Navigation Links
Phase 3 data Re: Anti-RSV antibody to be presented at Pediatric Academic Societies Annual Meeting
Date:5/5/2008

HONOLULU, HI, May 4, 2008 MedImmune today announced that researchers are currently presenting results from a MedImmune-sponsored Phase 3 study involving motavizumab, an investigational monoclonal antibody (MAb) that is being evaluated for its potential to prevent serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients. Kate OBrien, M.D., M.P.H., associate professor at the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, is the studys principal investigator. Aruna Chandran, M.D., M.P.H., a trial co-investigator, presents the data today at the Pediatric Academic Societies (PAS) Annual Meeting in Honolulu, HI.

This randomized Phase 3 study demonstrated that motavizumab reduced hospitalizations due to RSV by 83 percent as compared to placebo (8.3 percent in placebo arm versus 1.4 percent in motavizumab; p<0.001), as the trials primary endpoint. In addition, the trial showed a 71-percent reduction in the incidence of RSV-specific lower respiratory infections (LRIs) requiring outpatient management (9.5 percent in placebo group and 2.8 percent in the motavizumab group; p<0.001), which was a secondary endpoint.

The randomized, double-blind Phase 3 study involving 1,410 full-term healthy infants less than six months of age in some Southwest Native American populations was designed to compare monthly intramuscular injections of motavizumab against placebo. In previous epidemiologic studies these populations were shown to have high rates of hospitalization due to RSV. This study confirmed the high rates of serious RSV disease in this population. An interim analysis, reviewed by an independent data safety monitoring committee, concluded there was statistical evidence demonstrating that motavizumab reduced RSV hospitalizations and LRIs requiring outpatient medical management within this population.

The overall incidence and severity of adverse events (AEs) were similar between the motavizumab and the placebo groups in these Native American infants. The mortality rates were not statistically different between groups (0.4 percent in the placebo arm, n=2 and 0.3 percent in the motavizumab arm, n=3) and were not considered to be related to the study drug. As was suggested in the pivotal Phase 3 trial conducted in high-risk, preterm infants, rates of skin reactions were more common following motavizumab than placebo (by an approximately 2 percent increase in frequency). Motavizumab was otherwise well tolerated.


'/>"/>

Contact: Jennifer Paganelli
jennifer.paganelli@edelman.com
212-642-7774
Edelman Public Relations
Source:Eurekalert

Related medicine news :

1. Wal-Mart Launches Phase Three of $4 Prescription Program
2. Sanofi-aventis: Encouraging First-Quarter 2008 Results Further Positive Phase III Results for Eplivanserin
3. Antipodean Pharmaceuticals Announces Results of Phase 2 Study of Lead Compound MitoQ(R)
4. Arpida Provides Comprhensive Overview of Pivotal Phase III Trial Data
5. QLT initiates phase II study of punctal plug drug delivery system for glaucoma & ocular hypertension
6. Cystic Fibrosis Foundation announces positive early results for phase 2 clinical trial of VX-770
7. Many Phase 3 Cancer Drug Trials Yield Effective Medicines
8. Cancer treatments in phase 3 trials successful up to half of the time
9. Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant and Engages Merrill Lynch as Strategic Advisor
10. MGH initiates phase I diabetes trial
11. Enrollment completed in 2 pivotal phase III studies of the investigational cancer drug vandetanib
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... April 30, 2016 , ... World Patent Marketing ... Up Springboard, an automotive invention that improves the storage features of a pick ... billion," says Scott Cooper, CEO and Creative Director of World Patent Marketing. "Over ...
(Date:4/29/2016)... ... April 29, 2016 , ... Since launching its annual ... foundation serving the footwear industry, has broken all previous participation records in its ... across 23 states during the months of April and May, the 2016 Footwear ...
(Date:4/29/2016)... ... April 29, 2016 , ... Our bodies are bombarded daily ... confront and deal with these stressors is to adopt a more healthful diet, but ... you. Risa Groux, a certified Holistic Nutritionist and the creator of the Newport Beach ...
(Date:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... ... advocating optimistic healthcare awareness and author of best seller "LOVE, MEDICINE and MIRACLES") ... Radio Monday, May 2, 2016 and podcasted thereafter . Dr. Bernie Siegel, ...
(Date:4/29/2016)... ... April 29, 2016 , ... Coast Dental Fort Stewart is celebrating ... new location in the Exchange Furniture Mall at 112 Vilseck Road in Fort Stewart. ... Smart TV. Plus attendees will have the opportunity to meet general dentists Thomas Richards, ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... April 27, 2016 ... the  "Global Anesthesia Disposables Market 2016-2020"  report ... ) ,The global anesthesia disposables market ... of 4.03% during the period 2016-2020.  ... threat to patients, safety. Organizations like the ...
(Date:4/27/2016)... 2016 The global  gamma ... billion by 2022, according to a new report ... towards a healthy lifestyle is expected to drive ...      (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ) , ... health treatment expenditure has urged consumers to switch ...
(Date:4/26/2016)... April 26, 2016 Hill-Rom Holdings, Inc. (NYSE: ... presentation at the Deutsche Bank 41 st Annual Health ... EDT. You are invited to listen to the ... or access it directly at http://edge.media-server.com/m/p/mr4uxgas . A recorded ... conclusion of the live event and accessible at the links ...
Breaking Medicine Technology: