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Everolimus (RAD001) Significantly Extends Progression-Free Survival in Advanced Kidney Cancer Patients After Failure of Other Targeted Therapy
Date:2/27/2008

- Outstanding interim results cause independent data monitoring committee to immediately share findings; patients on placebo to be offered everolimus

- Everolimus (RAD001) tablet, taken once daily, demonstrated highly effective anti-tumor activity through continuous targeted inhibition of

mTOR - Results of RECORD-1 trial address unmet medical need in renal cell cancer

with worldwide regulatory filings planned for second half of 2008

- Complete results to be submitted as late-breaking abstract for

presentation at the American Society of Clinical Oncology meeting

EAST HANOVER, N.J., Feb. 28 /PRNewswire-FirstCall/ -- An independent data monitoring committee stopped a major Phase III clinical trial of the investigational drug everolimus (RAD001) today after interim results showed significantly better progression-free survival in patients with advanced kidney cancer who received everolimus compared to placebo.

The committee stopped the trial of more than 400 patients conducted in 12 countries because the study met its primary endpoint. The interim findings are being shared with investigators to allow them to offer everolimus to patients remaining on placebo. Everolimus may fulfill an unmet medical need for patients with advanced renal cell cancer (RCC) who currently have no approved treatment options.

Everolimus is a once-daily oral therapy that offers a new approach to cancer treatment by inhibiting the mTOR protein, a central regulator of tumor cell division and blood vessel growth in cancer cells. The trial included patients who had their cancer worsen despite receiving approved treatments for RCC, such as Nexavar(R) (sorafenib)(1) or Sutent(R) (sunitinib)(2) or both. In addition, prior therapy with Avastin(R) (bevacizumab)(3) and interferon was allowed.

"Everolimus has the potential to greatly help patients with kidney cancer, especially in advanced stage who up to now
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SOURCE Novartis Pharmaceuticals Corporation
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