Steven M. Greenberg, Associate Professor of Neurology at Harvard Medical School and Co-Director of the Neurology Clinical Trials Unit at the Massachusetts General Hospital (MGH) has been awarded a grant of approximately $U.S. 1 million from the National Institutes of Health (NIH) in support of Neurochem Inc's U.S. Phase II clinical trials of Cerebril. Investigation of Cerebril has been initiated in five U.S. clinical trial centers, including the MGH, for the prevention of recurrent Hemorrhagic Stroke due to Cerebral Amyloid Angiopathy (CAA).
Dr. Greenberg commented, "This will be the first study of a candidate drug for the treatment of CAA, a major cause of bleeding strokes in the elderly. The partnership between the National Institute of Neurological Disorders and Stroke, Neurochem and the participating stroke research centers underlines the importance of this rapidly growing area of investigation."
"This grant provides important support of Neurochem's approach to develop therapies to treat Hemorrhagic Stroke based on our understanding of the effects of amyloid formation in the brain," commented Denis Garceau, Neurochem's Vice President of Drug Development. "Over the past several years, the role of CAA as an underlying cause of disease, including Hemorrhagic Stroke, has become more widely recognized. This study continues to position Neurochem's leadership role in this field."
The U.S. Phase II clinical trial evaluates the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of Cerebril in CAA patients who have experienced lobar cerebral hemorrhage. The data obtained from this study will determine the optimal dosage for Phase II/Phase III trials and thus offer a potentially important step towards a preventive therapy for this currently untreatable condition. The trial is a multicenter, randomized, double-blind and parallel design study. Twenty-four CAA patients with lobar cerebral hemorrhage are randomized to receive three different dose levels of Cerebril for a period of twelve weeks.