TORONTO, ONTARIO–(Marketwired – May 4, 2017) – Arch Biopartners, Inc., (Arch or the Company) (TSX VENTURE:ARCH)(OTCBB:ACHFF) a portfolio-based biotechnology company, today announced Dalton Pharma Services (Dalton) has launched the good manufacturing practice (GMP) campaign for AB569, the Company’s inhalation drug candidate for treating antibiotic-resistant bacterial infections in the lungs.
Dalton will be responsible for the GMP preparation and filling of AB569 into glass vials. These vials will then form part of the clinical kits required to support the phase I safety trial for AB569 at the Cincinnati Veterans Affairs Medical Center (CVAMC) later this year.
Catalent Inhalation, a division of Catalent Pharma Solutions, (Catalent) previously completed the initial stability and formulation studies for AB569, which were both important production milestones in preparing a GMP pharmaceutical product for human trials and eventual drug approval by the U.S. Food and Drug Administration and other health authorities.
Catalent will continue to be involved in the final testing of the GMP supply of AB569 once the vial filling is completed by Dalton to enable the release of the final drug product. As these tasks near completion, Arch management expects to provide updates regarding the expected delivery time of the drug product to CVAMC to enable the start of the phase I safety trial.
Notes for Editors
About AB569 and Anti-biotic resistant airway infections in COPD and CF patients
AB569 was invented by Dr. Daniel Hassett, Professor at the University of Cincinnati College of Medicine, to treat antibiotic resistant bacterial lung infections, which is a significant problem for patients with either CF or COPD. AB569 is also a candidate treatment for antibiotic resistant urinary tract infections, skin infections and as a catheter lock solution. The University of Cincinnati has exclusively licensed AB569 to Arch.
AB569, as a bactericidal compound, constitutes an innovative potential treatment for dealing with pulmonary bacterial infections, some of which are resistant to all 26 approved antibiotics in the United State alone. In pre-clinical studies, AB569 has demonstrated significant ability to kill many types of Gram-negative and Gram-positive bacteria.
Arch has received orphan drug designation for AB569 from the U.S. Food and Drug Administration for the treatment of CF patients with Pseudomonas aeruginosa infections. Arch has also received an orphan medicinal product designation from the European Medicines Agency for the treatment of CF patients.
CF patients are predisposed to bacterial lung infections due to abnormal mucus production in the lungs and airways. In particular, Pseudomonas 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 mucoid form of P. aeruginosa 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 overall clinical prognosis.
Like CF patients, people with COPD have compromised innate immune systems and respiratory conditions that are vulnerable to chronic bacterial infections that are often refractory to conventional antibiotic regimens.
COPD is a major health problem worldwide and its prevalence is increasing (over 325,000,000 patients world-wide), ranked by the World Health Organization as the third leading cause of death. COPD is a general term to describe progressive lung diseases which includes chronic bronchitis, emphysema, and non-reversible asthma. Most cases are caused by inhaling pollutants, predominantly from smoking or exposure to lung pollutants in highly polluted cities around the world as well as the workplace.
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved and FDA registered cGMP contract service provider of integrated chemistry, drug development and manufacturing services to the pharmaceutical and biotechnology industries. Dalton brings 30 years of experience to their client’s projects and emphasize quality, speed and flexibility.
Dalton can accelerate a drug development program by integrating process development, cGMP API manufacturing and sterile or solid finished dose manufacturing all at a single location. For Dalton’s full range of in-house services including cGMP sterile fill/finish services please visit www.dalton.com.
CMO 2016 and 2017 Leadership Awards in the categories of Quality, Reliability, Capabilities, Expertise, Compatibility and Development from Life Science Leader reflects Dalton’s ongoing commitment to their clients, peers and the business community. In 2016 Dalton was certified as “A Great Place to Work.”
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, other public documents Arch has filed on SEDAR and its technologies including, please visit www.archbiopartners.com.
The Company has 54,849,679 common shares outstanding.
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.
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