02/10/2015 TGV-THERAPEUTICS INITIATES PILOT STUDY OF MUL-1867 IN CYSTIC FIBROSIS PATIENTS INFECTED WITH BURKHOLDERIA CEPACIA

New York, NY, February 10, 2015.  TGV-Therapeutics today announced the initiation of a  pilot-study of Mul-1867 in cystic fibrosis patients infected with Burkholderia cepacia.  The study will explore the efficacy of 0.2% nebulized Mul-1867, in 10 cystic fibrosis patients who did not respond to antibiotic therapy (tobramycin, aztreonam). The treatment regimen consisted of aerosolized Mul-1867, two times daily for 28 days. The patients will be evaluated at day 0 (the start of the first period of drug administration), day 7, day 14 and day 28.

About Burkholderia cepacia in Cystic Fibrosis

Burkholderia cepacia lung infection is characterized by severe progressive respiratory failure, necrotizing pneumonia, and B.cepacia bacteremia. For In the last decades B.cepacia has been recognized as a significant cystic fibrosis-associated airway pathogen that causes considerable morbidity in affected patients. The prevalence of B.cepacia colonization ranges from 4 up to 7% but despite the relatively small proportion of patients with CF infected with B.cepacia the organism has a major impact on CF morbidity and mortality.  Most Burkholderia cepacia strains are resistant to many, or all, of the antibacterial agents commonly used in cystic fibrosis, and selection of appropriate antibiotics for treatment of pulmonary exacerbations is therefore difficult.

TGV-Therapeuticals is an innovative new pharmaceutical company developing novel pulmonary drugs. TGV Therapeutics’ lead product is Mul-1867-CF (novel drug candidate), the first inhaled antimicrobial being developed against multidrug-resistant bacteria and fungi in cystic fibrosis patients.