Navigation Links
DP-b99 Phase IIb Trial Results to be Presented at the European,Stroke Conference

REHOVOT, Israel, May 29, 2007 /PRNewswire/ -- D-Pharm announced today that the results of the Phase IIb trial for its neuroprotective compound DP-b99 in the treatment of acute ischemic stroke patients will be presented at the European Stroke Conference. The data will be presented by the study's German principal investigator Prof. H. C. Diener, on Thursday May 31st at 14.30 in the Carron Room, at the Scottish Exhibition Conference Center in Glasgow. The abstract for the presentation may be viewed using the European Stroke Conference search engine at: http://www.eurostroke.eu/gla_searching.htm

DP-b99, discovered and developed by D-Pharm, is a unique neuroprotective drug that addresses an array of damaging processes occurring in the brains of stroke patients. A Phase IIb multicenter, double blind, placebo controlled, randomized trial to assess DP-b99's effect on stroke outcomes was completed in December 2006. The study enrolled 150 ischemic stroke patients with signs of cortical involvement and NIH Stroke Scale (NIHSS) score of 7-20. DP-b99 (1mg/kg/day) or placebo was administered i.v. within 1-9 hours of stroke-onset as a 4-day course of once-daily 2hr infusions with a 90-day follow-up.

The main pre-defined efficacy endpoints in the study included: the change in National Institute of Health Stroke Scale (NIHSS) score from day 0 to day 90; the percent of patients completely recovered after stroke (score 0 or 1, or same as pre-stroke) at day 90 as assessed by the modified Rankin scale or NIHSS.

The day 90 recovery rate in the DP-b99 treated group was two times higher than in the placebo group. Specifically, the recovery rate in the DP-b99 and placebo groups per modified Rankin scale was 30.6% and 16.0% (p=0.05), per NIHSS was 23.6% and 12.0% (p=0.08), and defined by either scale was 37.5% and 18.7% (p=0.02), respectively . The day 90 median change from baseline was 6.0 and 5.0 NIHSS points in the DP-b99 and placebo groups, respectively; the day 90 median change from baseline in patients with entry NIHSS score of 10-16 was 8.0 and 5.0 points in the DP-b99 and placebo groups, respectively (p=0.03).

The trial enrolled patients within the first 9 hours following appearance of stroke symptoms. The data indicate that the effect of DP-b99 on recovery was uniform across the full 9h window, confirming the wide therapeutic window for DP-b99.

The favorable safety and tolerability profile of DP-b99 was confirmed and is in line with D-Pharm's previous clinical experience from the Phase I and IIa studies. There were no significant differences in the number or type of serious adverse events, mortality rate or death causes between the DP-b99 and placebo groups.

These results show that DP-b99 doubled the chances to recover from ischemic stroke, has at least a 9hr therapeutic window and is safe. D-Pharm is planning to commence a pivotal Phase III study of DP-b99 in 2008.

About D-Pharm Ltd.

D-Pharm (www.dpharm.com) is a biopharmaceutical company pioneering the development of lipid-like therapeutics and has generated a rich product pipeline from its drug targeting and discovery technologies, Regulated Activation of Prodrugs (D-RAPTM) and Membrane Active Chelators (MAC). The company expects to discuss the further development of DP-b99 with regulatory authorities in the coming months.

D-Pharm's pipeline includes DP-VPA, a new chemical entity that is a modified and targeted version of valproic acid for epilepsy, bipolar disorder treatment and migraine prophylaxis, currently in Phase II development. DP-460 is in preclinical development intended as an oral, disease-modifying therapy for Alzheimer's disease.

    For further information please contact:


    Tami Horovitz, PhD.

    Tel: +972-8-9385100

 
   Fax: +972-8-9300795

    Email: 



thorovitz@dpharm.com

CONTACT: For further information please contact: Tami Horovitz, PhD., Tel:+972-8-9385100, Fax: +972-8-9300795, Email: thorovitz@dpharm.com

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
3. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
7. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
8. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
9. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
10. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... 20, 2017  Palladian Health, a leading provider ... launch of an opioid management program which assists ... and helps stem the growing tide of dependence ... treat chronic non-cancer pain (back pain, neck pain, ... lack of evidence regarding long-term effectiveness. ...
(Date:1/19/2017)... , Jan. 19, 2017 ... Summary GlobalData,s new report, "Germany Cataract Surgery Devices ... the Germany Cataract Surgery Devices market. The report provides ... and average prices (USD) within market segements - Phacoemulsification ... also provides company shares and distribution shares data for ...
(Date:1/19/2017)... Jan. 19, 2017 The U.S. Food and Drug ... Idiopathic Constipation (CIC) in adult patients. "No ... disorders," said Julie Beitz , M.D., director of the ... Drug Evaluation and Research. "With the availability of new therapies, ... for their condition." ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... ATP ... people’s everyday lives, recently attended the January ECRM Trade Show in Hilton Head, ... known for its large range of supplements that keep the body functioning at ...
(Date:1/20/2017)... ... ... “Mary Magdalene: Grace is Greater than Sin”: a unique and memorable piece of ... Magdalene: Grace is Greater than Sin” is the creation of published author, Brenda Roberts, ... who had little knowledge of the female characters portrayed in the Holy Bible. ...
(Date:1/20/2017)... ... January 20, 2017 , ... “Christmas in Suffolk”: a story of ... Seymour, who lives in Lafayette, Indiana where she works in a daycare and looks ... writes. , Published by Christian Faith Publishing, Sara Seymour’s new book is an adventure ...
(Date:1/19/2017)... ... , ... Today, the Centers for Medicare & Medicaid Services (CMS) announced over ... (APMs) in 2017. Clinicians who participate in APMs are paid for the quality of ... Administration’s effort to build a system that delivers better care and one in which ...
(Date:1/19/2017)... ... January 19, 2017 , ... This month, the CEO ... the name of their drug rehab center in Delray Beach, Florida has been changed ... not only stars such as Philip Seymour Hoffman and Chris Farley are dying from ...
Breaking Medicine News(10 mins):