Navigation Links
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.

"Our study results provide the first prospective clinical validation of neurogenesis as a target for the treatment of mood disorders like depression, in contrast to the traditional focus on affecting serotonin function for antidepressant drug development," said lead investigator Maurizio Fava, M.D., vice chair, department of psychiatry at Massachusetts General Hospital and professor of psychiatry at Harvard Medical School. "Researchers have speculated that the brain's ability to grow new brain cells may have an impact on depression, and we now know that we can stimulate the natural process of neurogenesis with a positive clinical impact on depression symptoms."

"BCI-952 was selected by our proprietary platform for the compound's neurogenic properties," said Jim Schoeneck, chief executive officer of BrainCells Inc. "The platform was able to identify the pathway, ratio of drug and dosing that shaped the clinical trial protocol, directing the first rational approach to drug development in the area of psychiatry."

The double blind, placebo-controlled, randomized study evaluated the efficacy of BCI-952 for the treatment of MDD in 142 patients over a six-week period. Patients were randomized into one of three arms, BCI-952 (n=67), buspirone (n=34) or placebo (n=33). Co-primary endpoints were the Clinical Global Impression-Improvement (CGI-I) and the Quick Inventory of Depressive Symptomatology (QIDS SR-16). Secondary endpoints included the CGI-S, IDSC30 and HAMA. The data presented at the NCDEU meeting focused on the MITT population using both the LOCF and MMRM analyses for the co-primary endpoints.

The CGI-I at week six demonstrated improvement relative to placebo using the MITT LOCF, MITT MMRM. The mean CGI-I scores were statistically significant relative to placebo using the MITT MMRM (p=0.046).The responders analysis for CGI-I (SCORE <=2) demonstrated a higher response rate (58%) for BCI-952 as compared to buspirone alone (38%) (p=0.063) and placebo (36%) (p=0.055).

The QIDS SR16 demonstrated numerical improvement as compared to placebo; however these improvements were not statistically significant.

BCI-952 also demonstrated improvements on the secondary endpoints of the IDSC30, HAMA and CGI-S. These improvements were statistically significant for IDSC30 (p=0.034) and HAMA (p=0.041).

Results of this study in patients with MDD showed that BCI-952 demonstrated improvements in multiple endpoints of depression. In addition, BCI-952 was well tolerated with a safety profile similar to placebo.

About BrainCells Inc.

BrainCells Inc. (BCI) is a drug discovery and development company leading the scientific research of neurogenesis by applying its robust and proprietary platform technology to identify novel pathways for small molecule therapeutics to treat various 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 indications. For more information, visit

    BrainCells Inc.
    Kim Richards
    Porter Novelli Life Sciences

SOURCE BrainCells Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
2. Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
3. CareFirst BCBS Covers eNO Measurement for Diagnosis, Asthma Treatment
4. Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations
5. Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations
6. Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
7. First Potential Lupus-Specific Treatment in Sight
8. New Research Shows: Neurofeedback is an Evidence-Based Treatment for ADHD
9. Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV
10. Ipsogen Reports Incorporation of the Genomic Grade in the 2009 St. Gallen International Consensus Meeting on the Primary Treatment of Early Breast Cancer
11. ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients
Post Your Comments:
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
(Date:6/23/2016)... 2016  MedSource announced today that it has ... solution of choice.  This latest decision demonstrates MedSource,s ... their clients by offering a state-of-the-art electronic data ... nowEDC as the EDC platform of choice in ... "nowEDC has long been a preferred EDC platform ...
(Date:6/23/2016)... HILLS, Calif. , June 23, 2016 Any ... the many challenges of the current process. Many of them ... because of the technical difficulties and high laboratory costs involved. ... have to offer it at such a high cost that ... afford it. Dr. Parsa Zadeh , founder ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... recently awarded their highest ... . , Millions of individuals in the United States and Canada wear eyeglasses. Once ... to both correct vision and make a fashion statement. Even celebrities use glasses as ...
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... California (PRWEB) , ... June 25, 2016 , ... "With ... fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... customizable and all within Final Cut Pro X . Simply select a ProHand ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
Breaking Medicine News(10 mins):