Navigation Links
Unlikely Treatment Identified by BrainCells Neurogenesis Platform Improved Clinical Outcomes in Patients Suffering From Depression
Date:7/27/2009

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, visithttp://www.braincellsinc.com.

    BrainCells Inc.
    Kim Richards
    Porter Novelli Life Sciences
    619-849-5377
    krichards@pnlifesciences.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:7/17/2017)... July 17, 2017  MedX Holdings, Inc., the manufacturer ... strengthening and rehabilitation equipment, today announced the national roll ... is considered the gold standard for the treatment of ... medical strengthening equipment. ... the physician or practice who prescribe the MedX Home ...
(Date:7/13/2017)... Mich. , July 13, 2017  Centurion Medical Products, a ... its DisImpactor ® fecal impaction removal device for hospice patient ... ... Patient pain management and ... for Hospice can help alleviate patient pain while preventing unneeded emergency ...
(Date:7/12/2017)... 12, 2017  Eli Lilly and Company (NYSE: ... companies to resolve pending patent litigation in the U.S. District ... regarding the Cialis ® (tadalafil) unit dose patent. ... 2020. As part of the agreement, Cialis exclusivity is now ... "The unit dose patent for Cialis is valid ...
Breaking Medicine Technology:
(Date:7/24/2017)... ... July 24, 2017 , ... Every year, thousands of dedicated Higher Education and ... annual event is coupled with a dynamic theme like Camp Canvas; this year, they’ve ... InstructureCon 0017. , To extend their partnership with Canvas beyond the LMS integration, ...
(Date:7/24/2017)... ... July 24, 2017 , ... ... already work hand-in-hand on an Innovation Collaboration program, have signed a five-year agreement ... and cost of the care members and patients receive. The agreement also signifies ...
(Date:7/24/2017)... ... July 24, 2017 , ... Anyone who uses scales ... watermelon, nor would a pharmacist using that same scale to dispense medication. The first ... , These illustrations show why it is important to have the right balance ...
(Date:7/24/2017)... , ... July 24, 2017 , ... ... sleep management solution focused on delivering end-to-end sleep health care at scale, ... Recent literature shows that adherence rates for positive airway pressure (PAP) therapy, the ...
(Date:7/24/2017)... ... July 24, 2017 , ... The Magic ... “Consumer’s Choice” Award, for favorite sex toy. Created in collaboration with website Kinkly.com, ... to be consumer voted. The Magic Wand Rechargeable won in stiff competition from ...
Breaking Medicine News(10 mins):