I'm honestly not very interested in it, from an investment standpoint, partly because I'm a woman. I haven't analyzed the Company fundamentals though. Personally, I can't imagine adhering to a therapy that would adversely affect my lifestyle. I'd rather change my diet and do no carbs, which is supposed to give the same like results. I also think it will be tough to get patients to comply (at least worn on the head) for the amount of hours required - other body parts might not be as much of an issue. I know that Stupp announced it as the new standard of care back at SNO in 2014, but it's not truly standard of care, it's simply an option at this point, and sales are not all they could be. I imagine majority of women and some men will have the same aversion that I would and veto it. My nephew was a GBM patient, unfortunately he succumbed to the disease years ago, he probably would have worn it, so I do see the device market as a niche only market. But again not optimistic that it will ever get full fledge adoption into the GBM space. I just think drugs will get approved first, and their device will never truly lift off, if that makes sense.
I also believe the findings were rather small. It could simply be patient selection bias that produced the results. It's amazing how easy it is to make GBM data look good, but then it isn't. From below though, it certainly appears decent. Considering it's a device it should have no affect on the approval pathway for GBM drugs and biologicals.
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The following summaries are based on notes taken during presentations at the 19th annual meeting of the Society for Neuro-Oncology, held in Miami Beach Florida, November 13-16 2014.
Wednesday November 12, 2014. Marriot Stanton Hotel
A couple days prior to the beginning of the SNO conference, a "satellite meeting" was held at the Marriot Stanton Hotel, South Beach, Miami. Highlights from these sessions included a talk by Eric Wong of Harvard Medical School and the Beth Israel Deaconess Medical Center. In a presentation entitled "Dexamethasone Exerts Profound Interference on NovoTTF-100A Efficacy for Recurrent Glioblastoma", Dr Wong presented retrospective data showing that patients treated with Tumor Treating Fields (NovoTTF, now called Optune) in a previous phase 3 trial had better response to this treament when they were taking less than 4.1 mg dexamethasone per day. The patients who had response to the electric fields (TTF) took 1-2 mg dexamethasone on average, while non-responders took higher doses (up to 6-7 mg). When the data was stratified by a dexamethasone intake of 4.1 mg per day, those taking under this amount had median overall survival of 11 months, while those taking more than this amount had median survival of only 4.8 months.
A talk by Kenneth Swanson of Harvard Medical School entitled "Disruption of Cell Division Within Anaphase by Tumor Treating Electric Fields (TTFields) Leads to Immunogenic Cell Death: Implications for Treating Gliobastoma" may shed some light on the reasons for the worse survival outcomes of patients treated with TTF who also took high doses of dexamethasone. In this talk, he described his work showing that NovoTTF disrupts cells as they enter anaphase, at the metaphase to anaphase transition, and made claims that a cytoskeletal protein called septin may be the true cellular target of NovoTTF. He also showed that NovoTTF-induced cell death leads to the exposure of calreticulin and other immunogenic molecules, and that part of the therapeutic effects of NovoTTF may be due to an activated immune response following immunogenic cell death. As dexamethasone in high doses has immunosuppressive effects, this could be the possible cause of the interference with NovoTTF of high dose dexamethasone. Swanson speculated that because NovoTTF partially acts through endoplasmic reticulum (ER) stress, other agents that also induce ER stress, such as celecoxib (Celebrex) may be synergistic with NovoTTF.
