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Arch Biopartners' Lead Anti-Bacterial Drug Candidate AB569 to Enter Investigator-Sponsored Phase I Human Trial

TORONTO, ONTARIO--(Marketwired - April 13, 2017) - Arch Biopartners Inc., (Arch or the Company) (TSX VENTURE:ARCH)(OTCBB:ACHFF) a portfolio-based biotechnology company, today announced that the Cincinnati Veterans Affairs Medical Center (CVAMC) will conduct an investigator initiated Phase I human trial to evaluate the safety and pharmacokinetic profile of AB569, the Company's inhalation drug candidate for treating antibiotic-resistant bacterial infections in the lungs.

The World Health Organization has declared antibiotic resistance to be one of the biggest threats to global health and development today. According to WHO, while there are new antibiotics currently in development, none are expected to be effective against the most dangerous forms of antibiotic-resistant bacteria. The Company's AB569 is a non-antibiotic drug that could be a viable alternative or adjunct therapy to current standard of care antibiotics.

AB569 consists of two active ingredients, sodium nitrite and ethylenediaminetetraacetic acid (EDTA) that have potent, synergistic bactericidal properties. AB569 has a novel mechanism of action that differs from that of antibiotics and was invented by Dr. Daniel Hassett at the University of Cincinnati College of Medicine.

In pre-clinical studies, Dr. Hassett and his team demonstrated the potency of acidified sodium nitrite and EDTA in killing drug resistant bacteria such as Pseudomonas aeruginosa, Staphylococcus aureus, Burkholderia cepacia under both aerobic and anaerobic planktonic (free-living) and biofilm (surface-attached) conditions. These bacteria are among the most common pathogens to chronically infect the lungs of patients with chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF).

"My lab has shown AB569 to be very efficacious at killing all of the Gram-negative and Gram-positive bacteria strains we have collected over the years from numerous hospital patients, many of which are highly resistant to antibiotics. AB569 has demonstrated it can kill all of these bacteria in our in vitro studies at concentrations that do not harm human cells. Furthermore, we have discovered that none of these pathogens are capable of developing resistance to AB569," said Dr. Hassett.

Dr. Ralph Panos, Chief of Medicine at CVAMC and world-renowned COPD expert, is the lead investigator of the trial. Arch is funding the study, contributing AB569 inhalation kits and other materials to support the trial.

"This is an important trial to show clinicians that AB569 is safe for use in humans. Once we establish that, we look forward to transitioning the AB569 program into a Phase II trial at CVAMC where we can test the drug's efficacy in treating antibiotic resistant infections in the lungs of patients with COPD. Greater than 40% of patients at the CVAMC have COPD and AB569 has the potential to solve a major clinical challenge we currently face," said Dr. Panos.

Clinical investigators at the CVAMC will evaluate single administration of nebulized AB569 in normal participants. The Phase I trial has been designed to determine the pharmacokinetic profile of plasma nitrite and nitrate metabolites, exhaled nitric oxide and circulating hemoglobin after a single inhalation of AB569. In addition, the trial also aims to determine the tolerance of nebulized AB569 in three escalating doses of acidified sodium nitrite and EDTA.

"At a time where new treatments are urgently needed to kill highly problematic, antibiotic-resistant bacteria, moving AB569 into a Phase I human trial at CVAMC is a major milestone for the program and the development of Arch Biopartners," said Claude Allary, a board member of Arch.

Dr. Hassett's team has also shown the potential of AB569 to be used for treating drug resistant urinary tract infections and as an effective catheter lock solution to inhibit infection and destroy bacterial biofilms commonly observed in dialysis patients.

The Company's sponsorship of the human trial application to the Internal Review Board of CVAMC and University of Cincinnati was facilitated through the Cincinnati Education and Research for Veteran's Foundation.

As a result of the approved Phase I human trial at CVAMC, Arch has initiated the GMP manufacturing of the AB569 drug product that is required for the trial. It is expected that the Phase I trial will be ready to start once the drug kits are completed and delivered to CVAMC.

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.

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.

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.

