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Novexel Starts Phase II Clinical Trial With NXL103 in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Date:11/6/2009

be identified in ABSSSI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of MRSA in community as well as hospital acquired infections has resulted in a need for empirical therapy of ABSSSI that is effective against MRSA.

About Novexel

Novexel is a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial resistance. The ever increasing resistance to marketed antibiotics has led to a clear need for novel drugs that are active against multi-drug resistant bacteria. Novexel's products are targeting the global hospital antibiotic market, which was worth an estimated $17bn in 2008.(1)

In addition to NXL103, Novexel is currently conducting two Phase II studies with NXL104 in combination with the cephalosporin antibiotic ceftazidime (CAZ/104) for serious Gram-negative infections. Patient recruitment in those studies (a) with complicated intra-abdominal infections (cIAIs) and (b) with complicated urinary tract infections (cUTIs) is nearing completion with the results expected in the first half of 2010.

A recent technical report from the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA) entitled "The bacterial challenge: time to react,"(2) voiced the need to narrow the gap between multi-resistant bacteria in the EU and the development of new antibacterial agents. In particular the report highlighted the growing problem of infections caused by multi-resistant Gram negative bacteria including Pseudomonas aeruginosa. These are the types of infections that Novexel is targeting with CAZ/104.

Novexel has three further programmes in preclinical development, NXL105, a novel anti-Pseudomonal antibiotic, NXL201, a novel echinocandin antifungal agent, and NXL104 in
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1. Novexel to Present Four Posters at the 19th European Congress of Clinical Microbiology and Infectious Diseases in Helsinki
2. Novexels NXL104/ceftazidime Combination Commences Second Phase II Clinical Trial in Hospital Patients With Complicated Intra-Abdominal Infections (cIAIs)
3. Novexels NXL104/ceftazidime Combination Commences Phase II Clinical Trial in Hospital Patients With Complicated Urinary Tract Infections
4. Novexel to Present Five Posters at the Joint Annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Disease Society of America (ICAAC/IDSA) Meeting
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