News & Events CTI Announces Complete Enrollment of Galectin Therapeutics Phase 2 Trial with GR-MD-02 in NASH Patients with Advanced Fibrosis

CTI Announces Complete Enrollment of Galectin Therapeutics Phase 2 Trial with GR-MD-02 in NASH Patients with Advanced Fibrosis

June 1, 2016

CTI Clinical Trial and Consulting Services Announces Complete Enrollment of Galectin Therapeutics Phase 2 Trial with GR-MD-02 in NASH Patients with Advanced Fibrosis

FOR IMMEDIATE RELEASE [Cincinnati, OH ~ June 1, 2016]

CTI Clinical Trial and Consulting Services (CTI) announces that enrollment is complete for the Galectin Therapeutics Phase 2 clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced fibrosis. CTI specialize in clinical trials with the unique challenges associated with hepatic populations, from mild to moderate liver disease to end stage acute and chronic liver disease.

“We are very pleased to partner with Galectin on this novel study in NASH, which affects millions of people around the world, and are excited the trial has reached this pivotal milestone,” according to Joseph McCafferty, Vice President, Global Business Development & Client Management.

"We are pleased that enrollment in our NASH-FX trial was completed right on schedule," said Peter G. Traber, M.D., Galectin's president, chief executive officer and chief medical officer.  "Since the diagnosis of NASH and the monitoring of the disease are hampered by the need for liver biopsy, in addition to providing proof-of-concept on the efficacy of GR-MD-02, this study explores the utility of three non-invasive measures of fibrosis which may be useful in the design and execution of later stage clinical studies and perhaps have relevance in commercial clinical settings."

The NASH-FX trial has enrolled a total of 30 liver biopsy-confirmed NASH patients with advanced fibrosis (stage 3) - 15 patients to receive 8 mg/kg of GR-MD-02 and 15 patients to receive placebo every other week for 16 weeks, for a total of nine doses. The effect of GR-MD-02 on liver fibrosis will be assessed by three independent non-invasive tests following the treatment period. The primary endpoint will be an assessment of fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan®), which is a validated and proprietary MRI protocol developed by Perspectum Diagnostics. Secondary endpoints will evaluate liver stiffness, which correlates to the degree of liver fibrosis, as assessed by magnetic resonance-elastography and by FibroScan®. More information on the NASH-FX trial may be found at www.clinicaltrials.gov.

About CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hematology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in Cincinnati, OH, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com

Media Contact: Allison Schroeder ●513.598.9290 ● aschroeder@ctifacts.com

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-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates.  NASH is estimated to affect up to 28 million people in the U.S.  Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who consume 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 1-2 million individuals in the U.S. have cirrhosis, a severe liver disease for which liver transplant is the only treatment available. Approximately 6,300 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of NASH or liver fibrosis. A recent analyst estimate indicated that by 2025 the worldwide market for NASH treatments could approach $35 billion.

About Galectin Therapeutics

Galectin Therapeutics 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, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com

Original Press Release

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