Navigation Links
D-Pharm Receives FDA Clearance to Commence a Phase III Trial of DP-b99 in Acute Stroke Patients

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 technology. D-Pharm successfully completed extensive testing of DP-b99 in pre-clinical and then in Phase I and Phase II clinical studies. Both preclinical and clinical studies indicate a favorable efficacy and safety profile for DP-b99. In the recently completed Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that completely recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window.

About Stroke

Every year approximately 780,000 Americans have a new or recurrent stroke. The second most common cause of death worldwide, stroke is also the leading cause of serious long-term disability; 15% to 30% of stroke survivors experience permanent disability. According to the American Heart Association, the estimated direct and indirect cost in 2009 of stroke in the US is

$68.9 billion. Only about 2 to 5% of acute stroke patients are eligible for treatment with tissue plasminogen activator (tPA), the only FDA approved drug treatment for acute stroke.

About D-Pharm Ltd.

D-Pharm ( is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics and has generated a rich pipeline of patent protected proprietary products. D-Pharm's pipeline includes advanced clinical stage products DP-b99 for treatment of acute ischemic stroke patients and DP-VPA, a novel drug for treatment of epilepsy, bipolar disorder and prophylaxis of migraine. DP-460 is in preclinical development intended as an oral, disease-modifying therapy for Alzheimer's disease. Other mimics of bioactive lipids, LipidoMimetix, are at an earlier developmental stage, for cancer.

    For further information please contact:

    Tami Horovitz, PhD.
    Tel: +972-8-9385100
    Fax: +972-8-9300795

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

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:
(Date:11/30/2015)... , Nov. 30, 2015  Culprits beware, ... assistant chemistry professor Jan Halámek, is taking crime ...   --> ...   --> --> ... UAlbany have discovered a straightforward concept for identifying ...
(Date:11/30/2015)... N.J. , Nov. 30, 2015  Champions Oncology, ... solutions and services to personalize the development and use ... , Chief Executive Officer, will be presenting at the ... at 4:30pm Pacific Standard Time (PST).  The conference, held ... Los Angeles, CA , will feature 200 ...
(Date:11/30/2015)... , Nov. 30, 2015  AbbVie, is introducing ... that focuses on a daily routine for managing the ... their medication can affect the way the body absorbs ... to their a daily routine are important. The goal ... help patients better manage their hypothyroidism by establishing a ...
(Date:11/28/2015)... , ... November 28, 2015 , ... • Jeon Jin ... avian, porcine and rodent control solutions , ... cinnamon oil, works across all sensory modalities including visual, smell, taste and touch, enabling ...
Breaking Biology Technology:
(Date:11/17/2015)... Mass. , Nov. 17, 2015 Pressure ... leader in the development and sale of broadly enabling, ... worldwide life sciences industry, today announced it has received ... its $5 million Private Placement (the "Offering"), increasing the ... $4,025,000.  One or more additional closings are expected in ...
(Date:11/12/2015)... 2015  A golden retriever that stayed healthy despite ... has provided a new lead for treating this muscle-wasting ... Institute of MIT and Harvard and the University of ... Cell, pinpoints a protective gene that ... effects. The Boston Children,s lab of Lou Kunkel ...
(Date:11/12/2015)...   Growing need for low-cost, easy to ... paving the way for use of biochemical sensors ... in clinical, agricultural, environmental, food and defense applications. ... medical applications, however, their adoption is increasing in ... emphasis on improving product quality and growing need ...
Breaking Biology News(10 mins):