Navigation Links
SanBio Announces FDA Clearance for the Initiation of a Phase I/2a Clinical Trial Testing Their Cell Therapy Product, SB623, in Patients with Traumatic Brain Injury
Date:6/10/2013

MOUNTAIN VIEW, Calif., June 10, 2013 /PRNewswire/ -- SanBio Inc., a California-based regenerative medicine company, announced today that the U.S. Food and Drug Administration has approved their Investigational New Drug application (IND) for the use of SB623, a novel allogeneic stem cell therapy product, in patients suffering from traumatic brain injuries (TBI's). This approval allows the company to proceed with a Phase 1/2a clinical trial testing the safety and feasibility of the therapy. The clinical trial is expected to be carried out at several major hospitals in the United States.

"This is the second clinical program for SanBio," said Keita Mori, SanBio's Chief Executive Officer, "we see this as a clear validation of our development program and a significant broadening of the therapeutic application of our lead product SB623 for the treatment of unaddressed chronic neurological deficits."

"We measure the responses of TBI patients to physical therapy every day. Progress is often painfully slow and incremental," said Dr. Daniel Lu, Principal Investigator, Neuroplasticity and Repair Laboratory and Director, Neuromotor Recovery Research Center, University of California, Los Angeles, "If this new cell therapy approach improves outcomes it could have a dramatic positive effect on many lives."

About Traumatic Brain Injury: According to the Center for Disease Control and Prevention, more the 1.7 million people in the United States sustain a traumatic brain injury each year, resulting in approximately 50,000 deaths and 275,000 hospitalizations. Many of these more severely injured patients suffer permanent disabilities, including loss of motor function and cognitive impairment. Other than physical rehabilitation there is no effective therapy. Direct medical costs and indirect costs such as lost productivity of TBI totaled an estimated $76.5 billion in the United States in 2000.

About SB623: SB623 is a proprietary cell therapy product consisting of cells derived from genetically modified bone marrow stromal cells obtained from healthy adult donors.  SB623 is administered adjacent to the damaged area of the brain. SB623 functions by producing factors that aid the regenerative process.

About SanBio: SanBio is a privately held San Francisco Bay Area biotechnology company focused on the discovery and development of new regenerative cell therapy products.

For more information: www.san-bio.com


'/>"/>
SOURCE SanBio, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
2. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
3. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
4. Misonix Announces New Distribution Agreement For Panama
5. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
6. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
7. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
8. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
9. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
10. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
11. STAAR Surgical Announces First Quarter 2012 Results Release Date and Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):