Tuesday June 15, 4:45 pm Eastern Time
Company Press Release
SOURCE: Cantab Pharmaceuticals plc
Cantab's Anti Cocaine Vaccine Demonstrates Safety
and Immunogenicity in Phase I Trial
- Results Presented at The 61st Annual Scientific Meeting of The American College on Problems
of Drug Dependence -
CAMBRIDGE, England, June 15 /PRNewswire/ -- Cantab Pharmaceuticals plc (Nasdaq: CNTBY; LSE: CTB) today
announced findings from a Phase I clinical trial with its anti cocaine vaccine, TA-CD. The principal investigator, Thomas
Kosten, MD, (VA Medical Center, West Haven, Connecticut) presented results at the 61st Annual Scientific Meeting of the
College on Problems of Drug Dependence (CPDD) in Acapulco, Mexico.
The trial, designed to demonstrate the safety and immunogenicity of TA-CD, was a double blind placebo-controlled dose
escalation study run at a drug rehabilitation facility in New England, USA.
Thirty-four subjects, all with a history of cocaine addiction, were enrolled in the trial. The trial protocol involved three injections
of vaccine at four-weekly intervals. Key findings from the trial included:
TA-CD was shown to have a positive safety and tolerability profile.
No serious vaccine-associated adverse events were reported.
All patients receiving the active vaccine mounted an antibody response
that was dose related.
Antibody responses persisted to at least day 84.
This antibody was shown to be capable of recognizing free cocaine in the blood.
''We were encouraged by the evidence that the vaccine was very well tolerated and able to generate sustained antibody
responses at all dose levels,'' said Dr. Kosten. ''I am very keen to see this vaccine development program move forward into
more advanced trials. TA-CD offers the potential for a new and highly viable approach to a very serious problem for which
there are no alternative pharmacotherapies available.''
This Phase I trial received funding support from the US National Institute on Drug Abuse (NIDA), one of the National
Institutes of Health, Bethesda, Maryland.
''These encouraging early clinical data with TA-CD broadly endorse the scientific rationale of our substance addiction vaccine
programs,'' said John St Clair Roberts, MD, Medical Director at Cantab. ''With this initial success as a platform, we look
forward to progressing not only TA-CD into Phase II trials, but also moving TA-NIC, our anti nicotine vaccine candidate
based on the same scientific strategy, swiftly through Phase I.''
A randomized placebo-controlled Phase II clinical trial is planned to commence in the second half of 1999. In addition to
providing further information on product safety and immunogenicity, it will aim to evaluate the effect of TA-CD on reducing
patient cocaine use.
Cantab Pharmaceuticals plc, based in Cambridge, UK, was established in 1989 to exploit advances in immunology. Cantab
has become a leader in the field of immunotherapy, developing novel products for the treatment and prevention of chronic
infectious diseases, cancer and substance addiction through use of its proprietary antigen and gene delivery systems.
SOURCE: Cantab Pharmaceuticals plc |
