TEL AVIV, Israel, April 1, 2015 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed"), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, today announced that it has appointed George Tonelli as Vice President of Clinical Operations.
Mr. Tonelli brings 20+ years of progressive experience in clinical operations, development and regulatory affairs. From 2005 to 2014, Mr. Tonelli planned and executed multiple clinical trials in the therapeutic area of Diabetes Mellitus at MannKind Corporation, culminating in the FDA approval of Afrezza®. Prior to MannKind, Mr. Tonelli held several leadership positions in clinical development and project management at Innapharma. Mr. Tonelli began his career in regulatory affairs in the Medical Research Division of American Cyanamid (Lederle Labs).
"George is a perfect fit to lead the expansion of the ARREST Study in the United States and oversee the trial's operations on a global basis," commented Allen Baharaff, Galmed's President and Chief Executive Officer. Mr. Baharaff continued, "George adds significant and complementary strengths and capabilities to our leadership team. We believe that George's extensive experience and proven talent in clinical operations is an important supplement to Galmed at this time. Importantly, Mr. Tonelli, who is permanently situated in the United States, will allow Galmed to consolidate our U.S.-based sites in the most timely and efficient manner possible. We are pleased to welcome Mr. Tonelli to the Galmed team."
Galmed's ARREST Study is a multi-center, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of aramchol. As noted previously, Galmed has commenced the operational phase of its multinational ARREST Study of aramchol, which is expected to take place in more than 70 centers in 12 countries, including the United States, and in accordance with FDA guidance.
Mr. Tonelli added, "I'm enthusiastic to be joining Galmed as we accelerate the development of aramchol. I look forward to leading the clinical operations of the ARREST Study and continuing Galmed's objective of developing a Non-Alcoholic Steato-hepatitis ("NASH") drug for this important unmet medical need."
About Galmed Pharmaceuticals Ltd.
Galmed is a clinical-stage biopharmaceutical company focused on the development and commercialization of a novel, once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones utilizing its proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs. Galmed believes that its product candidate, aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including NASH, which is a chronic disease that Galmed believes constitutes a large unmet medical need.
This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed's objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Galmed's most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission, or the SEC, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed's current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.