
In Vitro And In Vivo Efficacy Of Liposomal Ciprofloxacin Formulations Against MycAward last edited on: 9/11/13
Sponsored Program
SBIRAwarding Agency
NIH : NIAIDTotal Award Amount
$277,768Award Phase
1Solicitation Topic Code
-----Principal Investigator
James D BlanchardCompany Information
Phase I
Contract Number: 1R43AI106188-01Start Date: 8/1/13 Completed: 7/31/14
Phase I year
2013Phase I Amount
$277,768Public Health Relevance Statement:
Public Health Relevance:
Lung infections by Mycobacterium avium and Mycobacterium abscessus are increasing in incidence (1). M. avium-Mycobacterium intracellulare has become a common complication in patients with chronic lung disease, e.g., emphysema, cystic fibrosis and bronchiectasis (2). They may also give rise to severe respiratory diseases, such as bronchiectasis (3). It is also diagnosed in individuals with immune-suppression. In patients with AIDS, the M. avium infection is in the majority of the cases disseminated (12). Mycobacterium abscessus is associated with infection in patients with CF or follows M. avium infection in patients with chronic pulmonary conditions. Unfortunately, therapies for these infections often fail and the infections further compromise these patients' health. Also, a large percentage of the patients develop infections that are resistant to the available antibiotics, presumably because of inadequate concentrations at the sites of infection. There is thus a need to develop new anti-mycobacterial therapies for both diseases. The objective of this project is to test the efficacy of two new liposomal formulations of ciprofloxacin, developed specifically for inhalation to overcome the problems of systemic therapy, a) alone and b) in combination with other anti-mycobacterial agents, using in vitro and in vivo models of M. avium and M. abscessus lung infection and M. avium disseminated infection.
Project Terms:
Abscess; Acquired Immunodeficiency Syndrome; AIDS/HIV problem; Amikacin; Animals; Antibiotics; Antimycobacterial Agents; Bacteria; base; Biological Assay; Breathing; Bronchiectasis; Cefoxitin; chemotactic factor inactivator; Chronic; Chronic lung disease; Ciprofloxacin; Clarithromycin; Clinical; Clinical Research; Clinical Trials; Combined Modality Therapy; commercial application; Complication; Cyclic GMP; Cystic Fibrosis; cystic fibrosis mouse; cystic fibrosis patients; Data; Diagnosis; Disease; Dose; Drug Formulations; efficacy testing; efficacy trial; Encapsulated; Ethambutol; FDA approved; Funding; Future; Genus Mycobacterium; Health; Human; Imipenem; In Vitro; in vitro Model; in vivo; in vivo Model; Incidence; Individual; Infection; intraperitoneal; Liposomes; liquid formulation; Liver; Lung; Lung diseases; macrophage; Marketing; Measures; Microbial Biofilms; Modeling; mouse model; Mus; mycobacterial; Mycobacterium avium Complex; Mycobacterium avium-intracellulare Infection; Natural immunosuppression; Nebulizer; Oral; pathogen; patient population; Patients; Pharmaceutical Preparations; Phase; Program Development; programs; Pseudomonas aeruginosa; public health relevance; Pulmonary Emphysema; Regimen; Research; Resistance; Resistance development; Safety; Site; Small Business Innovation Research Grant; Solutions; Spleen; System; Systemic Therapy; Testing; Treatment Efficacy; Vial device
Phase II
Contract Number: ----------Start Date: 00/00/00 Completed: 00/00/00