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:2/8/2016)... Feb. 8, 2016  Unilife Corporation ("Unilife" or "Company") (NASDAQ: ... injectable drug delivery systems, today announced that it will release ... December 31, 2015 after market close on February 9, 2016. ... call to discuss these financial results.    About ... --> About Unilife Corporation ...
(Date:2/8/2016)... NORTHBROOK, Ill. , Feb. 8, 2016  Astellas Pharma ... today announced the promotion of James Robinson as ... the company,s operations in North and South America ... president, Astellas Pharma US, representing the commercial organization in ... assumed in 2013. Masao Yoshida , who ...
(Date:2/8/2016)... Palatin Technologies, Inc. (NYSE MKT: PTN), ... for the treatment of diseases with significant unmet ... the United States Patent and Trademark Office (USPTO) ... Patent Application Serial Number 14/313,258 (the ,258 application).  ... female sexual dysfunction using the formulation and dose ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... ... Remember the old saying “rub some dirt on it”? Perhaps you should try ... Clay” the health benefits of integrating clay into a daily diet are numerous, as ... motivational speaker, Perry A~ has since dedicated her life to learning about the benefits ...
(Date:2/8/2016)... , ... February 08, 2016 , ... ... wide variety of organizations. DocuSyst provides a cloud hosted environment for FileHold ... installations include integration with various 3rd party applications using the FileHold web services ...
(Date:2/8/2016)... ... 2016 , ... GrassrootsHealth published data from its D*action public ... in the GrassrootsHealth cohort with substantially higher vitamin D levels than a cohort ... states Carole Baggerly, Director of GrassrootsHealth, “the safety and benefits of vitamin ...
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... TopConsumerReviews.com recently ... in Mole removal products. , Moles are derived from a cluster of melanin when ... all the wrong places and create a lifetime of embarrassment. Historically, mole removal ...
(Date:2/8/2016)... ... , ... Guruji Mahendra Kumar Trivedi is offering 3 days of accelerated personal ... birthday on February 10th. During this time, people can achieve better health, greater ... people from over 40 different countries as an “ordinary man with an extraordinary gift.” ...
Breaking Medicine News(10 mins):