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RAD001 Phase II Trial Results Positive in Patients with Advanced Gastric Cancer After Failure of One or More Prior Treatments
Date:1/13/2009

- After eight weeks of treatment, RAD001 halted tumor growth in 55% of advanced gastric cancer patients previously treated with chemotherapy

- Based on these promising data, Novartis will initiate a Phase III trial of RAD001 for advanced gastric cancer patients

- Gastric cancer is the second leading cause of cancer death worldwide with the majority of new cases occurring in East Asia

EAST HANOVER, N.J., Jan. 13 /PRNewswire/ -- Data released today show RAD001 (also known as everolimus; proposed brand name Afinitor(R)) halted tumor growth in 55% of patients with advanced gastric cancer, a condition for which there are limited treatment options. In addition, 45% of patients in the study demonstrated some tumor shrinkage(1).

The data will be presented at the American Society of Clinical Oncology's 2009 Gastrointestinal Cancers Symposium on January 15.

The open label, single arm, multi-center Phase II study of 54 patients conducted in Japan, is designed to assess the efficacy and safety of RAD001 in patients with advanced gastric cancer whose disease progressed despite prior treatment. Patients enrolled in the trial were heavily pre-treated. All trial participants were from Japan and of Asian descent (1).

"There are very limited treatment options for patients who progressed despite the standard treatment for this aggressive cancer," said Atsushi Ohtsu, MD, PhD, Director, Research Center for Innovative Oncology, National Cancer Center Hospital East, Chiba, Japan. "The results from this study demonstrate that RAD001 has the potential to provide an effective new option for these patients."

A global Phase III clinical trial program to evaluate the efficacy and safety of RAD001 monotherapy in approximately 500 advanced gastric cancer patients will begin enrollment this year.

"Most advanced gastric cancer patients eventually sto
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SOURCE Novartis Pharmaceuticals Corporation
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