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Phase III trial of Novartis drug Afinitor® met primary endpoint

Novartis announced Phase III trial results that showed more than one-third of patients taking Afinitor® (everolimus) tablets* experienced a 50% or greater reduction in the size of their subependymal giant cell astrocytomas (SEGAs), non-cancerous brain tumors associated with tuberous sclerosis complex (TSC). This study, the largest prospective clinical trial to date in this patient population, is being presented on Saturday, July 9 at the International TSC Research Conference in Washington, D.C.

Tuberous sclerosis complex affects approximately one to two million people worldwide and is associated with a variety of resulting disorders including seizures, swelling in the brain (hydrocephalus), developmental delays and skin lesions. Also known as tuberous sclerosis (TS), TSC is a genetic disorder that may cause non-cancerous tumors to form in vital organs and can affect many different parts of the body, most commonly the brain and kidney. Signs and symptoms of TSC vary depending on which system and which organs are involved. SEGAs occur in up to 20% of patients with TSC. In countries where everolimus is not approved, brain surgery is the only treatment option for patients with growing SEGAs.

The 117-patient, randomized, placebo-controlled Phase III EXIST-1 (EXamining everolimus In a Study of TSC) trial met its primary endpoint of SEGA response rate, with 35% of patients (27 of 78) receiving everolimus experiencing a 50% or greater reduction in SEGA volume (sum of volumes of all target SEGAs) relative to baseline versus 0% of patients (0 of 39) on placebo (p<0.0001).

The Phase III study supports the findings of the Phase II study used for registration in several countries. The extension phase of the Phase II study, which is also being presented at the conference, provides data to support the treatment of patients with SEGA associated with TSC for a duration of up to three years.

Regulatory approvals for everolimus have been granted for this patient population as Afinitor in the United States, Canada, Brazil, Guatemala, the Philippines, Columbia and Korea, and as Votubia® in Switzerland. In June, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of everolimus for this use in the European Union (EU).

(www.pharmabiz.com)

 

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