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NsGene A/S today announced that its encapsulated cell (EC) biodelivery product, NsG0202, has successfully been implanted into the brains of three patients with Alzheimer’s disease (AD)
BALLERUP, Denmark | April 7, 2008 | The NsG0202 device for AD is the first in a pipeline of EC biodelivery products based on NsGene’s proprietary platform expected to enter clinical trials for neurological disorders over the next two years. The product is a disease modifying implant that represents a novel treatment method aimed at restoring brain function and not only at alleviating symptoms. Thereby, it may constitute a breakthrough in the treatment of severe diseases of the central nervous system, such as AD, Parkinson’s disease, and epilepsy.
The product consists of an implantable EC biodelivery device that secretes nerve growth factor (NGF). NGF has shown to have neuroprotective and regenerative effects when delivered to diseased neurons in relevant areas of the brain. NsG0202 is aimed at treating the progressive dementia associated with AD. The current phase Ib clinical trial is carried out in collaboration with the Department of Geriatrics and Department of Neurosurgery at the Karolinska University Hospital in Stockholm and is headed by Assoc. Prof. Maria Eriksdotter Jönhagen, Department of Geriatrics. Three patients were successfully implanted by the neurosurgical team headed by Prof. Bengt Linderoth. The devices were placed at precise anatomical locations using MRI-guided, stereotactic neurosurgery. After safety and functional evaluations, an additional three patients will be implanted. Thus, in total, six patients will participate in this year-long phase Ib study.
“This is a significant milestone for NsGene and our EC Biodelivery platform and pipeline” says Lars U. Wahlberg, Exec. Vice President and COO, NsGene. He continues: “The successful implantation of the first three patients suffering from Alzheimer’s disease has demonstrated that the devices can be implanted with both precision and safety and is paving the way for additional clinical studies.”
Background on EC biodelivery device
The EC-biodelivery is a cell-based biodelivery system of protein factors to the nervous system providing a controlled, site-specific and safe delivery of a variety of therapeutic substances. For central nervous system (CNS) indications, one or multiple EC biodelivery devices can be implanted in defined regions of the brain to deliver any proteins, including growth factors, antibodies, and neuropeptides, across the blood-brain-barrier. The proprietary EC biodelivery system consists of a catheter-like device containing in its active portion a genetically modified human cell line enclosed behind a semi-permeable hollow fiber membrane. The membrane allows for the influx of nutrients and the outflow of the therapeutic factor(s) but prevents the direct contact between the therapeutic cells and the host tissue. The encapsulated cells provide long-term factor secretion from the implanted device.
EC biodelivery is a strongly and broadly patented technology platform offering great safety advantages over direct gene therapy approaches, and technical and functional advantages over pump technologies.
Background on NsGene
NsGene A/S (www.nsgene.com) is a privately held Danish biotechnology company founded in December 1999 as a spin-off from NeuroSearch A/S. NsGene develops novel biologicals for the treatment of neurological diseases. Based on the EC biodelivery platform, NsGene develops EC biodelivery products for neurological diseases including Alzheimer’s disease, Parkinson’s disease and intractable epilepsy. In addition hereto, a number of EC biodelivery products for other indications are under investigation. Today, NsGene employs 27 people at its research facility located near Copenhagen in the Medicon Valley Region. For more information, please see www.nsgene.dk.
SOURCE: NsGENE |
