Kissei Pharmaceutical : Announces Negative Topline Results from the additional phase III Clinical Trial evaluating "KPS-0373 (Development Code)" for the Treatment of Spinocerebellar Ataxia
May 30, 2018 at 02:08 am EDT
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Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa (hereinafter referred to as 'Kissei')] today announced negative topline results of the additional phase III clinical trial of the investigational drug for the treatment of spinocerebellar ataxia under development (Development Code: KPS-0373). The primary endpoint of the trial was the mean change from baseline in SARA score for the assessment of ataxia, it did not demonstrate statistically significant difference from placebo.
Kissei will decide upon the appropriate future course of action with respect of KPS-0373, after we assess the results in detail including sub-group analysis based on severity.
This result will not impact on the company's financial results for the fiscal year ending March 31, 2019.
《Reference》
About Spinocerebellar Ataxia:Spinocerebellar ataxia is a neurodegenerative disease of unknown etiology with the manifestation of symptoms including ataxia due to cerebellar or spinal degeneration. It has been designated as an intractable disease by the Ministry of Health, Labour and Welfare, and there are 30,000 or more recognized patients in Japan.
About SARA (Scale for the assessment and rating of ataxia) :The SARA is a tool for assessing ataxia. It has 8 categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). When completing the outcome measure each category is assessed and scored accordingly. Scores for the 8 categories as follows: 1.Gait, 2.Stance, 3.Sitting, 4.Speech disturbance, 5.Finger chase, 6.Nose-finger test, 7.Fast alternating hand movement, 8.Heel-shin slide.
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Kissei Pharmaceutical Co. Ltd. published this content on 30 May 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 30 May 2018 06:07:12 UTC
KISSEI PHARMACEUTICAL CO.,LTD. is a Japan-based company mainly engaged in the manufacture and sale of pharmaceutical products. The Company is engaged in the collection and analysis of medicine development information, and the manufacture and sale of medicines. It is also engaged in the purchase and sale of related materials, system development and information process work, construction contract work such as new construction, expansion and renovation of factories, laboratories and offices, the management of facility and equipment work, information collection and development support work, noodle manufacture and sale, and insurance agency business.
Kissei Pharmaceutical : Announces Negative Topline Results from the additional phase III Clinical Trial evaluating "KPS-0373 (Development Code)" for the Treatment of Spinocerebellar Ataxia