Ciclofilin Pharmaceuticals Announces Formation of World-Class HBV and Liver Disease Scientific Advisory Board

SAN DIEGO, Dec. 2, 2015 (GLOBE NEWSWIRE) — Ciclofilin Pharmaceuticals Inc. (“Ciclofilin” or the “Company”), a privately held biotech, announced today that it has assembled a world-class team of scientists and clinicians to participate in the company’s Scientific Advisory Board (“SAB”). The SAB was established to guide the company through its drug development program for its lead drug candidate, CPI-431-32, for the treatment of HBV and liver disease.The Company’s SAB will be chaired by Dr. Philippe Gallay, Professor of The Scripps Research Institute, with members that include Dr. Tarek Hassanein, Dr. Keith Anderson, and Mr. Timothy Schroeder. Individual biographies of the SAB members are as follows:Philippe Gallay, Ph.D., Professor, Department of Immunology and Microbial Science at the Scripps Research Institute, San Diego, CA, USA. Dr. Gallay holds a Swiss Federal Diploma (MS), from the Institute of Biochemistry, Epalinges, Switzerland and a PhD from Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.   Dr. Gallay’s research program examines the molecular basis of HIV, HCV, and HBV pathogenesis, including characterization of host proteins modulating viral replication, such as various cyclophilins (Host Targeting Antivirals). In particular, Dr. Gallay has studied the role of cyclophilin inhibition on disease progression, and has investigated cyclophilin-NS5A complexes, viral mutations, and synergism with other antiviral compounds, including the Direct Acting Antivirals. Dr. Gallay has presented his research at numerous scientific and research symposia worldwide. He serves as a reviewer for more than 40 journals, has served as a Member on the Center for AIDS Research Developmental Grant Review Committee, and has served as an ad hoc member of the National Institute of Allergy and Infectious Diseases (NIAID), the Medical Research Council (MRC, UK), as well as an ad hoc member of similar committees in Netherlands, Austria, and Switzerland. Dr. Gallay has more than 90 peer-reviewed publications.Tarek Hassanein, M.D., FACP, FACG, AGAF, FAASLD, Professor of Medicine, UCSD School of Medicine, Director of Outreach Services, UCSD Center for Transplantation, Director, Southern California GI & Liver Centers, Medical Director, Southern California Research Center, USA. Dr. Hassanein graduated with a M.B., Ch.B. degree with honors, and holds a Master of Science and Internal Medicine, both from Alexandria University, Alexandria, Egypt. He is also Board certified with the American Board of Internal Medicine, the American Board of Gastroenterology, and with the American Board of Internal Medicine, Transplant Hepatology. Dr. Hassanein holds numerous Awards and Distinctions, most recently receiving the American Liver Foundation Achievement Award in 2014, and has served on the Editorial Boards of numerous journals in hepatology, gastroenterology and liver transplantation. Additionally, Dr. Hassanein has served on numerous Advisory Boards, Committees, and Steering Committees for the Pharmaceutical Industry and Foundations. He has been an Invited Lecturer on approximately 270 occasions, has participated in numerous Research Studies and has taught in the field for almost 20 years. He has authored or co-authored approximately 115 journal articles and more than 280 abstracts.Timothy Schroeder, Chief Executive Officer, CTI Clinical Trial & Consulting, Cincinnati, OH, USA. Timothy is Founder of CTI, and has over 30 years of clinical, academic, and industry experience in global drug and device development programs. CTI, founded in 1999, is a multi-national research firm with associates in North America, Europe, Latin America and Asia-Pacific. The firm has supported more than 75 drug and device approvals, and currently works on behalf of approximately 100 global pharmaceutical and biotechnology companies. Prior to founding CTI, Tim held numerous faculty positions with the University of Cincinnati College of Medicine. He was also the founding Executive Vice President of Clinical Development at SangStat Medical Corporation, which went public in 1995. Tim is currently a board member for over a dozen corporate and non-profit organizations, including Xavier University, which he attended.Keith E. Anderson, Ph.D. SVP, Technical Operations ProNAi, Vancouver, BC, Canada. Dr. Anderson has more than 18 years of operational experience with pharmaceutical companies in Canada, USA, and Europe. He has held senior executive positions at Ligand Pharmaceuticals, Ocera Therapeutics and Seragon Pharmaceuticals, including oversight of preclinical sciences, process chemistry, product development and commercial manufacturing and supply. Dr. Anderson has also developed product supply chain and sourcing strategies for commercial and development stage APIs, biologics, and drug products including injectables, oral, sustained release, and topical dosage forms. He has numerous publications and is a lead inventor on 4 patents, has an extensive track record on Regulatory CMC filings including multiple INDs, CTAs, IMPDs, Post Approval Supplements, and has been a key technical lead at multiple FDA/EMA meetings. His experience includes obtaining medical device (CE mark) approval in Europe. He has also been responsible for the implementation of Quality Management Systems, cGMP processes, SOPs and management of internal and external cGMP and ISO certification audits. In addition, he remains an invited lecturer at Georgetown-Howard University Center for Clinical and Translational Sciences (GHUCCTS) for the Master’s Degree Program in Clinical and Translational Sciences.“We are immensely excited to welcome these recognized experts to the Ciclofilin SAB,” commented Dr. Robert Foster, Ciclofilin’s CEO. “Our company’s lead drug candidate, CPI-431-32, is a cyclophilin inhibitor specifically designed to target the hepatitis B virus, and has demonstrated anti-fibrotic properties associated with the clinical sequelae of chronic HBV infection. Our SAB members have a deep understanding of how cyclophilin inhibition works, as well as the clinical consequences and challenges faced with treatments of HBV and liver disease, the design and implementation of clinical trial protocols, regulatory processes, the execution of non-clinical studies, and the management of drug manufacturing and supply chain issues. Having access to these industry leaders and their collective networks is a tremendous advantage for our company.”About Ciclofilin:Ciclofilin is a privately held life sciences company based in San Diego, California, with R&D facilities in Edmonton, Canada. The company’s lead drug candidate, CPI-431-32, is being developed as a treatment for chronic HBV infection. CPI-431-32 interferes with the ability of the HBV to infect cells, propagate, and cause disease primarily by preventing HBV interaction with host cell cyclophilins. CPI-431-32 also demonstrates anti-fibrotic activity in the liver, and may offer clinical benefits to patients in addition to anti-HBV activity.Forward-Looking StatementsThis press release contains forward-looking statements, including with respect to the potential of our lead drug CPI-431-32 for the treatment of HBV. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the significance of our preclinical results and potential applications of our compound for the treatment of HBV patients. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. These statements speak only as of the date of this release, and are subject to a number of risks, uncertainties and assumptions. Ciclofilin undertakes no obligation to update or revise these statements, except as required by applicable law.Investor Contact:

Ciclofilin Pharmaceuticals, Inc.
Dr. Robert T. Foster, CEO
+1 (780) 909-5041
Mr. Michael Kamdar, President
+1 (858) 733-1308

Media Contact:

Steve Kilmer
+1 (647) 872-4849