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:3/24/2017)... March 23, 2017  Provectus Biopharmaceuticals, Inc. (OTCQB: ... a clinical-stage oncology and dermatology biopharmaceutical company, today ... Commitment Term Sheet (the "Definitive Financing") it entered ... the Company,s stockholders, who are referred to in ... Form 8-K filed with the Securities and Exchange ...
(Date:3/23/2017)... -- Research and Markets has announced the addition of ... to 2025" report to their offering. ... The Global Cryostat Market is poised ... decade to reach approximately $3.5 billion by 2025. This ... given segments on global as well as regional levels presented in ...
(Date:3/23/2017)... Research and Markets has announced the addition of the ... Technique, Repair Procedure By Technique, By Region, By Country (2016-2021)" ... ... at a CAGR of 13.35% during 2016-2021 The strong ... growth in population with heart disease and rising advances in minimally ...
Breaking Medicine Technology:
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... The law ... White Plains, N.Y., is pleased to announce Westchester resident Lauren C. Enea has joined ... clerk for the firm, will concentrate her practice in elder law, Medicaid planning and ...
(Date:3/24/2017)... ... March 24, 2017 , ... “Finding Christ Through ... a devotional journal chronicling the writer’s path toward true communion with God. “Finding ... God #TruthwithGrace” is the creation of published author Lea Michelle Johnson, a follower ...
(Date:3/23/2017)... ... 2017 , ... In 2016 the World Health Organization declared the Zika virus ... Zika-related cases in the Americas within the next year. Lyme disease is one of ... skyrocketing to an estimated 329,000. Yet, Zika, Lyme and other insect borne illnesses are ...
(Date:3/23/2017)... ... March 23, 2017 , ... PAINWeekEnd (PWE) Oklahoma City, ... Broadway Avenue, will be an educational and exciting program providing busy clinicians and ... of chronic pain. , Oklahoma is in a healthcare crisis. The state ranks ...
(Date:3/23/2017)... ... ... March is National Kidney Month – the perfect time to pause and thank ... Every day, two kidneys filter about 120 to 150 quarts of blood. Put another ... regulating fluid levels and blood pressure, supporting bone health and promoting red blood cell ...
Breaking Medicine News(10 mins):