GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic(TM)/Zunrisa(TM) (C... ( Data Showed Clinically Meaningful...)

GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic(TM)/Zunrisa(TM) (Casopitant)

Date:5/29/2008

Data Showed Clinically Meaningful Benefits for Patients with Chemotherapy-Induced Nausea and Vomiting

PHILADELPHIA and LONDON, May 29 /PRNewswire-USNewswire/ -- GlaxoSmithKline (GSK) today announced the submission of a new drug application to the U.S. Food and Drug Administration and new data from two Phase III trials for Rezonic(TM)/Zunrisa(TM) (casopitant), a novel, investigational NK-1 receptor antagonist. The data demonstrated a significant and clinically meaningful reduction in the number of patients experiencing chemotherapy-induced nausea and vomiting (CINV). Adding a single oral dose regimen of casopitant to the standard dual therapy of Zofran(R) (ondansetron HCI) and dexamethasone, achieved this effect in patients taking highly emetogenic chemotherapy (HEC) and those on moderately emetogenic chemotherapy (MEC) treatment regimens.(1,2) CINV can be a serious, feared and distressing side effect of chemotherapy for patients and their families.(3) CINV can last for about five days and the risk of nausea and vomiting without prophylaxis is greater than 90 percent for patients receiving HEC and 30-90 percent for patients receiving MEC.(4,5)

Data from the two Phase III clinical trials demonstrated complete response rates of 86 percent for those patients given a single oral dose of casopitant together with the standard dual therapy in the HEC trial, and 73 percent for patients given either single oral or three-day oral doses of casopitant together with the standard dual therapy in the MEC trial.(1,2) This prophylactic treatment resulted in clinically meaningful and statistically significant improvements compared to controls.(1,2) To achieve complete response, patients had no vomiting or retching and took no rescue medications for five days following chemotherapy treatment.(1,2) These data for the single dose regimen - in addition to results for three-day oral and three-day IV/oral regimens - will be unveiled this week at the 44th Annual Meeting
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8
Related medicine technology :

1. GlaxoSmithKline Reports Further Progress of Oncology Portfolio
2. Paul Capital Healthcare Purchases Additional Royalty Interest in GlaxoSmithKlines Rotarix(R)
3. GlaxoSmithKline and Theravance Announce Start of Large Phase 2B ICS and LABA Studies for Asthma in the Horizon Program
4. Coley Pharmaceutical Group Receives $3.0 Million Milestone Payment from GlaxoSmithKline
5. New Data Show That GlaxoSmithKlines Rotarix(R) Could Be Given With Other Routine Infant Vaccines in the U.S.
6. GlaxoSmithKline Accelerates Review of Exelixis XL880
7. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
8. Genmab Announces Updates on Phase III Cancer Studies
9. Kiadis Pharma Announces Collaboration With the Julius Maximilians University of Wurzburg, Germany
10. Alfacell Corporation Announces Preliminary Results From ONCONASE(R) Phase IIIb Clinical Trial
11. BioElectronics Announces Major Clinical Trials

Post Your Comments:

(Date:5/21/2013)... , May 21, 2013 Accuray Incorporated ... the publication of study results involving hundreds of ... Radiosurgery System, the most widely used form of ... followed 304 patients for a median of 5 ... found that 97 percent of patients with low-risk ...

(Date:5/21/2013)... Janssen R&D Ireland (Janssen) today announced primary ... 3 PROMISE study demonstrating that use of the ... virologic response 12 weeks after the end of ... 1 chronic hepatitis C adult patients with compensated ... when administered once daily with pegylated interferon and ...

(Date:5/21/2013)... , May 21, 2013 Abaxis, Inc. (NasdaqGS: ... systems, announced today that Martin Mulroy ... Stifel Annual Dental & Veterinary Conference on Wednesday, May ... be held at Le Parker Meridien Hotel in ... Abaxis Abaxis develops, manufactures, markets and sells ...

Breaking Medicine Technology:New Data Validates CyberKnife SBRT for Prostate Cancer Treatment 2 New Data Validates CyberKnife SBRT for Prostate Cancer Treatment 3 Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients 2 Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients 3 Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients 4 Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients 5 Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients 6 Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients 7 Abaxis, Inc. to Present at the Stifel Annual Dental & Veterinary Conference 2

[0] New Data Validates CyberKnife SBRT for Prostate Cancer Treatment [0] Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients [0] Abaxis, Inc. to Present at the Stifel Annual Dental & Veterinary Conference

... N.J., Dec. 15 Synvista Therapeutics, Inc. (NYSE ... dosed the first patient in a 30-patient Phase 2 ... patients with psoriasis. The trial is planned to be ... assess the efficacy of topical SYI-2074, applied twice daily, ...

... DIEGO, Dec. 14 bioTheranostics, a bioMerieux company,that ... in,oncology, reported today findings from three studies using ... of disease recurrence in,individual patients. Data from the ... Breast Cancer Symposium (SABCS). , ...

Cached Medicine Technology:Synvista Therapeutics Announces First Dosing of SYI-2074 in Clinical Trial for Psoriasis 2 Synvista Therapeutics Announces First Dosing of SYI-2074 in Clinical Trial for Psoriasis 3 Three Clinical Studies of bioTheranostics Molecular Breast Cancer Diagnostics Presented at San Antonio Breast Cancer Symposium 2 Three Clinical Studies of bioTheranostics Molecular Breast Cancer Diagnostics Presented at San Antonio Breast Cancer Symposium 3 Three Clinical Studies of bioTheranostics Molecular Breast Cancer Diagnostics Presented at San Antonio Breast Cancer Symposium 4

Synvista Therapeutics Announces First Dosing of SYI-2074 in Clinical Trial for Psoriasis Three Clinical Studies of bioTheranostics Molecular Breast Cancer Diagnostics Presented at San Antonio Breast Cancer Symposium

(Date:5/21/2013)... (PRWEB) May 21, 2013 MedMar Healing ... drive to benefit Second Harvest Food Bank. Twenty-eight businesses, including ... participate in the food drive. The goal is to raise ... the economic problems facing their families in recent years. ... community and help those in need,” explains Douglas Chloupek of ...

(Date:5/21/2013)... recently published in the New England Journal of ... the University of Colorado School of Medicine finds that ... be used to identify individuals at risk for this ... common variant of the gene for mucin-5B, a protein ... the bronchial tubes. While this variant of the MUC5B ...

(Date:5/21/2013)... Research into genetic features of pulmonary fibrosis by ... of Medicine may lead to improved treatment of this ... by JAMA . , The study found that ... cases of pulmonary fibrosis, a chronic progressive disease with ... of the study, researchers may want to consider including ...

(Date:5/21/2013)... and technological research So Paulo Research Foundation, FAPESP, based ... estimated in US$ 680 million to support 17 Research, ... up to eleven years, subject to continuation reviews on ... the 17 RIDCs will come from FAPESP and the ... infrastructure). Host institutions will participate in a portion of ...

(Date:5/21/2013)... York (PRWEB) May 21, 2013 The ... robot lawsuit is nearing its conclusion in Washington ... Bloomberg.com, during closing statements yesterday, an attorney for the ... the company wanted to tie sales and services for ... the training to keep control of surgeons, to keep ...

Breaking Medicine News(10 mins):Health News:San Jose Cannabis Club Helps Feed Hungry Children with Second Harvest Food Bank 2 Health News:Researchers find genetic risk factor for pulmonary fibrosis 2 Health News:Researchers find genetic tie to improved survival time for pulmonary fibrosis 2 Health News:Research at the cutting edge of knowledge 2 Health News:Da Vinci Surgery Robot Lawsuit News: Bernstein Liebhard LLP Comments on Closing Arguments in Nation’s First Da Vinci Lawsuit Trial 2 Health News:Da Vinci Surgery Robot Lawsuit News: Bernstein Liebhard LLP Comments on Closing Arguments in Nation’s First Da Vinci Lawsuit Trial 3 Health News:Da Vinci Surgery Robot Lawsuit News: Bernstein Liebhard LLP Comments on Closing Arguments in Nation’s First Da Vinci Lawsuit Trial 4

[0] San Jose Cannabis Club Helps Feed Hungry Children with Second Harvest Food Bank [0] Researchers find genetic risk factor for pulmonary fibrosis [0] Researchers find genetic tie to improved survival time for pulmonary fibrosis [0] Research at the cutting edge of knowledge [0] Da Vinci Surgery Robot Lawsuit News: Bernstein Liebhard LLP Comments on Closing Arguments in Nation’s First Da Vinci Lawsuit Trial

... ... ... ... ...

... ... motorist and developed tinnitus, or severe ringing in her ears; she was granted compensation for ... ... carrier represented by East Tennessee attorney Brack Terry of Terry, Terry & Stapleton ...

... ... than £200 this month because of the cold snap. After one of the coldest Januarys in ... £226 – a £70 hike. , ... February 19, 2010 -- Britons are facing record energy bills of more than £200 this month ...

... Contrast-enhanced magnetic resonance imaging (MRI) may help physicians differentiate ... and wrist enabling more targeted therapies unique to each ... of the American Journal of Roentgenology . Contrast-enhanced ... internal bodily structures. Rheumatoid ...

... ... ... ... ...

MDS Announces Substantial Issuer Bid East Tennessee Attorney Brack Terry Obtains $120,000 Jury Award For Injured Mail Carrier It's Snow Joke as UK Gas and Electricity Bills Hit Record Highs -- Energyhelpline Calls for “Significant” Price Cuts Contrast-enhanced MRI could play a key role in differentiating between common types of arthritis FDA Cancer Drug Approval Rate Highlighted in JNCI 'The Dance' Fundraising Event on February 25th Will Feature Belladiva Show Band; Silent Auction Items Include a Two-Week Condo Stay in New Zealand

... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...

... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...

Medicine Products:

Chlamydia pneumoniae Antibodies, IgG & IgM by ELISA Chlamydia Group Antibody, Screen Chimerism, Recipient Pre-Transplant Chenodeoxycholic Acid