Danish biotech company NsGene will be the first in the world to implant genetically modified cells into patients' brains, writes professional journal Ingeniøren (The Engineer). The Swedish Medical Products Agency has approved NsGene's clinical trial application (CTA) to start a phase Ib study of NsG0202 for the treatment of Alzheimer's disease (AD).
NsG0202 consists of an implantable encapsulated cell biodelivery device that secretes nerve growth factor (NGF), which has shown to have a neuroprotective and regenerative effect when it is delivered to relevant areas of the brain. NsG0202 is aimed at treating the progressive dementia associated with AD.
"By letting genetically modified cells produce the drug inside the brain, it will be possible to give completely new types of drugs to patients," says managing director of NsGene Teit E. Johansen to Ingeniøren.
The phase Ib study will be carried out in collaboration with the Departments of Geriatrics and Neurosurgery at the Karolinska University Hospitals, Stockholm, Sweden. According to the plan, the first three patients out of a total of six suffering from AD, will have the biodelivery device implanted at the beginning of 2008. The study is scheduled to run for a year.
"This is a significant milestone for NsGene and our EC [encapsulated cell] biodelivery platform and pipeline," says NsGene executive vice president Lars U. Wahlberg in a press release. "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."
If everything goes according to plan, NsGene expects to start selling the product in 2010.