HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (NASDAQ: ARDM) (the “Company”) today announced that it will host a Key Opinion Leader (KOL) call on the topic of infection management in non-cystic fibrosis bronchiectasis (NCFBE) patients on Monday, September 18 at 11am Eastern Time.
The call will feature presentations by key opinion leaders Gregory Tino, MD (University of Pennsylvania), Prof. James Chalmers (University of Dundee), and Katie Laessig, MD (former FDA Deputy Director, Division of Anti-Infective Products), who will discuss the current standard of care for patients with NCFBE and the regulatory pathway for new treatments of bronchiectasis. The KOLs will be available to answer questions at the conclusion of the call.
Aradigm's management team will also provide a summary of the Company's Phase 3 efficacy and safety data on Linhaliq™, an investigational proprietary formulation of ciprofloxacin for inhalation. Linhaliq was evaluated in two Phase 3 studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of patients with NCFBE who have chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).
Gregory Tino, MD is an Associate Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. He is the Chief of the Department of Medicine at Penn Presbyterian Medical Center and Senior Vice Chair of the Department of Medicine of the Perelman School of Medicine at the University of Pennsylvania. Dr. Tino is an inaugural member of the Academy of Master Clinicians at Penn Medicine. Dr. Tino has a specific clinical and research interest in bronchiectasis and interstitial lung diseases. He has been a Principal or Sub-Investigator for several clinical trials in Idiopathic Pulmonary Fibrosis and Bronchiectasis. He is Past-Chair of the Assembly on Clinical Problems and has previously served on the Board of Directors of the American Thoracic Society, of which he is currently a member.
Professor James D Chalmers is the British Lung Foundation Professor of Respiratory Research, University of Dundee, Scotland. Prof. Chalmers did his undergraduate training in Glasgow and trained in Respiratory Medicine in Edinburgh before moving to Dundee, Scotland. He is a Consultant Respiratory Physician and runs the regional bronchiectasis service that cares for more than 600 patients with the disease, as well as having an active clinical interest in COPD, severe asthma and cystic fibrosis. He has published more than 150 peer reviewed publications and books. He chairs with European Bronchiectasis Registry and recently chaired the European Respiratory Society guidelines for bronchiectasis. He is chair of the British Thoracic Society Respiratory Infection Speciality Advisory Group, and is secretary of the European Board of Accreditation in Pneumology (EBAP) which accredits continuing medical education for respiratory physicians in Europe. In recognition of Professor Chalmers as an outstanding international leader of lung research, in 2017 he received the prestigious award by the British Lung Foundation to advance research on bronchiectasis. He also received the Romain Pauwels award, the highest scientific award from the European Respiratory Society, and the Patrick Neill Medal from the Royal Society of Edinburgh in 2017 for his contributions to bronchiectasis.
Dr. Katie Laessig is currently Senior Vice President of Regulatory Affairs and Medical Safety at RRD International, LLC. Dr. Laessig is a 16-year Food and Drug Administration (FDA) veteran and served as Deputy Director of the Division of Anti-Infective Products (DAIP), where she was responsible for review of antimicrobial drug and biologic products for the treatment as well as prevention of infectious diseases. Prior to joining DAIP, she held several positions of increasing responsibility within the Division of Anti-Viral Products (DAVP). She is board certified in infectious diseases and is a member of the Infectious Disease Society of America and the American Society for Tropical Medicine and Hygiene. Dr. Laessig earned her medical degree from the University of Maryland in Baltimore in 1992 and completed her internal medicine residency in 1995 and infectious diseases fellowship in 1997, both at George Washington University Medical Center in Washington, D.C.
Monday, September 18, 2017 @ 11am Eastern Time/8am Pacific Time
If you would like to ask a question during the live Q&A, please submit your request via email at Questions@LifeSciAdvisors.com.
About Non-Cystic Fibrosis Bronchiectasis
Non-cystic fibrosis bronchiectasis (NCFBE) is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition. NCFBE patients who have chronic infections with P. aeruginosa have a 6.5-fold increase in hospitalization, three times higher mortality, and a worse quality of life compared with those without P. aeruginosa infections.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm has completed two Phase 3 clinical trials with Linhaliq, an investigational proprietary formulation of ciprofloxacin for inhalation, for the treatment of NCFBE and submitted a New Drug Application to the FDA for this indication. Aradigm's inhaled ciprofloxacin formulations, including Linhaliq, are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.
More information about Aradigm can be found at www.aradigm.com.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation. Linhaliq is a registered trademark of Grifols, S.A.