has clinical utility in patients with recurrent GBM, based on the interim assessment of survival data. To manage this expanded clinical program in GBM, Nativis will engage the services of an independent clinical research organization.
Nativis Voyager is an investigational device and is not yet approved by the US Food and Drug Administration or any other health authority. The protocols for NAT-101 and NAT-109 were approved by the Western Institutional Review Board, and Nativis Voyager is considered a non-significant risk device.
GBM, the most malignant form of astrocytoma, is the most common primary intracranial neoplasm. The incidence of GBM increases steadily above 45 years of age with a prevalence of approximately 7,500 cases in the United States. Despite numerous attempts to improve the outcome of patients with GBM, the 5-year survival of these patients is only 10%, with median survival of 14 months. Essentially all patients will experience disease recurrence. For patients with recurrent disease, conventional chemotherapy is generally ineffective, with response rates less than 20%. With dismal prognoses and few effective treatments, new therapies are critically needed for patients with brain cancer.
Earlier this year, Nativis announced it had entered into an exclusive license agreement for the development and commercialization of Nativis’ proprietary ultra-low radio frequency energy (ulRFE®) technology for the potential treatment of Glioblastoma Multiforme (GBM) in the Japanese market, with Teijin Limited, 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 bio-electronics 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 conditions and other health-related 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 completed for melanoma, lung cancer, liver 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.