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Noscira presents new advances in the research on Alzheimer's disease
Noscira presents new advances in the research on Alzheimer's disease
10/03/2009- NOSCIRA, a company of Zeltia Group specializing in the research of Alzheimer's disease, presents results at the 9th International Congress on Alzheimer's and Parkinson's disease (Prague, 11-15 March)
- NP 12, one of the most promising compounds in this therapeutic area due to its modifying profile of the neurodegenerative process of the disease, has started to being administered to patients with Alzheimer's disease
- The company expects to have the first results of this study in the second half of 2009, which will serve as a basis for the design of a longer study in patients with Alzheimer's and a similar one in patients with Progressive Supranuclear Palsy
- NP 12, one of the most promising compounds in this therapeutic area due to its modifying profile of the neurodegenerative process of the disease, has started to being administered to patients with Alzheimer's disease
- The company expects to have the first results of this study in the second half of 2009, which will serve as a basis for the design of a longer study in patients with Alzheimer's and a similar one in patients with Progressive Supranuclear Palsy
Prague, March 10th 2009: Noscira will participate in the 14th symposium under the title "GSK3 as a molecular target" during the 9th International Congress on Alzheimer's and Parkinson's Disease: Advances, Concepts and New Challenges (AD / PD 2009) to be held in Prague on March 15 to 11. The symposium will be attended by three specialists in the Glycogen Synthase Kinase, GSK3, Dr. Fred Van Leuven of the Catholic University of Leuven, Belgium, Dr. Simon Lovestone, of the Institute of Psychiatry of London’s King's College and Dr. Miguel Medina, Director of Research at Noscira. Inhibition of GSK3 enzyme therapy is an innovative therapeutic way for Alzheimer's disease, which has aroused great interest among the scientific community due to the fact that GSK3 enzyme is involved in the two major hystopathological lesions of Alzheimer’s disease (senile plaques, neurofibrillary tangles).
Noscira is the only company with a compound in the clinic acting on this GSK3 target. NP 12 has shown in several animal models of Alzheimer's disease a significant improvement of cognitive performance and various histopathological parameters significant for the disease, such as a decrease in amyloid beta deposits, tau phosphorylation and neuroinflammation, as well as a significant reduction in neuronal loss. It is the only compound described so far capable of acting on these histopathological lesions, which suggests that NP-12 might have a modifying effect of the disease in patients.
The compound is being administered to patients with Alzheimer's disease, after safety studies in more than 150 healthy volunteers have been completed.
The company expects to have the first results of this study in the second half of this year. These data will provide the basis for the design of a study of longer duration in patients with Alzheimer's and another similar study in patients with Progressive Supranuclear Palsy.
Noscira will also present updated preclinical results of a new family of marine-derived compounds with potent neuroprotective activity. This new family significantly reduces secretion of β-amyloid peptide in cell lines and in primary neurons through the activation of the protein α-secretase.
Noscira will also present new results on a highly selective inhibitor of GSK3 of marine origin.
For more information:
Media: Fernando Mugarza, Communications, Zeltia Group Zeltia (Tel: 34 91 846 60 56) Investors: Alfonso Hurtado de Mendoza, Mercado de Capitales (Tel: 34 91 444 45 00)
Noscira: Belén Sopesén: Managing Director
This press release is also available at: http://www.noscira.com/
Zeltia
Zeltia S.A. is a pioneer Biotech Group, leader in Spain and sixth European Group by market capitalization. Zeltia Group is composed by following companies: PharmaMar, the leading global biotechnology company dedicated to advancing cancer treatment through the discovery and development of innovative marine-derived medicines; Noscira, a biotech company focused on the discovery and development of new drugs against Alzheimer's and other neurodegenerative diseases of the nervous system; Genomica, first Spanish company in the field of molecular diagnostics; Sylentis, an innovative company dedicated to the research of therapeutic applications of gene silencing (RNAi) technology; Zelnova & Xylazel highly profitable two companies, leaders in their market segments.
Noscira
Noscira, located in Madrid, Spain, is a biopharmaceutical company devoted to the research and development of innovative drugs for the treatment and prevention of neurodegenerative diseases, with special focus on Alzheimer’s disease (AD). Our search strategy combines a unique primary screening platform for marine samples highly specialised in AD, with a strong chemical optimisation effort.
