BrainCells Inc. Announces the Successful Completion of the Single Ascending Dose Study With BCI-838 and the Initiation of the Multiple Ascending Dose Study

BrainCells Inc. Announces the Successful Completion of the Single Ascending Dose Study With BCI-838 and the Initiation of the Multiple Ascending Dose Study

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.

BrainCells Inc. Announces the Successful Completion of the Single Ascending Dose Study With BCI-838 and the Initiation of the Multiple Ascending Dose Study

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.”

Unlikely treatment identified by Braincells neurogenesis platform improved clinical outcomes in patients suffering from depression

 
SAN DIEGO, July 27 /PRNewswire/ — BrainCells Inc., a company leading the scientific research of neurogenesis using its proprietary platform technology to identify novel pathways for the treatment of central nervous system (CNS) diseases, announced today results from the first clinical proof-of-concept study of BCI-952, a combination of low dose buspirone and melatonin, for the treatment of major depressive disorder (MDD). The data were presented at NCDEU 2009, a meeting co-sponsored by the National Institute of Mental Health and the American Society of Clinical Psychopharmacology. Neurogenesis is the process by which pre-existing stem cells in the hippocampus of the adult brain produce new brain cells, including neurons.

Unlikely treatment identified by Braincells neurogenesis platform improved clinical outcomes in patients suffering from depression

BrainCells Inc., a company leading the scientific research of neurogenesis using its proprietary platform technology to identify novel pathways for the treatment of central nervous system (CNS) diseases, announced today results from the first clinical proof-of-concept study of BCI-952, a combination of low dose buspirone and melatonin, for the treatment of major depressive disorder (MDD). The data were presented at NCDEU 2009, a meeting co-sponsored by the National Institute of Mental Health and the American Society of Clinical Psychopharmacology. Neurogenesis is the process by which pre-existing stem cells in the hippocampus of the adult brain produce new brain cells, including neurons.

BrainCells expands Series B financing to $50 million

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 raised an additional $20 million in an extension of its Series B financing, bringing the total to $50 million. New investor, New Enterprise Associates (NEA), along with current investors and Alexandria Real Estate Equities, Inc. participated in the extension. Other investors that participated in the Series B included MedImmune Ventures, Bay City Capital, Oxford Bioscience Partners, Technology Partners, Pappas Ventures and NeuroVentures. The financing will be used to continue clinical development of BCI’s product candidates including a Phase 2 trial with BCI-540, and to identify additional assets to further expand its pipeline.

BrainCells expands Series B financing to $50 million

 
San Diego, CA, 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 raised an additional $20 million in an extension of its Series B financing, bringing the total to $50 million. New investor, New Enterprise Associates (NEA), along with current investors and Alexandria Real Estate Equities, Inc. participated in the extension. Other investors that participated in the Series B included MedImmune Ventures, Bay City Capital, Oxford Bioscience Partners, Technology Partners, Pappas Ventures and NeuroVentures. The financing will be used to continue clinical development of BCI’s product candidates including a Phase 2 trial with BCI-540, and to identify additional assets to further expand its pipeline.

BrainCells Inc. initiates Phase 2 clinical trial with BCI-540 for depression with anxiety

 
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.

BrainCells, Taisho Pharmaceutical, sign licensing agreement for novel CNS program

BrainCells Inc. (BCI) and Taisho Pharmaceutical Co., Ltd. (Taisho) today announced that BCI has in-licensed a novel development program from Taisho that BCI will develop for central nervous system (CNS) indications, including mood disorders. Taisho retains rights to the program in Japan and China, while BCI will have rights for the remainder of the world. Financial terms were not disclosed.