Navigation Links
D-Pharm Receives FDA Clearance to Commence a Phase III Trial of DP-b99 in Acute Stroke Patients
Date:6/8/2009

REHOVOT, Israel, June 8 /PRNewswire/ -- D-Pharm announced today that its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the US Food and Drug Administration (FDA). D-Pharm plans to initiate the trial in the coming months, in over 100 clinical sites in North America, Europe, South Africa and Israel.

The forthcoming Phase III trial is a randomized, double blind, placebo-controlled study (study acronym MACSI: Membrane Activated Chelator Stroke Intervention). It is designed to compare the effect on ischemic stroke outcome between a placebo group and a group of patients treated with 1 mg/kg/day of DP-b99 for 4 consecutive days. D-Pharm plans to enroll 770 moderate to severely affected ischemic stroke patients worldwide, with first patients expected to be recruited in Israel and South Africa.

Dr. Gilad Rosenberg, D-Pharm's VP Clinical Development commented, "The FDA's IND procedure involved review of the entire DP-b99 data set. Following 30 days for review of our IND application, the FDA has no further questions relating to DP-b99's CMC, preclinical and clinical data package. I'm very pleased that the Agency is satisfied with our data and we can move forward with this important study without delay."

Prior to the IND submission D-Pharm successfully completed the program outlined at the pre-IND meeting held with the FDA in January 2008. The program included additional toxicity studies, a drug interaction study with rtPA, and an interaction study with warfarin in healthy volunteers, as well as scale-up and optimization of the DP-b99 manufacturing process.

About DP-b99

DP-b99 is a unique neuroprotective drug that addresses an array of brain damaging processes occurring in stroke patients and emerged from D-Pharm's proprietary Membrane Activated Chelator (MAC) platform technolog
'/>"/>

