Navigation Links
Cempra Announces Comparable Efficacy of Oral Solithromycin (CEM-101) Compared with Levofloxacin in Phase II Clinical Trial in Patients with Community-Acquired Bacterial Pneumonia (CABP)
Date:9/15/2011

CHAPEL HILL, N.C., Sept. 15, 2011 /PRNewswire/ -- Cempra Pharmaceuticals today announced results from its Phase II clinical trial investigating the efficacy, safety and tolerability of oral administration of our fourth generation macrolide, solithromycin (CEM-101), a fluoroketolide antibiotic, in comparison with oral levofloxacin for the treatment of community-acquired bacterial pneumonia (CABP).  In the Phase II trial, CEM-101 demonstrated efficacy comparable to levofloxacin and a favorable safety and tolerability profile, with a lower incidence of treatment emergent adverse events than levofloxacin.  

"Macrolides have been an important therapeutic option for physicians to use for the treatment of bacterial pneumonia and other infections, but antimicrobial resistance has been increasing among the major pathogens which cause these infections," said Professor Robert Moellering, M.D., Shields Warren-Mallinckrodt Professor of Medical Research at Harvard Medical School.  "A safe macrolide as potent as CEM-101 has the potential of being a very useful agent."

David Oldach, M.D., senior vice president of clinical research of Cempra added, "Results from this trial indicate that CEM-101 is a product candidate with efficacy comparable to levofloxacin, the current standard of care for the treatment of CABP and with a favorable safety profile.  We believe these data validate the dosing strategy of CEM-101 employed in this trial and strongly support progression into Phase III trials. We look forward to presenting the full data set at an upcoming scientific conference."

Study Design

The trial was a randomized double-blind, multi-center study to evaluate the efficacy and safety of oral CEM-101 compared to oral levofloxacin in the treatment of patients with CABP.  One hundred thirty two patients were randomized to receive either CEM-101 (800 mg on Day 1 followed by 400 mg on Days 2 to 5) or levofloxacin (750 mg on Days
'/>"/>

