FDA快速轨道半乳糖凝集素的脂肪肝的药物

StephenW

FDA Fast Tracks Galectin's Fatty Liver Drug


Galectin Therapeutics Receives FDA Fast Track Designation for GR-MD-02 for Fatty Liver Disease With Advanced Fibrosis

NORCROSS, Ga., Aug. 12, 2013 (GLOBE NEWSWIRE) -- Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted GR-MD-O2 (galactoarabino-rhamnogalacturonate) Fast Track designation for non-alcoholic steatohepatitis (NASH) with hepatic fibrosis, commonly known as fatty liver disease with advanced fibrosis.

Galectin Therapeutics is currently conducting a Phase 1 clinical trial to evaluate the safety, tolerability and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 over four weekly doses of GR-MD-02 treatment in patients with fatty liver disease with advanced fibrosis. The study will enroll eight patients in each dose escalation cohort and there will be at least three cohorts and potentially up to five cohorts, with a maximum of 40 patients at six clinical sites in the US, which each have extensive experience in clinical trials in liver disease. More information on the first-in-man Phase 1 clinical study of GR-MD-02 is available at http://clinicaltrials.gov/ct2/sh ... term=gt-020&rank=1.

"Our preclinical data has shown that GR-MD-02 has robust treatment effects in reversing fibrosis and cirrhosis. Fast Track designation enables us to expedite the compound's development and review process, with the ultimate goal of bringing a first-in-class treatment to the millions of Americans suffering from fatty liver disease with advanced fibrosis," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "We are very pleased that the FDA sees the clinical value of GR-MD-02 and seriousness of fatty liver disease, and we look forward to working closely with the FDA throughout this process."

The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

About GR-MD-02

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin proteins play a major role in diseases that involve scaring of organs such as cancer, and inflammatory and fibrotic disorders. The drug binds to galectin proteins and disrupts their function. Preclinical data has shown that GR-MD-02 has robust treatment effects in reversing fibrosis and cirrhosis in kidney, lung, and liver.

About Fatty Liver Disease with Advanced Fibrosis

Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, in the US. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the US. There are no drug therapies approved for the treatment of liver fibrosis.

About Galectin Therapeutics

Galectin Therapeutics (Nasdaq:GALT) is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.

StephenW

半乳糖凝集素治疗脂肪肝疾病获得FDA快速通道指定GR-MD-02高级纤维化

诺克罗斯，佐治亚州，2013年8月12日（GLOBE NEWSWIRE） - 半乳糖凝集素治疗（纳斯达克股票代码：GALT），目标半乳糖凝集素蛋白疗法治疗肝纤维化和癌症的领先开发商，今天宣布，美国食品和药物管理局（FDA ）已授出GR-MD-O2（galactoarabino rhamnogalacturonate）快车道指定非酒精性脂肪性肝炎（NASH），肝纤维化，俗称脂肪肝疾病的晚期肝纤维化。

半乳糖凝集素治疗，目前正在进行第一阶段的临床试验，以评估安全性，耐受性和探索性的生物标志物疗效GR-MD-02的单剂量和多剂量超过四个星期的剂量GR-MD-02治疗脂肪肝疾病患者晚期肝纤维化。这项研究将招收8名患者各剂量升级队列中，将有至少三个同伙，可能高达5个同伙，与最多40名患者在6个临床试验点在美国，每个人都有丰富的经验，在临床试验中，肝疾病。第一人第1阶段临床研究GR-MD-02的更多信息，可在http://clinicaltrials.gov/ct2/sh ... term=gt-020&rank=1。

“我们的临床前数据显示，GR-MD-02具有强大的扭转纤维化和肝硬化的治疗效果。快车道指定让我们加快化合物的开发和审查过程，与第一 - 在 - 类的治疗带来到的最终目标数以百万计的美国人患有脂肪肝疾病晚期肝纤维化，说：“”Peter G.特拉伯博士，主席，行政总裁兼首席医务官半乳糖凝集素Therapeutics公司“我们非常高兴的是，美国FDA认为的临床应用价值GR-MD-02和脂肪肝疾病的严重性，我们期待与FDA密切合作，在这整个过程。“

FDA的快速追踪计划的目的是加快检讨新的药物，用于治疗严重或危及生命的情况，并展示解决未满足的医疗需求的潜力。

关于GR-MD-02

GR-MD-02是一种复杂的碳水化合物，针对半乳糖凝集素-3，脂肪肝和肝纤维化的发病机制的关键蛋白的药物。半乳糖凝集素蛋白的疾病，涉及吓唬器官，如癌症，炎症和纤维化疾病中发挥了重要作用。药物半乳糖凝集素蛋白结合，破坏其功能。临床前数据表明，GR-MD-02具有强大的扭转肾，肺，肝纤维化和肝硬化的治疗效果。

关于脂肪性肝病与晚期肝纤维化

非酒精性脂肪性肝炎（NASH），也被称为脂肪肝疾病，肥胖率上升，估计影响9到15亿人，包括儿童，在美国已成为一种常见的肝脏疾病。脂肪肝疾病的特点是随着人喝很少或不含酒精的炎症和损伤的肝脏中的脂肪的存在下。随着时间的推移，脂肪肝疾病的患者可以发展纤维化，或肝脏上的疤痕，据估计，多达三百万个个体会发展为肝硬化，严重的肝脏疾病，肝移植是目前唯一的治疗方法。在年度基础上，在美国约6,300肝移植的手术进行。有没有批准用于治疗肝纤维化的药物治疗。

关于半乳糖凝集素治疗

半乳糖凝集素治疗（纳斯达克股票代码：GALT）发展前途的碳水化合物为基础的疗法，用于治疗肝纤维化的疾病和癌症基于对本公司的独特的理解，半乳糖凝集素蛋白质生物功能的关键调解人。我们利用广泛的科学研究和开发的专业知识，以及建立与外部资源的关系，以实现成本效益和效率的发展。我们所追求的清晰的发展途径，为我们的铅化合物在肝纤维化和癌症的临床增强和商品化。其他信息可www.galectintherapeutics.com。