MEDI is engaging in quite the PR blitz, with ASCO news coming out at the same time as Numax news, as well as FluMist news. What could be left in the PR cannon? Would be tempted to short any run on this stuff. The melanoma results look middling compared to other agents at similar stages of development (guess we AMEV holders should be happy Lilly bought us out). The Numax results are early, involve safety only, and were expected. The CAIV-T results, well, expected, I guess, but where are the numbers?
>>WASHINGTON, May 14 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) announced today data from a Phase 1/2 study demonstrating that Numax appears to be safe and well tolerated, with an acceptable pharmacokinetic profile, in infants at high risk of respiratory syncytial virus (RSV) disease. MedImmune is developing Numax as a potential improvement to Synagis® (palivizumab), which it introduced to the market in 1998 and has become the standard of care for protecting high-risk infants against RSV. To date, Synagis has successfully helped to reduce the incidence of serious lower respiratory tract illness in more than 700,000 high-risk infants.
"Numax has been shown in preclinical studies to be more potent than Synagis in reducing RSV replication in both the lower and upper respiratory tract," said Genevieve Losonsky, M.D., senior director, clinical development. "Our development goals for Numax are to fully assess its safety and to evaluate if the increased potency seen in preclinical studies can be translated into better efficacy against RSV hospitalizations, medically attended lower respiratory tract illness and upper respiratory tract disease, such as otitis media (middle ear infections)."
An abstract presented today at the annual meeting of the Pediatric Academic Societies in Washington, DC was entitled "Phase 1/2 Trial in High- Risk Infants of MEDI-524 (Numax(TM)) an Enhanced Potency Respiratory Syncytial Virus (RSV) Specific Monoclonal Antibody." The dose-escalation trial was conducted in North and South America and included 217 preterm infants (32-35 weeks gestational age) and infants with chronic lung disease of prematurity two years of age or younger. Each participant received up to five monthly intramuscular injections of Numax and had completed evaluations through 90 days after the final dose for safety, immunogenicity and pharmacokinetics.
In March, MedImmune presented results from Phase 1 and 2 studies of Numax, including data that showed Numax was present in the nasal secretions of patients receiving the antibody and inhibited viral replication in the nose. These results were presented at the 7th International Symposium on Respiratory Viral Infections in Curacao. More recently, MedImmune also initiated a Phase 2, second-season study to determine the safety of re-dosing children who received Numax in a prior RSV season.
RSV is the most common respiratory infection in infancy or childhood, resulting in more than 125,000 hospitalizations in the U.S. annually in children less than one year of age. Children born prematurely as well as those with chronic lung disease or congenital heart disease are at highest risk of severe disease and hospitalization due to RSV.
About Numax
Numax is a humanized monoclonal antibody currently being developed to potentially prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high-risk of RSV disease. In November 2004, MedImmune initiated a pivotal worldwide Phase 3 study comparing the safety and efficacy of Numax in reducing RSV disease in high-risk infants to that of Synagis. A Phase 3 study is also underway to evaluate the safety and efficacy of Numax in healthy Native American infants.<<
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>>WASHINGTON, May 14 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) announced today data from several studies that provide evidence that its live, attenuated intranasal influenza vaccines may provide broad protection against influenza. Results from clinical trials of the currently marketed FluMist® (Influenza Vaccine Live, Intranasal) and the investigational, next-generation refrigerator stable CAIV-T (cold adapted influenza vaccine, trivalent) are being presented at the annual meeting of the Pediatric Academic Societies (PAS) in Washington, DC, beginning on May 14, 2005.
"These presentations add to the growing body of data regarding the potential advantages of live, attenuated intranasal influenza vaccine technology," said Francois Lebel, M.D., vice president, medical affairs. "The studies support previous clinical observations that this vaccine technology appears to provide benefit during years in which the circulating strains of influenza were mismatched to the influenza vaccines administered in the community."
Each year, strains for the annual influenza vaccines are chosen in advance of the flu season. In some seasons, the predominantly circulating strains do not match those within the vaccines. When this "vaccine mismatch" occurs, it is more difficult for influenza vaccines to provide comprehensive protection. Significant vaccine mismatch has occurred in four of the last eight influenza seasons, including both the 2003-2004 and 2004-2005 seasons. Data from three studies and a retrospective review support the conclusion that FluMist helps provide protection in both matched and mismatched influenza seasons.
* "Live Attenuated Influenza Vaccine (LAIV) Administration in
Schoolchildren Coincident With the 2003-2004 Outbreak Provided Herd
Immunity Against a Drifted Influenza Variant A/Fujian/411/2002 (H3N2)."
Results from this herd immunity study indicated that immunizing school-
aged children helped protect both the children and the extended
community from influenza during a mismatched season.
* "Protection of Live Attenuated Intranasal Influenza Vaccine-Trivalent
(FluMist®) Against Pneumonia and Influenza (P-I) in School-Aged
Children in the 2003-2004 Influenza Type A (H3N2) Outbreak." Data from
this pilot, National Institutes of Health-sponsored, community-based
intervention trial suggest that FluMist may be efficacious when
administered during an influenza outbreak when the predominant
circulating strains were mismatched to the vaccine.
* "Cross-Protection Against Antigenic Variants by Live-Attenuated
Influenza Vaccine in Children." This is a retrospective review of
mismatch efficacy of live attenuated intranasal vaccine in children 6
months to 18 years of age from 1996 to 2002. Efficacy against the
mismatched strain A/H3N2 was 86 percent to 89 percent, and efficacy
against the mismatched type B strains was 50 percent to 66 percent.
* "A Pilot Study of the Effectiveness of a School-Based Influenza
Vaccination Program Using the Nasally Administered Vaccine FluMist." In
this pilot intervention study, children who were immunized with FluMist
in their schools experienced a reduction in medical visits and missed
school days in the mismatched 2003-2004 influenza season. Overall
school absenteeism was not statistically different among the
intervention and control schools.
Two Phase 3 placebo-controlled studies presented at the PAS meeting provide evidence for the safety and efficacy of CAIV-T in young children, including:
* "Efficacy of a Cold-Adapted, Live Attenuated, Influenza Vaccine in
Children Aged 6 to <36 Months Attending Day Care Centers in Europe and
Israel Against Culture-Confirmed Influenza"
* "Efficacy and Safety of a Live Attenuated, Trivalent Influenza Vaccine
(CAIV-T) in Children Living in South East Asia Against Community
Acquired Culture-Confirmed Influenza"
These studies add to the body of data presented at last year's PAS annual meeting, which included two international Phase 3 studies in children with a history of respiratory illness. Results from the studies presented in 2004 demonstrated a 35 percent to 53 percent relative decrease in influenza with CAIV-T as compared to the traditional injectable vaccine.<<
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Of course, it's the CAIV-T results that really matter here. Can't say as there's much hard data to chew on in this PR. I would imagine it's doing OK, but the price issue could still be a problem. As well as which flu season they are expected to market CAIV-T in. A miss would hurt. I haven't paid attention. Anybody?
Cheers, Tuck |
