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Xenova Group TA-CD Product Released From Clinic Hold By FDA NEW YORK -(Dow Jones)- Xenova Group PLC`s (XNVA) anti-cocaine addiction vaccine product candidate was released from clinical hold with immediate effect, following a review by the Food and Drug Administration. In a press release Monday, the pharmaceutical company said 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, according to the company. TA-CD is designed to work by generating antibodies in the bloodstream, 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. Xenova expects to begin a new Phase II cocaine study in the U.S. in the near future. Addicts will be given cocaine under controlled conditions before and after vaccination with TA-CD and their behavior monitored. The purpose of the study is to provide an assessment of the efficacy of TA-CD, as determined by quantitative behavioral and other measurements. -Sam Favate; Dow Jones Newswires; 201-938-5400 |
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| aus der Diskussion: | XENOVA - DISKUSSIONS-THREAD Nr. 2 (Stand: 06.11.2000) |
| Autor (Datum des Eintrages): | Wunram (09.07.01 09:56:48) |
| Beitrag: | 60 von 275 (ID:3912226) |
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