Healthcare Industry News: CERE-110
News Release - November 11, 2010
Ceregene Raises $11.5 Million in Series D FinancingAn Additional $733,437 Is Awarded From Therapeutic Discovery Tax Credit Grants
SAN DIEGO, Nov. 11, 2010 -- (Healthcare Sales & Marketing Network) -- Ceregene, Inc., a biopharmaceutical company, announced today that it has closed its Series D preferred financing in the amount of $11.5 million. The current venture round was co-led by Hamilton BioVentures and Alta Partners with participation from MPM Capital and Investor Growth Capital. The funds will be used to help support Ceregene's currently enrolling Phase 2b clinical study of CERE-120 for the treatment of Parkinson's disease.
Ceregene also reported that it submitted three projects as part of the Therapeutic Discovery Tax Credit program and was awarded the maximal amount of $244,479 on each, for a total of $733,437. These funds will help support Ceregene's Parkinson's disease program, its currently enrolling Phase 2 study of CERE-110 for the treatment of Alzheimer's disease and its ocular disease program. Details on the Parkinson's and Alzheimer's clinical studies can be found at www.ceregene.com.
In related news, Kerry Dance, Ph.D., Managing Director of Hamilton BioVentures will join Ceregene's board of directors. Dr. Dance was President of General Atomics Corporation. While at General Atomics he founded an in-house venture enterprise which produced a successful track record and spun off several successful enterprises, including the San Diego Super Computer Center. He has been involved in the biotechnology industry for over 10 years.
"The closing of our Series D financing coupled with our Therapeutic Tax Credit grant and recent support from The Michael J. Fox Foundation should provide us with the resources to complete our Phase 2b Parkinson's disease clinical study," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. Dr. Ostrove added, "we are encouraged by the data we obtained in our last Phase 2 study in Parkinson's disease which was recently published in the online version of Lancet Neurology (October 21, 2010, print version Dec. 2010) and expect to complete the new Phase 2b clinical study by the end of 2012."
Dr. Ostrove continues, "we are very pleased to have Dr. Kerry Dance join our board. His extensive leadership experience combined with his successful track record of biotech investments will be invaluable to us as we proceed to late-stage clinical studies of our promising therapies for Parkinson's and Alzheimer's disease."
"I am pleased to join the Ceregene board of directors and look forward to working with the company to help maximize the value of their Parkinson's disease and Alzheimer's disease Phase 2 clinical programs," stated Kerry Dance, Ph.D. of Hamilton BioVentures. "Because nervous system growth factors have the ability to restore dying neurons in the brain, keeping them alive and functioning better, these novel therapeutics should improve symptoms as well as have the ability to slow disease progression, making them unique among developing therapies."
About CERE-120 and its Potential for 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 dopamine neurons in the substantia nigra that degenerate in Parkinson's disease. Degeneration of these neurons is responsible for the major motor impairments of Parkinson's disease. In previous clinical trials, CERE-120 was delivered to the terminal fields, i.e., the ends of the degenerating neurons, located in an area of the brain called the putamen, using stereotactic injections. The cell bodies for these same neurons are located in a different area of the brain, called the substantia nigra. Based on insight gained from the past Phase 2 trial regarding the status of these neurons in advanced Parkinson's disease, the amended dosing regimen employed in the ongoing Phase 2b trial administers CERE-120 to both the substantia nigra as well as the putamen. Once delivered to the brain, CERE-120 provides stable, long-lasting expression of neurturin in a highly targeted fashion.
About CERE-110 and its Potential for Treating Alzheimer's Disease
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.
A Phase 2 randomized, controlled study is currently enrolling patients with mild to moderate Alzheimer's disease in 10 leading centers across the U.S. This study is being conducted in collaboration with the ADCS (Alzheimer's Disease Cooperative Study) and is supported by a $5.4 million grant from the National Institute of Aging at the National Institutes of Health (NIH).
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. Ceregene's clinical programs include CERE-110, an AAV2 based vector expressing nerve growth factor (NGF) currently in a multi-center, controlled Phase 2 study for the treatment of Alzheimer's disease (supported by the NIH and in collaboration with the ADCS), and CERE-120 (AAV2-Neurturin) 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, Inc. (Nasdaq:BPAX ).
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