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Wyeth's TORISEL Receives European Commission Approval for the Treatment of Advanced Kidney Cancer
Date:11/26/2007

In the study, TORISEL significantly increased median overall survival by 49 percent compared with interferon-alpha (10.9 months vs. 7.3 months, P=0.0078). TORISEL also was associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival (when the disease does not worsen; 5.6 months vs. 3.2 months, P=0.0042). The combination of TORISEL and interferon-alpha did not result in a significant increase in overall survival when compared with interferon-alpha alone.

"The European Commission's approval of TORISEL underscores the importance of this therapy for patients with advanced kidney cancer and reinforces the potential of this mechanism of action as a new approach in oncology," says Robert R. Ruffolo, Jr., Ph.D., President, Wyeth Research, and Senior Vice President, Wyeth.

About TORISEL

TORISEL is an mTOR inhibitor indicated in the European Union for the first-line treatment of patients with advanced RCC who have at least three of six prognostic risk factors. These risk factors include less than one year from time of initial RCC diagnosis to randomization, Karnofsky performance status of 60 or 70, hemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, lactate dehydrogenase > 1.5 times the upper limit of normal, and more than one metastatic organ site. In the United States, TORISEL is indicated for the treatment of advanced RCC.

Inhibition of mTOR in treated cancer cells blocked the translation of genes that regulate the cell cycle. In in vitro studies using renal cancer cell lines, TORISEL inhibited the activity of mTOR and resulted in reduced levels of certain cell growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor.

In March 2007, the European Association of Urology published guidelines recommending that TORISEL be considered as first-line treatment in patients with advanced
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SOURCE Wyeth Pharmaceuticals
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