Studies show novel device may enhance chemotherapy treatment in br...(tric fields have shown no effect on non-...),Health

Date:11/24/2008

tric fields have shown no effect on non-dividing, healthy cells in the same region, suggesting that the device can treat cancer without harming surrounding tissue, unlike chemotherapies that are typically associated with high toxicity resulting in serious side effects. The Novo-TTF is currently an investigational medical device and is not yet FDA approved.

NovoCure recently published data from its human pilot study for patients with later stage GBM tumors that recurred after surgery and radiation. The results of this study preliminarily indicate that the Novo-TTF more than doubled the median overall survival rates for recurrent GBM patients relative to historical data.

NovoCure is currently conducting a Phase III clinical trial at more than 20 centers in the US and Europe for patients with recurrent GBM and is planning to launch a Phase III clinical trial to evaluate Novo-TTF treatment in combination with standard chemotherapy in patients with newly diagnosed GBM in 2009. Please refer to www.novocuretrial.com or call 1 (800) 978-0265 for more information on the ongoing trial.

SNO STUDY DETAILS

The in vitro study looked at the effects of TTFields alone and in combination with DTIC, a precursor of MTIC (the active metabolite of Temozolomide) in human GBM cells. The results demonstrated that, when applied together with DTIC, TTFields drastically increased the sensitivity of GBM cells in culture to DTIC.

The open-label, single-arm prospective pilot clinical trial evaluated the efficacy and safety of the Novo-TTF device in combination with standard chemotherapy (temozolomide) in 10 patients with newly diagnosed GBM. The results of the study were compared to concurrent and historical control outcomes of standard chemotherapy when given alone. All patients were followed on a monthly basis and received treatment with the device for up to 18 months. The primary endpoints were feasibility, toxicity, time to disease progression
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Contact: Marissa Green marissa.green@edelman.com 323-202-1463 Edelman Public Relations Source:Eurekalert

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