Navigation Links
Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia,Clinical Trial

per protocol clinical cure rate compared to Biaxin(R) in CAP (cethromycin 91.5% (205/224) compared to Biaxin(R) 95.9% (212/221) [-9.1, +0.3], p=0.0775). Cethromycin's achievement of a 91.5% clinical cure rate is consistent with its Phase 2 clinical trial results at the same 300 mg once-daily dose for CAP. The comparator drug, Biaxin(R), achieved a cure rate higher than the historical rate observed in any reported Biaxin(R) CAP clinical trials to date.

Cethromycin also achieved positive safety results in the study. Cethromycin demonstrated an improved safety profile when compared with the results seen in its previous clinical trials. Additionally, the incidence of adverse events was not statistically different between cethromycin and Biaxin(R). The most common adverse events reported in patients receiving cethromycin were mild-to-moderate diarrhea (cethromycin 5.0%, Biaxin(R) 4.6%), headache (cethromycin 3.1%, Biaxin(R) 6.5%), nausea (cethromycin 2.7%, Biaxin(R) 3.8%), vomiting (cethromycin 2.7%, Biaxin(R) 1.5%), abdominal pain (cethromycin 1.5%, Biaxin(R) 3.1%) and taste disturbance (cethromycin 11.1%, Biaxin(R) 6.2%). No drug-related serious adverse events were observed in any study subject. Liver function tests and electrocardiogram monitoring demonstrated no significant differences between subjects receiving cethromycin and subjects receiving Biaxin(R), consistent with the hepatic and cardiac side effect profile reported in cethromycin's previous clinical trials.

Cethromycin is not approved as a treatment for CAP, and data from this analysis have not been reviewed by the FDA. No further details of the clinical study will be available until all data analyses are complete and results are presented in a public, scientific forum.

Program Design

The Phase 3 CAP clinical trial program is comprised of two randomized, well controlled, double-blind, multi-center, multi-national, comparator trials designed to assess the safety and effectiveness
'"/>




Page: 1 2 3 4 5

Related medicine technology :