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Press Releases 2018
December 11th 2018

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October 29th 2018

Arch Biopartners Provides Toxicology Update for Metablok

September 26th 2018

Arch Biopartners Announces Completion of GMP Manufacturing of Metablok Vials

August 14th 2018

Arch Biopartners Engages Dalton Pharma Services for GMP Manufacturing of Metablok

June 26th 2018

Arch Biopartners Receives $332,750 From the Exercise of Warrants

June 19th 2018

Arch Biopartners to Seek Regulatory Guidance From the U.S FDA for AB569

May 22nd 2018

Arch Biopartners Engages Nucro-Technics To Complete Toxicology Studies To Support Investigational New Drug Application For Metablok

May 16th 2018

Arch Biopartners Announces Listing on OTCQB Exchange

May 8th 2018

Arch Biopartners Completes Pre-IND Meeting with U.S. FDA on LSALT Peptide for Preventing Acute Kidney Injury in Cardiac Surgery Patients

March 27th 2018

Arch Biopartners Announces Issuance of U.S. Patent for Its Novel Antibacterial Drug AB569, Designed to Target Chronic Infection and Antibiotic Resistance

March 21st 2018

Arch Biopartners Granted Pre-Ind Meeting With FDA for Candidate Drug to Prevent Acute Kidney Injury

March 9th 2018

Arch Biopartners Closes $1.25M Non-Brokered Private Placement Financing

February 27th 2018

Arch Biopartners Announces Start of GMP Manufacturing for Metablok at CSBio

February 13th 2018

Arch Biopartners Announces AB569 Phase I Human Trial Begins Patient Recruitment and Enrollment Stage

Press Releases 2017
December 6th 2017

Arch Biopartners Announces Completion of GMP Manufacturing of AB569 and Start Date of Phase I Trial

November 1st 2017

Arch Biopartners Engages Nucro Technics to Begin Toxicology Studies for Metablok

October 10th 2017

Arch Biopartners Initiates Manufacturing Process for Metablok

September 28th 2017

Arch Biopartners' GMP Manufacturing of AB569 Progresses to Final Production Stage

September 12th 2017

Arch Biopartners Increases Non-Brokered Private Placement Financing

July 27th 2017

Arch Biopartners Provides Update on GMP Manufacturing of AB569

July 24th 2017

Arch Biopartners Retains Market Maker and Arranges Non Brokered Private Placement Financing

May 4th 2017

Arch Biopartners Announces Start of GMP Manufacturing for AB569 at Dalton Pharma Services

April 18th 2017

Grant of Options to Directors, Officers and Scientists

April 13th 2017

Arch Biopartners' Lead Anti-Bacterial Drug Candidate AB569 to Enter Investigator-Sponsored Phase I Human Trial

February 28th 2017

Arch Biopartners Closes Non-Brokered Private Placement Financing

February 23rd 2017

Arch Biopartners Announces TSXV Stock Ticker Symbol Change to "ARCH"

February 21st 2017

Arch Biopartners Announces Non-Brokered Private Placement Financing

Press Releases 2016
December 12th 2016

Arch Biopartners Appoints Patrick Vink to Board of Directors

October 27th 2016

Arch Biopartners Collaborates With Team at Cincinnati Veterans Affairs Medical Center to Prepare Phase I and II Human Trial Protocol and Application for AB569

October 11th 2016

Arch Biopartners Announces Issuance of U.S. Patent for Metablok

August 10th 2016

Arch Biopartners Engages Catalent to Begin Manufacturing Process for AB569

July 18th 2016

Arch Biopartners Forms Clinical and Medical Advisory Board for AB569

July 5th 2016

Arch "Borg" Peptide Coating Displays Anti Corrosion Performance on Stainless Steel

June 1st 2016

Arch Biopartners' AB569 Receives Final Approval from European Commission for Orphan Designation for Cystic Fibrosis

April 26th 2016

Arch Biopartners' AB569 Receives Positive Opinion from EMA COMP for Orphan Designation for Cystic Fibrosis

March 16th 2016

Arch Biopartners Enters Exclusive License Agreement With University of Cincinnati for AB569

March 1st 2016

Arch Scientists Publish Data on the Efficacy and Mechanism of Action of Lead Drug Candidate AB569

February 3rd 2016

Arch Biopartners Submits Orphan Drug Application for AB569 to European Medicines Agency

January 6th 2016

Arch Biopartners, McMaster Scientists, Expand MetaMx Collaboration with Mitacs Award

Press Releases 2015
December 1st 2015

Arch Biopartners Provides MetaMx Development Update

November 13th 2015

Arch Biopartners Receives Orphan Drug Designation from FDA for AB569

October 21st 2015

Arch Biopartners Retains Virtus Advisory to Provide Investor Relations Services

September 17th 2015

Arch Biopartners: AB569 Successfully Completes Pre-Clinical Validation Studies

August 5th 2015

Arch Biopartners Announces Issuance of U.S. Patent for Brain Tumor Targeting Peptides

August 4th 2015

Arch Biopartners Announces Issuance of a Second U.S. Patent for Peptide Solid Surface Interface

