Alcobra Ltd. Selects CNS Clinical Trials Expert Premier Research as CRO for Phase III Clinical Study of MG01CI as a Treatment for Adults With ADHD
TEL AVIV, Israel, Oct. 2, 2013 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD) (the "Company"), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, announced today that it has selected Premier Research as its Clinical Research Organization ("CRO") to conduct a Phase III clinical study of its proprietary drug MG01CI as a treatment for adults with Attention Deficit Hyperactivity Disorder (ADHD).
"We are delighted to partner with Premier Research as we embark upon our most important clinical study to date. Premier Research has extensive knowledge and expertise regarding central nervous system
(CNS) clinical trials, having conducted more than 150 CNS studies over the past five years, including numerous advanced stage ADHD trials,"
noted Dr. Jonathan Rubin, Chief Medical Officer of Alcobra Ltd. "Their experience, including site selection, clinical trial design and expertise in clinical trial operations, should prove invaluable as we work diligently to navigate through the FDA approval process to seek an adult ADHD indication for MG01CI."
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug, MG01CI, to treat cognitive dysfunction, such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MG01CI has completed Phase II studies to treat ADHD. The company was founded in 2008 and is headquartered in Tel Aviv, Israel.
About Premier Research
Premier Research is a leading global contract research organization
(CRO) serving biotech, pharmaceutical, and medical device corporations.
Its services include clinical research and regulatory outsourcing in the areas of CNS; infectious, cardiovascular, and respiratory disease; dermatology; and oncology. The company also has a wealth of experience in medical device, rare disease and pediatric research.
Premier Research has 22 offices (seven in North America, 15 in Europe) and operates in 30 countries. It employs more than 1,000 clinical professionals dedicated first and foremost to fulfilling each client's requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws.
Because such statements deal with future events and are based on Alcobra's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the expected commencement of a Phase III clinical study of MG01CI as a treatment of ADHD in adults as well as the potential to benefit from Premier Research's experience when conducting such study. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Alcobra Ltd.'s registration statement on Form F-1 filed with the Securities and Exchange Commission ("SEC") and in subsequent filings with the SEC. Except as otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
Israel Investor Contact:
Investor Relations Ltd.
Posted: October 2013