Xenova Group Starts Anti-Cocaine Vaccine Phase IIb Trial Friday October 24, 2:33 am ET
LONDON -(Dow Jones)- Xenova Group said Friday that it has initiated the first randomised, placebo controlled Phase IIb clinical trial for TA-CD, the company's therapeutic vaccine which is under development for the treatment of cocaine addiction.
TA-CD is being developed with the goal of assisting cocaine addicts in their attempt to quit cocaine. In previous clinical trials TA-CD has been shown to be both safe and well-tolerated, with vaccination generating a dose-related immune response.
Preclinical studies have demonstrated that vaccination produces a reduced self-administered consumption of cocaine. The primary objective of this new Phase IIb trial is to determine the efficacy of TA-CD in addicts seeking treatment for cocaine abuse, and to determine appropriate end-points for a Phase III study.
Up to 132 subjects, all of whom are methadone-dependent cocaine addicts being treated for drug dependency, will be recruited into the placebo-controlled, randomised, double-blinded clinical study. The trial will comprise two equal cohorts.
Half the subjects will be treated with active TA-CD and half will be given a placebo. Subjects will be monitored three times a week to assess cocaine usage, including testing for cocaine metabolites in urine, for a period of 20 weeks.
Patients will also undergo medical examinations and blood tests for anti- cocaine antibodies to assess the immunogenicity of the dosing schedule.
The trial, which is being supported by the U.S. National Institute for Drug Abuse (NIDA), is expected to last up to two years (depending upon the rate of recruitment) and will be conducted in the U.S. at a clinical centre with experience of drug treatment... |