SOURCE D-Pharm Ltd
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. D-Pharm Secures Funding From Israels Chief Scientists Office
2. D-Pharm Completes Pre-IND Meeting With the FDA for Treatment of Acute Stroke With DP-b99
3. Yongye Biotechnology International Receives License to Manufacture Products
4. EarlySenses EverOn(TM) System Receives FDA Clearance and CE Mark Certification
5. Optimal Reading Services Group, Inc. Receives Investment from Health Evolution Partners
6. Haemonetics Receives Favorable Ruling in Patent Lawsuit against Competitive Technology
7. ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema
8. Celsense, Inc Receives NIH Grant to Translate Cell Imaging Technology for Clinical Use
9. Mylan Receives Tentative FDA Approval for Generic Version of Singulair(R)
10. 500th Patient Receives Berlin Heart EXCOR Pediatric Ventricular Assist Device
11. SyntheMed Receives Australian Regulatory Approval for REPEL-CV(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2015)... COLUMBIA, Md. (PRWEB) February 27, 2015 ... Unified Chromatography system (Nexera UC) can sequentially analyze ... chromatographic separation combined with high-sensitivity detection of targets ... system is designed to fulfill the measurement requirements ... pesticides in food products, drug delivery and search ...
(Date:2/27/2015)... -- Steep Hill, the industry leader in cannabis testing and ... a full service medical cannabis quality assurance laboratory in ... scientific tools and methodology to the state, for regulatory ... the only laboratory licensed by the New Mexico Department ... order to meet the recently adopted regulatory requirements pertaining ...
(Date:2/26/2015)... TORONTO , Feb. 26, 2015 /PRNewswire/ - SQI ... SQIDF), a life sciences company that develops and commercializes ... reported its financial and operational results for the fiscal ... this press release are in Canadian dollars (CAD), unless ... Company continued to win new business from our existing ...
(Date:2/26/2015)... Angeles, CA (PRWEB) February 26, 2015 ... an online demonstration to support life extension technologies and ... 8pm UTC, Universal Coordinated Time, on March 21st 2015, ... the world. , Eric Schulke, Founder of MILE, ... must act with urgency. The Movement for Indefinite Life ...
Breaking Biology Technology:Shimadzu Corporation Launches Nexera UC - The World’s Foremost Unified Chromatography System 2Shimadzu Corporation Launches Nexera UC - The World’s Foremost Unified Chromatography System 3Steep Hill First to Receive Provisional Approval to Establish Laboratory Services for Cannabis Testing in State of New Mexico 2SQI Diagnostics Reports First Quarter Financial Results 2SQI Diagnostics Reports First Quarter Financial Results 3SQI Diagnostics Reports First Quarter Financial Results 4SQI Diagnostics Reports First Quarter Financial Results 5SQI Diagnostics Reports First Quarter Financial Results 6Indefinite Life Extension Activists Organize Online Demonstration 2Indefinite Life Extension Activists Organize Online Demonstration 3
... 19 LI-COR Biosciences has released a,new ... gels the Odyssey Infrared,Imaging System. The E-PAGE ... provide a high-throughput SDS-PAGE,method for processing protein samples. ... Blotting System, up to 96 different proteins samples ...
... Michigan-based platform company has been built upon the foundation of a ... dynamically build themselves on a wide variety of computational platforms. The ... sagging Michigan economy through the creation of thousands of new jobs ... ...
... Md., Nov. 19 PharmAthene, Inc.,(NYSE Alternext US: ... and chemical threats, announced today that,it has signed ... its,biodefense products in Israel. , ... countermeasures to combat the risk of,terrorist attacks with ...
Cached Biology Technology:Technical Note: E-PAGE(TM) 48- and 96-Well Gels on the Odyssey(R) Infrared Imaging System 2Michigan Company Founded upon What Could Be History's Most Important Breakthrough in AI and Robotics 2Michigan Company Founded upon What Could Be History's Most Important Breakthrough in AI and Robotics 3Michigan Company Founded upon What Could Be History's Most Important Breakthrough in AI and Robotics 4PharmAthene Signs Agreement with Medison Pharma Ltd. to Commercialize and Distribute Biodefense Medical Countermeasures in Israel 2PharmAthene Signs Agreement with Medison Pharma Ltd. to Commercialize and Distribute Biodefense Medical Countermeasures in Israel 3PharmAthene Signs Agreement with Medison Pharma Ltd. to Commercialize and Distribute Biodefense Medical Countermeasures in Israel 4
(Date:2/12/2015)... 12, 2015   MedNet Solutions , a ... study management systems, has recently bolstered its ... iMedNet as the eClinical ... and healthcare consultants.  Building on the Program,s existing ... and numerous co-marketing opportunities), MedNet,s new and improved ...
(Date:2/10/2015)... Feb. 10, 2015  Alere Inc. (NYSE: ALR), ... financial results for the quarter ended December 31, ... and President of Alere said, "We made substantial ... as the global leader in rapid diagnostics and ... Alere Health divestiture in early January enabled us ...
(Date:2/5/2015)... 2015  Marken is starting its 35 th ... a new marketing campaign to solidify its place as ... campaign focuses on First as a primary ... The first headline in the series, ... its client,s priorities. Marken recognizes the need to protect ...
Breaking Biology News(10 mins):MedNet Solutions Announces Key Enhancements To Its iMedNet Partner Program 2Alere Inc. Announces Fourth Quarter 2014 Results 2Alere Inc. Announces Fourth Quarter 2014 Results 3Alere Inc. Announces Fourth Quarter 2014 Results 4Alere Inc. Announces Fourth Quarter 2014 Results 5Alere Inc. Announces Fourth Quarter 2014 Results 6Alere Inc. Announces Fourth Quarter 2014 Results 7Alere Inc. Announces Fourth Quarter 2014 Results 8Alere Inc. Announces Fourth Quarter 2014 Results 9Alere Inc. Announces Fourth Quarter 2014 Results 10Alere Inc. Announces Fourth Quarter 2014 Results 11Alere Inc. Announces Fourth Quarter 2014 Results 12Alere Inc. Announces Fourth Quarter 2014 Results 13Alere Inc. Announces Fourth Quarter 2014 Results 14Alere Inc. Announces Fourth Quarter 2014 Results 15Alere Inc. Announces Fourth Quarter 2014 Results 16Alere Inc. Announces Fourth Quarter 2014 Results 17Alere Inc. Announces Fourth Quarter 2014 Results 18Alere Inc. Announces Fourth Quarter 2014 Results 19Alere Inc. Announces Fourth Quarter 2014 Results 20Alere Inc. Announces Fourth Quarter 2014 Results 21Alere Inc. Announces Fourth Quarter 2014 Results 22Alere Inc. Announces Fourth Quarter 2014 Results 23Alere Inc. Announces Fourth Quarter 2014 Results 24Alere Inc. Announces Fourth Quarter 2014 Results 25Alere Inc. Announces Fourth Quarter 2014 Results 26Alere Inc. Announces Fourth Quarter 2014 Results 27Alere Inc. Announces Fourth Quarter 2014 Results 28Alere Inc. Announces Fourth Quarter 2014 Results 29Alere Inc. Announces Fourth Quarter 2014 Results 30Alere Inc. Announces Fourth Quarter 2014 Results 31Alere Inc. Announces Fourth Quarter 2014 Results 32Alere Inc. Announces Fourth Quarter 2014 Results 33Alere Inc. Announces Fourth Quarter 2014 Results 34Alere Inc. Announces Fourth Quarter 2014 Results 35
... The USDA,s National Institute of Food and Agriculture ... for humanitarian assistance programs. "The United States is ... people around the world who are suffering during emergency ... of Food and Agriculture (NIFA). "These projects will improve ...
... cycle created when an obese individual overeats to compensate ... fewer pleasure receptors and overeat to compensate, according to ... research fellow and Oregon Research Institute senior scientist Eric ... The Journal of Neuroscience . Stice shows evidence ...
... Plant biologists have been making groundbreaking advances in ... including discoveries that will help lead to improvements in ... Now two of the nation,s largest private sponsors ... support for some of the country,s most innovative plant ...
Cached Biology News:Research examines vicious cycle of overeating and obesity 2ASPB applauds HHMI and GBMF for launching plant science program 2ASPB applauds HHMI and GBMF for launching plant science program 3
... Enzyme concentration - 5 units/µL ,• High ... yields ,• Leaves an 'A' overhang ,• ... which exhibits very high activity in primer ... ensure the quality of the enzyme, each ...
... Gold® DNA Polymerase is a chemically modified ... chemical moiety is attached to the enzyme, ... the first ramp of thermal cycling (when ... temperatures), the enzyme is inactive. The result ...
Ps-Aeruginosa (IgG) -Ab EIA Sample Size: 100 l...
Request Info...
Biology Products: