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Novartis' Afinitor drug meets primary goal of phase 3 trial for TSC drug

Published: 02:45 09 Jul 2011 AEST

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Novartis (NYSE:NVS) announced Friday its everolimus drug, branded as Afinitor, achieved its phase three primary goal, reducing the size of a type of brain tumour in patients with tuberous sclerosis complex (TSC), a genetic disorder.

The 117-person study, which was mainly intended to examine the efficacy and safety of the Afinitor drug compared to a placebo, showed over one third of patients experienced a 50% or greater reduction in subpendymal giant cell astrocytoma (SEGA) tumour size, compared to no patients in the placebo arm.

"This study, which included SEGA patients from infancy to adulthood, provides compelling evidence of the impact of everolimus in reducing SEGA size," said the study's lead investigator, Dr. Sergiusz Jozwiak.

Affecting between one million and two million people worldwide, TSC often results in seizures, swelling in the brain, developmental delays and skin lesions. The disorder also causes non-cancerous tumours to form in vital organs, like the brain and kidney.

Novartis' Afinitor drug, which is currently approved in several countries like the U.S. and Switzerland to treat TSC patients with a SEGA tumour who are unable to undergo surgery, works by targeting the mTOR protein. The protein, which regulates tumour growth, is more active in patents with TSC.

Where everolimus is not approved, for example in the EU, brain surgery is the only treatment available to patients with these types of tumours.

In June, the Committee for Medicinal Products for Human Use expressed a positive opinion on the approval of the everolimus drug in the European Union, Novartis said.

Other end points during the phase three study that were met include a reduction in the time to SEGA progression and skin lesion response rate.

Based in Basel, Switzerland, Novartis is focused on healthcare, and provides a variety of medicines, vaccines and diagnostic tools to consumers and industry professionals.

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