TORONTO, ONTARIO–(Marketwired – March 1, 2016) – Arch Biopartners Inc (Arch) or (the Company) (TSX VENTURE:ACH)(OTCBB:FOIFF) announced today that Dr. Daniel Hassett’s team at the University of Cincinnati College of Medicine, and its collaborators, have published details regarding the efficacy of AB569 in killing the pathogenic bacterium Pseudomonas aeruginosa (P. aeruginosa) in the peer-reviewed journal Frontiers in Microbiology. The findings indicate that low doses of acidified nitrite and EDTA (active ingredients of AB569) are highly effective at killing P. aeruginosa. In addition, the article provides information on the drug’s mechanism of action.
The published data show that treatment of P. aeruginosa with acidified nitrite plus EDTA had the most dramatic and synergistic effect, with virtually all bacteria killed by 25 mM (aerobic), 15 mM (anaerobic) acidified nitrite and EDTA (1mM, aerobic, anaerobic) at pH 6.5 (pH of the CF airway mucus), respectively.
“Our findings indicate the synergistic killing effect of acidified nitrite and EDTA on P. aeruginosa is so strong at lower doses that we expect no adverse toxicology effects once we test AB569 in a future human trial involving cystic fibrosis (CF) patients with chronic P. aeruginosa lung infections,” said Dr. Hassett, Professor, Department of Molecular Genetics, Biochemistry and Microbiology, University of Cincinnati College of Medicine.
“Many patients grow bacteria that are not easily treated with currently available antibiotics,” said Dr. Patricia Joseph, Professor of Medicine and Director of the Adult CF Program at the University of Cincinnati College of Medicine. “As bacteria evolve to become antibiotic-resistant (often termed “super-bugs”), we are entering the “post-antibiotic” era of infection management. As a result, CF investigators are looking for alternative treatment options to help control the lung infections that eventually destroy lung tissue and result in death for patients with CF. AB569, which combines acidified sodium nitrite with EDTA, has the potential to be such a therapy. The ability to kill highly problematic bacteria such as P. aeruginosa without evidence of injury to lung tissue is extremely exciting. This is true, not just for CF, but for other lung infections such as chronic obstructive pulmonary disease (COPD).”
Details of these findings are reported in the journal Frontiers in Microbiology. The publication, titled “A Putative ABC Transporter Permease is Necessary for Resistance to Acidified Nitrite and EDTA in Pseudomonas aeruginosa Under Aerobic, Anaerobic, Planktonic or Biofilm Conditions” by McDaniel et. al. can be found at http://journal.frontiersin.org/article/10.3389/fmicb.2016.00291/abstract . The paper demonstrates key data on the synergistic effects of acidified nitrite and EDTA (active ingredients of AB569) on destroying P. aeruginosa as well as identifying bacterial properties that confer susceptibility to the drug.
The Company has an exclusive option to license AB569 from the University of Cincinnati.
Orphan Drug Designation for AB569 (sodium nitrite and EDTA)
In November 2015, the U.S. F.D.A. granted orphan drug designation for the combination of the two active ingredients of AB569, sodium nitrite and ethylenediaminetetraacetic acid (EDTA), for the treatment of P. aeruginosa lung infections in patients with CF. AB569 is to be administered to patients as a nebulized (inhaled) solution.
Earlier this month, Arch submitted an orphan drug application for AB569 to the European Medicines Authority. The Company was notified by the EMA on February 22nd that its application has been validated and is now under review. The review period for the application is expected to end in late May, 2016.
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 mean prevalence of CF 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.
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.
Cystic Fibrosis
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 or early 2017.
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.
Forward-Looking Statements
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
