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Serono Announces Initiation of the Reflex Trial to Evaluate New Formulation of Rebif(R) in Patients at Risk of Developing Multiple Sclerosis 12 December 2006
First Trial Assessing Therapeutic Benefit of Two Different Dosage Regimens of Disease Modifying Therapy in People With First Clinical Symptoms Suggesting Multiple Sclerosis.
Serono announced today the initiation of a Phase III clinical trial to evaluate the effect of two dosage regimens of the new formulation of Rebif(R) (interferon beta-1a 44 mcg, three times a week or once a week) on the time to conversion to multiple sclerosis (MS) in people with first clinical symptoms suggestive of the disease. The trial, called the REFLEX study (REbif FLEXible dosing in early MS), will involve 480 patients considered at risk of developing MS because of a recently experienced isolated demyelinating event and of typical magnetic resonance imaging (MRI) brain scans.

"It has been demonstrated that early treatment with interferon-beta can reduce the risk of developing multiple sclerosis. Optimising the impact of such treatment on development of irreversible neurological damage and ascertainment of long term outcomes is still subject of active experimental and clinical research", said Professor Ludwig Kappos, from the Department of Neurology, University Hospital Basel, Switzerland, and a member of the Steering Committee of the REFLEX study. "The REFLEX study will determine the respective therapeutic benefit of two different dosage regimens of the new formulation of Rebif(R) for people at risk of developing multiple sclerosis."

The REFLEX study is a randomised, double-blind, placebo-controlled, multicenter trial. Study participants will receive either the new formulation of Rebif(R) 44 mcg three times a week (160 patients), or the new formulation of Rebif(R) 44 mcg once a week (160 patients), or placebo (160 patients) as a subcutaneous injection for a period of 24 months, unless they suffer from a second attack leading to a diagnosis of clinically definite MS. In this case, patients will be offered open label treatment with the new formulation of Rebif(R) 44 mcg three times a week. The primary endpoint of the study is time to conversion to MS, according to the McDonald criteria. Other endpoints will include assessments of MRI brain scans, clinical relapses and disability progression.

The REFLEX study will also evaluate the effect of the new formulation of Rebif(R) on cognitive function as measured by the Paced Auditory Serial Addition Test (PASAT). Cognitive dysfunction can occur early in MS and impact memory, ability to process information and learning. A sub-study will assess retinal nerve fiber thickness (a marker of axonal loss) by means of optical coherence tomography (OCT). This sub-study will be conducted in selected centers, equipped with this leading edge technology. In addition, the REFLEX study will aim at identifying genetic/genomic profiles associated with disease and treatment outcomes.

The new formulation of Rebif(R) has been developed by an innovative approach, using state-of-the-art technologies. It is under regulatory review by the European Medicines Agency, the US Food and Drug Administration and other healthcare authorities, and is not currently approved.

Source: Serono International S A