Therapy for Reducing P. Aeruginosa Lung Infections Planned Phase 1 Trial

Arch Biopartners recently completed a good manufacturing practice (GMP) production campaign for AB569, a potential inhalation treatment for antibiotic-resistant bacterial lung infections in people with cystic fibrosis (CF) chronic obstructive pulmonary disease (COPD) and other conditions. The campaign, intended to ensure the quality of the investigative therapy, was directed by Dalton Pharma Services.

AB569 is composed of ethylenediaminetetraacetic acid (EDTA) and sodium nitrite, two compounds approved by the U.S. Food and Drug Administration (FDA) for use in people. AB569 can be administered alone or in combination with other compounds to treat multi-drug resistant bacterial infections that can cause reduced lung function.

Pseudomonas aeruginosa is one of the most common bacterial infections in patients with respiratory diseases, including CF, COPD, and pneumonia.

In preclinical studies, AB569 was shown to be capable of killing drug-resistant bacteria like P. aeruginosa and other common pathogens associated with chronic lung infections.

The company also announced that a Phase 1 clinical trial to investigate the safety and pharmacokinetic profile of AB569, planned to start in January, will be conducted at the Cincinnati Veterans Affairs Medical Center (CVAMC). According to an Arch Biopartners press release, Ralph Panos, chief of medicine at CVAMC, will lead the trial.

Three escalating doses of nebulized AB569 will be used to evaluate tolerance to the treatment in about 25 healthy volunteers. Each will be given a single administration of nebulized AB569  to characterize the pharmacokinetic profile of plasma nitrite and nitrate metabolites, exhaled nitric oxide, and circulating hemoglobin.

Pharmacokinetics studies how a drug is absorbed, distributed and metabolized in, and expelled by, the body.

Should the Phase 1 trial in volunteers be successful, Arch Biopartners plans to move its AB569 program into a Phase 2 trial to test its effectiveness in treating chronic P.aeruginosa infections in COPD patients.

AB569 received orphan drug status by the FDA in November 2015 as a potential treatment of P. aeruginosa lung infections in CF patients. Orphan drug status is given to investigative medicines intended for people with rare diseases to speed their development and testing.

Original article: https://cysticfibrosisnewstoday.com/2017/12/12/arch-biopartners-readies-ab569-potential-treatment-for-cf-copd-lung-infections-for-phase-1-trial/

Pushing the envelope promising for patients

http://www.theherald.com.au/story/4762046/pushing-the-envelope-promising-for-patients/

A HUNTER-based fitness study looking at the effects of interval training on children with cystic fibrosis is achieving some “outstanding” results, a local exercise physiologist says. Continue reading Pushing the envelope promising for patients

Cystic Fibrosis Step by Step: Organizational Needs

Because CF has so many moving parts, it is important to keep all medications and treatments organized.
https://www.youtube.com/watch?v=ILS28TW5Hrs&feature=youtu.be

To read Gunnar’s blog, please visit www.gunnaresiason.com. Continue reading Cystic Fibrosis Step by Step: Organizational Needs

Cystic Fibrosis Patients Shouldn’t Skip Supplements

http://www.pharmacytimes.com/

Improved diagnosis and treatment has extended cystic fibrosis (CF) patients’ life expectancy into adulthood. Continue reading Cystic Fibrosis Patients Shouldn’t Skip Supplements

PEP Devices Can Help Reduce CF Pulmonary Flare-ups, Review Finds

http://cysticfibrosisnewstoday.com/2015/12/30/pep-devices-can-help-reduce-cf-pulmonary-flare-ups-review-finds/

From Cystic Fibrosis News Today
By Malika Ammam, PhD

A review study suggests that positive expiratory pressure (PEP) devices are more effective than other airway clearance approaches in reducing pulmonary exacerbations in patients Continue reading PEP Devices Can Help Reduce CF Pulmonary Flare-ups, Review Finds

Cystic Fibrosis Phase 2 Trial of Drug Aiming to Stabilize Key CF Gene Underway

http://cysticfibrosisnewstoday.com/2015/12/02/cystic-fibrosis-phase-2-trial-drug-aiming-stabilize-key-cf-gene-underway/

Published originally in Cystic Fibrosis News Today
By Charles Moore

Nivalis Therapeutics, Inc., a Boulder, Colorado-based clinical stage pharmaceutical company, announced that the first patient has been dosed in the Phase 2 clinical trial of its lead investigational drug, N91115, a stabilizer Continue reading Cystic Fibrosis Phase 2 Trial of Drug Aiming to Stabilize Key CF Gene Underway

Scripps scientists find protein flaw in cystic fibrosis

Just like some people talk too much and hang out with the wrong crowd, a mutant protein responsible for most cases of cystic fibrosis acts similarly, scientists at The Scripps Research Institute reported Monday.
The cystic fibrosis transmembrane conductance regulator protein is so busy Continue reading Scripps scientists find protein flaw in cystic fibrosis

Arch Biopartners Receives Orphan Drug Designation from FDA for AB569

Arch Biopartners Inc., 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 Continue reading Arch Biopartners Receives Orphan Drug Designation from FDA for AB569

Corbus Pharmaceuticals Announces First Patient Dosed in Phase 2 Study of Resunab(TM) for Treatment of Cystic Fibrosis

Corbus Pharmaceuticals Holdings, Inc. CRBP, +4.60% (“Corbus” or the “Company”), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that the first Continue reading Corbus Pharmaceuticals Announces First Patient Dosed in Phase 2 Study of Resunab(TM) for Treatment of Cystic Fibrosis