Strong Ph II data for Celtic cocaine addiction vacc

US drugmaker Celtic Pharma say that preliminary results from two Phase II studies of TA-CD, its novel immunotherapy vaccine for the treatment of cocaine addiction, were presented and reviewed at a meeting of National Institute on Drug Abuse officials, consisting of drug addiction experts from leading US research institutions as well as members of the Celtic Pharma team.

The first study was a Phase IIa trial of TA-CD in chronic cocaine-dependent volunteers who were not actively seeking to reduce or stop their drug use. Results demonstrated that volunteers who successfully developed good levels of anti-cocaine antibodies in their blood experienced an attenuation of the euphoria normally expected from its use. This response also resulted in a substantial reduction in the volunteers' reported usage.

The second trial was a double-blinded, placebo-controlled Phase IIb study in 114 patients, evaluating the agent in cocaine users who were also on methadone maintenance therapy for the treatment of heroin addiction. The primary end-point - improvement in abstinence from cocaine for three consecutive weeks - was not achieved, in part, due to a higher-than-expected placebo effect, Celtic noted. Nevertheless, some significant indications of efficacy were demonstrated, including twice as many patients in the treatment group achieving a 50% or greater increase in cocaine-free days as measured by urine analysis, the firm concluded.