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news.Ceregene, a biopharmaceutical company, has announced that the University of California, San Diego has received a $5.4 million grant from the National Institute of Aging at the National Institutes of Health to support a Phase II clinical study of Ceregene's CERE-110, a gene therapy product designed to deliver nerve growth factor for the treatment of Alzheimer's disease.
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A Phase I study of CERE-110 indicated that a single administration of the therapy was well tolerated, though the study was too small to make a definitive statement about treatment efficacy.
Ceregene anticipates initiating the Phase II study, which is expected to enroll 50 patients with mild to moderate Alzheimer’s disease at multiple clinical trial sites in the US early 2009. The study will be double-blinded and will evaluate the treatment arm versus an appropriate control arm with respect to safety measures and cognitive function and quality of life at two years.
Raymond Bartus, president and CEO of Ceregene, said: “The safety profile that we have observed from CERE-110 in the Phase I study is very encouraging, and we are delighted that this National Institutes of Health grant will enable us to further evaluate this product candidate. We are especially grateful for this funding given that it was based on peer review, and we look forward to using it to advance this product.”