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ADLS 1.46 Advanced Life Sciences Announces Formation of National Advisory Board for Cethromycin PR Newswire "US Press Releases "
CHICAGO , Aug. 2 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced the formation of its National Advisory Board for Cethromycin, consisting of ten well-known experts in community acquired pneumonia, other respiratory-tract infections, and antibiotic therapies. The company has appointed the following to this Board: Dr. Antonio Anzueto, Dr. Naga Chalasani, Dr. Nathan Dean, Dr. Thomas File Jr., Dr. Paul Iannini, Dr. Donald Low, Dr. Lionel Mandell, Dr. Mark Metersky, Dr. Michael Niederman and Dr. Richard Wunderink. These experts will provide guidance concerning Cethromycin's ongoing development and regulatory strategy and execution, as well as advise on the drug's possible future value in clinical practice.
(Logo: http://www.newscom.com/cgi-bin/prnh/20050428/CGTH039LOGO)
"We are pleased to be working with thought leaders who bring with them the highest level of expertise in the areas of infectious disease, pulmonary, nephrology, microbiology and antibiotic research as part of our Advisory Board for Cethromycin," said Dr. Michael Flavin, chief executive officer for Advanced Life Sciences. "The unparalleled experience of this group will assist us as we bring this important new antibiotic through the regulatory and NDA submission process and toward the market."
"Despite the continuing emergence of antimicrobial resistance in important respiratory pathogens, such as the pneumococci, over the last decade we have seen fewer and fewer new agents that effectively address this challenge" said Dr. Low. "Cethromycin, a new antimicrobial drug in the ketolide class, may be the solution to this important public health problem, as it has demonstrated a broad spectrum of antibacterial activity and minimal pneumococcal resistance has been observed with this antibiotic class. It is my privilege to participate as a member of the National Advisory Board for Cethromycin."
Members of the National Advisory Board for Cethromycin are as follows:
Dr. Antonio Anzueto
Antonio R. Anzueto, MD is a Professor of Medicine/Pulmonary Medicine - Critical Care at the University of Texas Health Science Center at San Antonio ; Chief of the Pulmonary Section, Medical Director and Director of the Pulmonary Function Lab , Director of the Pulmonary Service Spinal Cord Unit, Medical Director of the Respiratory Therapy Department and the Bronchoscopy Laboratory , and a staff physician in the South Texas Veterans Health Care System Audie L. Murphy Memorial Veterans Hospital Division.
Dr. Anzueto has taught numerous courses on pneumonia, nosocomial pneumonia, bloodborne pathogens, and the influence of gene polymorphisms on antibiotic use. He has also conducted and is currently participating in research studies in the areas of respiratory infections (community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute respiratory distress syndrome, chronic obstructive pulmonary disease), mechanical ventilation, and septic shock. Dr. Anzueto has also been the invited speaker to numerous medical meetings and has authored over 260 abstracts, 31 book chapters, and 180 articles on topics relating to these areas.
Dr. Naga Chalasani
Naga P. Chalasani, MD, FACG is currently Associate Professor of Medicine and is the Director of the Division of Gastroenterology and Hepatology in the Department of Medicine at Indiana University School of Medicine in Indianapolis, Indiana .
Dr. Chalasani is currently a fellow and member of the Clinical Research Committee of the American College of Gastroenterology , Chair of the Abstract Review Committee and a member of the Clinical Research Committee for the American Association for the Study of Liver Diseases (AASLD). He is also a member of the American Gastroenterology Association , American Society for Gastrointestinal Endoscopy , and the Central Society for Clinical Research . He is on the editorial boards of 6 medical journals, including Gastroenterology, Hepatology, and the American Journal of Medicine . He is an ad hoc reviewer of 12 medical journals. Dr. Chalasani established an adult liver transplant program at Indiana University Medical Center , and has chaired multiple scientific sessions at the annual meetings for Digestive Disease Week (DDW) and AASLD for the past 7 years. He has written several editorials in various gastroenterology, hepatology, and liver transplant journals. He has published nearly 100 peer-reviewed papers in biomedical journals and has multiple NIH grants to conduct investigations related to fatty liver disease and drug hepatotoxicity.
Dr. Nathan Dean
Nathan C. Dean, MD is Section Chief of Pulmonary, Critical Care and Sleep Medicine at LDS Hospital and Adjunct Professor of Medicine at the University of Utah School of Medicine . For the past 10 years, he has been the Chair of Intermountain Health Care Lower Respiratory Tract Infection Team in Salt Lake City . He is also the Medical Advisor for the Alta Ski Patrol in Salt Lake City .
For the past 5 years, Dr. Dean has been an investigator for several studies, including a grant project studying emergency department pneumonia patients, the VALID Study on the role of recombinant protein C-surfactant in community-acquired pneumonia (CAP), and the CAPTIVATE Study on the role of tifacogin as adjunctive therapy for CAP. In addition, for the past 25 years he has been a medicine ward attending physician at LDS Hospital and taught several courses on CAP. Dr. Dean has authored over 35 publications, editorials, abstracts, review articles and 2 book chapters. He has been an invited lecturer at numerous international, and local and regional medical meetings for the American Thoracic Society and the International Society of Chemotherapy on CAP guidelines and practice updates.
