NeuroSearchs associerede selskab, NsGene A/S har nået en betydningsfuld milepæl med den succesfulde fase Ib dosering af NsG0202 i Alzheimers patienter

Investornyheder


NeuroSearchs associerede selskab, NsGene A/S har nået en betydningsfuld milepæl
med den succesfulde fase Ib dosering af NsG0202 i Alzheimers patienter 

NsGene A/S, der er 25% ejet af NeuroSearch, har i dag meddelt, at tre patienter
med Alzheimers sygdom har fået selskabets nye ”biodelivery” produkt, NsG0202,
succesfuldt implanteret i hjernen som led i et igangværende fase Ib klinisk
studie. Fase Ib studiet blev indledt af NsGene i december 2007 i samarbejde med
universitetshospitalet Karolinska i Stockholm, og efter evaluering af sikkerhed
og funktionsdygtighed vil yderligere tre Alzheimers patienter få implanteret
NsG0202 i dette 1-årige studie. 

NsG0202 til behandling af Alzheimers sygdom bygger på NsGenes patenterede og
unikke EC (indkapslede celler) biodelivery platform og består af et
implanterbart produkt, der udskiller nervevækstfaktoren NGF (Nerve Growth
Factor). NGF har vist sig at have en beskyttende og genopbyggende effekt på
syge nerveceller ved levering til relevante områder i hjernen. Således
repræsenterer NsG0202 en helt ny behandlingsform inden for Alzheimers sygdom og
med det formål ikke blot at lindre symptomer, men at genetablere
hjernefunktion. 

EC biodelivery tilgangen kan udgøre et gennembrud inden for behandling af
alvorlige neurologiske lidelser, såsom Alzheimers sygdom, Parkinsons sygdom og
epilepsi, og NsG0202 er det første af flere sygdomsmodificerende produkter i
NsGenes pipeline, der forventes at gå i klinisk udvikling inden for de næste to
år. 
 
Lars U. Wahlberg, Executive Vice President og COO i NsGene udtaler: 
“Dette er en betydningsfuld milepæl for NsGene og for vores EC biodelivery
platform og pipeline. Den succesfulde implantation i de første tre patienter
med Alzheimers sygdom har påvist, at produktet kan indsættes både præcist og
sikkert, hvilket baner vejen for yderligere kliniske studier.” 

Flemming Pedersen, adm. direktør i NeuroSearch udtaler: 
“NsGenes EC biodelivery teknologi repræsenterer en helt ny og meget lovende
tilgang til behandling af neurologiske sygdomme. Det er i dag kun muligt at
tilbyde eksempelvis Alzheimers, Parkinsons og epilepsipatienter midlertidig
symptomlindring, men NsGenes produkter har potentialet til at kunne introducere
fremtidige sygdomsmodificerende behandlinger. Med den succesfulde implantation
af NsG0202 er NsGene godt på vej til at bevise, at det er muligt at levere
biologiske stoffer til hjernen på en sikker måde. Dette er et kvantespring
fremad for NsGene, og som en storaktionær i selskabet er vi meget tilfredse med
deres fremgang." 

For yderligere oplysninger se vedlagte pressemeddelelse fra NsGene A/S. 


Kontaktpersoner:
Flemming Pedersen, adm. direktør, telefon: 4460 8214 eller 2148 0118
Hanne Leth Hillman, Vice President, Director of IR & Corporate Communications,
telefon: 4460 8212 eller 4017 5103 
 

NeuroSearch (NEUR) er et skandinavisk biofarmaceutisk selskab noteret på OMX
Den Nordiske Børs København A/S. Kerneforretningen dækker udvikling af nye
lægemidler baseret på en bred og veletableret forskningsplatform med fokus på
ionkanaler og sygdomme i centralnervesystemet (CNS). En betydelig del af
selskabets aktiviteter er partnerfinansieret via en bred strategisk alliance
med GlaxoSmithKline (GSK) og samarbejdsaftaler med bl.a. Abbott og Astellas.
Lægemiddelpipelinen omfatter 13 kliniske (fase I-III) udviklingsprogrammer:
ACR16 inden for Huntingtons sygdom (fase III forberedelse), tesofensine inden
for fedme (fase III forberedelse), NS2359 inden for depression (fase II) og
ADHD (fase II) i samarbejde med GSK,  ABT-894 inden for ADHD (fase II) og
smerte (fase II) i samarbejde med Abbott, ACR16 inden for skizofreni (fase I) i
samarbejde med Astellas, ACR325 inden for maniodepressiv sygdom/Parkinsons
sygdom (fase I), ABT-107 og ABT-560 til behandling af flere forskellige
CNS-sygdomme, begge (fase I) i samarbejde med Abbott, NSD-644 inden for smerte
mv. (fase I) i samarbejde med GSK, ACR343 inden for Parkinsons sygdom (fase I)
samt NSD-788 inden for angst mv. (fase I). NeuroSearch har desuden en bred
portefølje af prækliniske lægemiddelkandidater og har kapitalandele i flere
biotekvirksomheder. 

 


Copenhagen, Denmark, April 7th, 2008

PRESS RELEASE - FOR IMMEDIATE RELEASE

Danish biotech company's restorative Alzheimer's product has successfully been
implanted in patients 

NsGene A/S today announced that its encapsulated cell (EC) biodelivery product,
NsG0202, has successfully been implanted to the brains of three patients with
Alzheimer's disease (AD). 

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.” 

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 Institutet, mobile phone: +46 73 9177407.


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 treat¬ment 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. For more information
please see www.nsgene.dk.