Noscira has two compounds (NP-12 and NP-61) in clinical development with a privileged position in the current scenario of compounds in development for AD. Additionally, Noscira have a strong portfolio of projects in preclinical stage.
Noscira is a subsidiary of Zeltia Group (Madrid Stock Exchage: ZEL.MC; Bloomberg: ZEL SM; Reuters: ZEL.MC), Spanish group leader in biotechnology and chemical sector.
For Additional information about Noscira contact the website http://www.noscira.com/
NP-12
GSK-3 overexpression produces tau hyperphosphorylation, an anomalous process present in several neurodegenerative diseases known generally as tauopathies, such as Alzheimer’s disease, Progressive Supranuclear Palsy (PSP), Pick’s disease, etc…
NP-12 is an orally bioavailable GSK-3 inhibitor with a potential disease-modifying effect for Alzheimer´s disease (AD), which is being developed by Noscira. Currently, NP-12 is in Phase II clinical trials for the treatment of AD in EU.
NP-12 is the only GSK-3 inhibitor in clinical development and the only compound that acts on several key histopathological features of AD: reduces phosphorylation of tau protein and neuronal loss in hippocampus and entorhinal cortex, improves the spatial memory deficit and significantly reduces amyloid plaque load in brain. It has also shown to be neuroprotective in vivo as well as a potent anti-inflammatory effect in various animal models.
NP-12 has been administered to more than 150 healthy young and elderly volunteers during 2006-2008 in three double blind phase I studies. The compound was well tolerated at the established doses. The first phase II trial has been approved in the last quarter 2008 and will explore safety and clinical effects of several doses of the compound administered for 3 months in a sample of 30 AD patients.
In addition, Noscira has planned to begin the development of NP-12 for PSP in the third quarter of 2009.
Noscira is seeking a partner for further development and commercialisation of NP-12 in all countries except EU.
NP-61
Beta-amyloid peptide (Aβ) is a peptide generated from the proteolytic processing of the amyloid precursor protein (APP) and can form extracellular insoluble aggregates that constitute the first step in a pathological cascade leading to neuronal death and dementia.
NP-61 is an orally bioavailable acetylcholinesterase inhibitor and β-amyloid modulator, which is being developed by Noscira for the treatment of AD. NP-61 is a potential disease modifier for early (even preclinical) stages of the disease and may be also a concomitant symptomatic treatment for mild to severe AD cases.
NP-61 is able of efficiently inhibiting in vitro AChE-dependent Aβ aggregation. Moreover, systemic administration of NP-61 led to a significant, dose-dependent reduction of AChE in rat brain cortex. Also, sustained oral treatment with NP-61 significantly reduces amyloid load in cortex and hippocampus of APP transgenic mice and induces an improvement in their spatial memory.
The first in man single ascending dose Phase I study showed that the compound was well tolerated at the studied doses in 70 young and elderly healthy volunteers. In 2008, a second single ascending dose Phase I study started to determine the maximum tolerated dose in 40 male and female elderly healthy volunteers. In 2009, a 14-day-multiple-dose-study in elderly volunteers is on schedule.
Noscira is seeking a partner for further development and commercialisation of NP-61 in all countries except EU.
NP-17
Noscira have isolated and identified a series of marine-origin-compounds capable of inhibiting the amyloid peptide formation through a mechanism of action that would complement the BACE inhibition. The lead compound of this program, NP-17, is the only α-secretase activator described to date and a potential disease-modifying treatment for AD.
NP-17 is an orally bioavailable molecule, which inhibits Aβ peptide formation in cell lines and primary neurons through activation of α-secretase and shows a potent neuroprotective effect against various toxic extracellular stimuli in vitro e in vivo. This compound has demonstrated efficacy in animal models, and additional in vivo efficacy studies are ongoing.
Regulatory safety and toxicology studies have been initiated with NP-17. Furthermore, the beginning of Phase I clinical trials is scheduled for IQ 2010.
Alzheimer’s disease
Alzheimer’s disease (‘AD’) is a neurodegenerative disease characterised clinically by the progressive loss of cognitive functions, especially memory in initial phases, and histopathologically by deposits of β-amyloid peptide as neuritic senile plaques in the brain cortex and subcortical grey matter as well as intraneuronal neurofibrillary tangles formed by deposits of tau protein.
Around 26 million people are affected by Alzheimer’s disease worldwide, of which more than the half is entitled to seven major pharmaceutical markets. It is calculated that the number of AD sufferers worldwide will triple by the year 2050. The increase of the prevalence is a result of the progressive rise in life expectancy, the improvement in health care and diagnosis techniques (biomarkers, neuroimaging).
Current treatment for Alzheimer’s disease is merely symptomatic, offering slight improvements and effective only during a limited period of time, and can not delay the course of the disease. There is a need for a drug which produces a significant effect on the degenerative process causing AD and which changes in a substantial and sustained way the progression.
Progressive Supranuclear Palsy
Progressive Supranuclear Palsy (PSP) is a neurodegenerative disorder characterised by ocular motor defects, mainly impaired vertical gaze, falls and Parkinson’s-like symptoms. Its prevalence is estimated at between 5 and 6.4 cases per 100,000 inhabitants.
There are currently no treatments that slow or modify the progression of the disease.
Noscira is the only company with a compound in the clinic acting on this GSK3 target. NP 12 has shown in several animal models of Alzheimer's disease a significant improvement of cognitive performance and various histopathological parameters significant for the disease, such as a decrease in amyloid beta deposits, tau phosphorylation and neuroinflammation, as well as a significant reduction in neuronal loss. It is the only compound described so far capable of acting on these histopathological lesions, which suggests that NP-12 might have a modifying effect of the disease in patients.
The compound is being administered to patients with Alzheimer's disease, after safety studies in more than 150 healthy volunteers have been completed.
The company expects to have the first results of this study in the second half of this year. These data will provide the basis for the design of a study of longer duration in patients with Alzheimer's and another similar study in patients with Progressive Supranuclear Palsy.
Noscira will also present updated preclinical results of a new family of marine-derived compounds with potent neuroprotective activity. This new family significantly reduces secretion of β-amyloid peptide in cell lines and in primary neurons through the activation of the protein α-secretase.
Noscira will also present new results on a highly selective inhibitor of GSK3 of marine origin.
For more information:
Media: Fernando Mugarza, Communications, Zeltia Group Zeltia (Tel: 34 91 846 60 56) Investors: Alfonso Hurtado de Mendoza, Mercado de Capitales (Tel: 34 91 444 45 00)
Noscira: Belén Sopesén: Managing Director
This press release is also available at: http://www.noscira.com/
Zeltia
Zeltia S.A. is a pioneer Biotech Group, leader in Spain and sixth European Group by market capitalization. Zeltia Group is composed by following companies: PharmaMar, the leading global biotechnology company dedicated to advancing cancer treatment through the discovery and development of innovative marine-derived medicines; Noscira, a biotech company focused on the discovery and development of new drugs against Alzheimer's and other neurodegenerative diseases of the nervous system; Genomica, first Spanish company in the field of molecular diagnostics; Sylentis, an innovative company dedicated to the research of therapeutic applications of gene silencing (RNAi) technology; Zelnova & Xylazel highly profitable two companies, leaders in their market segments.
Noscira
Noscira, located in Madrid, Spain, is a biopharmaceutical company devoted to the research and development of innovative drugs for the treatment and prevention of neurodegenerative diseases, with special focus on Alzheimer’s disease (AD). Our search strategy combines a unique primary screening platform for marine samples highly specialised in AD, with a strong chemical optimisation effort.
Noscira has two compounds (NP-12 and NP-61) in clinical development with a privileged position in the current scenario of compounds in development for AD. Additionally, Noscira have a strong portfolio of projects in preclinical stage.
Noscira is a subsidiary of Zeltia Group (Madrid Stock Exchage: ZEL.MC; Bloomberg: ZEL SM; Reuters: ZEL.MC), Spanish group leader in biotechnology and chemical sector.
For Additional information about Noscira contact the website http://www.noscira.com/
NP-12
GSK-3 overexpression produces tau hyperphosphorylation, an anomalous process present in several neurodegenerative diseases known generally as tauopathies, such as Alzheimer’s disease, Progressive Supranuclear Palsy (PSP), Pick’s disease, etc…
NP-12 is an orally bioavailable GSK-3 inhibitor with a potential disease-modifying effect for Alzheimer´s disease (AD), which is being developed by Noscira. Currently, NP-12 is in Phase II clinical trials for the treatment of AD in EU.
