Teva Pharmaceutical Industries and Active Biotech have completed patient enrollment for the second pivotal Phase III clinical trial, BRAVO, evaluating the novel, oral once-daily immunomodulating compound, laquinimod, for the treatment of relapsing-remitting multiple sclerosis (RRMS). BRAVO is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex.

“Teva and Active Biotech are encouraged by the potential of laquinimod to address patients' unmet need for an oral immunomodulating MS therapy that provides efficacy while maintaining safety,” said Moshe Manor, Teva’s group vice president, Global Branded Products. “We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for RRMS patients.”

The companies recruited more than 1,200 patients at 156 sites in the U.S., Europe, Israel and South Africa for this trial. The first global Phase III trial of laquinimod completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites. The trial is currently ongoing. In February 2009, laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Pfizer released results from a Phase III trial of Sutent in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors, which is a different type of cancer than the more common pancreatic adenocarcinoma. Study findings demonstrated that median progression-free survival (PFS) was 11.1 months in patients treated with Sutent compared to 5.5 months in patients treated with placebo. Researcherspresented the data at the 11th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The independent Data Monitoring Committee (DMC) recommended halting the trial earlier this year because Sutent showed significant benefit and the study had met its primary endpoint. Full analysis of the data is ongoing.

“In this study, Sutent demonstrated an impressive improvement in progression-free survival for patients with pancreatic islet cell tumors,” said Dr. Eric Raymond, M.D., Ph.D., professor of Medical Oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France, and lead investigator on this study. “This is encouraging news for patients, especially given that there are limited treatment options for this type of advanced cancer.”

“The observation of substantial improvement in progression-free survival in Sutent-treated patients was the basis for the independent Data Monitoring Committee’s recommendation to halt accrual to the study early,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “This is welcome news, as there is currently no standard of care for patients with pancreatic islet cell tumors who progress on prior therapy.”

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