NovoCure presents results from breast cancer pilot study

Apr 15 2008

NovoCure has announced that it presented the results from a single-arm pilot trial evaluating the Novo-TTF, a non-invasive portable medical device, combined with neo-adjuvant chemotherapy for the treatment of patients with locally advanced breast cancer.

Tumor volume shrank by 86-100 percent in the first four patients treated with the combined therapy, and one patient has experienced a complete response.

The data, which was presented during the annual meeting of the American Association for Cancer Research, also indicated that the Novo-TTF device can be safely combined with chemotherapy. It should be noted that these results are preliminary and the study is ongoing. In addition, NovoCure presented in vitro data from studies of the Novo-TTF treatment combined with chemotherapy to treat breast cancer and non-small cell lung cancer cells in culture, as well as animal data from VX2 tumors. The in vitro data demonstrated that the combination of chemotherapy with the Novo-TTF may produce additive as well as synergistic effects of one treatment plus the other.

The Novo-TTF device disrupts cancer cell proliferation and tumor growth by creating low intensity, intermediate frequency, alternating electric fields in the region of a tumor. These electric fields exert forces on the dividing cancer cells that prevent tumor growth. In pre-clinical and clinical studies to date, the electric 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 chemotherapy. Chemotherapy is typically associated with high toxicity that kills both healthy and cancerous cells. The Novo-TTF is currently an investigational medical device and is not yet FDA approved.

“We are delighted that the American Association of Cancer Research gave us the opportunity to present publicly, for the first time, preliminary human data related to the combination of low intensity, intermediate frequency, alternating electric fields and chemotherapy agents for breast cancer patients,” said Professor Yoram Palti, M.D., Ph.D. and NovoCure founder. “These results add to the growing body of evidence that the Novo-TTF may be a valuable option for patients with solid tumor cancer.”

NovoCure also continues to develop the Novo-TTF as a treatment for glioblastoma multiforme (GBM) brain tumors. NovoCure recently published data from its human pilot study for patients with 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 glioblastoma.

http://www.novocuretrial.com/