1. Advanced Life Sciences to Host Conference Call to Discuss Data From Cethromycins First of Two Phase 3 Pneumonia Trials
2. Cethromycin Shown Effective Against Anthrax in Study
3. Hypertension Vaccine CYT006-AngQb Achieves Strong Blood Pressure Reduction During Important Early Morning Period When Most Adverse Cardiovascular Events Occur
4. Ontak (denileukin diftitox) Achieves 49.1% Overall Response Rate in Phase III Trial of Cutaneous T-Cell Lymphoma (CTCL)
5. Micromet Achieves Milestone in BiTE Research Collaboration with MedImmune
6. Addex Achieves Statistically Significant Outcome in Phase IIa Clinical Trial With ADX10059 in Gastro-Esophageal Reflux Disease
7. Vicals Vaxfectin Adjuvant Achieves Dose-Sparing Effect With Seasonal Influenza Vaccine
8. Mymetics HIV Vaccine Achieves Research Breakthrough, Eliciting Protective Antibody Response in Mucosal Tissues of Non-Human Primate Model
9. Integrated Biopharmas Proprietary Vaccine Technology Achieves Strong Positive Results
10. Integrated BioPharmas Proprietary Vaccine Technology Achieves Strong Positive Results
11. ENDEAVOR IV Clinical Trial Meets Primary Endpoint
Post Your Comments:
(Date:1/22/2015)... Jan. 22, 2015 Increasing sophistication among enterprise buyers ... localization purchasing in 2015, says Moravia CMO, ... recent study by market research firm Common Sense Advisory, ... for their translation and localization needs. "From a language ...
(Date:1/22/2015)... , Jan. 22, 2015 Research and Markets ... of the "Microbiology Testing/Clinical Microbiology Market by ... Forecast to 2019" report to their offering. ... array of techniques for the detection of infectious ...
(Date:1/22/2015)... BETHESDA, Md. , Jan. 22, 2015 The Parenteral ... Manufacturing Science Program SM : Enabling Pharmaceutical Manufacturing,s Future. ... will fulfill the following goals: , Highlight the ... , Strengthen and build practical solutions by filling known gaps ...
Breaking Medicine Technology:Moravia Sees Single-Sourcing as Key Localization Trend in 2015 2Global Microbiology Testing/Clinical Microbiology (Instrument, Analyzer, Incubator, Kit, Microscope, Molecular Diagnostics) Market - Forecast to 2019 2Global Microbiology Testing/Clinical Microbiology (Instrument, Analyzer, Incubator, Kit, Microscope, Molecular Diagnostics) Market - Forecast to 2019 3PDA Launches Manufacturing Science Program(SM) 2PDA Launches Manufacturing Science Program(SM) 3
... 2007 /PRNewswire/ --,An activity-based cost analysis demonstrated that ... weeks replaced thrice weekly,administration of epoetin alfa, hemodialysis ... more than $44,000 per year per 100,patients. These ... in hemodialysis patients, were presented today,during an oral ...
... Md., April 23, 2007--A part of the brain ... thinner in youth with a risk gene for ... the National Institute of Mental,Health (NIMH), one of ... thinner entorhinal cortex, a structure in the lower ...
Cached Medicine Technology:Prospective Model Outlined Potential Time and Cost Savings of,Once-Monthly Anemia Treatment 2Prospective Model Outlined Potential Time and Cost Savings of,Once-Monthly Anemia Treatment 3Cortex Area Thinner in Youth with Alzheimers-Related Gene 2Cortex Area Thinner in Youth with Alzheimers-Related Gene 3Cortex Area Thinner in Youth with Alzheimers-Related Gene 4
(Date:1/22/2015)... Minn. (PRWEB) January 22, 2015 Blue Cross ... those Minnesotans who exemplify what it means to “Live Fearless.” ... chance for people to share their stories about how they ... or simply inspired others by living in the moment. By ...
(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and David Leadbetter ... to bestow a Juvent Sports Achievement award upon an ... The award commemorated and congratulated McKitrick for her record ... her first amateur tournament in 1979 and most recently ...
(Date:1/22/2015)... January 22, 2015 Autocarinsurancebest.com has released a ... a commercial auto insurance policy . , Auto insurance ... vehicles. It is no longer necessary to call an agent ... now available online on a single website: http://autocarinsurancebest.com/ . ...
(Date:1/22/2015)... Joan Lunden, award-winning American journalist, beloved ... upcoming 32nd Annual Miami Breast Cancer Conference ... LLC (PER®) , shares that “a fast-growing, virulent” cancer ... she had not followed up her clean mammogram with ...
(Date:1/22/2015)... 23, 2015 Recently, Weddingshe.com has added many ... has announced its highest annual revenues in the past three ... popular glamorous wedding dresses. , According to the sales manager ... dress promotions for them in 2015. This point can be ...
Breaking Medicine News(10 mins):Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2
... ... retail sites. , ... (PRWEB) May 26, 2010 -- Buckts Firefox Add-on delivers discounts and coupons for over ... a shopper visits an online retailer, clicking on the highlighted ShoppingBuckt icon from the ...
... ... to assess up to $100,000 per-violation penalties , ... Alexandria, VA (Vocus) May 26, 2010 -- More than ... Certificate Exchange Network (CEN) offered by the National Association of Chain Drug Stores (NACDS) ...
... ahead of expected changes to oversight of supplement industry ... investigation of dietary herbal supplements has found trace amounts ... all products tested, plus myriad illegal health claims made ... reported Wednesday. , The levels of heavy metal contaminants ...
... sex hormones, such as testosterone, have well defined roles in ... that they also play an important role in female fertility. ... male sex hormones in the ovaries helps regulate female fertility, ... of follicles that contain growing eggs. This study ...
... disease are not only at risk for serious heart-related ... regardless of the type of surgical intervention they receive ... study by Nationwide Children,s Hospital, and appearing in ... ahead of print. Necrotizing enterocolitis (NEC) is ...
... ... mistake in Ohio. , ... NY (PRWEB) May 10, 2010 -- Embryo mix-ups at fertility clinics are extremely uncommon. However, when ... involved., , , , ,A doctor had given Carolyn Savage the wrong embryo and she became ...
Cached Medicine News:Health News:Retailers and Manufacturers Quickly Adopt Online Network to Address CPSIA Compliance 2Health News:Retailers and Manufacturers Quickly Adopt Online Network to Address CPSIA Compliance 3Health News:Many Supplements Said to Contain Toxins, Make False Health Claims 2Health News:Male sex hormones in ovaries essential for female fertility 2Health News:Male sex hormones in ovaries essential for female fertility 3Health News:Study sheds light on deadly GI disease in infants born with complex congenital heart disease 2Health News:Study sheds light on deadly GI disease in infants born with complex congenital heart disease 3Health News:An Embryo Mix up Would Involve New York Medical Malpractice Lawyers 2
Triturus® is an open and completely automated ELISA immunoassay analyzer which can perform a variety of different tests on a series of samples and process several batches simultaneously....
... The current available techniques for prenatal diagnosis ... with their use a small but significant ... current standard care offers invasive prenatal baby ... risk of chromosomal or genetic abnormalities are ...
Custom Pediatric Nebulizer Assembly W/Tubing...
... only HER-2 assessment test approved by the ... three claims: prognosis, adriamycin-based chemotherapy selection and ... is the only FISH-based DNA probe HER-2 ... as an appropriate test to aid in ...
Medicine Products: