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BrainCells Inc. Announces the Successful Completion of the Single Ascending Dose Study With BCI-838 and the Initiation of the Multiple Ascending Dose Study
Date:2/29/2012

CI-838 has the potential to provide meaningful clinical benefits for patients suffering from TRD.  We believe that BCI-838 may have comparable efficacy to ketamine without the liability of psychosis, the need for intravenous administration or inpatient monitoring.  Furthermore, the neurogenic effect of BCI-838 in the hippocampus suggests that BCI-838 may be a novel treatment for a broader population of patients with mood or cognitive disorders," said Steven D. Targum. M.D., Chief Medical Officer.  "The Phase 1 MAD study will be completed by June and we intend to study MDD patients who are treatment-resistant shortly thereafter."

About TRD and MDD

Major Depressive Disorder (MDD) is a highly prevalent disorder causing marked social and economic problems for affected patients and their families. According to the World Health Organization, MDD is the leading cause of disability worldwide. MDD is associated with high morbidity contributing to greater health risks and a high risk for mortality.

Many depressed patients are not correctly diagnosed and may receive no treatment at all.  Many other MDD patients who are treated do not achieve a full remission of their symptoms despite treatment. In the NIMH sponsored STAR*D study (Sequenced Treatment Alternatives to Relieve Depression), only 36.8% of patients achieved remission with citalopram, a first-line antidepressant treatment in the sequence. In fact, several other studies have also shown that less than 50% of treated MDD patients achieve more than a 50% reduction of their symptoms.  Some MDD patients appear to be resistant to antidepressant treatment. Treatment resistant depression (TRD) is defined as the failure to fully respond to an antidepressant treatment despite having had an adequate dose and duration of treatment. Despite the availability of many new therapeutic agents in recent decades, these medications have revealed issues related to limited efficacy and to
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SOURCE BrainCells Inc.
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