Navigation Links
Advanced Life Sciences Announces Supplemental Efficacy Data from,First Pivotal Phase 3 Pneumonia Clinical Trial

mycin 91.5% (205/224) compared to Biaxin(R) 95.9% (212/221) [-9.1, +0.3] p=0.0775). Based on the 95.9% clinical cure rate for Biaxin(R) being 90% or greater, a delta value of 10% or less on the lower bound and greater than zero on the upper bound [-9.1, +0.3] establishes non-inferiority. Under this analysis, the Company met the non-inferiority endpoint of per protocol clinical cure rate. Since p>0.05, there is not a statistically significant difference between cethromycin and Biaxin(R), which supports non-inferiority.

Supplemental Data

The Company today confirmed supplemental efficacy data with its clinical research organization and announced results in the following endpoints:

    -- Modified intent-to-treat clinical cure rate -- cethromycin 82.9%

       (213/257) compared to Biaxin(R) 88.5% (224/253) [-11.9, +0.6]

       (p=0.0769).  Based on the 88.5% clinical cure rate for Biaxin(R) being

       between 80% and 90%, a delta value of 15% or less on the lower bound

       and greater than zero on the upper bound [-11.9, +0.6] establishes

       non-inferiority.  Under this analysis, the study met the endpoint of

       modified intent-to-treat clinical cure rate.  Since p>0.05, there is

       not a statistically significant difference between cethromycin and

       Biaxin(R), which supports non-inferiority.

    -- Per protocol radiographic success rate -- cethromycin 94.2% (211/224)

       compared to Biaxin(R) 95.9% (212/221) [-6.0, +2.5] (p=0.5130).  Based

       on the 95.9% clinical cure rate for Biaxin(R) being 90% or greater, a

       delta value of 10% or less on the lower bound and greater than zero on

       the upper bound [-6.0, +2.5] establishes non-inferiority.  Under this

       analysis, the study met the endpoint of per protocol radiographic

       success rate.  Since p>0.05, there is not a statistically significant

       difference between cethromycin and Biaxin(R), which supports non-

       inferiority
'"/>




Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. BusinessWeek Article Highlights Promising Breakthrough Treatment for Advanced Coronary Artery Disease
3. BusinessWeek Article Highlights Promising Breakthrough Treatment for Advanced Coronary Artery Disease
4. Advanced Life Sciences to Host Conference Call to Discuss Data From Cethromycins First of Two Phase 3 Pneumonia Trials
5. Progenics and Wyeth Announce Positive Results from Three-Month Clinical-Extension Study of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients with Advanced Illness
6. Advanced Cell Technology Develops First Human Embryonic Stem Cell Line without Destroying an Embryo
7. Neurologix Announces Publication of Landmark Gene Therapy Study Demonstrating Safety and Statistically Significant Improvement in Patients With Advanced Parkinsons Disease
8. Advanced Viral Research Corp. Announces Positive Preliminary Findings from Ongoing Phase II Dermatological Study
9. Clinical Data Reported on Vidaza in Hematologic Malignancies and Advanced Solid Tumors
10. Updated Study Results Reinforce Survival Benefit of Taxotere (Docetaxel) for Men with Advanced, Hormone-Resistant Prostate Cancer
11. GSKS Pazopanib Shows Positive Results in Patients with Advanced Renal Cell Carcinoma, Ovarian Cancer and Soft Tissue Sarcoma
Post Your Comments:
(Date:7/14/2014)... 14, 2014 Decision Resources Group finds ... influence perceptions of emerging drugs for both oncologists ... oncologists (50 medical oncologists and 50 hematological oncologists) ... managed care organizations (MCOs), reveals that despite lower ... majority of payers say this designation will likely ...
(Date:7/14/2014)... 2014  More than any other generation, Millennials born in ... -- but their eyes don,t. These mobile devices demand a ... the eye has not evolved to cope with them. The ... do comfortably often results in tired eyes, focusing problems, headaches ... Strain. Now ZEISS has invented a new type of lens ...
(Date:7/14/2014)... July 14, 2014  Diomics, Inc., provider of ... that the United States Patent and Trademark Office ... covering novel biologic sample collection materials, devices made ... forensics and diagnostics. The primary ... swabbing. Recovery of DNA from a number of ...
Breaking Medicine Technology:Breakthrough Therapy Designation is Likely to Sway Oncologists' Confidence in An Agent and Encourage Prescribing 2Breakthrough Therapy Designation is Likely to Sway Oncologists' Confidence in An Agent and Encourage Prescribing 3New Eyeglass Lens Helps Our Eyes Keep Up with our Digital Lives 2New Eyeglass Lens Helps Our Eyes Keep Up with our Digital Lives 3Diomics Announces Issuance Of U.S. Patents For Novel Biologic Sample DNA Collection Materials For Use In Forensics And Diagnostics 2
(Date:7/14/2014)... Texas (PRWEB) July 14, 2014 The ... encourage investment in the Global Mobile Health Solutions market. ... in the Health IT for Economic and Clinical Health ... February 2009. , Analysts forecast the Global Mobile ... of 34.88 percent over the period 2013-2018. According to ...
(Date:7/14/2014)... The report “Intelligent Building Automation Technologies ... Safety, Facility Management], IT Technologies & Industry Verticals ... - 2019)” defines and segments the IBAS market ... forecasting of revenues. The report also identifies the ... impacting it, along with the technology roadmap and ...
(Date:7/14/2014)... Physical fitness may buffer some of the adverse health ... study by researchers from the American Cancer Society, The ... appears in the journal Mayo Clinic Proceeding s, ... obesity and blood markers associated with cardiovascular disease is ... Sedentary behavior has been linked to an increase risk ...
(Date:7/14/2014)... TX (PRWEB) July 14, 2014 ... heart valves market in Americas. The analysis includes ... the 2007–2020 period and key company share data ... US, Canada, Brazil and Mexico. It uses data ... secondary research and in-house analysis. , Scope, ...
(Date:7/14/2014)... Secure Decisions, a leading provider of ... the Software Assurance Marketplace (SWAMP) to build a powerful ... drives everyday life. , The SWAMP, implemented by a ... Morgridge Institute for Research, is funded by the Department ... practices by building a free facility with a diverse ...
Breaking Medicine News(10 mins):Health News:Mobile Health Solutions Market to Grow at 34.88% CAGR by 2018, Says a New Research Report at Sandlerresearch.org 2Health News:Mobile Health Solutions Market to Grow at 34.88% CAGR by 2018, Says a New Research Report at Sandlerresearch.org 3Health News:Mobile Health Solutions Market to Grow at 34.88% CAGR by 2018, Says a New Research Report at Sandlerresearch.org 4Health News:Intelligent Building Automation Technologies Market Worth $74.8 Billion by 2019 - New Report by MarketsandMarkets 2Health News:Intelligent Building Automation Technologies Market Worth $74.8 Billion by 2019 - New Report by MarketsandMarkets 3Health News:Intelligent Building Automation Technologies Market Worth $74.8 Billion by 2019 - New Report by MarketsandMarkets 4Health News:Physical fitness associated with less pronounced effect of sedentary behavior 2Health News:Americas Transcatheter Heart Valves Market 2020 Forecasts in New Research Report at LifeScienceIndustryResearch.com 2Health News:Americas Transcatheter Heart Valves Market 2020 Forecasts in New Research Report at LifeScienceIndustryResearch.com 3Health News:Americas Transcatheter Heart Valves Market 2020 Forecasts in New Research Report at LifeScienceIndustryResearch.com 4Health News:Madison-based SWAMP, Secure Decisions partner to enhance software security 2Health News:Madison-based SWAMP, Secure Decisions partner to enhance software security 3
... made him the last of his line, researchers say ... powerful Habsburg royal family ruled Spain for centuries until the ... , Now, a new study suggests the reason for their ... and their unfortunate habit of marrying their own relatives. ...
... the highest level of excellence, achieving ASQ CQI Certifications. , ... ... Board of the American Society for Quality is pleased to announce ... completed the requirements to be named an ASQ-Certified Quality Inspector (ASQ ...
... 8 Saints Mary and Elizabeth Medical Center, 2233 ... Blue Cross and Blue Shield of Illinois, Childhood Health ... for children at risk for obesity and diabetes. This ... Obesity is an epidemic in the United States. Since ...
... 8 This Sunday, individuals all over the ... the women who gave them life: their mothers. While people ... the International Breast Milk Project (IBMP) hopes to inspire some ... organization that helps mothers in the United States send their ...
... Protect Patients and Consumers ROCKVILLE, Md., May 8 ... substantial increase in funding for the Food and ... budget. Following the Obama administration,s voiced support for ... increase the agency,s ability to protect American patients ...
... May 8 PRO-DEX, INC. (Nasdaq: PDEX ) ... of the Company,s fiscal 2009 third quarter financial results. The ... on Thursday, May 14, 2009 at 4:30 p.m. Eastern Time ... Company,s website at www.pro-dex.com . Mark ...
Cached Medicine News:Health News:Inbreeding May Have Doomed Spain's Habsburg Dynasty 2Health News:Inbreeding May Have Doomed Spain's Habsburg Dynasty 3Health News:Clinical Instrument Repair Consultants Receive ASQ-Certified Quality Inspector 2Health News:Blue Cross and Blue Shield Funds Diabetes Education at Saints Mary and Elizabeth Medical Center 2Health News:International Breast Milk Project Helps Mothers Worldwide 2Health News:USP Applauds President's Budget Support for FDA 2Health News:Pro-Dex, Inc. Announces Fiscal 2009 Third Quarter Financial Results Conference Call and Webcast 2