ROCKVILLE, Md., July 27, 2015 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today the formation of a clinical advisory board (CAB). Led by CASI's Chief Medical Officer Rong Chen, MD, Ph.D, the board will leverage its extensive clinical experience and expertise to assist the company with overall product development strategies and clinical practice. The members of the clinical advisory board are:
Ghassan K. Abou-Alfa, M.D.: Dr. Abou-Alfa is an associate professor of the Gastrointestinal Oncology Service at Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College in New York, and is a prominent figure in the treatment of gastrointestinal malignancies and in particular, hepatocellular carcinoma, fibrolamellar carcinoma, and biliary cancers. His research is dedicated to finding novel therapies and improving the effectiveness of current therapies for hepatocellular carcinoma and biliary cancers, while continuing to understand the basic mechanisms of the diseases and their therapies. Dr. Abou-Alfa is dedicated to developing therapeutic strategies that help overcome resistance to sorafenib. He, along with colleagues, founded the nationwide Fibrolamellar Consortium that has helped numerous fibrolamellar carcinoma patients.
S. Gail Eckhardt, M.D.: Dr. Eckhardt is a tenured Professor in the Division of Medical Oncology at the University of Colorado, School of Medicine where she also holds the Stapp/Harlow Endowed Chair for Cancer Research. After a post-doctoral fellowship at the Scripps Research Foundation, she completed her training in Medical Oncology at the University of California San Diego. Dr. Eckhardt has served on numerous committees/study sections, including the ASCO Molecular Oncology Task Force, the ASCO Board of Directors, the FDA Oncology Drugs Advisory Committee, and the NCI Cancer Centers Study Section. She is a member of the NCI Investigational Drug Steering Committee and the NCI Colorectal Cancer Task Force and serves on several External Advisory Boards of NCI designated Cancer Centers. Dr. Eckhardt is the Principal Investigator on grants involving early clinical trials and colorectal cancer research, has conducted numerous Phase 1 and 2 clinical trials and has published over 170 manuscripts. She is an internationally recognized expert on drug development.
Robert J. Mayer, M.D.: Dr. Mayer is Faculty Vice President for Academic Affairs at the Dana-Farber Cancer Institute, Senior Physician at the Brigham and Women's Hospital, and the Stephen B. Kay Professor of Medicine at the Harvard Medical Schoolwhere he is also the Faculty Associate Dean for Admissions. He directed the Institute's Medical Oncology Fellowship Program for 36 years, overseeing the training of several hundred oncologists. Dr. Mayer's research interests focus on gastrointestinal cancer, a subject about which he has published extensively. Dr. Mayer established the Center for Gastrointestinal Oncology at the Dana-Farber Cancer Institute and is the past Chair of the Gastrointestinal Cancer Committee of the Cancer and Leukemia Group B, a cooperative group sponsored by the National Cancer Institute. Dr. Mayer's extensive experience and knowledge of clinical development and network of clinicians will provide CASI with important insight and access.
Rong Chen, M.D., Ph.D.: Dr. Chen is CASI's chief medical officer. Dr. Chen has extensive experience in drug development, both in China and globally, which will be invaluable to his work at CASI.
Ken K. Ren, M.D., Ph.D., CASI'S Chief Executive Officer, commented, "We are very pleased to have this distinguished group of oncology investigators join our Clinical Advisory Board. These individuals have a wealth of experience in the field and will provide invaluable advice for our clinical program as we advance ENMD-2076, expand our clinical pipeline, and take CASI to the next level."
About CASI Pharmaceuticals, Inc.
CASI is a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China. CASI's product pipeline includes exclusive rights to ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vinCRIStine sulfate LIPOSOME injection) and EVOMELATM (CE-Melphalan HCI) for injection for greater China (including Taiwan, Hong Kong and Macau). CASI's development pipeline also includes its proprietary drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial) currently under reformulation development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in the Company's filings with the U.S. Securities and Exchange Commission.
ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. Aurora kinases are key regulators of mitosis (cell division), and are often over-expressed in human cancers. ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases, which have been shown to play important roles in the pathology of several cancers. ENMD-2076 has shown promising activity in Phase 1 clinical trials in solid tumors including ovarian, breast, liver, renal and sarcoma, as well as in leukemia and multiple myeloma. ENMD-2076 is currently in Phase 2 clinical trials in multiple indications, including triple-negative breast cancer, soft tissue sarcoma and ovarian clear cell carcinomas and is preparing for a Phase 2 trial in fibrolamellar carcinoma. ENMD-2076 has received orphan drug designation from the U.S. FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia, and hepatocellular carcinoma.
Forward Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility in the market price of our common stock; the difficulty of executing our business strategy in China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidate or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early-stage products under development; the risk that results in preclinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third parties; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest stockholders that differ from our other stockholders; and the risk of substantial dilution of existing stockholders in future stock issuances. Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.