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:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... Francisco, CA (PRWEB) , ... June 24, 2016 ... ... CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive ... self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB ... Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards ... in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Any dentist who has made an implant supported ... Many of them do not even offer this as a ... laboratory costs involved. And those who ARE able to offer ... high cost that the majority of today,s patients would not ... Zadeh , founder of Dental Evolutions Inc. and inventor of ...
(Date:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Issue 52" report to their offering. ... treatment creates a favourable commercial environment for MedImmune to enter. ... base that will serve to drive considerable growth for effective ... serve to cap sales considerably, but development is still in ...
Breaking Medicine Technology: