FDA Grants Fast Track Status to Tideglusib (ZentylorTM) for Progressive Supranuclear PalsyBy Zeltia, PRNE
Thursday, September 9, 2010
Fast Track status is granted to facilitate development and expedite the review of a drug for a serious or potentially fatal illness and to meet an unmet medical need.
MADRID, September 10, 2010 - Noscira, a Grupo Zeltia (ZEL.MC) subsidiary specialised in research and
development of drugs to treat neurodegenerative diseases, has announced that
the U.S. Food and Drug Administration (FDA) has granted Fast Track status to
its neuroprotector drug Tideglusib (ZentylorTM) to treat Progressive
Supranuclear Palsy (PSP), a fast-advancing fatal degenerative brain disorder.
A Phase II trial with Tideglusib (ZentylorTM) in PSP commenced in December
2009 and is currently in progress.
The FDA grants Fast Track status to facilitate the development and
expedite the review of a drug to treat serious and potentially fatal diseases
and to fill an unmet medical need. Fast Track status also enables a company
to present rolling submissions, i.e. the various sections of a New Drug
Application (NDA) may be presented and reviewed as they are completed,
instead of following the regular model, which requires presentation of the
Belen Sopesen, CEO of Noscira: "Fast Track status is very positive for
the company and is an incentive to continue advancing in the clinical
development of Tideglusib (ZentylorTM) in Progressive Supranuclear Palsy, an
illness for which patients have no treatment options."
On 11 November 2009, Noscira announced that the FDA and the EU had
granted Tideglusib (ZentylorTM) orphan drug status for treating PSP.
Tideglusib (ZentylorTM) is the only GSK-3 inhibitor in clinical development
Zeltia S.A. is a world-leading biopharmaceutical company specialised in
the development of marine-based drugs for use in oncology and central nervous
system illnesses. The main Grupo Zeltia companies are: PharmaMar, the
world-leading biotechnology company in advancing cancer care through the
discovery and development of innovative marine-derived medicines; Noscira, a
biotech firm focused on discovering and developing new drugs against
Alzheimer's disease and other neurodegenerative diseases of the central
nervous system; Genomica, Spain's leading molecular diagnostics company;
Sylentis, dedicated to researching therapeutic applications of gene silencing
(RNAi); and a chemical division comprising Zelnova and Xylazel, two highly
profitable companies that are leaders in their respective market segments.
Noscira, which is based in Madrid (Spain), is a biopharmaceutical company
which researches and develops innovative drugs for treating and preventing
diseases of the nervous system. Since its inception, the company has
specialised in Alzheimer's disease. Noscira's search strategy combines a
unique, highly-specialised primary screening platform for marine samples with
a strong focus on chemical optimisation. The company has two clinical
compounds (NP-12 and NP-61) which are well-positioned in the pipeline for
treating Alzheimer's disease. It also has a solid pipeline of products in the
pre-clinical phases. Noscira is a subsidiary of Grupo Zeltia (Madrid stock
exchange: ZEL.MC; Bloomberg: ZEL SM; Reuters: ZEL.MC), Spain's leading
biotechnology and chemical company.
About Tideglusib (NP-12)
Overexpression of GSK-3 leads to hyperphosphorylation of the tau protein,
an anomaly which occurs in a number of neurodegenerative diseases known
collectively as tauopathies, which include Alzheimer's disease (AD),
Progressive Supranuclear Palsy (PSP) and Pick disease. NP-12 is a GSK-3
inhibitor with oral bioavailability and great therapeutic potential as a
disease-modifying treatment for Alzheimer's.
NP-12 is currently undergoing Phase II clinical trials for Alzheimer's
disease in the EU. NP-12, the only GSK-3 inhibitor under clinical development
for AD, has proven to be capable of acting on all of the histopathological
lesions associated with the disease in experimental models: it reduces
phosphorylation of the tau protein and hippocampal and entorhinal cortex
neuron loss, improves spatial memory deficits and significantly reduces the
accumulation of amyloid plaques in the brain. NP-12 also provides
neuroprotection in vivo and has a potent anti-inflammatory effect in a range
of animal models.
About Progressive Supranuclear Palsy
PSP is a neurodegenerative disease characterised by oculomotor
disturbances, specifically difficulties in moving the eye vertically, falling
down and Parkinsonian symptoms.
The disease affects an estimated 5-6.4 out of every 100,000 people.
There is currently no treatment capable of delaying or altering the
progression of the illness.
For more information, contact Zeltia at +34-91-444-4500.
This note is also available in the "News" section of the Zeltia
(www.zeltia.com) and Noscira (www.noscira.com) websites
Carlos Martinez de la Serna of Zeltia, +34-91-444-4500
Tags: Madrid, Scandinavia, September 10, Western Europe, Zeltia