Ceregene, Inc. is a biotechnology company based in San Diego-based delivery of neurotrophic factors for the treatment of neurodegenerative disorders using gene and retina. Clinical programs include CERE-110 Ceregene, an AAV2 vector expressing nerve growth factor currently in a multicenter, randomized, controlled Phase 2 study for the treatment, and CERE-120 for Parkinson’s disease. CERE-140 is in preclinical development of several blinding eye disorders. Ceregene was launched in January 2001. The company’s investors include Alta Partners, MPM Capital, Investor Growth Capital and BioSante Pharmaceuticals which acquired its position after its merger with Cell Genesys, Inc.Foundation Michael J. Fox for Parkinson’s Research will provide $ 2.5 million to support new Ceregene Inc. Phase 2 study of CERE-120. CERE-120 has the potential to improve motor function and slow progression. Competitive funding has been awarded the MJFF Bonds 2010 program on neurotrophic factors.
But existing studies have produced conflicting results about the dangers associated with specific drugs.
The principal investigators of this award are Ceregene Senior Vice President and Chief Scientific Officer Raymond T. Bartus, Ph.D. and Joao Siffert, MD, medical director of Ceregene. Now we look forward to testing these improvements in a controlled clinical trial in PD patients to establish more clearly the safety and efficacy of CERE-120 improved, said Dr. Bartus.
CERE-120 is composed of an adeno-associated virus carrying the gene for neurturin, a naturally occurring protein known to repair damage and death of dopamine-secreting neurons, keeping alive and restore normal function. Neurturin is a member of the family of proteins such as glial cell-derived neurotrophic factor . The two molecules have similar pharmacological properties, and both have been shown to benefit the midbrain dopamine neurons that degenerate in Parkinson’s disease. The degeneration of these neurons is responsible for the major motor deficits of Parkinson’s disease. CERE-120 was administered by injection stereotactic terminal fields, ie, the ends of the degenerating neurons, located in an area of the brain called the putamen. The cell bodies of these neurons are located in a different area of the brain called the substantia nigra. The revised dosing regimen used in Phase 1 is administered CERE-120 for both the substantia nigra and the putamen, which represents the gaps in the ability of these neurons degenerate efficiently transport neurturin from its terminals to its cell bodies. Once CERE-120 is delivered to the brain, providing stable, long-term expression of neurturin in a very targeted way. However, CERE-120 showed an improvement in several secondary endpoints at 12 months and more than 18 months CERE-120 demonstrated a statistically significant effect on the primary endpoint. Equally important, no action on the sham-surgery control group improved compared with CERE-120-treated. Based on these results, and knowledge drawn from the analysis of brain tissue after the death of two patients receiving CERE-120, the company revised the dosing regimen that is reflected in the ongoing Phase 1, which closed recruitment, and The planned Phase 2.
Ceregene is enthusiastic about the continued support of the Michael J. Fox Foundation and this award will allow us to insert the appropriate number of PD patients in the statistical power of our next phase 2 controlled clinical trial, said Jeffrey M.D., President and CEO Ceregene, Inc. This funding marks the fourth the price of the Michael J. Fox Foundation for Ceregene and we are grateful for their support, noted Dr.
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