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Novartis Drug Afinitor® Effective in Patients With Non-Cancerous Kidney Tumors Associated With TSC in Phase III Trial
Date:9/23/2011

ignificant improvement in skin lesions including facial angiofibromas was observed, which can be a key concern for people living with TSC."  

Everolimus targets mTOR, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism(8). Tuberous sclerosis complex is caused by defects in the TSC1 and/or TSC2 genes(9). When these genes are defective, mTOR activity is increased, which can cause uncontrolled tumor cell growth and proliferation, blood vessel growth and altered cellular metabolism(2,9). By inhibiting mTOR activity in this signaling pathway, everolimus may reduce cell proliferation and blood vessel growth related to angiomyolipoma associated with TSC(2,8,9).

"The positive findings seen in this trial coupled with the known efficacy of everolimus in patients with SEGA point to the important role of mTOR inhibition with everolimus in treating these manifestations of TSC," said Herve Hoppenot, President, Novartis Oncology. "The outcomes support our further research efforts evaluating everolimus as a treatment option across the various conditions associated with TSC."

Affecting approximately 25,000 to 40,000 people in the US and one to two million people worldwide, TSC is associated with a variety of resulting disorders including skin lesions, seizures, swelling in the brain (hydrocephalus) and developmental delays(3,9).

About EXIST-2 EXIST-2 is a prospective, double-blind, randomized, parallel group, placebo-controlled, international, multicenter Phase III study of everolimus versus placebo for the treatment of patients with angiomyolipoma associated with TSC(1,10). Trial patients (median age=31, range 18-61) were randomized 2:1 to receive either everolimus (n=79) or placebo (n=39) at a daily starting dose of 10 mg. By the cut-off of June 30, 2011, the median treatment duration in the double-blind period was 38.1 weeks (range 2-105 weeks) in the everolimus arm and 3
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SOURCE Novartis Pharmaceuticals Corporation
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