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BrainCells Inc. Initiates Phase 2 Clinical Trial with BCI-540 for Depression with Anxiety


4/17/2008 4:35:45 PM

SAN DIEGO, April 17, 2008 – BrainCells Inc. (BCI), a biopharmaceutical company utilizing its platform technology to identify and develop compounds that promote the growth of new neurons for the treatment of central nervous system (CNS) diseases, announced today that it has initiated a Phase 2a clinical trial with its lead product candidate, BCI-540, for the treatment of depression with anxiety.

“We are encouraged by the enthusiasm expressed by our clinical investigators who view BCI-540 as a potential alternative to today’s widely prescribed treatments for depression,” noted Carrolee Barlow, M.D., Ph.D., Chief Scientific Officer at BCI. “Current therapies directly impact serotonin levels causing many unpleasant side effects, however we have shown that BCI-540 directly impacts neurogenesis without affecting serotonin levels. We are excited about the potential of this compound to change the way mood disorders are treated.”

The twelve-week randomized double-blind, placebo-controlled study will evaluate safety, efficacy and tolerability of BCI-540 to determine whether 80 mg given once or three times daily is effective in the treatment of depression with anxiety versus placebo.

“BCI is utilizing our understanding of the power of neurogenesis coupled with our proprietary neurogenic platform technology to identify a strong portfolio of clinical candidates, such as BCI-540, that we plan to move into the clinic this year,” said Jim Schoeneck, CEO at BCI. “Moving BCI-540 into the clinic is an important milestone and we are now actively enrolling patients and anticipate completing enrollment by the end of this year.”

About BrainCells Inc. BrainCells Inc. (BCI) is a San Diego-based drug discovery and development company that is applying its proprietary neurogenesis platform technology to identify and reposition compounds for the treatment of central nervous system (CNS) diseases. Neurogenesis is the process by which endogenous stem cells in the adult human brain produce new brain tissue, including neurons. With its predictive screening platform, BCI can direct the selection and development of neurogenic compounds, increasing the opportunity for successful clinical trials in a variety of CNS indications. For more information, visit http://www.braincellsinc.com.



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