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[求助]
求助大虾帮我查找关于Diamyd公司产品diapep277的1、2、3期临床报告
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求助大虾帮我查找关于Diamyd公司产品diapep277的1、2、3期临床报告 这个药刚刚完成三期临床，万分感激！ 有pharmaprojects数据库的尽量帮帮忙吧 |
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痴夷子皮
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【答案】应助回帖
★
感谢参与，应助指数 +1
zhoudeli: 金币+1, 多谢参与 2012-05-04 10:00:55
感谢参与，应助指数 +1
zhoudeli: 金币+1, 多谢参与 2012-05-04 10:00:55
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Detailed Information DiaPep227 (AVE-0277) is an hsp60-derived peptide, under development by Andromeda Biotech for the treatment and prevention of Type 1 diabetes (newly-diagnosed or established disease with some remaining endogenous insulin production) and latent adult autoimmune Type 2 diabetes (LADA). It acts by specific modulation of the autoimmune response from a proinflammatory (Th1) type to an anti-inflammatory (Th2) type to maintain residual β-cell function and halt disease progression (The Lancet, 24 Nov 2001, 358, 1749; Press release, Sanofi-Aventis, 19 Apr 2004; Company Web Page, Andromeda, 27 Oct 2008). Clinical Phase III Diabetes, Type 1 Teva A 1st double-blind, placebo-controlled Phase III trial in 456 patients in Europe, Israel and S Africa with newly-diagnosed Type 1 diabetes and LADA, to assess the safety and efficacy of DiaPep227, met its primary endpoint, defined as the change from baseline in C-peptide levels at the end of the study. Significant preservation of C-peptide was demonstrated in patients treated with DiaPep277 compared to the placebo arm. The decline in C-peptide levels was more pronounced in the placebo arm than in the treated group. The difference between the arms reached 0.949nmol/l/20min. This difference reflects a relative preservation of 23.4% compared to placebo. Evaluation of the primary endpoint was performed on patients in the modified ITT population who have at least one measurement post baseline. Additional analyses of clinical, efficacy and safety data from this study are ongoing (Press releases, Andromeda, 23 Jun 2008 & 8 Sep 2009 ; Press release, Andromeda, 22 Nov 2011, http://www.andromedabio.com/page.php?pageID=69). It is in a 2nd randomized, double-blind, placebo-controlled, parallel-group confirmatory Phase III trial (DIA-AID2) in 450 newly diagnosed Type 1 diabetics, in Austria, Belarus, Canada, Czech Republic, Finland, Germany, Hungary, Israel, Italy, Lithuania, Russia, Spain and the US, to assess DiaPep277 1mg sc x24mth on safety. The primary endpoint is beta cell preservation of function (Press release, Andromeda, 31 May 2010, http://www.andromedabio.com/page.php?pageID=56; Company Web Page, Andromeda, 5 May 2011, http://andromedabio.com/clinical_trials.php; ClinicalTrials.gov, 5 May 2011, http://clinicaltrials.gov/ct2/show/NCT01103284). Completion of patient recruitment is anticipated by the 1st half of 2012 (Press release, Andromeda, 22 Nov 2011, http://www.andromedabio.com/page.php?pageID=69). Final data is expected in 2014 or by the end of 2015 (Company presentation, Evotec, 8 Feb 2012, Page 16, http://evotec.sissy.bgcc.at/uplo ... on_February_e.pdf). First Phase III data are expected in 2012 (Press release, Evotec, 12 May 2011, http://www.evotec.com/archive/en ... e-business/2155/1). It is in an extension study in Israel, S Africa (submitted for approval) and Europe (planned) in patients who completed 2yr of treatment in the previous Phase III trial and still maintain beta cell function (Company Web Page, Anrdromeda, 10 Feb 2009). Phase II Data are expected in 2012 (Company Web Page, Evotec, 25 May 2011, http://www.evotec.com/articles/e ... -partnerships/4/6). In combined analysis from Phase II trials, DiaPep277 results in a dose-dependent improvement in C-peptide levels. DiaPep77 1mg q 3mth was the most effective regimen (10th BIO-Europe (Cologne), 2004). Evotec In a terminated Phase II trial in Germany, Italy and the UK, and a US Phase II trial, in LADA patients, there were no safety issues in >250 patients (2nd Qtr Res, Aventis, 2002; 10th BIO-Europe (Cologne), 2004; ClinicalTrials.gov Web Page, 13 Feb 2007, NCT00058981). Diabetes, Type 1 Sanofi Six Phase II studies in newly diagnosed and established adult Type 1 diabetics and 2 clinical trials in children with newly diagnosed Type 1 diabetes were conducted (BIO 2003 (Washington, DC); 2nd Qtr Res, Aventis, 2002; 10th BIO-Europe (Cologne), 2004). Diabetes, Type 1 Evotec In a placebo-controlled, randomized, double-blind, 10mth Phase II trial in 35 recently-diagnosed Type 1 diabetics, DiaPep227 at mth 0, 1 and 6 + daily insulin injections resulted in C-peptide concentration increases from 0.66 to 0.93nM cf a decrease of 1.12 to 0.26nM with placebo. The need for insulin injections increased over 10mth from 0.37 to 0.67U/kg daily in the placebo group cf an increase from 0.34 to 0.43U/kg in the treated group. DiaPep227 arrested disease progression and prevented further destruction of insulin-producing pancreatic β-cells (Press releases, Peptor, 22 Nov 2001 & 14 Jan 2002). Phase I It was well tolerated in Phase I trials (BIO 2003 (Washington, DC)). |
2楼2012-05-04 09:24:38
痴夷子皮
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【答案】应助回帖
★ ★ ★ ★ ★ ★ ★ ★
eileenshen: 金币+8, ★★★很有帮助, 非常感谢你的帮助 2012-05-04 14:50:01
eileenshen: 金币+8, ★★★很有帮助, 非常感谢你的帮助 2012-05-04 14:50:01
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http://g.zhubajie.com/urllink.php?id=12300407koak830c54h3e2qa pharmaprojects报告 |
3楼2012-05-04 09:26:55
4楼2012-05-06 16:51:07
痴夷子皮
版主 (文坛精英)
老痞
- DRDEPI: 8
- 应助: 2016 (讲师)
- 贵宾: 5.368
- 金币: 54487.3
- 散金: 41688
- 红花: 303
- 沙发: 1206
- 帖子: 32611
- 在线: 4303.7小时
- 虫号: 674536
- 注册: 2008-12-14
- 性别: GG
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- 管辖: 人文社科
5楼2012-05-06 17:17:19
