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May 12, 2008

Novartis released positive results from a phase III trial of Menveo, a vaccine for the prevention of meningitis. This head to head study enrolled 2,100 subjects, aged eleven to eighteen years, who received a single vaccination with either Menveo or Menactra, an FDA approved vaccine. Data showed that the subjects who were immunized with Menveo generated higher levels of antibodies against four meningococcal serogroups: A, C, W-135 and Y. One month after vaccination geometric mean titers for Menveo versus Menactra were: serogroup A, 29 versus 18; serogroup C, 59 versus 47; serogroup W-135, 87 versus 44 and serogroup Y, 51 versus 18. The percentage of subjects who achieved a protective immune response, determined by a human serum bactericidal antibody titer (hSBA) > 1:8, with Menveo compared to Menactra was: serogroup A, 75% versus 67%; serogroup C, 84% versus 84%; serogroup W-135, 96% versus 88%; and serogroup Y, 88% versus 69%. In addition, among adolescents with low levels of immunity at the time of vaccination, 81% who received Menveo generated a protective immune response against serogroup Y versus 54% with Menactra. Based on positive phase results Novartis plans to submit a BLA to the FDA by the end of 2008.

January 14, 2008

Novartis issued positive results from a phase II trial of Menveo, a vaccine for the treatment of meningococcal disease. This randomized, open-label trial enrolled four hundred and twenty one infants in the United Kingdom and Canada. The trial was designed to evaluate multiple schedules, including two three-dose primary schedules, at either two, three and four months and two, four and six months. Some of the infants received either an additional dose of Menveo or a plain meningococcal polysaccharide at twelve months. One month after the last primary immunization, the percentage of infants with human serum bactericidal antibody assay (hSBA) titers greater than or equal to 1:4 in the 2, 3, 4-month group was 93% or above for all four serogroups: A, C, W-135 and Y. Immunization at two, four and six months resulted in a similarly high percentage of infants achieving immune response for serogroups C, W-135 and Y, and 81% for serogroup A. The dose at twelve months generated a strong immune response across all four serogroups, was shown to increase levels of immunity, and is likely to provide sustained protection. Phase III trials of Menveo are currently underway.

November 26, 2007

Advanced Life Sciences reported positive results from a phase III trial of cethromycin for the treatment of community acquired pneumonia. This double-blind, randomized, comparator study, dubbed CL-05, enrolled 584 adult subjects in the US, Canada and South Africa. The subjects received cethromycin 300 mg once-daily or Biaxin 250 mg twice-daily, the current standard of care, for seven days. The primary efficacy endpoint was statistical non-inferiority in the clinical cure rate at the test-of-cure visit between the two treatment arms. This endpoint was achieved, with a clinical cure rate in the cethromycin group of 94.0% compared to Biaxin with a cure rate of 93.8%. In the bacteriologically evaluable population, cethromycin had a clinical cure rate of 95.9% compared to Biaxin with a cure rate of 97.1%. Treatment was well tolerated. Based on the results, Advanced Life Sciences plans to move towards the filing of an NDA with the FDA.

Novartis reported positive results from a phase II trial of Menveo, a vaccine for the prevention of meningitis in infants. This trial enrolled 175 infants who were randomized to receive either two doses of Menveo at both six and twelve months of age, one dose of Menveo at twelve months or a currently approved meningococcal meningitis serogroup C vaccine also at twelve months and then followed by Menveo at eighteen months. Following vaccination, the infants were measured for immune response to antigens via the hSBA, or the human serum bactericidal antibody assay. One month after vaccination, infants receiving Menveo achieved protective antibody levels >1:4 for all four meningococcal serogroups (A, C, W-135 and Y). After two doses of Menveo, the percentage of infants achieving hSBA titer >1:4 was 100% for the serogroups C, W-135 and Y35 and 86% for serogroup A. After a single dose of Menveo at twelve months, the percentages were > 93% for serogroups C and W-135 and > 75% for serogroups A and Y. Of the infants who received the Menveo booster at eighteen months following a single dose at twelve months, 100% achieved hSBA titers > 1:4 for serogroup C, 62% for A, 84% for W-135 and 81% for Y. Treatment was well tolerated in this population. Treatment was well tolerated. Phase III trials are underway and regulatory submissions are expected in 2008.