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Ceregene Completes Enrollment of Second Phase 2 Study of CERE-120 for the Treatment of Parkinson's Disease
Date:12/1/2011

SAN DIEGO, Dec. 1, 2011 /PRNewswire/ -- Ceregene, Inc. reported today that it has completed enrollment in its Phase 2b trial of CERE-120, a gene therapy product expressing the neurturin (NRTN) gene for the treatment of Parkinson's disease.  This Phase 2b study enrolled 51 patients at 11 medical centers throughout the United States.  CERE-120 is comprised of an AAV vector intended to provide constant, sustained expression of neurturin (NRTN), a neurotrophic factor shown to rescue dying dopaminergic neurons, restoring their function and protecting them from cell death.

Ceregene also reported that it has been chosen to present its work on CERE-120 at Windhover's annual Therapeutic Area Partnership conference as one of the "Top 10 Neuroscience Projects to Watch".  Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer will present at the Boston conference on Thursday December 1st at 1:30 pm.

"Safely completing enrollment in our current Phase 2b CERE-120 Parkinson's study is an important milestone in Ceregene's history, as this study builds on the results of an earlier Phase 2 trial and is powered to demonstrate statistical significance of clinical benefit for CERE-120," stated Jeffrey M. Ostrove, Ph.D., Ceregene's president and chief executive officer.  "We have been fortunate to work with many of the world's leading Parkinson's disease experts in both the clinical trial design and implementation," noted Dr. Ostrove.

"The protocol and dosing scheme developed for the current study leveraged the unique and important insight we gained from the results of our previous clinical studies with CERE-120," noted Dr. Bartus. "Among other things, we observed a fundamental deficiency in the degenerating neurons of Parkinson's disease, which limits how effectively material, like NRTN, is transported from the terminals of these neurons to their cell bodies.  This provided the key insight required to recognize the need to inject CERE-120 directly into the substantia nigra, thus reducing dependency on retrograde transport."  Additionally, because of the safety record thus far established with CERE-120, the current Phase 2b study injected a 4-fold higher CERE-120 dose into the putamen, compared to prior studies.  "These dosing changes are intended to help assure that the entire degenerating neuron is exposed to sufficient neurotrophic factor, stimulating a more robust neurotrophic response, which in turn, should further enhance and accelerate neuronal repair and clinical benefit," continued Dr. Bartus. 

Ceregene's previous Phase 2a clinical study of CERE-120 demonstrated "proof of concept", showing efficacy on a number of secondary clinical motor and quality of endpoints, with no measurement similarly favoring the sham control treatment.  While that study missed the primary endpoint at 12 months post treatment, a statistically significant improvement from CERE-120 was seen on this measure at 15 and 18 months, post treatment (p=0.023).  Moreover, even more secondary endpoints showed benefit at these longer, post-treatment time points.  The current Phase 2b study will analyze patient outcomes following 15 to 24 months post treatment.  The primary endpoint in both Phase 2 trials is the "UPDRS off" score which is a measure of motor function commonly used in clinical trials of Parkinson's disease.  Ceregene expects to report data from the new Phase 2b study near the end of the first quarter of 2013.

This and prior CERE-120 clinical studies were partially supported by a series of generous grants from the Michael J. Fox Foundation for Parkinson's Disease Research.  Participating Medical Centers included The University of California, San Francisco; Emory University; Baylor College of Medicine; Duke University Medical Center; University of Alabama, Birmingham; Stanford University School of Medicine; The University of Pennsylvania; Columbia University Medical Center; Rush University Medical Center; Beth Israel Medical Center, NY; and Mount Sinai Medical Center, NY.

About CERE-120 and its Application to Treating Parkinson's Disease
CERE-120 is composed of an adeno-associated virus (AAV) vector carrying the gene for neurturin, a naturally occurring protein known to repair damaged and dying dopamine-secreting neurons, keeping them alive and restoring normal function.  Neurturin is a member of the same protein family as glial cell-derived neurotrophic factor (GDNF).  The two molecules have similar pharmacological properties, and both have been shown to benefit the midbrain dopamine neurons that degenerate in Parkinson's disease.  Degeneration of these neurons is responsible for the major motor impairments of Parkinson's disease.  CERE-120 is delivered by stereotactic injection to the terminal fields (i.e., the ends of the degenerating neurons), located in an area of the brain called the putamen, as well as the cell bodies for these same neurons, located in a different area of the brain, called the substantia nigra.  Once CERE-120 is delivered to the brain, it provides stable, long-lasting expression of neurturin in a controlled and highly targeted fashion.

About Parkinson's Disease
Parkinson's disease is a progressive movement disorder that affects a million people in the United States.  Its main symptoms, stiffness, tremors and slowed movements and gait, are caused by a loss of dopamine-containing nerve cells in the substantia nigra, which project their axons to the putamen.  Dopamine is a neurotransmitter involved in controlling movement and coordination, so Parkinson's patients exhibit a progressive inability to initiate and control physical movements.  There is currently no treatment that can reverse the degeneration of these neurons, let alone cure Parkinson's disease.

About Ceregene

Ceregene, Inc. is a San Diego-based biotechnology company focused on the delivery of nervous system growth (neurotrophic) factors for the treatment of neurodegenerative and retinal disorders using gene delivery.  In addition to CERE-120 for Parkinson's disease, Ceregene's other clinical program includes CERE-110, an AAV2 based vector expressing nerve growth factor (NGF).  CERE-110 is currently being evaluated in a multi-center, controlled Phase 2 study in Alzheimer's disease, in collaboration with the Alzheimer's Disease Cooperative Study and partially funded by the National Institutes of Health (NIH).  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).

About The Michael J. Fox Foundation for Parkinson's Research
As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today.  The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $270 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure.


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