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

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:

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:
(Date:11/30/2015)... 2015 North America was ... grow at a CAGR of 7.6% from 2015 to 2020. ... 135.6 million in 2014, and is expected to grow at a ... to the new Market Research Report "North America Cardiac Output Monitoring ... (Hospitals, ambulatory care, others) - Analysis And Forecast To 2020", the ...
(Date:11/30/2015)... --> --> ... by Product (Soft Tissue, All Tissue, Dental Welding Lasers), Application ... Geography - Global Forecast to 2020", published by MarketsandMarkets, is ... CAGR of 5.2% during the forecast period from 2015 to ... 62 Figures spread through 167 P ages and in-depth ...
(Date:11/30/2015)... MOUNTLAKE TERRACE, Wash. and ST. ... Cross and Express Scripts (NASDAQ: ESRX ) today ... benefit agreement. The partnership, which began in 1999, will ... --> --> After evaluating pharmacy ... process, Premera concluded that Express Scripts continues to offer ...
Breaking Medicine Technology:
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... Foundation (Meso Foundation) released information for caregivers and held two webinars on topics ... available on demand free of charge at . , With a ...
(Date:11/30/2015)... ... November 30, 2015 , ... Thermi™, a world ... announce that its ThermiRFR temperature controlled radiofrequency platform has received CE marking and ... platform which uses temperature as a clinical endpoint. The technology has been ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... vehicle experience this summer, ushering in a new era of publicly accessible automated ... electric shuttle, will continue to offer guests an up-close look at the shuttle ...
(Date:11/30/2015)... ... November 30, 2015 , ... On Saturday, October 24th, 2015, at the Mill ... fundraising event, a 5K walk known as “Making Strides Against Breast Cancer”. Patients and ... is also located in Battle Creek, joined in for this campaign that sought to ...
(Date:11/30/2015)... ... November 30, 2015 , ... During the week of ... raise funds for its research, education, support, and advocacy efforts. The campaign is ... , The Mesothelioma Applied Research Foundation, which also goes by Meso Foundation, holds ...
Breaking Medicine News(10 mins):