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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


2/29/2012 11:30:04 AM

SAN DIEGO, Feb. 29, 2012 /PRNewswire/ -- BrainCells Inc., a leading biotechnology company developing novel compounds for the treatment of central nervous system (CNS) diseases, announced today that the Phase 1 single ascending dose (SAD) study of BCI-838 has been successfully completed and that the company has initiated the Phase 1 multiple ascending dose (MAD) study. The SAD study evaluated BCI-838 for safety, tolerability, pharmacokinetics and food effect in healthy male subjects. Single oral doses of BCI-838 up to 900 mg were administered and the drug was well tolerated. No serious adverse events were reported and all adverse events were mild in intensity, transient, and resolved without sequelae.

"BCI-838's biological activity mimics that of ketamine, an intravenous anesthetic, which has been shown to be efficacious in treating patients with TRD. Since ketamine is associated with a number of unwanted side effects such as short-term dissociation and psychosis, safer compounds that act in a similar fashion promise to revolutionize the way the disease is managed for these patients," said Robert Williamson, Chief Executive Officer.

BCI-632 increases synaptic glutamate by inhibiting the mGlu2/3 auto-receptor, which is located predominantly at the pre-synaptic site. As in the case of ketamine, the long-lasting efficacy of BCI-632 can be blocked by either inhibition of AMPA receptors, mTOR or the BDNF signaling pathway. In contrast to ketamine, BCI-632 does not cause psychosis or dissociative effects. In addition, BCI-632 also stimulates serotonin release and, after chronic dosing, hippocampal neurogenesis.

"BCI-838 is an oral prodrug for the active compound BCI-632 that is an mGluR2/3 antagonist," said John Hutchinson, Ph.D. Senior Vice President of Research. "BCI-632 has been shown to work acutely in a range of animal models of depression, anxiety, cognition and Alzheimer's disease."

"BCI-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 tolerability. Currently available antidepressants are associated with adverse events, such as gastrointestinal symptoms, agitation, and sexual dysfunction that may affect treatment compliance.

About BrainCells Inc.

BrainCells Inc. is a clinical stage company that is developing novel therapies for the treatment of central nervous system (CNS) diseases based on the principal of blocking or antagonizing select metabotropic glutamate receptors (mGluR). Glutamate, an amino acid, functions as a neurotransmitter and glutamate receptors are implicated in a number of CNS diseases due to their central role in excitation of neural cells. BrainCells has identified a novel mGluR2/3 antagonist, BCI-632. The compound and its prodrug, BCI-838, have been extensively studied in preclinical models suggesting broad therapeutic potential in the treatment of MDD, TRD and potentially Alzheimer's disease (AD).

For more information, contact Rob Williamson at 858-812-7700.

SOURCE BrainCells Inc.



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