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Noscira Presents Results of Phase IIa Clinical Trial with Nypta(R) (Tideglusib) on Alzheimer's Disease at International Conference on Alzheimer's Disease (ICAD)
Date:7/15/2010

- Treatment with Nypta(R) (Tideglusib) (NP-12) was tolerated and produced positive effects on Alzheimer's patients in four of the five efficacy variables examined in the trial.

- In view of the promising results of this trial, Noscira is preparing the next Phase IIb trial on Alzheimer's patients in order to progress with the clinical development of this novel compound.

MADRID, July 15 /PRNewswire/ -- Noscira, the Grupo Zeltia (ZEL.MC) subsidiary specialized in researching and developing drugs for treating neurodegenerative diseases, presented the results of a Phase IIa clinical trial of Nypta(R) (Tideglusib) on Alzheimer's disease (AD) at the International Conference on Alzheimer's Disease (ICAD), held in Honolulu (Hawaii) from July 10-15, 2010.

Dr. Teodoro del Ser, Director of Clinical Development at Noscira, gave an oral session in the "Therapeutic Strategies" symposium in which he reported that treatment with Nypta(R) (Tideglusib) for 20 weeks was tolerated and had a positive impact on patients' cognitive performance. In order for these results to be statistically significant, they must be confirmed in a Phase IIb trial in which a larger group of patients will be treated for one year.

The Phase IIa trial, which was conducted at three centers in Germany based on advice from experts at the European Medicines Agency (EMA), is the first clinical trial of Nypta(R) (Tideglusib) on a group of Alzheimer's patients. The trial was designed with the primary goal of assessing the safety and tolerability of Nypta(R) (Tideglusib) on these patients.

The treatment was well tolerated. The drug was also observed to have a positive effect on patients' cognitive performance, though this is not statistically significant due to the small sample size and short treatment period.

Nevertheless, the following findings are indicative of therapeutic benefit:

  • Patients treated with Nypta(R) (Tideglusib) in addition to an acetylcholinesterase inhibitor as base treatment showed a consistent improvement in four of the five clinical efficacy variables that were assessed: Mini Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale (ADAS-cog), Geriatric Depression State and Global Clinical Assessment. Those variables are cognitive-behavioral scales for confirming and quantifying a person's mental state.
  • The improvement was more appreciable in the patients who attained the highest dose: they improved in the MMSE and ADAS-cog cognitive scales, the effect being greater than when using cholinesterase inhibitors alone.
  • Moreover, the number of patients that showed stabilization or improvement in the MMSE scale was significantly greater in the group treated with Nypta(R) (Tideglusib).

About Zeltia:

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. Grupo Zeltia consists mainly of the following companies: PharmaMar, a biotechnology company that is the world leader 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, which focuses on 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.

About Noscira:

Noscira, which is headquartered 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 and 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 Nypta(R) (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 disease. 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.

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


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