MADRID, Spain, April 24 /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/
Manuel de la Cruz, mcruz@llorenteycuenca.com, Tel: +34-91-563-77-22