SOURCE Cempra Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Cempra Pharmaceuticals to Present at the 2011 Wells Fargo Healthcare Conference
2. Cempra Pharmaceuticals to Present at the Jefferies 2011 Global Healthcare Conference
3. Cempra Pharmaceuticals to Present at Two Investor Conferences in Paris
4. Intravenous (IV) Administration of Cempra Pharmaceuticals Solithromycin (CEM-101) Demonstrates Excellent Systemic Tolerability in a Phase 1 Clinical Trial
5. Cempra Pharmaceuticals to Present at Two Upcoming Cambridge Healthtech Institute (CHI) Conferences
6. Cempra Pharmaceuticals to Present at Two Upcoming Investor Conferences
7. Cempra Expands Clinical Management Team to Advance Leading Antibacterial Clinical Programs Solithromycin and TAKSTA™
8. Cempra Pharmaceuticals Names Carl Foster Executive Vice President of Business Development
9. Cempra Pharmaceuticals Names Richard Kent, M.D., to Its Board of Directors
10. Cempra Pharmaceuticals to Present at the UBS Global Life Sciences Conference
11. Cempra Pharmaceuticals to Present at the Piper Jaffray 21st Annual Health Care Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... YORK , Jan. 15, 2014 ... report is available in its catalogue: ... for Advanced Drug Delivery Systems -- Focus ... STUDY OBJECTIVES ...
(Date:1/14/2014)... HeartWare International, Inc . (NASDAQ: HTWR ... support technologies that are revolutionizing the treatment of advanced ... the fourth quarter of 2013 will be approximately $53 ... million. "Our full-year revenue growth of 87% ...
(Date:1/14/2014)... 2014 Dynamic Healthcare Services, Inc. ("DHS"), a portfolio company ... Progressive Home Medical Equipment, Inc. ("Progressive") of Clarion, ... the acquisition were not disclosed. Progressive is ... wide range of sleep, mobility, and respiratory products to customers ...
Breaking Medicine Technology:Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 16Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 17Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 18HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 2HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 3HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 4Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 3
... 26, 2012  Richard Wolf Medical Instruments Corporation celebrates ... minimally invasive solutions that spare patients the costs ... (Logo:  http://photos.prnewswire.com/prnh/20120426/CG95191LOGO ) ... allowing doctors to visualize and access elusive sites ...
... April 26, 2012 - The Consumer Healthcare Products ... for signing into law House Bill 363, legislation ... implementing a drug offender registry, stricter penalties for ... stop-sale technology.  HB 363 and its companion legislation ...
Cached Medicine Technology:Richard Wolf Medical Instruments Corporation: 40 Years of Innovation 2
(Date:4/17/2014)... published in the April issue of Immunity , ... for Medical Research, says it,s time to take a ... treating sepsis, which kills millions worldwide every year, ... molecules released into the bloodstream to fight an injury ... necessary for maintaining good health without inflammation, wounds ...
(Date:4/17/2014)... University synthetic biology team has created a new ... therapeutics that could travel the body and selectively ... Engineering cell-based, biological devices that monitor and modify ... synthetic biology. However, no existing technology enabled bioengineers ... physiological state and respond in a customized fashion. ...
(Date:4/17/2014)... 17, 2014) Doctors who treat patients with ... (LAM) can face an agonizing treatment decision. , ... disease and help relieve shortness of breath. But ... sirolimus can cause potentially fatal complications following transplantation. ... Daniel Dilling, medical director of Loyola University Medical ...
(Date:4/17/2014)... cause of neuronal death in Parkinson,s disease is still ... be mistaken for foreign invaders and killed by the ... diseases like type I diabetes, celiac disease, and multiple ... April 16, 2014, in Nature Communications . , ... Parkinson,s disease; but if true, it could lead to ...
(Date:4/17/2014)... 17, 2014 By discovering a new mechanism that ... stroke, researchers at UC Irvine and the Salk Institute ... limit or prevent stroke-induced brain damage. , A complex ... of death and primary reason for disability in the ... stroke and lets blood-borne material into the brain, causing ...
Breaking Medicine News(10 mins):Health News:Feinstein Institute researcher publishes new perspective on sepsis 2Health News:Building 'smart' cell-based therapies 2Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3Health News:Is Parkinson's an autoimmune disease? 2Health News:Study IDs new cause of brain bleeding immediately after stroke 2
... of New England and the Rhode Island House and senate ... multiple sclerosis, AIDS and other chronic // diseases ... these patients. The new bill allows patients to have possession ... marijuana was illegal. But, the Governor Carcieri still oppose the ...
... has a counter which states that heart conditions became worse ... heart disease when they were fed a soy diet. ... mice carried and were severely affected by the soy diet. ... failure. This study was done by University of Colorado at ...
... a pilot study by The New Women's Health Initiative ... fat but rich in carbohydrates results in negligible weight ... between weight alterations in postmenopausal women Vis a Vis ... in this category were advised to reduce the fat ...
... was misled about the dangers of taking cannabis when the ... than a year ago, the British Home Secretary admits today. ... decision taken by his predecessor, David Blunkett, Charles Clarke said ... link between cannabis and mental illness. He made these damning ...
... in the offing for abdominal aortic aneurysm, a blood vessel condition ... ,This condition, a swelling // in the ... bursts, accounts for 1.36% of deaths in men over 65 in ... for men in that age group, Pulse magazine says. ...
... customers to trap doctors who conduct sex determination tests for ... State’s sex ratio is less than 800 females for every ... would be paid up to Rs.5,000 to help nab diagnostic ... Family Welfare Secretary D.S. Guru said field officers of the ...
Cached Medicine News:Health News:UK public misled over downgrading cannabis: Govt 2Health News:Experts urging artery screening in the UK 2
Rapid Plasma Reagin (RPR) set is a non-treponemal flocculation test that is,used for the qualitative and semi-quantitative determination of reagin,antibodies in serum or plasma from persons with syph...
... For use as a ... detecting IgG antibody to Toxoplasma ... to rubella virus (rubella IgG), ... IgG) and IgG antibody to ...
... VITROS Anti-HCV assay is the third diagnostic,hepatitis ... Drug,Administration capable of being run in a ... with Intellicheck. Now the laboratory staff,can run ... of more than 27 assays, and provide ...
... For use as a quality ... immunoglobulin M (IgM) antibodies to ... IgM), IgM antibodies to hepatitis ... B e antigen (HBeAg) and ...
Medicine Products: