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« : 18 Temmuz 2008 - 14:42:17 » |
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Teva ve Active Biotech AB sirketlerinin duyurusuna gore, Laquinimod (oral hap) calismalari icin Bravo Phase III (3. evre) calismalarina kayitlar basladi. Bu calisma 2 yildir, global duzeyde yapiliyor. Bu calismanin amaci, Placebo oral habina karsi ilacin etkinligini, guvenirligini ve dayanikliligini test etmek ve Avonex ilacina karsi olusabilecek riskler ve faydalar hakkinda bilgi saglamak.
Bravo'nun 3. evre calismalari Nisan ayinda basladi ve yaklasik 1200 hastanin (relapsing-remitting hastasi) bu calismaya kayit olmalari amaclaniyor. Suan Laquinimod'un (oral hap) denemelerde 1000 hasta bulunuyor. Yapilan aciklamada, "Laquinimod'un (oral hap) deneysel calismalari diger MS bilesimlerine, calismalarina benzemiyor. Calisanlar umuyorki, bu calisma onlarin bu konu uzerindeki, MS'le savasma uzerine yeteneklerini genisletecektir."
Yapilan baska bir aciklamada, Laquinimod'un (oral hap) Placebo oral habiyla yapilan kiyaslamasinda, MR cekimlerinde Laquinimod'un hastalik gelisimini %60 azalttigi ve RRMS hastalari icin uygun oldugu belirtildi. Suan hastalar tedavilerine devam ediyorlar.
Second large global phase III trial of oral laquinimod for Multiple Sclerosis starts enrollment 16 July 2008
Teva Pharmaceutical Industries Ltd. and Active Biotech AB announced today that patients are being enrolled for the BRAVO Phase III pivotal trial.
BRAVO is a global, 24-month, double-blind study designed to evaluate the efficacy, safety and tolerability of the oral compound laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex® .
The BRAVO trial, which was initiated in April this year, aims to enroll approximately 1,200 patients with relapsing-remitting multiple sclerosis (RRMS). A second global Phase III trial of laquinimod including 1,000 patients, ALLEGRO, is also ongoing and recruiting patients globally. "All currently approved multiple sclerosis (MS) treatments are administered via injection or infusion. The ability to provide a safe and effective oral treatment option would be a significant advancement for the treatment of MS,” said Dr. Timothy Vollmer, Medical Director, Rocky Mountain MS Center, Denver, Colorado, and principal investigator of the BRAVO study. "Additionally, the mode of action for laquinimod is unlike any other MS compound, existing or experimental. We are hopeful that this research will expand our abilities to combat the disease through novel targeting.”
Data recently published in The Lancet demonstrated that oral dose of laquinimod significantly reduced the median magnetic resonance imaging (MRI) disease activity by 60 percent, compared to placebo and was well tolerated in RRMS patients. The majority of patients from the study are still receiving treatment with laquinimod in an open-label extension trial.
"The safety profiles of oral therapies are of increasing interest to the MS community; We are hopeful that laquinimod will be both efficacious and safe thus providing patients with an optimal risk-benefit profile,” said Dr. Per Soelberg Sorensen, Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital, and principal investigator of the BRAVO study.
Source: Die Welt © Die Welt (16/07/08)
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