Arch Biopartners Announces AB569 Phase I Human Trial Begins Patient Recruitment and Enrollment Stage
- Category: Small Molecules
- Published on Tuesday, 13 February 2018 17:31
- Hits: 586
TORONTO, Canada I February 13, 2018 I Arch Biopartners Inc., (Arch or the Company) (TSX Venture:ARCH) (OTCBB:ACHFF) a portfolio based biotechnology company, announced today the investigator initiated phase I human trial for AB569 at the Cincinnati Veterans Affairs Medical Center (CVAMC) is now actively recruiting and enrolling healthy volunteers, after AB569 inhalation drug kits made for the human trial were delivered to CVAMC in January.
AB569 is the Company’s inhalation drug candidate for treating antibiotic-resistant bacterial infections in the lungs of cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) patients as well as many other indications. The drug was invented by Dr. Daniel Hassett, Professor of Molecular Genetic, Biochemistry and Microbiology at the University of Cincinnati College of Medicine.
“This phase I trial to evaluate the safety and pharmacokinetic profile of AB569 at CVAMC is an important first step to establish AB569 as a non-antibiotic drug candidate for treating drug resistant bacterial infections in the lung. AB569’s clinical impact in subsequent phase II trials will depend on AB569’s safety profile in this first-in-human study at CVAMC,” said Dr. Ralph Panos, Chief of Medicine at CVAMC and lead investigator of the AB569 trial.
AB569 is a potential stand alone or complementary treatment to existing and emerging standard of care therapies for CF and COPD patients that have reduced lung function due to multi-drug resistant bacterial infections.
AB569 is mainly composed of two compounds: ethylenediaminetetraacetic acid (EDTA) and sodium nitrite, which are already approved by the U.S. Food and Drug Administration (FDA) for use in humans in other medical applications. In pre-clinical studies, AB569 has demonstrated significant ability to kill many types of Gram-negative and Gram-positive bacteria and to disperse bacterial biofilms.
Dr. Panos’ clinical research team will evaluate single administration of nebulized AB569 in up to 25 normal, healthy participants. The Phase I trial has been designed to determine the pharmacokinetic profile of plasma nitrite and nitrate metabolites, exhaled nitric oxide and circulating hemoglobin after a single inhalation of AB569. In addition, the trial also aims to determine the tolerance of nebulized AB569 in three escalating doses of acidified sodium nitrite and EDTA.
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 inflammation, 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, its technologies and other public documents Arch has filed on SEDAR, please visit www.archbiopartners.com
SOURCE: Arch Biopartners