Investor News
NeuroSearch's associated company, NsGene, announces the successful implantation
of its novel and advanced biodelivery product, NsG0202 in six patients with
Alzheimer's disease
NsGene A/S, 25% owned by NeuroSearch, today announced that its EC (encapsulated
cell) biodelivery product, NsG0202, has now been successfully implanted in a
total of six patients with Alzheimer's disease as part of an ongoing Phase Ib
clinical trial.
In March 2008, NsGene implanted NsG0202 in three patients suffering from
Alzheimer's disease. Based on a very positive outcome of a safety review of
these patients, three additional Alzheimer's patients have now been successfully
implanted. Besides safety and tolerability, indications of therapeutic effects
will also be evaluated in the Phase Ib trial to guide also the continued
clinical development of the product.
NsG0202 consists of an implantable EC biodelivery device, containing genetically
modified cells that secrete nerve growth factor (NGF) to the surrounding brain
tissue. NGF has shown to have neuroprotective and regenerative effects when
delivered to diseased neurons in relevant areas of the brain. Therefore, NsG0202
represents a unique and entirely new disease-modifying therapeutic concept,
aiming at treating the progressive dementia associated with Alzheimer's disease.
The EC biodelivery approach may constitute a breakthrough in the treatment of
severe neurological disorders, such as Alzheimer's disease, Parkinson's disease,
and epilepsy. NsG0202 is the first in NsGene's pipeline of EC biodelivery
products to have entered clinical phase to be studied on patients, and more are
expected to follow over the coming years.
Lars U. Wahlberg, Executive Vice President and COO, NsGene comments:
“This is yet another highly significant milestone for NsGene and for our EC
biodelivery platform and pipeline in particular. The successful implantation of
multiple regenerative implants in patients suffering from Alzheimer's disease
demonstrates that the EC biodelivery devices can be implanted with both
precision and safety, paving the way for the potential launch of a novel
treatment to fill a great medical need in the area of Alzheimer's disease.”
Flemming Pedersen, CEO of NeuroSearch comments:
“We are very encouraged by NsGene's strong progress. In our view, the EC
biodelivery product NsG0202 clearly represents one of the most promising
Alzheimer's drugs in development with a potential to become one of the first
disease modifying treatments for this disease, which remains one of the largest
challenges as well as opportunities for the pharmaceutical industry.”
For further information, please see attached press release from NsGene.
Contact persons:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118
Hanne Leth Hillman, Vice President, Director of IR & Corporate Communications,
telephone: + 45 4460 8212 or +45 4017 5103
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on Nasdaq
OMX Copenhagen. The company's core business covers the development of novel
drugs, based on a broad and well-established drug discovery platform focusing on
ion channels and CNS disorders. A substantial share of its activities is partner
financed through a broad alliance with GlaxoSmithKline (GSK) and collaborations
with, among others, Abbott and Astellas. NeuroSearch's drug pipeline comprises
14 clinical (Phase I-III) development programmes: ACR16 for Huntington's disease
(Phase III), tesofensine for obesity and in Type 2 diabetes (Phase III in
preparation), NS2359 for depression (Phase II) and ADHD (Phase II) in
partnership with GSK, ABT-894 for ADHD (Phase II) and pain (Phase II) in
partnership with Abbott, ACR16 for schizophrenia (Phase I) in partnership with
Astellas, ACR325 for Parkinson's disease (Phase II in preparation) and bipolar
disorder (Phase II in preparation), ABT-107 and ABT-560 for the treatment of
various CNS disorders - both (Phase I) in collaboration with Abbott, NSD-644 for
pain (Phase I) in partnership with GSK, ACR343 for Parkinson's disease (Phase I)
and NSD-788 for anxiety/depression (Phase I). In addition, NeuroSearch has a
broad portfolio of preclinical drug candidates and holds equity interests in
several biotech companies.
Copenhagen, Denmark, November 3, 2008
PRESS RELEASE - FOR IMMEDIATE RELEASE
NsGene's advanced encapsulated cell biodelivery product for Alzheimer's disease
treatment now successfully implanted in six patients
Today the Danish biotechnology company, NsGene A/S, announced that its
encapsulated cell (EC) biodelivery product, NsG0202, has now been successfully
implanted in a total of six patients with Alzheimer's disease (AD) at Karolinska
University Hospital in Stockholm as part of an ongoing Phase Ib clinical trial.
