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Ceregene Phase 2 Clinical Trial for Alzheimer's Disease to be Funded by $5.4 Million Grant From National Institutes of Health

Wednesday, November 5, 2008 General News J E 4
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SAN DIEGO, Nov. 4 Ceregene, Inc., a biopharmaceuticalcompany, today announced that the University of California, San Diego (UCSD)has received a $5.4 million grant from the National Institute of Aging at theNational Institutes of Health (NIH) to support a Phase 2 clinical study ofCeregene's CERE-110, a gene therapy product designed to deliver nerve growthfactor (NGF) for the treatment of Alzheimer's disease. A Phase 1 study ofCERE-110 indicated that a single administration of the therapy was welltolerated, though the study was too small to make a definitive statement abouttreatment efficacy.

Ceregene anticipates initiating the Phase 2 study, which is expected toenroll 50 patients with mild to moderate Alzheimer's disease at multipleclinical trial sites in the U.S. early next year. The study will bedouble-blinded and will evaluate the treatment arm versus an appropriatecontrol arm with respect to safety measures and cognitive function and qualityof life at two years.

"We are pleased to be involved in evaluating CERE-110 which we believe maybe a promising therapy for Alzheimer's disease," stated Paul Aisen, M.D.,principal investigator of the planned Phase 2 trial and director of theAlzheimer's Disease Cooperative Study at University of California, San Diego,a preeminent research consortium for testing new treatments for Alzheimer'sdisease. "Over five million people in the U.S. are currently living withAlzheimer's disease -- a disease which is devastating to patients and theirfamilies -- and we are in need of more effective treatment options for thesepatients."

"The safety profile that we have observed from CERE-110 in the Phase 1study is very encouraging, and we are delighted that this NIH grant willenable us to further evaluate this product candidate. We are especiallygrateful for this funding given that it was based on peer review, and we lookforward to using it to advance this product. The development of CERE-110 wasled by Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chiefscientific officer and is a continuation of the pioneering work of MarkTuszynski, M.D., Ph.D., Ceregene's co-founder and a professor of Neurosciencesat UCSD," stated Jeffrey M. Ostrove, Ph.D., president and chief executiveofficer of Ceregene. "Similar to the other therapies in our pipeline whichtarget Parkinson's disease, ocular disorders and ALS (Lou Gehrig's disease),CERE-110 may have the ability to not only treat the symptoms of Alzheimer'sdisease but to protect dying neurons and potentially result in the slowing ofdisease progression."

About CERE-110

CERE-110 is composed of an adeno-associated viral (AAV) vector carryingthe gene for NGF, a naturally occurring protein that maintains survival ofnerve cells in the brain. CERE-110 is surgically injected into the NucleusBasalis of Meynert (NBM), a brain region where cholinergic cell degenerationoccurs in Alzheimer's disease. The cholinergic system is important in memoryand cognitive function, and a restoration in the function of this system mayimprove memory in individuals with Alzheimer's disease. Delivery of NGF usingan AAV vector should have the potential to induce sustained expression of NGF,resulting in long-lasting restoration of the function.

The Phase 1 study was conducted at Rush University Medical Center, Chicagoand UCSD. The open-label study involved 10 subjects with mild-to-moderateAlzheimer's disease. The administration of CERE-110 was generally safe andwell tolerated. The 10 participants underwent cognitive testing, measures ofactivities of daily living, MRI scans and PET (positron emission tomography)scans. Increases in brain metabolism were observed in several cortical regionsat six months and 12 months (p < 0.05) in four subjects as compared to otherseverity-matched individuals with Alzheimer's disease suggesting a potentialreversal of patterns typically observed in Alzheimer's disease.

About Alzheimer's Disease

Alzheimer's disease is a progressive disorder of the brain that graduallyaffects one's memory and ability to learn, reason, communicate and carry outdaily activities. There are now more than five million people in the UnitedStates living with Alzheimer's disease, and there is currently no cure.

About Ceregene

Ceregene, Inc. is a San Diego-based biotechnology company focused on thedelivery of nervous system growth factors for the treatment ofneurodegenerative disorders using gene delivery. Ceregene's clinical programsinclude CERE-110, an AAV2 based vector expressing nerve growth factor that iscurrently in Phase 1 studies for the treatment of Alzheimer's disease, andCERE-120 (AAV2-Neurturin) which has completed enrollment of a controlled Phase2 study for Parkinson's disease. CERE-135 and CERE-140 are in preclinicaldevelopment for ALS (Lou Gehrig's disease) and ocular disorders, respectively.Ceregene was launched in January 2001. The company's investors include AltaPartners, MPM Capital, Investor Growth Capital and Cell Genesys, Inc.(Nasdaq: CEGE) as well as Hamilton BioVentures and California TechnologyPartners.

SOURCE Ceregene, Inc.
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