Ceregene And Alzheimer's Disease Cooperative Study Group Complete Enrollment Of CERE-110 Phase 2 Trial

 Ceregene And Alzheimer's Disease Cooperative Study Group Complete Enrollment
                          Of CERE-110 Phase 2 Trial

PR Newswire

SAN DIEGO, March 13, 2013

SAN DIEGO, March 13, 2013 /PRNewswire/ -- Ceregene, Inc. today announced the
completion of enrollment in its double-blind Phase 2 clinical study of
CERE-110 (AAV-NGF), a gene therapy product designed to deliver nerve growth
factor (NGF) for the treatment of Alzheimer's disease. The clinical study was
carried out in collaboration with the Alzheimer's Disease Cooperative Study
(ADCS) based at the University of California San Diego (UCSD) and funded by a
grant from the National Institute on Aging (NIA), part of the National
Institutes of Health (NIH). 

Forty-nine (49) patients with mild to moderate Alzheimer's disease were
treated with CERE-110 at 10 clinical sites throughout the U.S. Approximately
half of the patients received CERE-110 while the other half received an
appropriate sham (placebo) surgery control treatment.Patients will be
followed for a minimum of two years with respect to safety, brain imaging, as
well as measures of cognitive function and quality of life. Standard tests
used in Alzheimer's clinical trials.

"We are very excited that enrollment in the first blinded study of NGF gene
therapy for Alzheimer's disease is now completed and appreciate the courage of
all of the patients and their family members that enrolled in this very
important study.We also appreciate the efforts of the ADCS and the National
Institute on Aging for carrying out and supporting the operational aspects of
this study" stated Jeffrey M. Ostrove, Ph.D., president and chief executive
officer of Ceregene, Inc., the developer of CERE-110. Dr. Ostrove added "In
addition to CERE-110 for Alzheimer's disease, we have also completed
enrollment in two controlled Phase 2 clinical trials of CERE-120 for
Parkinson's disease. At this time, we would like to recognize the leadership
role of Raymond T. Bartus, Ph.D., our chief scientific officer who led the
development efforts for both of these potential products for the treatment of
our most common neurodegenerative disorders".

"We were very pleased to be involved in evaluating CERE-110. We believe
CERE-110 may prove to be an effective therapy for Alzheimer's disease," stated
Paul Aisen, M.D., Project Director of the Phase Two trial and director of the
Alzheimer's Disease Cooperative Study at University of California San Diego, a
preeminent research consortium for testing new treatments for Alzheimer's
disease. "If the results prove positive, which is our hope, this therapy could
help the over five million people in the U.S. currently living with
Alzheimer's disease in need of more effective treatment options."

About CERE-110
CERE-110 is composed of an adeno-associated viral (AAV) vector carrying the
gene for NGF, a naturally occurring protein that maintains survival of nerve
cells in the brain.CERE-110 is surgically injected into the Nucleus Basalis
of Meynert (NBM), a brain region where cholinergic cell degeneration occurs in
Alzheimer's disease. The cholinergic system is important in memory and
cognitive function, and a restoration in the function of this system may
improve memory in individuals with Alzheimer's disease. Delivery of NGF using
an AAV vector should have the potential to induce sustained expression of NGF,
resulting in long-lasting restoration of the function.

About Alzheimer's Disease
Alzheimer's disease is a progressive disorder of the brain that gradually
affects one's memory and ability to learn, reason, communicate and carry out
daily activities.There are now more than five million people in the United
States living with Alzheimer's disease, and there is currently no cure.

About Ceregene
Ceregene, Inc. is a San Diego-based biotechnology company focused on the
delivery of nervous system growth factors for the treatment of
neurodegenerative disorders using gene delivery. Ceregene's clinical programs
include CERE-110, an AAV2 based vector expressing nerve growth factor for the
treatment of Alzheimer's disease, and CERE-120 (AAV2-Neurturin) which has
completed enrollment of a controlled Phase 2 study for Parkinson's disease.
Ceregene was launched in January 2001. The company's investors include Alta
Partners, MPM Capital, Hamilton BioVentures, Investor Growth Capital,
California Technology Partners and BioSante Pharmaceuticals (Nasdaq:BPAX).

SOURCE Ceregene, Inc.

Website: http://www.ceregene.com
Contact: Jeffrey M. Ostrove, Ph.D., President and CEO, Ceregene, Inc.,
+1-858-458-8808
 
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