Aradigm Corp. (ARDM) Receives NIH Grant To Study Pulmaquin, Lipoquin As Treatment Of Pulmonary Non-Tuberculosis Mycobacterial Infections

Aug. 05, 2013 10:44 AM ETARDM
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Aradigm, a specialty pharmaceutical company focused on developing and commercializing a portfolio of drugs for the treatment of severe respiratory diseases, has been awarded a Small Business Initiative Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH).

The $278,000 grant was awarded to assist Aradigm in the investigation of the treatment of pulmonary non-tuberculous mycobacteria (PNTM) infections with the company's inhaled liposomal ciprofloxacin products, Pulmaquin® and Lipoquin®. The principal investigator is Dr. James D. Blanchard, principal scientist of Preclinical Development at Aradigm. Dr. Luiz Bermudez at the Oregon State University, Corvallis, will lead the laboratory research as a part of the consortium.

"I am very pleased that the National Institutes of Health recognized the potential of our therapeutic approach to become an effective tool to help patients with PNTM infections, a severe chronic respiratory condition that is a growing concern in the U.S. and other countries," Igor Gonda, president and CEO of Aradigm stated in the press release. "I congratulate Drs. Bermudez and Blanchard on the award that will enable them to leverage the synergies of world class scientists from Oregon State University and Aradigm. We already have a substantial amount of safety information in animal models and humans, as well as efficacy in other infections for Pulmaquin and Lipoquin. This one-year consortium program is an essential prerequisite for entry into advanced human clinical trials in patients with PNTM."

PNTM infections are a significant and rising cause of morbidity among older adults in the United States. The current clinical paradigm is to treat patients with lung or disseminated disease with combination therapy given orally or intravenously, therapies that Aradigm says often fail.

Pulmaquin has undergone preclinical tests and the ORBIT-2 phase 2b bronchiectasis study, in which outstanding antimicrobial activity and good safety and tolerability were found; the positive impact on prevention of exacerbations compared to placebo was also observed. Aradigm is currently finalizing plans to initiate the phase 3 clinical program in BE with Pulmaquin. Aradigm previously reported positive results in phase 2a studies of Lipoquin.

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