TORONTO, ONTARIO–(Marketwired – Oct. 27, 2016) – Arch Biopartners, Inc., (Arch or the Company) (TSX VENTURE:ACH)(OTCBB:FOIFF) today announced it has agreed to sponsor Dr. Ralph Panos and his clinical trial team at the Cincinnati Veterans Affairs Medical Center (CVAMC) to prepare a phase I and phase II human trial protocol and an application to conduct investigator initiated trials evaluating the safety and efficacy of AB569.
“We are excited to support Dr. Panos and his team to prepare an application to perform the first human trials for AB569, which we believe will validate the clinical potential of AB569 and may provide an accelerated route toward a New Drug Application with the FDA,” said Richard Muruve, CEO of Arch.
Under the terms of the agreement, which was facilitated through the Cincinnati Education and Research for Veteran’s Foundation, Dr. Panos will draft the clinical trial protocol (“Protocol”) for phase I and II human trials.
Once completed, the Protocol will form part of an application to conduct an investigator initiated trial at CVAMC with Dr. Panos as the principal investigator. The application is expected to be submitted to the internal review board (IRB) of the CVAMC by December, 2016. IRB feedback is anticipated before January, 2017 and the trial is expected to start immediately upon an approval to proceed. Once the Phase I clinical trial is completed with positive safety results, the study will immediately transition to a Phase II clinical trial of AB569 in patients with chronic obstructive pulmonary disease (COPD) that have severe bacterial lung infections that are resistant to antibiotics.
Separately, Catalent Pharma Solutions in North Carolina continues to make preparations at its facilities to provide a GMP supply of AB569 which is expected to be ready for clinical trial purposes by January, 2017.
Notes for Editors
Dr. Ralph J. Panos, MD, Chief of Medicine, Cincinnati Veterans Affairs Medical Center – Dr. Panos is the Chief of Medicine and Medical Director of the Veterans Integrated Service Network 10 TeleICU Program at the Cincinnati Veterans Affairs Medical Center. 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.
He has worked at the CVAMC 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.
Dr. Panos has been engaged in pulmonary and critical care research from both basic science and clinical perspectives for approximately 20 years and has been involved extensively in clinical studies of COPD for the past 5 years. His clinical trial team has performed a series of clinical investigations that characterize the population of Veterans with COPD at the CVAMC and these studies led to the development and funding of an innovative, comprehensive COPD management program at the CVAMC. In addition, Dr. Panos’s clinic has been a center for NIH (LOTT), VA (Breath), and industry sponsored trials in COPD with a very successful history of study recruitment and enrollment.
About AB569 and Anti-biotic resistant airway infections in COPD and CF patients
AB569 was invented by Dr. Daniel Hassett, Professor at the University of Cincinnati College of Medicine, to treat antibiotic resistant bacterial lung infections, which is a significant problem for patients with either cystic fibrosis (“CF”) or COPD. AB569 is also a candidate treatment for antibiotic resistant urinary tract infections, gastrointestinal infections and skin infections. AB569 has been exclusively licensed to Arch by the University of Cincinnati.
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.
Like CF patients, people with COPD have compromised immune systems and respiratory conditions that are vulnerable to chronic bacterial infections that often resist antibiotics.
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. Most cases are caused by inhaling pollutants, usually from smoking or exposure to lung pollutants in the workplace.
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; Metablok, a potential treatment for sepsis and cancer metastasis; MetaMx, which targets elusive brain tumor initiating cells; 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.
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