Nicotine-Qbeta: Interim Phase II data

Interim data from a double-blind Phase II trial in 200 cigarette smokers showed that repeated administrations of 100 µg NIC002 missed the primary endpoint of continuous abstinence from smoking from weeks 8 to 12 after start of treatment vs. placebo. Cytos said the vaccine failed to induce "sufficiently high" antibody titers, which may have led to the missed endpoint. The vaccine was well tolerated. Cytos said Novartis will conduct additional analyses of the data and determine next steps once the 12-month trial is complete. Novartis has exclusive, worldwide rights to develop and commercialize the vaccine to treat nicotine addiction from Cytos under a 2007 deal (see BioCentury, April 30, 2007). ...