Authors: Charles Cobbs (Swedish Medical Center, WA, USA)
Take a look behind the scenes of a recent research article published in CNS Oncology entitled, ‘An early feasibility study of the Nativis Voyager® device in patients with recurrent glioblastoma: first cohort in US’, as we ask senior author Charles Cobbs (Swedish Medical Center, WA, USA) about the problems facing the treatment of glioblastoma and the ground-breaking technology required for this research.
What was the process or inspiration that lead to the idea for the Voyager technology?
The inspiration behind the development of the Voyager technology originated with the idea that the movement of electrostatic surface charge may play an important role in the electrostatic interactions between drugs and receptors. This question drove the development of a magnetometer capable of measuring the magnetic wake produced by the motions of surface charge and subsequently the development of the Voyager transduction device that reproduces portions of these same fields.
The magnetic field produced by the motions of molecular surface charge are incredibly small (i.e., 10-15 tesla or less). The collection of this data required the development of one of the most sensitive, highly-shielded, broadband, magnetic sensors produced anywhere in the world.
Over several years and many prototypes, the Voyager transduction system was developed.
What, in your opinion, are the main problems with the current standards of care for glioblastoma and how could the Voyager begin to overcome these problems?
Currently, glioblastoma is treated with toxic chemotherapy and radiation, both of which have a negative impact on overall health and quality of life. Furthermore, glioblastoma cells disperse widely in the brain, so a new treatment must overcome the blood–brain barrier and have widespread effects. Despite aggressive treatment, virtually all patients experience recurrent disease. The median survival post-diagnosis is 15 months. Glioblastoma is costly in terms of healthcare resources utilized and is a strain on caregivers.
The development of a single, magic bullet to treat glioblastoma is unlikely, and continued use of multiple therapeutic approaches is more likely. Likewise, curing glioblastoma is unlikely, at least in the near-term. Thus, prolonging life and minimizing the negative impact on quality of life is the current treatment goal. Voyager has demonstrated the potential to contribute to both treatment goals. Prolonged stable disease and a good quality of life is a win for patients and their caregivers.
What challenges did you face in developing the device and in the safety trials?
Once the underlying technology was refined, the technical development of the Voyager was straightforward. The Voyager is a simple, home-use device – it has three relatively simple components. Voyager is not invasive, so sterilization is not needed. There is no calibration, customization, installation, or servicing required.
Training for clinical staff, patients and caregivers is not complex. Physicians, patients and caregivers are motivated to find new and better treatments for glioblastoma, so enrollment and retention in the feasibility trials were not difficult.
There has been a challenge in gaining acceptance and understanding of the underlying technology and the technical rationale for the ability of the Voyager to have a biologic effect in human disease. Some physicians are ‘early adopters’ and others remain skeptical.
What do you think are the most promising signs from your research to date and what is the next step in the development of this technology?
The data from ∼120 patients with recurrent glioblastoma suggest that the Voyager has a benign safety profile and a potential survival benefit over standard chemotherapies. The device is easy-to-use and lightweight, enabling patients to carry out their normal activities of daily living with limited interference from the device.
Early data from ∼35 patients with newly diagnosed glioblastoma patients suggest a similar benign safety profile in this patient population, with patients receiving concurrent treatment with temozolomide and radiation. Meaningful efficacy data in newly diagnosed glioblastoma patients won’t be available for another 6–12 months.
The current version of the Voyager uses a single, specific electromagnetic signal, referred to as the cognate. With the incorporation of additional specific cognates, unique features of glioblastoma could be targeted and have the potential to provide greater efficacy with a similar benign safety profile. Such a ‘cocktail’ of cognates would require additional clinical trials.
Beyond glioblastoma, this technology could be used to target other types of cancer as well as indications such as pain management.
You say the technology has been met with some scepticism, what is the most common misconception or doubt that your peers voice, and what is the clarification or reply that you find has the most success in bringing them around to your ideas?
When we first explain the technology to other physicians and scientists, we inevitably get questions such as, “You’re recording what?” and “You’re treating brain cancer how?” Sometimes it takes two or three conversations before people understand the physics behind the technology and can then begin to look at the data. It is the data – in animals and humans – that convince people that this technology has potential to treat serious human diseases, such as brain cancer.
Providing the Voyager trials are accompanied by more success in the future, how long would you expect before it could become part of the standard of care for glioblastoma?
The randomized, blinded clinical trials will take 3–4 years to conduct and analyze. Health authority review and approval will take another year. Therefore, broad use of the device is 4–5 years into the future.
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