Patient Dosing Begins in Phase IIa Cocaine Administration Trial For Anti-Cocaine Addiction Vaccine TA-CD
SLOUGH, England, April 14 /PRNewswire-FirstCall/ -- Xenova Group plc (Nasdaq: XNVA - News; London Stock Exchange: XEN - News) today announced that patient dosing has begun in a Phase IIa cocaine administration trial for Xenova's therapeutic vaccine TA-CD, which is under development for the treatment of cocaine addiction. The ten-patient open label trial is being conducted in the United States and is designed to evaluate the effect of TA-CD on behavioural changes associated with cocaine administration.
Cocaine-dependent volunteers, specifically selected from those not seeking to quit, undergo psychological and physiological assessments whilst cocaine is administered under laboratory conditions. The effect of TA-CD will be determined by comparing findings from before and after a four-dose immunisation course. 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. TA-CD is the first vaccine to be developed with the goal of assisting cocaine abusers in their attempt to quit cocaine.
Previous clinical studies have shown that administration of TA-CD leads to the generation of antibodies that can bind free cocaine. TA-CD is a cocaine derivative conjugated to a carrier protein and formulated with an adjuvant. Ultimately, it is intended for use alongside behavioural therapy programmes in patients who are trying actively to overcome their cocaine addiction.
Cocaine abusers who make an attempt to quit, are at risk of relapse if they 'slip' and use cocaine. By vaccinating those who wish to quit, it is intended that if the patient 'slips' the cocaine will bind to antibodies in the blood stream and interfere with the ability of the cocaine to enter the brain and stimulate the reward centres. The objective of vaccination with TA-CD is to reduce the euphoria obtained by the individual, thus diminishing the reinforcing effects of cocaine and increasing the likelihood of a successful attempt to quit.
Currently, there is no effective pharmacotherapy available for the approximately 900,000 individuals in the USA each year who seek medical help with respect to their cocaine addiction.
"There is a substantial need for new approaches to help drug addicts overcome their habit," said David Oxlade, Chief Executive of Xenova. "TA-CD has made promising progress in earlier clinical studies and this additional trial is designed to show for the first time whether addicts' behaviour can be altered by administration of the TA-CD vaccine," he added.
Notes to Editors
Xenova Group plc's product pipeline focuses principally on the therapeutic areas of cancer and immune system disorders. Xenova has a broad pipeline of programmes in clinical development. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with significant pharmaceutical and biopharmaceutical companies including Lilly, Pfizer, Celltech, Genentech, QLT and Millennium Pharmaceuticals.
TA-CD is designed for use alongside a behavioural therapy program in patients who are trying actively to overcome their cocaine addiction. TA-CD represents a completely new approach to the treatment of cocaine addiction by way of immune intervention. The vaccine aims to build an antibody response against the drug which will neutralize its effect on the brain. The results of an earlier four-dose Phase IIa dose escalation study, which were reported in July 2001, found that TA-CD was well tolerated both systemically and locally, and an attenuation of the usual euphoric effects of cocaine was reported amongst five of six patients who relapsed during the study, providing anecdotal evidence of the benefit TA-CD may provide. In April 2002 patient dosing began in an open label Phase IIa dose escalation trial for TA-CD, which was designed to evaluate the safety and immunogenicity of TA-CD using a 4 or 5 dose vaccination schedule. This study is being funded in part by the National Institute on Drug Abuse (NIDA). NIDA has also supported earlier clinical work as part of this program.
Regular cocaine users number more than two million in the U.S. alone. Of these, approximately 900,000 seek treatment each year. Most cocaine addicts are treated by a specialist physician or psychiatrist in drug rehabilitation centres. However, due to a high relapse rate reported with current treatment, there is a clear need for an effective treatment to be used alongside a behavioural therapy program, where currently nothing is available.
For further information about Xenova and its products please visit the Xenova website at www.xenova.co.uk |
