BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

BHR Pharma, LLC SyNAPSe® Trial Reaches Enrollment Midpoint


7/25/2012 10:18:23 AM

PHOENIX, July 24, 2012 /PRNewswire/ -- BHR Pharma announced today that it had reached its SyNAPSe® clinical trial enrollment midpoint of 590 patients during a presentation by David Okonkwo, MD, PhD, University of Pittsburgh Medical Center Brain Trauma Research Center Clinical Director, at the National Neurotrauma Society's 2012 Annual Meeting. The milestone for the global Phase 3, multi-center trial was achieved when a study subject was randomized by Songklanagarind Hospital in Thailand.

SyNAPSe is evaluating the effectiveness of BHR-100, a proprietary intravenous progesterone infusion formulation, as a neuroprotective agent for treating severe traumatic brain injury (TBI) patients. The U.S. Food and Drug Administration granted Orphan Drug designation to BHR-100 and placed the drug on a Fast Track status designed to accelerate its potential approval.

The trial currently has 149 participating sites (Level 1 and 2 trauma centers) worldwide. The total enrollment target is 1,180 severe TBI patients.

"This significant milestone is a testament to the work of more than 1,000 medical professionals participating in our study around the globe that are committed to advancing scientific understanding of progesterone as a neuroprotective treatment for traumatic brain injury," said Thomas W. MacAllister, JD, PhD, and President & CEO of BHR Pharma. "Their dedicated efforts are redefining TBI standard of care and getting us closer to the world's first-ever approvable treatment for this unmet medical need."

TBI is a serious public health problem that affects more than 1.7 million Americans each year. Despite significant efforts in more than 75 clinical trials over the past 20 years, there is still no approved treatment for TBI.

Previous research has shown progesterone exerts its neuroprotective effects by protecting or rebuilding the blood-brain barrier, decreasing development of cerebral edema (brain swelling), down-regulating the inflammatory cascade and limiting cellular necrosis and apoptosis (programmed cell death).

Building on the SyNAPSe study of BHR-100 and promising research conducted by Emory University, BHR is also developing BHR-310, an intranasal progesterone powder. This nasal spray is being evaluated as a potential treatment that can be administered to wounded warriors or athletes with TBI quickly after injury on the battlefield or playing field. Preclinical studies of BHR-310 in rats and monkeys support the feasibility of a high-dose, rapidly absorbed intranasal progesterone product able to deliver clinically meaningful doses of progesterone to the brain.

About BHR Pharma

Founded in January 2008, BHR Pharma, LLC (www.bhr-pharma.com) is a pharmaceutical research and development company located near Washington, DC. BHR is committed to bringing to market specialty treatments that employ non-oral delivery systems, with an emphasis on unmet and underserved medical needs. The company is a wholly owned subsidiary of Besins Healthcare SA (www.besins-healthcare.com), which markets healthcare products in 93 countries.

SOURCE BHR Pharma



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES