Alexian Brothers Hospital Network Clinical Trails
Alexian Brothers Hospital Network Participating in a New Phase III MS Study to Evaluate the Efficacy and Safety of FTY720, a Novel, Investigational, Once-Daily Oral Medication
Patient enrollment starting now — For more information call 847-981-3656
Elk Grove Village, IL March 1, 2007 Alexian Brothers Hospital Network announced today that it is now screening patients for enrollment in a new Phase III study to evaluate the efficacy and safety of FTY720 (fingolimod), a novel, investigational, once-daily, oral medication, in relapsing-remitting multiple sclerosis (RRMS). The 24-month, randomized, double-blind, placebo-controlled study program, called “FREEDOMS” (FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis) is sponsored by Novartis and will include more than 2,000 MS patients in approximately 200 study centers worldwide. FREEDOMS-II is the US arm of the international study program.
“If the Phase III FREEDOMS study program confirms the data demonstrated in the Phase II study program and leads to FDA approval, FTY720 may represent an improvement when compared to currently-available injectable medications,” said Dr. Vipan Gupta, Alexian Brothers Principal Study Investigator.
The FREEDOMS study program will include patients with RRMS between the ages of 18 and 55. Eligible patients will be equally randomized to either receive study treatment with FTY720 1.25 mg, FTY720 0.5 mg or placebo once daily for up to 24 months. The primary endpoint will be the relapse rate at 24 months.
In MS, inflammatory lymphocytes (T-cells) are believed to be responsible for the destruction of the protective myelin coating, which surrounds the nerves in key areas of the brain and spinal cord. This destruction hinders the ability of nerves to send electrical signals, resulting in problems with muscle movement, coordination, balance and cognition.
FTY720 has a novel mode of action different from all available therapies. It binds to the sphingosine 1-phosphate receptor-1 (S1P1) on circulating lymphocytes and reversibly traps a proportion of them in the lymph nodes. As a result, FTY720 lowers the number of activated T-cells circulating in the bloodstream and central nervous system.
The Phase II 12-month results, recently published in the New England Journal of Medicine, demonstrated that FTY720 reduced the rate of clinical relapses and inflammatory disease activity as measured by MRI over the first six months of the study compared to placebo. After six months placebo patients were switched to active therapy. The Phase II 24-month data presented at the ECTRIMS meeting in September, 2006 showed that many patients taking once-daily oral FTY720 remained free of relapses over two years. They also maintained a low rate of inflammatory disease as measured by magnetic resonance imaging (MRI). Patients who received placebo for the first six months also experienced an improvement after switching to FTY720, and the improvement was sustained through month 24.
Over two million people worldwide, and approximately 400,000 in the US, are estimated to suffer from multiple sclerosis, which is the leading cause of neurological disability in young adults. MS has a significant impact on the patient’s social activities, employment and overall quality of life. MS is the most common chronic, disabling disease of the central nervous system affecting twice as many women than men. The relapsing-remitting (RRMS) course is the most common form of the disease. Patients suffer acute self-limiting attacks (relapses) of neurological dysfunction followed by complete or incomplete remission in function. Over time, transmission of electrical nerve impulses is disrupted, nerve cells are destroyed, and patients experience symptoms ranging from fatigue, tingling, numbness and blurred vision to poor muscle control with partial or complete paralysis, speech or mental impairment.
Contact Corey McGregor at 847-981-3656 for more information about the FREEDOMS-II study.
