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The initial Phase II trial with NXL104/ceftazidime will be inhospitalized patients with complicated urinary tract infections (cUTIs). Fromnational databases providing hospital patient discharge data(i), Novexelestimates that more than 1.1 million patients were treated for cUTIs in thehospital in the seven major pharmaceutical markets in 2007.NXL104/ceftazidime is being developed to treat hospital infections that arecaused by Gram negative bacteria, including those resistant to many currentlyused antibiotics.
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This Phase II trial is a prospective, multicenter, investigator-blinded,randomized study which is designed to evaluate the efficacy, safety, andtolerability of NXL104/ceftazidime vs. imipenem cilastatin (Primaxin(R) orTienam(R), Merck & Co. Inc., NYSE: MRK) in the treatment of adults withcUTIs. Complicated urinary tract infections include acute pyelonephritis, UTIin men, or UTI associated with obstruction, foreign bodies, or urologicabnormalities. A total of approximately 150 patients will be enrolled, with75 patients being included in each treatment arm.
The primary objective of the study is to evaluate the microbiologicalresponse to NXL104/ceftazidime in the treatment of adult patients with cUTIsas compared to imipenem/cilastatin. This evaluation will be based on the Testof Cure visit five to nine days post-therapy. After at least 4 days of IVantibiotic therapy, patients may be switched to oral ciprofloxacin, if theymeet protocol-defined criteria. The total duration of antibiotic therapy foreach patient should be 7 to 14 days. The results of this study are expectedin late 2009.
In completed Phase I studies in healthy subjects NXL104/ceftazidime wasgenerally well tolerated and the pharmacokinetics of the two components werewell matched. Additional studies in special populations are ongoing.
Iain Buchanan, Novexel's CEO, said, "We continue to believe that thisnovel combination, which is based around our novel beta-lactamase inhibitor,NXL104, has the potential to play an important role in confronting theincreasing problem of hospital infections caused by resistant Gram negativebacteria. The start of our first Phase II study with NXL104 in combinationwith ceftazidime is an important milestone for the company."
Under an independent development program, Forest Laboratories (NYSE :FRX) will combine NXL104 in a treatment regimen with Forest's ceftaroline, anovel, bactericidal injectable broad spectrum cephalosporin being developedas a therapeutic agent for the treatment of gram-positive pathogens includingmethicillin resistant staphylococcus aureus (MRSA), and multi-drug resistantstreptococcus pneumoniae (MDRSP), as well as common gram-negative organisms.Ceftaroline is being studied as a monotherapy in Phase III clinical trials byForest. In January 2008, Novexel granted Forest a license to develop,manufacture and commercialise NXL104, only in combination with ceftaroline,in North America.
Novexel retains worldwide rights on the NXL104/ceftazidime combination.
About NXL104
NXL104 is a novel injectable non beta lactam, beta-lactamase inhibitor,which is being developed to address the increasing problem of microbialresistance to beta lactam antibiotics (penicillins, cephalosporins,carbopenems) mediated by beta-lactamase enzymes. NXL104 is a significantadvance, as it is able to inhibit a broader range of beta-lactamases thancurrently marketed beta-lactam inhibitors. Its spectrum includes class A(including ESBL and KPC) and class C enzymes. NXL104 in combination withceftazidime will be targeting infections caused by Gram negative bacteria,including Enterobacteriaceae and Pseudomonas.
About Novexel
Novexel is a speciality pharmaceutical company focused on the discoveryand development of novel antibiotics designed to overcome the significantglobal problem of microbial resistance. The ever increasing resistance tomarketed antibiotics has led to a clear need for novel drugs that are activeagainst multi-drug resistant bacteria. Novexel's products are targeting theglobal hospital antibiotic market, which was worth an estimated $15bn in 2007according to information derived from the IMS Midas(R) database.
Novexel currently has two novel antibacterials in Phase II clinicaldevelopment. These are the injectable beta-lactamase inhibitor, NXL104, whichis being developed in combination with the cephalosporin antibioticceftazidime for serious Gram negative infections, and the oral streptograminantibiotic, NXL103, for the treatment of Gram positive infections, with afocus on treatment in the hospital setting and intravenous (IV) to oralswitch. Novexel has three further programmes in preclinical development,NXL105, a novel anti-Pseudomonal antibiotic, NXL201, a novel echinocandinantifungal agent, and NXL104 in combination with ceftaroline. This latterproduct is being developed by our partner, Forest Laboratories, solely forNorth American markets.
Novexel was created in December 2004 as an independent spin-out of thesanofi-aventis (Euronext Paris: SAN, NYSE: SNY) anti-infectives unit. Novexelhas a team of 50 employees with significant experience in anti-infectiveresearch and development, who are located in Paris, France and Philadelphia,USA.--------------------------------- (i) USA: HCUPnet; France, Agence technique de l'Information sur l'Hospitalisation ; UK The Information Center (Hospital Episode Statistics) ; Germany, Federal Health Monitoring; Spain, Eurostat; Italy & Japan: OECD. For further information please contact: Novexel Gordon Waldron, CFO [email protected] Citigate Dewe Rogerson Amber Bielecka/David Dible/Nina Enegren Tel.: +44(0)207-638-95-71 [email protected]
SOURCE Novexel
