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NovoCure Ltd. announces closing of financing round
Date:9/28/2009

ntly completed enrollment of a 236-patient, multi-center, randomized Pivotal clinical trial studying the safety and efficacy of the Novo-TTF device treating patients with recurrent GBM compared to standard-of-care chemotherapy. The results of this trial will be presented to the Food and Drug Administration (FDA) as part of a PMA application planned for early next year.

A new, multi-center, Pivotal clinical trial to study the efficacy of the novel Novo-TTF device in combination with standard-of-care chemotherapy (temozolomide) compared to standard-of-care chemotherapy alone in patients with newly-diagnosed GBM is now open in the United States, Europe and Israel. Data from a Pilot study of Novo-TTF in combination with chemotherapy in patients with newly diagnosed GBM suggest that the device may significantly improve upon the standard-of-care when used in combination with chemotherapy. As published in BMC Medical Physics in January of this year, patients treated with TTFields in a Pilot clinical trial for newly diagnosed GBM showed a median time to disease progression of 155 weeks compared to approximately 31weeks for concurrent control patients receiving standard-of-care chemotherapy alone. With 80% still living at the time of publication, the TTF treated patients had not yet reached the median overall survival at 39 months, compared to historical published median overall survival of 14.6 months for newly diagnosed GBM patients receiving standard-of-care chemotherapy alone. The ability to add the Novo-TTF to standard-of-care chemotherapy with minimal additional toxicity makes the treatment particularly attractive. Details about the newly diagnosed GBM trial including trial locations can be found on the NovoCure website (www.novocuretrial.com).


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Contact: Jennifer Paganelli Schwartz
jennifer.schwartz@edelman.com
212-642-7774
Edelman Public Relations
Source:Eurekalert

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