FDA Releases Anti-Cocaine Vaccine From Clinical Hold And Trials Resume.(TA-CD resumes trials)

2001 AUG 15 - (NewsRx.com & NewsRx.net) --

Xenova Group plc (XNVA) announced that, following a U.S. Food and Drug Administration (FDA) review of the company's recently submitted toxicology and clinical study results, the FDA has notified Xenova that its TA-CD (anti-cocaine addiction vaccine) product candidate has been released from clinical hold with immediate effect.

The TA-CD Phase IIa study had been placed on precautionary hold in August 2000 following the observation that a related product caused eye irritation in preclinical studies. No such effects were observed with TA-CD in man and extensive further testing of the related product has shown no safety implications. These results were submitted to the FDA in May 2001 and, following FDA review, the clinical hold on the TA-CD IND was removed.

TA-CD is designed to work by generating antibodies in the bloodstream, thus preventing cocaine from crossing from the bloodstream into the brain, and stopping cocaine from blocking dopamine uptake, which is the cause of the high that addicts obtain. Patients may therefore be expected to benefit most from the support offered by TA-CD during the approximately nine-month period that it takes for the addiction craving for cocaine to be lost.

It was also announced that the successful results of this Phase IIa trial were presented at the 63rd Annual Scientific Meeting of the College on Problems of Drug Dependence, in Arizona. The nine-patient study, in outpatient cocaine addicts, was conducted by Dr. Thomas Kosten, professor of psychiatry, Yale University School of Medicine, New Haven, Connecticut, and was designed to evaluate the safety and immunogenicity of TA-CD using a four-dose accelerated vaccination schedule.

TA-CD was shown to be well tolerated systemically and locally and was able to generate higher and earlier antibody titers than those seen in a Phase I 34-patient trial using a three-dose vaccination schedule, ...