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Exsulin 又一个新希望!
谢谢网友 希望会有的 提供的信息。我在网上查看了关于 ExsulinCorporation公司的新药 ExsulinTM
的确也蛮有希望的。
大家可以看看哈。
http://translate.google.com.hk/t ... 717.html&anno=2
Exsulin公司 SOURCE Exsulin Corporation
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http://www.exsulin.com http://www.exsulin.com
Exsulin公司宣布在1型和2型的新阶段胰岛再生处理试验结果公布2型糖尿病 Exsulin Corporation Announces Publication of Phase 2 Trial Results for Novel Islet Regeneration Treatment in Type 1 & Type 2 Diabetes
药物开发公司Exsulin重点治疗1型和2型糖尿病对再生疗法的发展 Drug Development Company Exsulin Focuses on Development of Regeneration Therapies for Treatment of Type 1 and Type 2 Diabetes
新的临床试验表明,进一步促进胰岛再生处理要返回群众的生产胰岛素糖尿病 New Clinical Trial Indicated to Further Advance Islet Regeneration Treatment to Return Insulin Production in People with Diabetes
明尼阿波利斯,8月18日/新华美通/ - Exsulin公司今天宣布,立即实现里程碑计划将作为一个很好的支持位于明尼苏达州的致力于再生疗法用于糖尿病治疗的开发公司前进。 MINNEAPOLIS, Aug. 18 /PRNewswire/ -- Exsulin Corporation today announced milestones achieved and immediate plans to move forward as a well supported Minnesota-based company dedicated to the development of regeneration therapies for the treatment of diabetes mellitus. Exsulin的重点是研制的一种药物可能成为从1型(T1DM的)和2型糖尿病(2型糖尿病)患者治疗的突破。 Exsulin's focus is on development of a drug with potential to become a breakthrough therapy for patients suffering from type 1 (T1DM) and type 2 diabetes (T2DM). 第二阶段人类糖尿病,临床试验数据Exsulin(商标)(磷化铟镓肽),一人肽制剂的目的是恢复能力正常的胰腺中产生胰岛素与刚刚在网上公布了糖尿病/代谢研究与评论。 Phase II human clinical trial data of Exsulin(TM) (INGAP peptide), a peptide drug product aimed at restoring the ability of the pancreas to produce insulin normally in people with diabetes mellitus, have just been published online by Diabetes/Metabolism Research and Reviews.
Exsulin公司,由糖尿病行业的专业人士创办,是由一名临床验证,开发和管理的管理团队,是由全球公认的糖尿病专家表示。 Exsulin Corporation, founded by diabetes industry professionals, is supported by a proven clinical, development and regulatory management team and is advised by globally recognized diabetes experts. 为了进一步落实和支持在最近的试验数据记录公布的结果,Exsulin已收到了既定的患者(不初诊)T1DM的,一个没有其他积极的临床试验,目前人口的子集试验许可。 To follow on and support the results documented in the recent trial data publication, Exsulin has received clearances for a trial in patients with established (not newly diagnosed) T1DM, a population subset with no other currently active clinical trials. 由Exsulin取得了其他一些项目包括重新和药品,重点支持独立的实验室研究采购,并确保监管授权开始一个新的临床试验。 Other milestones achieved by Exsulin include reformulation and procurement of drug product, support of key independent laboratory research, and securing regulatory authorization to initiate a new clinical trial.
“自从1921年发现胰岛素具有里程碑意义的,只有增量已经取得了进展,胰岛素治疗,仍然艰难和危险 - 尤其是对与T1DM的人,”克亚历山大弗莱明说,医学博士,创始人兼董事长,Exsulin公司。 "Since the landmark discovery of insulin in 1921, only incremental progress has been made in insulin therapy, which remains difficult and hazardous - particularly for people with T1DM," said G. Alexander Fleming, MD, founder and chairman, Exsulin Corporation. “这些研究结果是非常令人鼓舞的Exsulin治疗可以恢复正常的胰岛素分泌,从而使胰岛素依赖型糖尿病患者是T1DM并实现正常的血糖控制,同时减少或终止其对胰岛素治疗的依赖。” "These study results are very encouraging that Exsulin therapy could restore normal insulin secretion, which would allow insulin dependent T1DM and T2DM patients to achieve normal glucose control while decreasing or ending their dependence on insulin treatment."
前两个阶段的第二安慰剂控制的12个星期的试验 - 一个在T1DM的2型糖尿病患者和患者之一 - 测试两个每日一次的剂量及注射Exsulin为T1DM的发现,继续研究和2型糖尿病治疗是必要的。 The first two phase II placebo-controlled 12-week trials - one in T1DM patients and one in T2DM patients - tested two doses of once-daily injected Exsulin and found that continued study for both T1DM and T2DM treatment is warranted. Exsulin是一个正在为它的再生能力,在胰腺小岛,其中包含产生胰岛素的β细胞研究激素。 Exsulin is a hormone that is being studied for its ability to regenerate islets in the pancreas, which contain the insulin-producing beta cells. 恢复胰岛素分泌减少或消除可能维持与胰岛素依赖型糖尿病是T1DM和所有患者的血糖控制正常的挑战。 Restoration of insulin secretion could potentially reduce or eliminate the challenges of maintaining normal glucose control for all patients with T1DM and insulin dependent T2DM.