Dr. Thomas File Jr.
Thomas M. File Jr., MD, MS is Chief of the Infectious Disease Service and Director of HIV Research at Summa Health System in Akron, Ohio , and Professor of Internal Medicine, Master Teacher, and Head of the Infectious Disease Section at the Northeastern Ohio Universities College of Medicine in Rootstown. He is currently Chairperson of the Standards and Practice Guidelines Committee of the Infectious Diseases Society of America (IDSA).
Primary research interests that Dr. File has pursued include community-acquired respiratory tract infections, bacterial resistance in respiratory infections, infections in patients with diabetes, and evaluation of new antimicrobial agents. A frequent lecturer both nationally and internationally, Dr. File has published more than 200 articles, abstracts, and textbook chapters, focusing on the diagnosis, etiology, and treatment of infectious diseases, especially on respiratory tract infections. He recently co-edited the book Community-Acquired Respiratory Infections. In addition, he currently serves on the editorial boards of Journal of Respiratory Disease and Infectious Disease News and is editor-in-chief of Infectious Diseases in Clinical Practice.
Dr. Paul Iannini
Paul B. Iannini, MD, is Chairman of the Department of Medicine and Executive Director of Medical Services for WellSpan Healthcare at York Hospital in York, Pennsylvania . He is also Clinical Professor of Medicine at Yale University School of Medicine in New Haven, Connecticut .
Dr. Iannini's primary research interest is in infectious diseases. A frequent lecturer and presenter at conferences both nationally and internationally, Dr. Iannini has been an invited speaker at numerous Infectious Disease Society of America (IDSA) annual meetings, and he has authored more than 100 journal articles as well as 5 books on various infectious disease topics and 2 monographs on community-acquired respiratory infections. Dr. Iannini is a scientific reviewer for The American Journal of the Medical Sciences , Clinical Infectious Diseases, and Clinical Pharmacology and Therapeutics. He is an editorial board member and a correspondence editor of Expert Opinion on Drug Safety.
Dr. Donald Low
Donald E. Low, MD, FRCPSC is currently Head the Division of Microbiology, Department of Laboratory Medicine and Pathobiology at the University of Toronto in Toronto, Ontario . He is also Chief of University Health Network and Mount Sinai Hospital Department of Microbiology , as well as Professor for the Departments of Microbiology and Medicine at the University of Toronto . In addition, Dr. Low is Medical Director of the Public Health Laboratories for the Ontario Ministry of Health and Long-Term Care .
Dr. Low is a prolific writer in the areas of infectious diseases, chemotherapy, and microbiology, and has authored hundreds of publications including 37 book chapters, over 300 peer-reviewed publications, and numerous editorials, letters, and invited articles. Dr. Low is a reviewer for 7 granting agencies in Canada and is on the editorial boards of the Journal of Antimicrobial Chemotherapy , Antimicrobial Agents & Chemotherapy, and Canadian Journal of Infectious Diseases , and a member of the editorial advisory board of the Journal of Infectious Diseases . He is a reviewer for numerous journals including the New England Journal of Medicine and Clinical Infectious Disease . Dr. Low is past president of the Canadian Infectious Disease Society and is a member of the American Association of Physicians .
Dr. Lionel Mandell
Lionel Ari Mandell, MD, FRCP is currently Professor of Medicine at McMaster University in Hamilton, Ontario . Dr. Mandell also serves on the Canadian Scientific Advisory Committee on Anti-Infective Therapies and is Co-Chair of the Joint Committee on Community-Acquired Pneumonia (CAP) for the American Thoracic Society and the Infectious Diseases Society of America (IDSA).
Over the past 30 years, Dr. Mandell has served as co-chair of numerous CAP conferences and from 2000 to 2005, he served on the Practice Guidelines Committee for the IDSA. He has also been on many expert advisory boards for anti-infectives, chemotherapy, respiratory infections, microbial strategies, and antimicrobial utilization. From 1996 to 2000, Dr. Mandell was the President of the Canadian Foundation for Infectious Diseases. He currently serves on the editorial boards for Pulmonary Infectious Diseases, Clinical Microbiology and Infection, Clinical Infectious Diseases, Infectious Disease in Clinical Practice, and Annals of Clinical Microbiology and Antimicrobials. He has previously served on the editorial boards for 10 other medical journals. He is also the referee for 18 medical journals, including Annals of Internal Medicine, Chest, JAMA, and Journal of Infectious Diseases . Dr. Mandell is currently an external grant reviewer for the Swiss National Scientific Foundation , Canadian Institute for Health Research , and Ontario Ministry of Health . He has written 33 books or book chapters, and published over 182 papers and 140 abstracts. He has been an invited speaker or chairman of many medical meetings on various topics, including infectious diseases, respiratory, nosocomial, pelvic, and fungal infections, oncology/chemotherapy, and antimicrobial therapy, guidelines, and resistance.
