Scientists have demonstrated in the laboratory that a novel topical nanoemulsion kills the highly resistant strains of bacteria that cause chronic illness and death among individuals with cystic fibrosis (CF). The findings represent a new model for treating resistant bacteria that lead to pulmonary failure in patients with CF, according to the study authors.
"Respiratory tract infections are the primary cause of death in persons with cystic fibrosis, and there are simply no effective therapies for patients infected with Burkholderia (B. cepacia) and other bacterial species that are resistant to all known antibiotics," says John LiPuma, MD, professor and associate chair for research in the department of pediatrics at the University of Michigan. "The nanoemulsion we tested was bactericidal against all but two of 150 bacterial strains, regardless of their levels of resistance, and it inhibited the growth of all the strains."
During the study, the scientists applied various concentrations of NanoBio’s topical nanoemulsion to 150 multi-drug resistant and panresistant (completely resistant) bacteria obtained from the lungs of patients with CF. All strains of bacteria except two were killed by a concentration representing one-sixteenth the nanoemulsion formulation that has been used by NanoBio in recent clinical trials to treat skin infections.
"The strength of a topical or inhaled therapy is that you can achieve high local concentrations of the drug that you could never achieve with an oral systemic drug because it would cause systemic toxicity," says James R. Baker Jr., MD, founder and chairman of NanoBio Corp. "We can nebulize our nanoemulsion so that it is deposited directly into the lungs to kill these highly resistant infections that cannot be effectively treated with available antibiotics."
The nanoemulsion also demonstrated bactericidal activity in the presence of CF sputum and against bacterial biofilms, protective coatings that surround bacterial colonies and block the penetration of drugs.
NanoBio is currently conducting preclinical nebulization and toxicity studies with multiple nanoemulsion formulations. The company expects to initiate a phase 1 study in humans with CF in 2010.
Results of the study from NanoBio Corp, Ann Arbor, Mich, and the University of Michigan are published in the January issue of Antimicrobial Agents and Chemotherapy.