TORONTO, ONTARIO–(Marketwired – July 18, 2016) – Arch Biopartners, Inc., (Arch or the Company) (TSX VENTURE:ACH)(OTCBB:FOIFF) today announced the formation of a clinical and medical advisory board for AB569, the Company’s bactericidal drug for treating antibiotic resistant infections in lungs and the urinary tract.
In this capacity, the advisory board will provide guidance and expertise on obtaining regulatory approvals, human trial design and patient enrolment to enable first-in-human trials for AB569 in patients with chronic lung infections.
The new members of the clinical and medical advisory board are for the following diseases:
Cystic Fibrosis (CF):
Dr. Bruce Trapnell, MD, Director, Translational Pulmonary Science Center, Cincinnati Children’s Hospital Medical Center (CCHMC), Professor of Medicine and Pediatrics, University of Cincinnati (UC) – Dr. Trapnell received his medical degree from the University of Maryland in 1985, medical internship and residency training at the Ohio State University Hospitals and completed a pulmonary medicine fellowship at the National Institutes of Health (NIH), where he then served as senior attending physician. Subsequently, he established the Division of Pulmonary and Virology Studies at Genetic Therapy, Inc., a subsidiary of Novartis AG, and served as Vice President before joining the faculty of CCHMC in 1997. Dr. Trapnell’s work has focused on the molecular pathogenesis, diagnosis, and therapy of rare diseases including CF, the role of GM-CSF in alveolar macrophage function in health and disease, and human gene therapy.
Dr. Trapnell also serves as Director of the NIH-funded Rare Lung Diseases Clinical Research Consortium, Scientific Director of the Pulmonary Alveolar Proteinosis Foundation, Assistant Director of the Cincinnati Adult CF Care Center, and the Vice Chair of the Medical and Scientific Advisory Council of the Alpha-1 Foundation. He has served as a standing member of the NIH Lung Cellular and Immunobiology Study Section, received numerous awards including election to the Association of American Physicians and is a member of the National Health Council.
Dr. Patricia Joseph, MD, Professor of Medicine and Pediatrics, UC College of Medicine and Director of the Adult CF Center at the UC Medical Center – Dr. Joseph received her medical degree and then completed her combined residency in Medicine-Pediatrics from the University of Tennessee College of Medicine in 1988. She then went on to complete a Fellowship in Pulmonary and Critical Care at Massachusetts General Hospital. Dr. Joseph has dedicated her professional career to the care of patients with CF and has worked to improve patient health by focusing on patient centered outcomes. Throughout her career she has participated in numerous clinical trials, with a focus on adult CF lung disease.
Dr. Joseph is currently co-director (Adults), with Dr. J.P. Clancy (Pediatrics), of the CF Foundation Therapeutics Development Network (TDN). Through efficient study design, optimized clinical trial execution and high-quality data, the TDN’s objective is to help speed the delivery of new and better therapies to people with CF.
Dr. John P. Clancy, MD, Professor, Cincinnati Children’s Hospital Medical Center – Dr. Clancy has served in several leadership roles at University of Alabama, CCHMC and within the international CF community. Some of his leadership roles include membership on the CFF Clinical Research Committee (2003 to present), the CFF-TDN Steering Committee (2002 to 2007), the CFF-TDN Translational Research Center Committee (2008 to present), DSMB membership for the Rare Lung Disease Consortium within the NIH Rare Disease Research Network (2005 to 2009, Chairman from 2010 to present); organizing committee membership for the North American CF Conference (2003 to present) and the European CF Society (2010), co-chair of the CFFT Biomarkers Consortium (2010 to present), member of the Promotion and Tenure Committee for the UAB Department of Pediatrics (2003 to 2010) and the UAB SOM (2007 to 2010, including committee chair).
He has been the initial recipient of three endowed chairs, including the Raymond K. Lyrene Chair in Pediatric Pulmonary Medicine at the University of Alabama (2005), and the Tom Boat Chair in Cystic Fibrosis Clinical and Translational Research at Cincinnati Children’s (2011) and the Gunnar Esiason/Cincinnati Bell Chair in Life Sciences Research (2013).