July 23rd 2015

Arch Scientists Use 'BORG' Peptides to Improve Biocompatibilty of Polysulfone for Use in Dialysis

June 8th 2015

Dr. Sheila Singh, MD PhD. Joins Arch Biopartners as Medical and Clincial Advisor

April 1st 2015

Arch Biopartners 2015 AGM Results and Technology Status Update

March 18th 2015

Arch Biopartners Identifies Candidate Drug to Treat Psuedomonas Respiratory Infections

February 25th 2015

Arch Biopartners Announces Issuance of U.S. Patent for Peptide Solid Surface Interface

February 19th 2015

Arch Biopartners Receives Final Approval to List on TSX Venture Exchange

January 26th 2015

Arch Biopartners Completes Private Placement

January 16th 2015

Arch Biopartners Receives Conditional Approval for Listing on TSXV

January 6th 2015

Arch Biopartners Announces Private Placement

Press Releases 2014
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Arch Biopartners Completes Clinical Development Plan for MetaMx

October 15th 2014

Arch Biopartners Introduces Metablok, a Novel Therapeutic Candidate for Blocking Sepsis, Cancer Metastasis

August 21st 2014

Arch Biopartners Appoints Adrian Haigh to Board of Directors

May 29th 2014

Arch Biopartners Hires d3 Medicine to Develop a Human Trial for Brain Tumor Targeting Technology

April 17th 2014

Arch Biopartners Appoints Claude Allary to Board of Directors

March 28th 2014

Arch Biopartners Enters Option to License University of Cincinnati Patent for Treating Bacterial Respiratory Infections

March 12th 2014

Arch Biopartners Announcement

February 25th 2014

Arch Biopartners Completes Private Placement and Receives NRC Funding

Press Releases 2013
November 20th 2013

Brain Tumor Cell Targeting Technology: Data to Be Presented at the Society of Neuro-Oncology Quadrennial Meeting

September 17th 2013

Arch Biopartners Appoints Former Roche Executives Patrick Smith and Craig Rayner as Drug Development Advisors

September 12th 2013

Arch Biopartners Announces Issuance of U.S. Patent for Brain Tumor Cell Targeting Technology

August 14th 2013

Arch Biopartners Joins the Life Sciences Canadian Technology Accelerator in San Francisco

June 6th 2013

Arch Biopartners Announces Issuance of Additional U.S. Patent for Biofilm Inhibitor

April 22nd 2013

Brain Tumour Targeting Team Awarded Additional Funding

April 3rd 2013

Arch Scientists Publish Data Linking Inflammatory Enzymes to Inflammatory Bowel Disease

April 1st 2013

Arch Biopartners Announces Shareholder Approval to Allow Listing to Move to New Exchange

Press Releases 2012
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Arch Scientists Publish New Stainless Steel Anti Corrosion and Biofilm Data

October 18th 2012

Dr. Julia Liu to Present at American College of Gastroenterology Annual Meeting Oct 22, 2012

September 6th 2012

Arch Biopartners Enters Option to Acquire Irritable Bowel Syndrome Diagnostic Technology

August 21st 2012

Arch Scientists Successfully Image Brain Tumour Initiating Cells Using MRI

March 15th 2012

Arch Awarded Funding from the Government of Canada to Develop Brain Tumour Targeting Technology

February 28th 2012

Arch Scientists to Lead Anti Corrosion Project for Auto Industry

January 24th 2012

Arch Biopartners Appoints Claude Allary as Special Advisor

Press Releases 2011
December 19th 2011

Arch Scientists Inhibit Biofilm Formation and Increase Hardness on Titantium

November 7th 2011

Arch Biopartners Engages Intertek Cantox to Devise Drug Development Plan for Lead Cancer Compound

September 7th 2011

Arch Biopartners Identify Lead Compound for Pancreatic Cancer and Non Small Cell Lung Cancer

July 18th 2011

Arch Biopartners Hires Investor Relations Firm

July 14th 2011

Arch Biopartners Announces Issuance of New U.S. Patent for Biofilm Inhibitor

July 6th 2011

Arch Biopartners, U of Calgary Extend Agreement

June 27th 2011

Arch Biopartners Enters Agreement to Develop Prototype Diagnostic Imaging Agents for Brain Tumor Stem Cells

June 23rd 2011

Arch Biopartners Scientists Awarded Funding to Further Develop Brain Tumour Targeting Technology

May 24th 2011

Arch Scientists to Present at ESF-LFUI Conference in Austria

May 10th 2011

Arch Scientists Create New Bio-Organic Metal That Is Harder, Resists Corrosion

April 11th 2011

Arch Cancer Therapeutics' Technology Update

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