NP-12 is the only GSK-3 inhibitor in clinical development and the only compound that acts on several key histopathological features of AD: reduces phosphorylation of tau protein and neuronal loss in hippocampus and entorhinal cortex, improves the spatial memory deficit and significantly reduces amyloid plaque load in brain. It has also shown to be neuroprotective in vivo as well as a potent anti-inflammatory effect in various animal models.
NP-12 has been administered to more than 150 healthy young and elderly volunteers during 2006-2008 in three double blind phase I studies. The compound was well tolerated at the established doses. The first phase II trial has been approved in the last quarter 2008 and will explore safety and clinical effects of several doses of the compound administered for 3 months in a sample of 30 AD patients.
In addition, Noscira has planned to begin the development of NP-12 for PSP in the third quarter of 2009.
Noscira is seeking a partner for further development and commercialisation of NP-12 in all countries except EU.
NP-61
Beta-amyloid peptide (Aβ) is a peptide generated from the proteolytic processing of the amyloid precursor protein (APP) and can form extracellular insoluble aggregates that constitute the first step in a pathological cascade leading to neuronal death and dementia.
NP-61 is an orally bioavailable acetylcholinesterase inhibitor and β-amyloid modulator, which is being developed by Noscira for the treatment of AD. NP-61 is a potential disease modifier for early (even preclinical) stages of the disease and may be also a concomitant symptomatic treatment for mild to severe AD cases.
NP-61 is able of efficiently inhibiting in vitro AChE-dependent Aβ aggregation. Moreover, systemic administration of NP-61 led to a significant, dose-dependent reduction of AChE in rat brain cortex. Also, sustained oral treatment with NP-61 significantly reduces amyloid load in cortex and hippocampus of APP transgenic mice and induces an improvement in their spatial memory.
The first in man single ascending dose Phase I study showed that the compound was well tolerated at the studied doses in 70 young and elderly healthy volunteers. In 2008, a second single ascending dose Phase I study started to determine the maximum tolerated dose in 40 male and female elderly healthy volunteers. In 2009, a 14-day-multiple-dose-study in elderly volunteers is on schedule.
Noscira is seeking a partner for further development and commercialisation of NP-61 in all countries except EU.
NP-17
Noscira have isolated and identified a series of marine-origin-compounds capable of inhibiting the amyloid peptide formation through a mechanism of action that would complement the BACE inhibition. The lead compound of this program, NP-17, is the only α-secretase activator described to date and a potential disease-modifying treatment for AD.
NP-17 is an orally bioavailable molecule, which inhibits Aβ peptide formation in cell lines and primary neurons through activation of α-secretase and shows a potent neuroprotective effect against various toxic extracellular stimuli in vitro e in vivo. This compound has demonstrated efficacy in animal models, and additional in vivo efficacy studies are ongoing.
Regulatory safety and toxicology studies have been initiated with NP-17. Furthermore, the beginning of Phase I clinical trials is scheduled for IQ 2010.
Alzheimer’s disease
Alzheimer’s disease (‘AD’) is a neurodegenerative disease characterised clinically by the progressive loss of cognitive functions, especially memory in initial phases, and histopathologically by deposits of β-amyloid peptide as neuritic senile plaques in the brain cortex and subcortical grey matter as well as intraneuronal neurofibrillary tangles formed by deposits of tau protein.
Around 26 million people are affected by Alzheimer’s disease worldwide, of which more than the half is entitled to seven major pharmaceutical markets. It is calculated that the number of AD sufferers worldwide will triple by the year 2050. The increase of the prevalence is a result of the progressive rise in life expectancy, the improvement in health care and diagnosis techniques (biomarkers, neuroimaging).
Current treatment for Alzheimer’s disease is merely symptomatic, offering slight improvements and effective only during a limited period of time, and can not delay the course of the disease. There is a need for a drug which produces a significant effect on the degenerative process causing AD and which changes in a substantial and sustained way the progression.
Progressive Supranuclear Palsy
Progressive Supranuclear Palsy (PSP) is a neurodegenerative disorder characterised by ocular motor defects, mainly impaired vertical gaze, falls and Parkinson’s-like symptoms. Its prevalence is estimated at between 5 and 6.4 cases per 100,000 inhabitants.
There are currently no treatments that slow or modify the progression of the disease.
© 2008 Noscira S.A. tel. 91 806 11 30 noscira@noscira.com