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The NsG0202 product for AD is the first in a pipeline of disease modifying products based on NsGene's EC biodelivery platform expected to enter clinical trials for neurological disorders over the next two years
COPENHAGEN, Denmark | December 12, 2007 | NsGene A/S announced today that its Clinical Trial Application (CTA) to start a phase Ib study of NsG0202 for Alzheimer's disease (AD) has been approved by the Swedish Medical Products Agency (MPA).
The NsG0202 product for AD is the first in a pipeline of disease modifying products based on NsGene's EC biodelivery platform expected to enter clinical trials for neurological disorders over the next two years. The advanced implant product 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.NsG0202 consists of an implantable encapsulated cell (EC) biodelivery device that secretes nerve growth factor (NGF). NGF has shown to have neuroprotective and regenerative effects when delivered to relevant areas of the brain.
NsG0202 is aimed at treating the progressive dementia associated with AD. The Phase Ib study is carried out in collaboration with the Departments of Geriatrics and Neurosurgery at the Karolinska University Hospitals, Stockholm, Sweden, and is headed by Assoc. Prof. Maria Eriksdotter Jönhagen, Department of Geriatrics. It is expected that the initial three patients will have the EC biodelivery device implanted in the beginning of 2008. In all, six patients will participate in this phase Ib study, which will run for one year.
“This is a significant milestone for NsGene and our EC biodelivery platform and pipeline” says Lars U. Wahlberg, Exec. Vice President & COO, NsGene. He continues: “With the CTA approval we have validated that our novel platform technology fulfil the necessary manufacturing and regulatory requirements to progress into clinical evaluation. The EC biodelivery platform has the potential of generating a broad product pipeline in multiple therapeutic areas such as Parkinson's disease and epilepsy and with the initial CTA approval in hand, our pipeline of EC biodelivery products has moved significantly closer to the market place”
.Teit E. Johansen, President & CEO of NsGene is very excited about the CTA approval of the EC biodelivery product for Alzheimer's disease. He states: “This landmark achievement brings NsGene a step closer to a breakthrough for a treatment of this devastating disease and, by entering the clinic, the Company has risen to the next level of corporate development including partnering opportunities for a maximal exploitation of our NsG0202 product”.
Background on EC biodelivery device
The EC biodelivery device 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 platform 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, a Danish pharmaceutical company. 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 (ECB-AD), Parkinson's disease (ECB-PD) and intractable epilepsy (ECB-EP). 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.
SOURCE: NEUROSEARCH
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