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Translated summary of immediate announcement of parent company Bio-Light Israeli Life Science Investments (TASE:BOLT)
Obecure Ltd. (Obecure) announced the beginning of a Phase Ib clinical trial, BET-209, to investigate the potential and safety of the use of HistaleanTM in a high dosage (144 mg. daily) for the prevention of weight gain in pre-menopausal women (ages 18-45) taking the anti-psychotic drug Zyprexa® (Olanzapine).
The Company decided to conduct this trial after considering and reassessing the interim analysis findings of its prior study conducted in schizophrenia patients, as well as its post-hoc findings in its prior obesity trial. .
The trial involves the participation of 50 healthy women and will investigate, over a period of a month, the safety of co-administering Olanzapine with HistaleanTM, as compared to safety in a control group treated with olanzapine and placebo. The drug's potential in terms of attenuating the weight gain expected as a result of treatment with olanzapine, will also be assessed.
The trial received the approval of the applicable regulatory agencies and is expected to be completed by over the course of the second half of 2009. |