Arch Biopartners' AB569 Receives Positive Opinion from EMA COMP for Orphan Designation for Cystic Fibrosis
TORONTO, ONTARIO--(Marketwired - April 26, 2016) - Arch Biopartners Inc. (Arch or the Company) (TSX VENTURE:ACH)(OTCBB:FOIFF), a portfolio based biotechnology company, today announced the European Medicines Authority (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending AB569 for designation as an orphan medicinal product for the treatment of patients with cystic fibrosis (CF).
The orphan medicinal products designation is recommended for the two active ingredients of AB569, sodium nitrite and ethylenediaminetetraacetic acid (EDTA). AB569 was invented by Dr. Daniel Hassett at the University of Cincinnati College of Medicine to treat antibiotic resistant bacterial lung infections, which is a significant problem for patients with CF. "This very positive development will serve to accelerate our transition into CF clinical trials that are already planned at the University of Cincinnati and Cincinnati Children's Hospital," said Dr. Hassett.
"The positive opinion by the COMP in favour of orphan medicinal status for the treatment of CF is indicative of the clinical need to combat antibiotic resistant airway infections often found in CF patients," said Dr. Daniel Muruve, Chief Science Officer of Arch.
The COMP's positive opinion will be forwarded to the European Commission (EC) for final approval of the orphan designation for AB569, expected to be completed in the next few weeks.
The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug Designation for AB569 in the treatment of antibiotic resistant Pseudomonasaeruginosa (P. aeruginosa) pulmonary infections in patients with CF.
Arch has recently arranged the manufacturing and toxicology program for AB569 and plans to submit an investigational new drug application to the FDA in the second half of 2016.
The Need for a New Treatment for P. aeruginosa Pulmonary Infections in CF patients
P. aeruginosa is a significant cause of bacterial respiratory infections in patients who have cystic fibrosis or chronic obstructive pulmonary disease (COPD). It is also a common cause of pneumonia.
Cystic fibrosis patients are predisposed to lung infections due to abnormal mucus production in the lungs and airways. P. 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 mean prevalence of cystic fibrosis is approximately 0.74 cases per 10,000 people among 27 European Union countries, which is well below the defined limit for a rare or orphan disease. The mucoid form of P. aeruginosa, often found in CF patients, 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 prognosis. AB569 constitutes an innovative potential treatment for dealing with mucoid and nonmucoid P. aeruginosa pulmonary infections that are resistant to traditional antibiotics.
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 MetaMx, which targets illusive brain tumor initiating cells; AB569, a potential new treatment for Pseudomonas aeruginosa pulmonary infections; and, Metablok, a potential treatment for sepsis and cancer metastasis.
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 has 53,189,679 common shares outstanding.
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