Dr. Mark Metersky
Mark Lewis Metersky, MD, is Associate Director of the Pulmonary Hypertension Center at the University of Connecticut Health Center in Farmington. He also serves as Professor of Clinical Medicine, Director of Pulmonary/Critical Care Fellowship Program, and attending physician for the Pulmonary Division and Critical Care Service at the University of Connecticut School of Medicine in Farmington. Since 1991 Dr. Metersky has served continuously as an educator through various academic appointments.
Dr. Metersky's principal area of scientific inquiry is infectious disease, and he has been a frequent speaker and presenter both nationally and internationally as well as an investigator for clinical research studies. He has authored nearly 100 publications, abstracts, and presentations as well as 3 books on various facets of infectious disease. He serves on the editorial boards of Journal of Bronchology and Chest , and is a reviewer for 11 journals including Chest, Archives of Internal Medicine, and Clinical Microbiology and Infection.
Dr. Michael Niederman
Michael S. Niederman MD, FACP, FCCP, FCCM is Professor of Medicine and Vice-Chairman of the Department of Medicine at the State University of New York at Stony Brook. He is also Chairman of the Department of Medicine at Winthrop-University Hospital in Mineola, New York .
Dr. Niederman's interests have included mechanisms of airway colonization, particularly the role of bacterial adherence in colonization of the airway of mechanically ventilated patients. He has also participated in a variety of clinical research projects, including antibiotic trials for respiratory infections. He has served as the Chairman of the American Thoracic Society Assembly on Microbiology, Tuberculosis, and Pulmonary Infections, and he was the Chairman of the 1993 American Thoracic Society's Consensus Statement on Community-Acquired Pneumonia (CAP), and Co-Chairman of the 2001 Consensus Statement Committee on Community-Acquired Pneumonia. In addition, Dr. Niederman has had a long-standing interest in nosocomial pneumonia and served as the Co-Chairman of the 1996 ATS Committee that wrote the guidelines for the treatment of nosocomial pneumonia. He was also Co-Chairman of the ATS/IDSA Guideline Committee that published guidelines for hospital acquired pneumonia in 2005 and he was a member of the ATS/IDSA Consensus Panel that published CAP guidelines in 2007. Dr. Niederman has authored over 300 peer-reviewed or review articles on respiratory infections. He is also a Co-Editor of the first and second editions of the textbook, Respiratory Infections: A Scientific Basis for Management, as well as, Editor-in-Chief of Clinical Pulmonary Medicine. He serves or has served on the editorial boards of the American Journal of Respiratory and Critical Care Medicine , Critical Care Medicine, and Chest, and is a reviewer for various other publications. Dr. Niederman has lectured nationally and internationally and has an ongoing interest in the impact of antibiotic resistance on the management and outcomes of respiratory infections.
Dr. Richard Wunderink
Richard Glenn Wunderink, MD is currently Professor of Medicine, Division of Pulmonary and Critical Care Medicine and a faculty member of the Center for Genetic Medicine at Northwestern University Feinberg School of Medicine in Chicago, Illinois . He holds hospital appointments at the Veterans Affairs Chicago Healthcare System as well as at Northwestern Memorial Hospital where he is also the Director of the Medical Intensive Care Unit.
Dr. Wunderink has served as Co-Chairman of the recently published American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA) Consensus Guidelines Committee for Community-Acquired Pneumonia , the Community-Acquired Pneumonia (CAP) Advisory Panel of the Centers for Medicare/Medicaid Services for 2 years, the Bioterrorism Committee on Pandemic Influenza Workgroup for the Illinois Department of Public Health , and the National Institutes of Health Acute Lung Injury SCCOR Data Safety Monitoring Board . He is prolific in his field and is a member of the Editorial Board of the Proceedings of the ATS, and a reviewer for 13 medical journals, including Chest, American Journal of Medicine , and Clinical Infectious Disease. He has authored over 100 publications, editorials and reviews, letters, and abstracts as well as 14 books or book chapters on the topics of respiratory infections, infectious diseases, pulmonary and critical care, and immunology. He has been an invited speaker to many recent annual meetings for the ATS, IDSA, and the International Society of Chemotherapy on the issues of sepsis, CAP, and ventilator-associated pneumonia.
About Community Acquired Pneumonia (CAP)
CAP is the sixth most common cause of death in the United States . CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5-6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.
Macrolides and penicillins are currently the first-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action which can overcome this emerging resistance.
About Cethromycin
Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin - and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, Cethromycin has also been shown to be effective in animal studies for the prophylactic treatment of inhalation anthrax post exposure. The FDA has designated Cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the FDA has not yet approved the drug for marketing in this or any other indication.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation. The Company's lead candidate, Cethromycin, is a novel once-a-day antibiotic in late-stage clinical development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at http://www.advancedlifesciences.com.
Forward-Looking Statements
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, clinical trials, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences' filings with the Securities and Exchange Commission . Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
SOURCE Advanced Life Sciences Holdings, Inc.