Novexel Reports Positive Phase II Trial Results With NXL103 in Adult Patients With Community Acquired... ( PARIS October 23 /- Novexel a spe...)

Novexel Reports Positive Phase II Trial Results With NXL103 in Adult Patients With Community Acquired Pneumonia

Date:10/23/2008

PARIS, October 23 /PRNewswire/ -- Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial resistance, announces positive results from its Phase II clinical trial evaluating NXL103 in the treatment of community acquired pneumonia (CAP). NXL103 is a novel oral streptogramin antibiotic that has potent in vitro activity against certain Gram positive bacteria including methicillin resistant Staphylococcus aureus (MRSA) as well as the important respiratory pathogens including penicillin, macrolide and quinolone resistant strains.

The NXL103 Phase II study was a double-blind, multinational, randomized, comparative study that evaluated this novel oral antibacterial as a treatment for mild to moderate CAP. The study recruited 300 adult patients in 9 countries in both the Northern and Southern hemispheres. Patients were randomised (1:1:1) to three treatment arms: 500mg of NXL103 twice a day, 600mg NXL103 twice a day or 1,000 mg of amoxicillin three times a day for 7 days. The key endpoints of the study were the clinical outcome in the clinically evaluable population at the early follow-up visit (7 to 14 days post-therapy) and safety. In this study, both doses of NXL103 were effective, with clinical response rates similar to those seen in the amoxicillin group. For the primary efficacy analysis, response rates were 91.4% in the 500mg NXL103 group; 94.7% in the 600mg NXL103 group; and 88.5% in the amoxicillin group. NXL103 was generally well tolerated with the most frequent adverse events related to gastrointestinal intolerance. There were no serious drug-related adverse events reported in the study.

The complete results from this Phase II trial will be published in the first half of 2009.

NXL103 has a spectrum of activity that indicates it has the potential to be effective in the treatment of skin and skin structure infections, includi
'/>"/>

0

GOOD

Page: 1 2 3
Related medicine technology :

1. Genmab A/S - Company Announcement: Genmab Reports Results of Portfolio
2. Genaera Corporation Reports Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting
3. Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien(TM) Study
4. BioView Reports Interim Results of Early Detection Lung Cancer Diagnostic Test
5. Bioheart Reports Promising Results From Preclinical Study of Adipose-Derived Acute Cell Therapy
6. MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes
7. Bionovo Reports on Metabolic Studies Related to Its Menopausal Hot Flash Drug Candidate
8. Nutrition 21 Reports That National Toxicology Program Studies Support the Safety of Chromium Picolinate
9. Human Genome Sciences Reports Initial Results of Randomized Phase 2 Trial of HGS-ETR1 in Combination With Bortezomib in Advanced Multiple Myeloma
10. Regado Biosciences Reports Clinical Results for REG1 Anticoagulation System at European Society of Cardiology Congress 2008
11. Algeta Reports Positive Headline Phase II Data on Pain Palliation With Alpharadin

Post Your Comments:

Novexel Reports Positive Phase II Trial Results With NXL103 in Adult Patients With Community Acquired...( PARIS October 23 /- Novexel a spe...),Health