TORONTO, ONTARIO–(Marketwired – March 28, 2014) – Arch Biopartners Inc (Arch) or (the Company) (CSE:ACH)(OTCBB:FOIFF) announced today it has entered into a one year option agreement with the University of Cincinnati (UC) to exclusively license the commercial rights to a U.S.
Patent for treating bacterial respiratory infections using acidified nitrite. This technology was invented by UC Professor, Dr. Daniel Hassett.
During the option period, Arch and Dr. Hassett’s team within the UC network will assess the potential and logistics of conducting a Phase II clinical trial to test the technology’s efficacy in treating bacterial respiratory infections that are resistant to antibiotics.
Two deadly diseases, cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD), are characterized by airway bacterial infections that significantly impact the overall quality of patient’s lives. There are approximately 40,000 CF patients and some 14.2 million individuals diagnosed with COPD in the United States. In both diseases, the Gram-negative bacterium, Pseudomonas aeruginosa (PA), constitutes a significant and problematic cause of the pulmonary exacerbations that result in frequent hospitalizations of these patients.
In particular, the mucoid form of PA 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 PA, 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. The technology developed by Dr. Hassett constitutes an innovative, non-antibiotic method for dealing with mucoid PA infections where the emergence of resistance is highly unlikely.
As a result, the first phase II human trial Arch and Dr. Hassett’s team are considering is one that tests the technology’s efficacy in destroying mucoid PA in CF patients.
Following a successful trial with CF patients, the next objective will be to test the technology in a phase II study involving COPD patients.
Phase I Clinical Work Done to Date
In Phase 1 human studies of over 80 healthy volunteers, the drug was safe at, or below, the maximal tolerated dose. In both single dose and multiple ascending dose studies for up to one week, the only adverse events were a drop in systemic blood pressure, dizziness and methemoglobinemia (methemoglobin was less than 5% of hemoglobin). Fourteen pulmonary arterial hypertension (PAH) patients, including three that have completed at least 16 weeks of dosing up to 4 times per day, had no significant adverse events.
From a human use standpoint, the drug has no adverse effects on human airway epithelial cells at concentrations up to 300 millimolar, 20 times higher than the dose needed to kill mucoid PA.
About Dr. Daniel Hassett
Dr. Hassett is a Professor in the Department of Molecular Genetics, Biochemistry and Microbiology at the University of Cincinnati College of Medicine. As an expert in bacterial pathogenesis he has been working with the major CF pathogens including PA, Staphylococcus aureus and Burkholderia cepacia. He has over 130 published manuscripts.
In 2006, he discovered that anaerobic, acidified sodium nitrite (A-NO2-) (i) killed mucoid PA in refractory communities known as biofilms, (ii) in a mouse model of PA chronic infection and (iii) in airway surface liquid derived from a CF lung transplant patient. The results of his studies were published in the prestigious Journal of Clinical Investigation.
Dr. Hassett and the University of Cincinnati were issued a patent by the US Patent and Trademark Office on October 15, 2013 (US Patent #8,557,300). The A-NO2- translational approach for the treatment of mucoid PA is also effective at killing methicillin resistant Staphylococcus aureus and Burkholderia cepacia.
About Arch Biopartners
Arch Biopartners is a portfolio based biotechnology company established to develop new products and technology for sale to pharmaceutical and industrial companies. The Company’s website address is: www.archbiopartners.com.
For more information on the Company, please consult the other public documents filed on SEDAR at www.sedar.com.
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