Chronic Obstructive Pulmonary Disease (COPD):
Dr. Ralph J. Panos, MD, Chief of Medicine, Cincinnati Veterans Affairs Medical Center (CVAMC)– Dr. Panos is the Chief of Medicine and Medical Director of the Veterans Integrated Service Network 10 TeleICU Program at the Cincinnati VAMC. Dr. Panos obtained undergraduate and medical degrees from Brown University; performed his internal medical residency and chief residency at the University of Maryland in Baltimore; and, completed a pulmonary fellowship at the University of Colorado. His academic appointments include Northwestern University, Penn State, and now the University of Cincinnati. His research currently has a clinical and translational focus centering on interstitial lung disease and COPD.
He has worked at the Cincinnati VAMC for over 10 years holding positions as the Chief of the Pulmonary, Critical Care, and Sleep Medicine Section and Associate Chief of Staff for Research and Development. He serves as President and Chairman of the Board of the Cincinnati Education &Research for Veterans Foundation (CERV). Dr. Panos is Professor of Medicine, Pulmonary, Critical Care, and Sleep Medicine, and Associate Chief of Medicine for Veterans Affairs, Department of Internal Medicine, University of Cincinnati College of Medicine.
About AB569 and Anti-biotic resistant airway infections in CF and COPD patients
AB569 was invented by Dr. Daniel Hassett, Professor at the UC College of Medicine, to treat antibiotic resistant bacterial lung infections, which is a significant problem for patients with either CF or COPD. AB569 has been exclusively licensed to Arch by UC.
AB569, as a bactericidal compound, constitutes an innovative potential treatment for dealing with pulmonary bacterial infections that are resistant to traditional antibiotics. In pre-clinical studies, AB569 has demonstrated significant ability to kill many types of Gram-negative and Gram-positive bacteria.
Cystic fibrosis patients are predisposed to bacterial lung infections due to abnormal mucus production in the lungs and airways. In particular, Pseudomonas aeruginosa infects 40% of CF patients between the ages of 6 and 10 years of age. By the age of 17, the frequency of infection increases to 60% and reaches approximately 75% of all CF patients between the ages of 25 and 34.
The mucoid form of P. aeruginosa is a very challenging infection to treat due to its high resistance to both antibiotics and phagocyte-mediated killing. Once patients present with the mucoid form of P. aeruginosa, their overall lung function precipitously declines, resulting in a poor overall prognosis.
COPD is a major health problem worldwide and its prevalence is increasing (315,000,000 patients world-wide), ranked by the World Health Organization as the third leading cause of death. COPD is a general term to describe progressive lung diseases which includes chronic bronchitis, emphysema, and non-reversible asthma.
Like CF patients, people with COPD have compromised immune systems and respiratory conditions that are vulnerable to chronic bacterial infections that often resist antibiotics.
The COPD Foundation estimates that there are over 24 million people in the US that have COPD with most cases caused by inhaling pollutants, usually from smoking or exposure to lung pollutants in the workplace.
There are approximately 36,000 CF patients in the USA and the mean prevalence of CF is approximately 0.74 cases per 10,000 people among 27 European Union countries.
Arch was recently granted orphan drug designation for AB569’s active ingredients for the treatment of CF patients with chronic lung infections from both the US Food and Drug Administration and the European Medicines Agency.
About Arch Biopartners
Arch Biopartners Inc. is focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact. Arch works closely with the scientific community, universities and research institutions to advance and build the value of select preclinical technologies, develop the most promising intellectual property, and create value for its investors.
Arch has established a diverse portfolio that includes AB569, a potential new treatment for antibiotic resistant bacterial infections; MetaMx, which targets elusive brain tumor initiating cells; Metablok, a potential treatment for sepsis and cancer metastasis; and, ‘Borg’ peptide coatings that increase corrosion resistance and decrease biofilm on various medical grade metals and plastics.
For more information on Arch Biopartners, other public documents Arch has filed on SEDAR and its technologies including, please visit www.archbiopartners.com.
The Company currently has 53,849,679 common shares outstanding.
All statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management’s estimates or opinions change.
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