Navigation Links
Novexel's NXL104/ceftazidime Combination Commences Second Phase II Clinical Trial in Hospital Patients With Complicated Intra-Abdominal Infections (cIAIs)
Date:3/3/2009

PARIS, March 3 /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 today that its most advanced injectable antibacterial, which combines Novexel's broad spectrum beta lactamase inhibitor, NXL104, with the well established cephalosporin antibiotic, ceftazidime, has entered a second Phase II clinical trial.

This Phase II trial with NXL104/ceftazidime will be in hospitalized patients with complicated intra-abdominal infections (cIAIs). In 2007, Novexel estimates that more than 300,000 patients were treated for cIAIs in hospital in the seven major pharmaceutical markets. This estimate is based on national databases providing hospital patient discharge data.

NXL104/ceftazidime is being developed to treat hospital infections that are caused by Gram negative bacteria, including those resistant to many currently used antibiotics. This Phase II trial is a prospective, multicenter, double-blind, randomized study which is designed to evaluate the efficacy, safety, and tolerability of NXL104/ceftazidime plus metronidazole vs. meropenem (Merrem(R) or Meronem(R), AstraZeneca, NYSE: AZN) in the treatment of adults with cIAIs. Complicated intra-abdominal infections include those infections requiring surgical intervention and which extend beyond the hollow viscus into the peritoneal space. A total of approximately 200 patients will be enrolled, with 100 patients being included in each treatment arm.

The primary objective of the study is to evaluate the clinical response to NXL104/ceftazidime plus metronidazole in the treatment of adult patients with cIAIs as compared to meropenem. This evaluation will be based on the Test of Cure visit two weeks post-therapy. The total duration of antibiotic therapy for each patient should be 5 to 14 days. The results of this study are expected in early 2010.

This second Phase II trial in cIAIs, follows a Phase II clinical trial of NXL104/cetazidime in hospitalized patients with complicated urinary tracts infections (cUTIs). This study which began in November is due to complete in late 2009.

In completed Phase I studies in healthy subjects NXL104/ceftazidime was generally well tolerated and the pharmacokinetics of the two components were well matched. Additional studies in special populations are ongoing.

Iain Buchanan, Novexel's CEO, said, "The start of this second Phase II study demonstrates Novexel's commitment to developing NXL104 in combination with ceftazidime in a broad range of indications where resistant Gram negative bacteria are present or are suspected. NXL104 has the ability to inhibit the activity of a broader range of clinically important beta-lactamases than currently marketed beta-lactam inhibitors and we believe that this combination product could provide an important new treatment option in the hospital."

Under an independent development program, Forest Laboratories (NYSE : FRX) will combine NXL104 in a treatment regimen with Forest's ceftaroline, a novel, bactericidal injectable broad spectrum cephalosporin. Ceftaroline is being developed as a therapeutic agent for the treatment of gram-positive pathogens including methicillin resistant staphylococcus aureus (MRSA), and multi-drug resistant streptococcus pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline is being studied as a monotherapy in Phase III clinical trials by Forest. 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 microbial resistance to beta lactam antibiotics (penicillins, cephalosporins, carbopenems) mediated by beta-lactamase enzymes.

NXL104 is a significant advance, as it is able to inhibit a broader range of beta-lactamases than currently marketed inhibitors. Its spectrum includes class A (including ESBL and KPC) and class C enzymes. NXL104 in combination with ceftazidime will be targeting infections caused by Gram negative bacteria, including Enterobacteriaceae and Pseudomonas.

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 $15bn in 2007 according to information derived from the IMS Midas(R) database.

Novexel currently has two novel antibacterials in Phase II clinical development. These are the injectable beta-lactamase inhibitor, NXL104, which is being developed in combination with the cephalosporin antibiotic ceftazidime for serious Gram negative infections, and the oral streptogramin antibiotic, NXL103, for the treatment of Gram positive infections, with a focus on treatment in the hospital setting and intravenous (IV) to oral switch. Novexel has three further programmes in preclinical development, NXL105, a novel anti-Pseudomonal antibiotic, NXL201, a novel echinocandin antifungal agent, and NXL104 in combination with ceftaroline. This latter product is being developed by our partner, Forest Laboratories, solely for North American markets.