在T1DM的研究(精神1),精氨酸刺激C -肽(的AUC0 - 30)显着增加,从基线在600毫克团队精神2架C -)刺激肽(P = 0.0058,在2型糖尿病患者( 与安慰剂相比 ),而被显着更好地保存= 0.031 比安慰剂)在600毫克组30洗脱(天在 P。 In the T1DM study (SPIRIT 1), Arginine-stimulated C-peptide (AUC0-30) significantly increased from baseline in the 600 mg group ( p = 0.0058 versus placebo) while in the T2DM patients (SPIRIT 2) stimulated C-peptide was significantly better preserved in the 600 mg group 30 days after washout ( p = 0.031 versus placebo). 2型糖尿病患者,糖化血色素下降,分别为120,p值=天0.009),明显多在600毫克组与安慰剂相比,在第90天(-0.94%和-0.47%,30天之后冲洗(-0.73% 与 -0.24% ,P均= 0.013)。 In T2DM patients, A1C decreased significantly more in the 600 mg group compared to placebo at day 90 (-0.94% versus -0.47%, respectively, p = 0.009) and day 120, 30 days after washout (-0.73% versus -0.24%, respectively, p = 0.013). 这是伴随着平均血糖明显下降。 This was accompanied by significant reductions in mean glucose. 安慰剂调整糖化血红蛋白呈下调T1DM的患者。 Placebo-adjusted A1C trended downward in T1DM patients. 活化C -肽是由专家推荐的内源性胰岛素分泌最好的措施,并已通过美国FDA公认为是治疗的主要为T1DM的监管疗效终点。 Stimulated C-peptide is recommended by experts as the best measure of endogenous insulin secretion and has been acknowledged by FDA to be the primary regulatory efficacy endpoint for T1DM therapies. 越来越多的证据强调,所保留的少量的胰岛素分泌,甚至有助于预防并发症,并与T1DM的人民造成严重的低血糖。 Increasing evidence underscores that even small amounts of retained insulin secretion helps to prevent complications and serious hypoglycemia in people with T1DM.
糖尿病是一种危及生命的情况影响到近24亿人在美国和超过200万。 Diabetes is a life threatening condition affecting nearly 24 million people in the United States and over 200 million worldwide. 糖尿病一直没有治愈的药物的最重要和最昂贵的慢性疾病之一。 Diabetes has remained one of medicine's most significant and costly chronic diseases without a cure. 通过恢复天然胰岛素的分泌,Exsulin可能会潜在地减少,如危及生命的低血糖,失明,肾衰竭,心脏衰竭及截肢手术糖尿病相关并发症的高风险的危险。 By restoring natural insulin secretion, Exsulin may potentially reduce the high risk of dangerous complications associated with diabetes such as life-threatening hypoglycemia, blindness, kidney failure, cardiac failure, and amputation. 有超过两百万北T1DM的美国人谁拥有的两倍以上,与胰岛素依赖型糖尿病多。 There are more than two million North Americans who have T1DM and more than twice as many with insulin dependent T2DM. 在2型糖尿病,胰岛素分泌β细胞质量已经减少了50%,在诊断的时间和继续下降整个病程。 In T2DM, insulin-secreting beta cell mass is already reduced by 50% at the time of diagnosis and continues to decline throughout the course of the disease. 与β细胞质量造成重大损失的病人是完全依赖注射胰岛素。 Patients with a significant loss of beta cell mass are totally dependent on injected insulin. 胰岛素治疗造成的威胁,包括低血糖生命危险很大的挑战。 Insulin therapy poses substantial challenges including danger of life threatening low blood sugar levels.
“我们相信,这些试验结果和进一步的研究将确认Exsulin作为糖尿病治疗取得突破的潜力,”丽莎说,扬沙,创始人兼首席执行官,Exsulin公司。 "We believe these trial results and further studies will confirm the potential for Exsulin as a breakthrough in diabetes treatment," said Lisa Jansa, founder and CEO, Exsulin Corporation. “Exsulin将很快开始新的第二阶段在领先的糖尿病研究中心的临床试验。” "Exsulin will soon begin new Phase II clinical trials at leading diabetes research centers."
有关这刊物的作者 About the Publication Authors
约翰巴斯博士,是过去,美国糖尿病协会(ADA)的总裁,教授,临床研究,目前在美国北卡罗莱纳大学医学院内科主任,糖尿病保健中心主任,内分泌科和行政副院长教堂山,北卡罗莱纳州。 John Buse, MD, is past-president of American Diabetes Association (ADA) and is currently Professor of Medicine, Director, Diabetes Care Center and Chief, Division of Endocrinology and Executive Associate Dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, North Carolina. 罗伯特Ratner医师,是医学,乔治华盛顿大学医学院,MedStar研究所副教授。 Robert Ratner, MD, is Associate Professor of Medicine, George Washington University School of Medicine, MedStar Research Institute. 凯瑟琳顿感,医学博士是内分泌,内分泌,糖尿病和新陈代谢,俄亥俄州立大学医学院部。 Kathleen Dungan, MD, is an endocrinologist, Division of Endocrinology, Diabetes, and Metabolism, The Ohio State University School of Medicine.
关于Exsulin公司 About Exsulin Corporation
在明尼阿波利斯的基础上,Exsulin公司已到了一个平台,能够为扭转了1型和2型糖尿病的根本原因的研究和胰岛细胞再生的方法全球发展的权利。 Based in Minneapolis, Exsulin Corporation has global rights to a platform that enables research and development of islet cell regeneration approaches for reversing a fundamental cause of type 1 and type 2 diabetes. Exsulin旨在改变对糖尿病保健的未来,赢得了医疗保健制度的重大成本节约。 Exsulin aims to change the future of diabetes care and win significant cost savings for the healthcare system. Exsulin与领先的研究实验室,并在多个国家进行临床调查人员提前了解和治疗糖尿病。 Exsulin works with leading research labs and clinical investigators in multiple countries to advance understanding and treatment of diabetes. 更多信息可在www.exs ü lin.com 。 More information can be found at www.exs u lin.com . |
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yff:
谢谢你的消息!!!金钱 + 1
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