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news.Israeli drug development firm BioLineRx has reported positive results from the phase I trial of its experimental oral compound, the first GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia.
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The company said that data from the placebo-controlled trial, which studied healthy adult males, aged 21 to 45, demonstrated biochemical evidence of dopamine blockade, which is indicative of efficacy. Dopamine hyperactivity is implicated in schizophrenia, and is the mechanism of action for various antipsychotic drugs.
BioLineRx added that the phase I trial also demonstrated that the compound appeared to be protective against extrapyramidal symptoms, a severe side effect of many antipsychotic medications.
BL-1020 was extremely well tolerated in the placebo-controlled trial, as no ECG psychiatric or neurological abnormalities were seen at any of the doses tested, which ranged from 4mg to 40mg.
As a result of these encouraging results, BioLineRx plans to initiate a phase II clinical trial for BL-1020 to determine the maximum tolerated dose in schizophrenic patients. The trial is expected to begin in the end of June 2007.