The NsG0202 product consists of an implantable EC biodelivery device containing
human cells genetically modified to secrete nerve growth factor (NGF) to the
surrounding brain. When delivered directly to these cells at the base of the
brain, NGF has been shown to have neuroprotective and regenerative effects on
brain cells that die in AD. The NsG0202 product represents a unique and new
disease-modifying therapeutic concept, aimed at treating the progressive
dementia associated with AD.
The clinical development was started in the spring of 2008 when NsG0202 was
implanted in three patients suffering from AD. Based on the recent favourable
safety review of these patients, three additional patients have now been
successfully implanted in a dose-escalation step. In these patients, four NGF
secreting implants were placed at precise anatomical locations using MRI-guided,
stereotactic neurosurgery. Both the novel EC biodelivery product and the
implantation procedure were very well tolerated by all patients. Besides safety
and tolerability, indications of therapeutic effects will also be evaluated in
this phase Ib trial to help guide the continued clinical development of the
product.
“This is yet another highly significant milestone for NsGene and for our EC
biodelivery platform and pipeline in particular” says Lars U. Wahlberg, Exec.
Vice President and COO, NsGene. He continues: “The successful implantation of
multiple regenerative implants in patients suffering from Alzheimer's disease
demonstrates that the EC biodelivery devices can be implanted with both
precision and safety, paving the way for the potential launch of a novel
treatment to fill a great medical need in the area of Alzheimer's disease.”
The phase Ib study is being performed in close collaboration with principal
investigator Assoc. Prof. Maria Eriksdotter Jönhagen and Prof. Åke Seiger at the
Department of Geriatrics and Prof. Bengt Linderoth and Dr. Göran Lind at the
Department of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden.
All patients are now enrolled in the study, which will be completed by the end
of 2009. A successful outcome will support future multicenter studies aimed at
demonstrating efficacy of NsG0202 in the treatment of Alzheimer's disease.
The NsG0202 product for AD is the first in NsGene's pipeline of EC biodelivery
products entering clinical development for neurological disorders over the next
two years. Based on the proprietary EC biodelivery technology platform, the
development of multiple novel EC biodelivery products is possible. The
biodelivery implants are aimed at restoring brain function and not only at
alleviating symptoms. Therefore, this technology has the potential of
transforming the treatment of degenerative disorders of the central nervous
system, including AD, Parkinson's disease, and intractable epilepsy.
For further information please contact:
Lars U. Wahlberg, Executive Vice president and COO, NsGene A/S, Phone: +45 44 60
89 13, Mobile phone: +45 2360 3198, E-mail: luw@nsgene.dk
Maria Eriksdotter Jönhagen, MD, Associate Professor, Dept. of Geriatrics,
Karolinska University Hospital, Huddinge, Phone: +46-8-58586449, mobile phone:
+46-70-560 8907, E-mail: maria.eriksdotter.jonhagen@ki.se
Bengt Linderoth, Professor, Dept. of Neurosurgery, Karolinska University
Hospital - Solna, Phone: +46-51772592, E-mail: bengt.linderoth@karolinska.se
Åke Seiger, Professor, Karolinska Institute, mobile phone: +46 73 9177407.
Background on EC biodelivery
EC biodelivery is a strongly and broadly patented technology platform capable of
cell-based biodelivery of biological compounds to the peripheral or central
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 an immunoprotective
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 of the therapeutic cells with the host tissue and immune system. The
encapsulated cells provide long-term factor secretion from the implanted device.
Background on NsGene
NsGene A/S (www.nsgene.dk) 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 30 people at its
research facility located near Copenhagen in the Medicon Valley Region. For more
information, please see www.nsgene.dk.
NeuroSearch's associated company, NsGene, announces the successful implantation of its novel and advanced biodelivery product, NsG0202 in six patients with Alzheimer's disease
| Source: NTG Nordic Transport Group A/S
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