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Neuropharma Introduces in Clinical Trials its First Medicine for the Treatment of Alzheimer's

Madrid, Spain (ots/PRNewswire)

  • Preliminary Tests Demonstrate That the NP031112 Molecule has a Very Innovative Therapeutic Potential
  • Phase I Will Consist of Two Stages: in the First One the Drug Will be Administrated in Scalating Single Doses, and in the Second One, in a Repeated Dose for Seven Days.
Neuropharma, a subsidiary of the Zeltia Group specialized in the
research and development of medicines for the treatment of
neurodegenerative disorders, has managed to place in clinical trials
its first molecule for the treatment of the Alzheimer's disease.
The NP031112 molecule acts as an inhibitor of GSK3 and has
received the  approval of the German authorities and of the Ethical
Committee to start  Phase I clinical trials to develop a
disease-modifying agent for treating Alzheimer's disease patients.
Consequently, Neuropharma has reached its first landmark by
placing a compound in the clinical phase in slightly over two years
from its discovery.
The preclinical proof-of-concept studies carried out in animal
models, together with regulatory safety studies have demonstrated the
compound's real possibilities to treat Alzheimer's with a few
manageable side effects and a very innovative therapeutic potential.
Phase I of the clinical investigation, consisting in safety and
staged doses to healthy volunteers, will be performed at the Parexel
unit in Berlin. Parexel is a Contract Research Organization
specialized in carrying out and monitoring clinical trials.
The above mentioned clinical phase I will consist of two parts. In
the first one the drug will be administrated in scalating single
doses. In the second one, a seven-days repeated dose willl be
administered in order to establish the safe doses for the design of
the clinical phases II and III.
José Maria Fernández Sousa-Faro, Chaiman of the Zeltia Group,
points out that this achievement of Neuropharma demonstrates the
commitment of the Zeltia Group is searching for new treatments of
important diseases, not only against cancer through PharmaMar, but
also to find the cure for other socially important pathologies, such
as Alzheimer's disease.
For Pilar de la Huerta, Managing Director of Neuropharma, "This is
a very exciting moment for the company. In less than three years we
have managed to start clinical trials with a promising molecule for
the treatment of Alzheimer's disease. We are fulfilling the
milestones that the company established in its five years business
plan, designed in the summer of 2004. We feel strongly satisfied with
our work and effort, and at the same time, excited by the excellent
results that we have been having with this  molecule. We trust that
its behaviour in clinical trials will support our  expectations."
For additional information:
    Manuel de la Cruz
     mcruz@llorenteycuenca.com
    Phone. +34-91-563-77-22
Notes to Editors:
Alzheimer's disease:
Alzheimer's disease is the most frequent cause of dementia in the
elderly, and a serious degenerative disorder, produced by the gradual
loss of neuronal cells. At this point, the cause of this disease is
not well understood.
The brains of the Alzheimer patients present two main
histopathological hallmarks: an intracellular lesion, neurofibrillary
tangles formed by the hyperphosphorylated tau protein, and an
extracellular lesion, senile plaques formed by the aggregation of the
beta-amyloid peptide. Both lesions lead to neuronal death.
GSK3 Inhibitors
The glycogen synthase kinase 3 (GSK3) is a kinase originally
identified  by its role in the regulation of the glycogen metabolism.
In addition to be involved in the processes of cellular signalling
of insulin and IGF-1, it is highly expressed in the brain, existing
numerous evidences that involve GSK3 with the hyperphosphorylation of
the tau protein. That is to say, with the appearance of the
neurofibrillary tangles in Alzheimer's disease.
All this data suggests that the deregulation of GSK3 can play a
key role in the pathogenesis of Alzheimer's disease. Consequently,
GSK3 has turned into a very promising therapeutic target for the
treatment of Alzheimer's disease and other pathologies of the central
nervous system.
The heterocyclical molecules called tiadizolidinones (TDZDs), of
whose family proceeds the NP031112 molecule, represents the first
non-ATP competitive inhibitors of GSK3 described so far and have been
proposed as new effective drugs for the treatment of
neurodegenerative disorders, where the hyperphosphorylation of the
tau protein plays a leading role, as in the case of Alzheimer's.
Neuropharma
Founded in 2000, Neuropharma is a biopharmaceutical company in
which Zeltia S.A. has a participation of 75%, while the remaining 25%
belongs to private investors.
The company is focused in the investigation and development of new
medicines for the treatment and the prevention of the nervous system
illnesses. At the moment, 90% of its investigations are related to
the Alzheimer's disease.
Neuropharma is a branch of the Zeltia Group (Madrid Stock
Exchange: ZEL.MC; Bloomberg: ZEL SM; Reuters: ZEL.MC), and a Spanish
holding that leads the biotechnological and chemical sector. Find
more information about Neuropharma in its website:
http://www.neuropharma.es/

Contact:

Manuel de la Cruz, mcruz@llorenteycuenca.com, Tel: +34-91-563-77-22