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:7/24/2017)... 2017  Diplomat Pharmacy, Inc. (NYSE: DPLO ... quarter 2017 operating results on Monday, August 7, 2017 ... at 5:00 p.m. ET. ... live broadcast of the conference call by dialing 877-201-0168 ... 51641230 approximately 15 minutes prior to the call. A ...
(Date:7/20/2017)... PAUL, Minn. , July 20, 2017  Prime Therapeutics ... Jonathan Gavras , M.D., following today,s Institute for Clinical ... report on the effectiveness and value of abuse-deterrent ... manager on the policy roundtable at the meeting. ... is not a material cost benefit to the use of ...
(Date:7/14/2017)... -- It should come as no surprise to anyone that ... midst of a crippling opioid epidemic. According to the ... overdose deaths from opiate-based medications has quadrupled, Says, Dr. ... from 2001 to 2015". During this time, the prescription rate ... drawing a compelling link between prescription and eventual addiction. The ...
Breaking Medicine Technology:
(Date:7/24/2017)... Los Angeles, CA (PRWEB) , ... July 24, 2017 , ... ... that will spotlight doctors and the cosmetic surgeries they perform on a daily basis. ... in performing the cosmetic surgery procedures they specialize in at their practices. , ...
(Date:7/24/2017)... ... 2017 , ... Peruvian Ayahuasca retreat, East West Lodge, announced ... and divided between two full-time university students enrolled in U.S. or Canadian accredited ... apply for the scholarship, students are asked to submit an essay between 750 ...
(Date:7/24/2017)... ... July 24, 2017 , ... ... initiatives designed to promote awareness for Topricin’s revolutionary, natural, after-burn skin care product, ... of the leading causes of long term skin conditions, including cancer. In ...
(Date:7/24/2017)... ... 24, 2017 , ... Anyone who uses scales know they have limits; a ... using that same scale to dispense medication. The first example is an issue of ... why it is important to have the right balance for the process. METTLER TOLEDO’s ...
(Date:7/24/2017)... TX (PRWEB) , ... July 24, 2017 , ... Paul ... of the nation’s top level plastic surgeons, invited to attend Allergan’s recent meeting with ... 10 most valued companies in the world, Allergan is bringing a newly defined structure ...
Breaking Medicine News(10 mins):