New York, NY April 14, 2008 NovoCure announced today 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. Please refer to www.novocuretrial.com or call 1 (800) 978-0265 for more information on this trial.
AACR STUDY DETAILS
NovoCure presented data at the AACR from studies of the effect of combining the Novo-TTF with chemotherapy for the treatment of cancer tumors. The data included results for both safety and efficacy endpoints. An in vitro study determined the cell growth rates in human breast and non-small cell lung carcinoma cultures treated with the Novo-TTF, paclitaxel, doxorubicin and cyclophosphamide separately and in combination. The results varied from a simple additive effect (TTFields and doxorubicin) to an enhanced, synergistic effect (Novo-TTF and cyclophosphamide; Novo-TTF and paclitaxel). The study also showed that when the Novo-TTF was combined with all these agents, significantly less chemotherapy was needed to achieve the same beneficial effect as when chemotherapy was used alone. NovoCure then replicated the in vitro studies in an animal model by implanting VX2 tumors under the kidney capsule of rabbits. This in vivo study demonstrated similar outcomes to the in vitro study.
NovoCure built upon the animal and laboratory work with a single-arm human pilot trial to determine the safety and efficacy of the Novo-TTF with neo-adjuvant chemotherapy (doxorubicin or epirubicin together with docetaxel) in locally advanced breast cancer patients. This study is under way. Neo-adjuvant refers to chemotherapy delivered in advance of surgery in an effort to shrink the tumor so as to improve operative outcomes. The early results from the first four patients with combined therapy to date indicate that tumor volume shrank significantly by 86%, 89% and 96% and an additional patient has experienced a complete response.
The Novo-TTF is currently being studied in patients with brain cancer and breast cancer. Treatment related toxicity is a major limitation of all current cancer treatments and often prevents the delivery of effective doses. No clinically significant side effects due to the Novo-TTF have been seen throughout these trials to date. The only device-related side effect observed was a mild to moderate contact dermatitis beneath the electrodes, which responded well to the application of topical cream and periodic electrode relocation.
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Edelman Public Relations