Navigation Links
BHR Pharma Expands SyNAPSe® Trial into Thailand, China and Russia
Date:6/12/2012

HERNDON, Va., June 12, 2012 /PRNewswire/ -- BHR Pharma's SyNAPSe® clinical trial is now enrolling patients suffering from severe traumatic brain injury (TBI) at 14 sites in Thailand, China and Russia.  The trial currently has 153 participating sites (Level 1 and 2 trauma centers) worldwide.

The 500th of 1,180 patients needed to complete the global Phase III, multi-center trial was enrolled at the end of May in the United States.

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

"In the past four months we've added 28 clinical trial sites, including additional centers in the United States and Europe, and we're working towards opening six Malaysian sites in the near future," said Thomas W. MacAllister, JD, PhD, President & CEO of BHR Pharma.  "We're on track to complete enrollment for this pivotal clinical trial early next year, with the intent of bringing the first-ever treatment for TBI to market."

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). 

"Unfortunately, little can be done to reverse the initial brain damage caused by a TBI. Once a TBI occurs, medical treatment focuses on preventing further injury and promoting rehabilitation," said Dr. MacAllister. "BHR-100 is designed to protect brain cells from dying right after the injury, which may facilitate outcomes previously not thought to be possible."

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
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. New company announcement: TERGUS PHARMA
2. Berg Pharma presents at ASCO, poised to lead field in cancer metabolism with Phase II trials of BPM 31510
3. Terry Yon Encourages Higher Standards of Pharmaceutical Care
4. Biodel Obtains Exclusive License to Aegis Therapeutics Technologies for Development and Commercialization of Glucagon Pharmaceutical Formulations
5. Community Pharmacists Take on Medication Non-Adherence to Improve Patient Health
6. Argus Expands Specialty Pharmacy with Amber Pharmacy Collaboration
7. PharmaNet/i3 Receives Distinguished Partner Award from the US Chinese Anti-Cancer Association
8. Valeant Pharmaceuticals To Host Investor Day
9. OICR funds Fluorinov Pharma Inc. to further develop its novel drug for the treatment of blood cancers
10. First sales of DIFICLIR™ by Astellas Pharma Europe triggers 10 Million Euro Milestone Payment to Optimer Pharmaceuticals
11. InnoPharma Inc. Raises $8 Million in Venture Debt
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... -- As the latest Obamacare repeal effort moves is debated, ... and Lindsey Graham (R-SC) medical device market ... is in an odd place.  The industry wants repeal ... on medical device sales passed along with the Affordable ... visits and hospital customers with the funding to invest ...
(Date:9/18/2017)... , Sept. 18, 2017 EpiVax, ... of bioinformatics and immune engineering, today announced ... influenza A (H7N9) vaccine. ... to seasonal influenza and presents a challenge ... prior exposure to be effective. Using state-of-the-art ...
(Date:9/9/2017)... Sept. 8, 2017 ... MRI Unit coming to Washington DC ... When: Tuesday, September 12 th – Monday, September 18 th ... offering free MRI brain scans to the public.Where:  ... parked at 501 K Street NW, Washington, D.C.What:BTF brings its nationwide initiative, ...
Breaking Medicine Technology:
(Date:9/22/2017)... ... 2017 , ... On Sunday, September 24, hundreds will gather at Flo Jo ... considered the fastest woman of all time. Flo Jo passed away from complications ... the National Anthem. Mary was a contestant on the 2012 season of America’s ...
(Date:9/22/2017)... (PRWEB) , ... September 22, 2017 , ... ... assembles Passive House buildings, and Richard Pedranti Architect (RPA), a full-service ... from the strategic partner’s Solsken Line of Model Homes . Independently, Ecocor ...
(Date:9/22/2017)... ... September 22, 2017 , ... SABRE is ... Sweepstakes.,  , Molli C., a graduate student from Sonora, California, who will begin ... at St. Thomas University in Miami, Florida, was selected from a pool of ...
(Date:9/22/2017)... ... ... “Cursed with a Curse: The Truth about Tithing”: a ... when breaking free from this misconception. “Cursed with a Curse: The Truth about ... Christian Faith Publishing, Lysa M. Harrison’s new book is a powerful and thought-provoking ...
(Date:9/22/2017)... ... 2017 , ... "Success Files," a short- and long-form documentary ... a disease estimated to affect the lives of more than 5 million Americans ... a leading voice in the fight for cure and research into the disease, ...
Breaking Medicine News(10 mins):