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Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint of Reducing SEGA Tumor Size in Patients With Tuberous Sclerosis
Date:7/7/2011

emarks of Wyeth Pharmaceuticals Inc.

References

  1. Jozwiak, et al. Everolimus treatment of subependymal giant cell astrocytomas (SEGAs) associated with tuberous sclerosis complex (TSC): the EXIST-1 trial. International TSC Research Conference. July 2011, Washington, D.C.
  2. Krueger, et al. Everolimus for Subependymal Giant-Cell Astrocytomas in Tuberous Sclerosis. New Eng J Med 2010;363:1801-11.
  3. Medkour A, et al. Neonatal Subependymal Giant Cell Astrocytoma. Pediatr Neurosurg 2002;36:271–274.
  4. Nabbout R, et al. Early diagnosis of subependymal giant cell astrocytoma in children with tuberous sclerosis. J Neurol Neurosurg Psychiatry 1999;66:370–375.
  5. Franz, et al. Long-term safety and efficacy results of oral everolimus in patients with subependymal giant cell astrocytomas (SEGA) in tuberous sclerosis complex (TSC). International TSC Research Conference. July 2011, Washington, D.C.
  6. National Institute of Neurological Disorders and Stroke. Tuberous Sclerosis Fact Sheet. Available at http://www.ninds.nih.gov/disorders/tuberous_sclerosis/detail_tuberous_sclerosis.htm. Accessed July 2011.
  7. Afinitor® (everolimus) tablets prescribing information. May 2011.
  8. Inoki, et al. Tuberous sclerosis complex, implication from a rare genetic disease to common cancer treatment. Human Molecular Genetics 2009;18(1):R94-R100.
  9. Motzer, et. al. Phase 3 Trial of Everolimus for Metastatic Renal Cell Carcinoma. Cancer 2010 Sep;116(18):4256-4265.
  10. Efficacy and Safety of RAD001 in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC) (EXIST-1). Available at: http://clinicaltrials.gov/ct2/show/NCT00789828?term=exist-1&rank=1. Accesse
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