FDA Grants Fast Track Status to Tideglusib (Zentylor) for Progressive Supranuclear Palsy
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
The Phase II trial for Progressive Supranuclear Palsy (PSP) commenced in December 2009 and is currently in progress
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'
MADRID, Sept. 9 /PRNewswire/ -- Noscira, a Grupo Zeltia (ZEL.MC) subsidiary specialized 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 complete application.
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 November 11, 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 for PSP.
Zeltia S.A. is a world-leading biopharmaceutical company specialized 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 specialized in Alzheimer's disease. Noscira's search strategy combines a unique, highly-specialized primary screening platform for marine samples with a strong focus on chemical optimization. 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 characterized 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
Posted: September 2010