TORONTO, ONTARIO–(Marketwired – Nov. 13, 2015) – Arch Biopartners Inc., (Arch or the Company) (TSX VENTURE:ACH)(OTCBB:FOIFF) a portfolio based biotechnology company focused on developing innovative technologies that make a significant clinical impact on patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for AB569 in the treatment of Pseudomonas aeruginosa (P. aeruginosa) pulmonary infections in patients with cystic fibrosis.
The Orphan Drug Designation has been granted for the combination of two active ingredients of AB569: sodium nitrite and ethylenediaminetetraacetic acid. AB569 is to be administered to patients as a nebulized (inhaled) solution. AB569 was invented at the University of Cincinnati in the lab of Dr. Daniel Hassett.
“This Orphan Drug Designation from the FDA supports our effort to advance AB569 as a potential treatment for P. aeruginosa lung infections in patients with cystic fibrosis,” said Richard Muruve, CEO of Arch. “The designation also complements a strong patent position for this new biocide drug treatment. We are currently finalizing the manufacturing and toxicology requirements for AB569 in order to prepare an Investigational New Drug application.”
The FDA Office of Orphan Products Development grants Orphan Drug Designation to drugs and biologics to encourage the development of new medicines for the safe and effective treatment of underserved, rare diseases or disorders that affect less than 200,000 patients in the U.S.
The Orphan Drug Designation qualifies Arch for a seven-year term of market exclusivity to sell AB569 in the U.S. following FDA approval of the drug. Additionally, as Arch takes AB569 through the regulatory and human trial process, the Orphan Drug Designation provides an accelerated review and approval process, potential grant funding, tax benefits and an exemption from certain user fees.
“AB569 has a dramatic and synergistic effect at killing P. aeruginosa both in vitro and in vivo, including antibiotic-resistant strains,” said Dr. Hassett. “The individual active ingredients of the drug have been approved as safe for use in humans in the past. Our team at the University of Cincinnati looks forward to working with Arch to advance AB569 into clinical trials for cystic fibrosis patients who urgently need more effective treatments for their P. aeruginosa respiratory infections.”
The Clinical Need for a New Treatment for P. aeruginosa Pulmonary Infections
P. aeruginosa is a significant cause of bacterial respiratory infections in patients who have cystic fibrosis (CF) or chronic obstructive pulmonary disease. It is also a common cause of pneumonia.
There are approximately 40,000 CF patients in the U.S. 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.
Thus, there is an urgent clinical need for the development of novel effective treatments in this area. AB569 constitutes an innovative potential treatment for dealing with mucoid and nonmucoid P. aeruginosa pulmonary infections that are resistant to traditional antibiotics.
CF is an autosomal recessive genetic disease that causes abnormalities of the CF transmembrane conductance regulator (CFTR) protein. CFTR is a critical regulator of sweat, digestive fluids, and mucus production.
CF 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.
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. MetaMx and AB569 are both on track to enter human clinical trials in late 2016.
For more information on the Arch Biopartners Inc., please consult the other public documents filed on SEDAR at www.sedar.com.
The Company has 53,189,679 common shares outstanding.
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