Results of second Phase IIa dose escalation study of TA-CD vaccine for treatment of cocaine dependence
Slough, UK, 17 June, 2003 - Xenova Group plc (NASDAQ NM: XNVA; London Stock Exchange: XEN) today reported the results of a second Phase IIa study for TA-CD, its candidate therapeutic vaccine for the treatment of cocaine dependence. The results of this dose escalation trial, which was carried out by Professor Thomas Kosten at Yale University, were announced at the 65th Annual Meeting of The College on Problems of Drug Dependence at Bal Harbour, Florida 14-19th June.
TA-CD is being developed with the goal of assisting cocaine abusers in their attempt to quit cocaine. This new trial, which is the second Phase II study to be carried out on TA-CD, started in April 2002. It involved the enrolment of 13 subjects, all of whom were cocaine abusers seeking help with their addiction at the start of the trial. Patients were treated with up to five injections of the vaccine over a twelve week period using doses up to 360 (micro)g each. Of the thirteen enrolled, twelve subjects completed the 12 month evaluation period to assess safety, immune response and cocaine usage.
The results showed the vaccine to be safe and well tolerated with a dose-related immune response. Of those 16 patients in the two Phase IIa studies who used cocaine at any time following vaccination, 14 reported a reduction of the usual euphoric effect normally associated with cocaine use, providing further anecdotal evidence of the vaccine's proposed mode of action.
'This trial is another important milestone for this programme and paves the way for the start of forthcoming efficacy trials,' commented David Oxlade, Chief Executive of Xenova.
This study is being funded, in part, by the US National Institute on Drug Abuse (NIDA). NIDA has also supported earlier clinical work on TA-CD |
