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

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
Edelman Public Relations

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:
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... for Tuberous Sclerosis Complex (TSC), as well as raising public awareness of the ... they need it—presented a third donation of $35,000 to bolster progress at the ...
(Date:11/25/2015)... ... 25, 2015 , ... Bunion Bootie , the newest ... of the early holiday shopping season. Starting Wednesday November 25th, Bunion Booties are ... Friday promotional pricing is in addition to any automatic discounts applied when buying ...
(Date:11/24/2015)... ... ... Dr. Todd S. Afferica, a noted general dentist in Norcross, GA ... Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many of his dental procedures. ... traditional cutting tools, such as the scalpel and high-speed drill, which can both cause ...
(Date:11/24/2015)... ... , ... Charitable giving is at its peak during the holidays. In ... of the year totalling over $358 billion in 2014. With more than 1.5 ... those individuals who want to “give back” during the holidays. , “With so many ...
(Date:11/24/2015)... (PRWEB) , ... November 25, 2015 , ... ... technologies and development solutions for drugs, biologics, consumer health and global clinical supply ... present at the upcoming Clinical Trial Supply East Asia Conference, to be held ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... -- Teledyne DALSA , a Teledyne Technologies company and ... its CMOS X-Ray detector for mammography at the ... 3, at McCormick Place in Chicago . ... imaging will be on display in the South Hall, Booth ... X-Ray detectors is the industry benchmark for high speed imaging ...
(Date:11/24/2015)... , Nov. 24, 2015  Boston Scientific Corporation (NYSE: ... Oppenheimer 26th Annual Healthcare Conference on December 8, in ... Susie Lisa , vice president, Investor Relations, will participate ... beginning at approximately 8:35 a.m. ET. --> ... in a 30-minute question-and-answer session with the host analyst ...
(Date:11/24/2015)... 2015   Renowned ... deliver s advice and insights on supplements ... More than 50% of Dubai ... to the DHA   femMED launches comprehensive solutions for women ... Dubai residents are not consuming enough to keep themselves ...
Breaking Medicine Technology: