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Clinical Update - Debio 9902 (ZT-1) for Alzheimer's Disease

Presentation of Final Phase I Monthly Implant and Phase IIa Daily Oral Results

LAUSANNE, Switzerland, June 11, 2007 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist in oncology and serious medical conditions, presented final results of two Debio 9902 (formerly ZT-1) studies for the treatment of Alzheimer's disease (AD) at the Alzheimer's Association International Conference on the Prevention of Dementia, in Washington, DC:

- The phase I monthly sustained release implant study showed that Debio 9902 was well tolerated after repeated doses up to 15mg/per month and there were no safety concerns.

- The phase IIa once-daily oral study for a treatment period of 9 months showed that Debio 9902 was safe and effective in the treatment of moderate AD.

In a phase I study, healthy volunteers were administered once monthly subcutaneous injections of Debio 9902 SR implants up to 15mg. Sustained levels of Huperzine A (Hup A), the active metabolite of Debio 9902, were observed up to four weeks and Debio 9902 was well tolerated.

In a phase IIa study with the oral formulation of Debio 9902 in mild to moderate AD patients, improvements were observed on 3 efficacy scales, the assessment cognitive sub-scale (ADAS-cog), the Mini mental state examination (MMSE) and the Neuropsychiatric inventory questionnaire (NPI-Q). The study included a randomized part which lasted 3 months and which was followed by an additional 6 month open label part. The efficacy shown with the oral formulation, the good safety profile and the sustained release of Debio 9902 implants over one month have led to an ongoing phase II 'BRAINz' study in AD patients.

"The continuous release of Debio 9902 SR implants provides a new treatment alternative with the potential for better tolerance through a progressive, steady release of the active compound, therefore increasing p
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TAG: Clinical Update Debio for Alzheimer Disease
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