American Headway 2B Pdf

Axovant Announces Negative Topline Results of Intepirdine Phase 3 MINDSET Trial in Alzheimers. After 2. 4 weeks of treatment, change from baseline in cognition was non significantly improved in the intepirdine arm versus the placebo arm 0. ADAS Cog points p value 0. In addition, there was essentially no difference between the intepirdine and placebo arms in change from baseline in activities of daily living 0. ADCS ADL points p value 0. Of the endpoints analyzed to date, the only endpoint in which any significant improvement was seen in the intepirdine arm versus the placebo arm was in the first key secondary endpoint, the Clinician Interview Based Impression of Change plus caregiver interview, or CIBIC 0. CIBIC points p value 0. The Company will work with investigators to conclude the MINDSET open label extension study. While we are deeply disappointed by these trial results, we also are saddened for the millions of patients and families impacted by Alzheimers disease. However, we believe that the fight against Alzheimers and other important areas of unmet need in neurology is too important to be derailed by this setback, said David Hung, M. D., chief executive officer of Axovant. We are grateful to the investigators, patients and caregivers who participated in this important trial and supported us in this journey. Moreover, we remain committed to advancing our pipeline, which includes our Phase 2b HEADWAY study of intepirdine, and nelotanserin, our highly selective inverse agonist of the 5 HT2. A receptor in Phase 2 development, both of which are being evaluated in patients with dementia with Lewy bodies. The HEADWAY trial studying intepirdine in patients with dementia with Lewy bodies DLB remains on track to report topline results at the end of 2. This study investigates two doses of intepirdine, 3. MINDSET trial and 7. HT6 and 5 HT2. A receptors. Intepirdine has received Fast Track designation from the U. S. Food and Drug Administration for the treatment of DLB. About MINDSETThe global, randomized, double blind, placebo controlled Phase 3 MINDSET trial evaluated the efficacy, safety and tolerability of intepirdine in patients with mild to moderate AD on donepezil therapy over 2. The trial compared once daily oral doses of intepirdine 3. The Mini Mental State Examination MMSE score at baseline ranged from 1. Co primary efficacy endpoints were ADAS Cog and the ADCS ADL. About Alzheimers Disease. Alzheimers disease AD, the most common form of dementia, is a chronic, progressive neurodegenerative disorder that worsens over time. It is the fifth leading cause of death among people age 6. United States. i According to the Alzheimers Association, about 5. U. S. today are affected by AD,i and that number could triple by 2. In addition to the suffering and devastating effect on quality of life experienced by both patients and caregivers, AD costs the U. Carsharing or car sharing US and AU or car clubs UK is a model of car rental where people rent cars for short periods of time, often by the hour. S. approximately 2. No new chemical entities for AD have been approved by the FDA since 2. About Intepirdine. Intepirdine is an oral, once daily, investigational drug in development for the treatment of mild to moderate AD and dementia with Lewy bodies DLB. A potent antagonist of the 5 HT6 receptor, intepirdine promotes the release of acetylcholine in the brain. This neurotransmitter is believed to be critical for alertness, memory, thought and judgment the key components of cognition and function that are impaired in patients with dementia. At higher doses, intepirdine also blocks the 5 HT2. A receptor, which is believed to play a role in the psychosis, REM sleep behavior disorder and motor dysfunction seen in patients with DLB. TeleconferenceWebcast Details. To participate in the live conference call today, September 2. EDT, please dial 3. U. S. and Canada or 1 8. The live call is being webcast and can be accessed on the Events and Presentations page of the Investors section of the Companys website at http investors. A replay of the webcast will be available for 3. About Axovant Sciences. Axovant is a clinical stage biopharmaceutical company focused on developing and commercializing innovative medicines to broadly address multiple forms of dementia and related neurological disorders. Axovant is developing a pipeline of product candidates that focuses on the cognitive, functional and behavioral aspects of debilitating conditions such as Alzheimers disease, Lewy body dementia and other neurological disorders. For more information, visit www. Forward Looking Statements This press release contains forward looking statements, including statements regarding Axovants plans for the development of its pipeline and completion of the MINDSET open label extension study, as well as the HEADWAY study. Lalitha Sahasranama Stotram In Telugu Song. Forward looking statements can be identified by the words believe, anticipate, continue, estimate, project, expect, plan, potential, intends, will, would, could, should or the negative or plural of these words or other similar expressions that are predictions or indicate future events, trends or prospects. Nh c iu kin nhiu acc qu nn share bt cho ae tinhte Danh sch acc mua update ngy 25102017 Mi ae cmt gii thiu thm app v. BackgroundBevacizumab and the antimetabolites capecitabine and gemcitabine have been shown to improve outcomes when added to taxanes in patients with metastatic. Original Article. Paclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer. Comparative Adjectives List Pdf. Kathy Miller, M. D., Molin Wang, Ph. D., Julie Gralow, M. D., Maura. 2b These are the things you are to teach and urge on them. If anyone teaches false doctrines and does not agree to the sound instruction of our Lord Jesus Christ. American Headway 2B Pdf' title='American Headway 2B Pdf' />Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to risks associated with the success, cost and timing of our product development activities and clinical trials, increased regulatory requirements, and interim results or other preliminary analyses do not ensure that later or final results in a clinical trial or in related or similar clinical trials will replicate those interim results. There can be no assurance that any of our product candidates will ever receive regulatory approval or be successfully commercialized. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward looking statements, as well as risks relating to Axovants business in general, see the Risk Factors section of our quarterly report on Form 1. Q filed with the Securities and Exchange Commission SEC on August 7, 2. Axovant makes with the SEC from time to time. These forward looking statements are based on information available to Axovant as of the date of this press release and speak only as of the date of this release. Axovant disclaims any obligation to update these forward looking statements, except as may be required by law. Contacts Investors Jonathan Neelyjonathan. Media. Brian Reid. W2. O Groupbreidw. Samina Bari. Samina. PMC4. 09. 56. 96View original content http www. SOURCE Axovant Sciences Related Linkshttp www. Technology and Science News ABC News.