September 28, 2009 NovoCure, Ltd., a privately held medical device company focused on developing the Novo-TTF device, a non-invasive portable medical device for the treatment of cancer, announced the completion of a new funding round today. Key investors in this round included Pfizer Inc, Johnson & Johnson Development Corporation and Index Ventures. "We are very pleased that Pfizer, Johnson & Johnson Development Corporation and Index have taken an interest in the work we're doing with the Novo-TTF device," said William Doyle, Chairman of the Board of NovoCure. "The proceeds from their investment will be used to fund NovoCure's newly-diagnosed GBM pivotal clinical trial."
"The NovoCure TTF therapy is a completely novel approach to fighting cancer," said Bill Burkoth, Director of Pfizer Ventures. "Pilot clinical trials suggest that TTF therapy plus chemotherapy has the potential to significantly improve patient survival.
This investment aligns with Pfizer's goal to help oncology patients live longer, healthier lives."
The Novo-TTF device is a unique cancer treatment that uses specially tuned, low intensity electrical fields (Tumor Treating Fields or TTFields) to disrupt cell division. Rapidly dividing cancerous cells are affected by the TTFields , causing them to either break apart or not divide properly, while healthy, non-dividing cells are not affected, yielding a targeted treatment with minimal side effects. The fields are applied to the tumor region using non-invasive, insulated electrodes placed on a patient's skin. The electrodes, which look like bandages, are attached by wires to a battery operated, portable device that generates the fields.
INITIATION OF CLINICAL TRIAL FOR NEWLY DIAGNOSED GBM
The Novo-TTF device has been tested in more than 175 patients with various types of cancers including recurrent and newly-diagnosed glioblastoma multiforme (GBM), breast cancer and lung cancer.
NovoCure recently 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).
|Contact: Jennifer Paganelli Schwartz|
Edelman Public Relations