Novexel was created in December 2004 as an independent spin-out of the sanofi-aventis (Euronext Paris: SAN, NYSE: SNY) anti-infectives unit. Novexel has a team of 50 employees with significant experience in anti-infective research and development, who are located in Paris, France and Philadelphia, USA.

    For further information please contact:
    Novexel
    Gordon Waldron, CFO
    gordon.waldron@novexel.com

    Citigate Dewe Rogerson
    Amber Bielecka/David Dible/Nina Enegren
    Tel.: +44(0)207-638-95-71
    amber.bielecka@citigatedr.co.uk


'/>"/>
SOURCE Novexel
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Novexels NXL104/ceftazidime Combination Commences Phase II Clinical Trial in Hospital Patients With Complicated Urinary Tract Infections
2. CuraGen and TopoTarget Initiate Phase I/II Clinical Trial of Belinostat (PXD101) Combination Therapy for Acute Myeloid Leukemia
3. Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
4. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
5. Xeloda XeNA Study Analyses of Xeloda, Docetaxel and Herceptin Combination Therapy for Metastatic Breast Cancer Featured at Major New Breast Cancer Symposium
6. Xeloda(R) XeNA Study Analyses of Xeloda, Docetaxel and Herceptin Combination Therapy for Metastatic Breast Cancer Featured at Major New Breast Cancer Symposium
7. Vion Pharmaceuticals Announces Initiation of a Phase I/II Trial of Cloretazine(R) (VNP40101M) in Combination with Temodar(R) in Adult Brain Tumors
8. New Phase 3 Study in Treatment-Naive Adults with HIV Evaluates Efficacy and Safety of Once-Daily PREZISTA(TM)/ritonavir vs. KALETRA(R) as Part of HIV Combination Therapy
9. New Data Show Ceftobiprole as Effective as Combination Therapy in Treating Patients With Complicated Skin Infections, Including MRSA
10. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
11. Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/7/2017)...   BioLife Solutions , Inc. (NASDAQ: BLFS ... grade cell and tissue hypothermic storage and ... , President and CEO, will be presenting at two investment ... Renshaw 19 th Annual Global Investment Conference on Tuesday, ... time). The conference is being held at the New York ...
(Date:9/6/2017)... , Sept. 6, 2017   PDI , a ... it will host an educational session focused on the ... infection (CLABSI) prevention at the 2017 Annual Scientific Meeting ... will take place at the Phoenix ... from Sept. 16-19, will also feature PDI,s ...
(Date:9/5/2017)... -- Sapheneia and Scannerside received FDA 510(k) clearance to ... third-party Vendor neutral CT product that makes it affordable ... current MITA standards. ... specifically designed to provide CT operators, prior to a ... a predefined threshold. Scannerside Dose Check is intended to ...
Breaking Medicine Technology:
(Date:9/21/2017)... Falls Church, VA (PRWEB) , ... September 21, ... ... Use Policy , **An FDAnews Management Report**, http://www.fdanews.com/products/54818-promotional-communication      , In the ... every edge they can get while staying in compliance with FDA rules. , ...
(Date:9/21/2017)... WA (PRWEB) , ... September 21, 2017 , ... ... technology using Microscan’s LVS 7510 at the Global GS1 Healthcare Conference 2017 in ... of the life-sciences industry for ensuring label quality and improving patient safety. ...
(Date:9/21/2017)... ... September 21, 2017 , ... FlipBelt, the fitness brand that ... detail to the athletic wear market with the launch of their FlipBelt Crops. , ... their essentials securely at their fingertips while at the gym, on the trail, or ...
(Date:9/20/2017)... ... September 20, 2017 , ... FirstAlign ( http://www.firstalign.com ), combines ... Artificial Intelligence (AI) thinking, announced today the launch of its revamped web presence. ... information that offers a more comprehensive understanding of the organization’s business and machine ...
(Date:9/20/2017)... ... September 20, 2017 , ... ... and commercialization, has just released a new white paper discussing the benefits ... than ever about medical device, pharmaceutical, and combination product organizations making sure ...
Breaking Medicine News(10 mins):