Navigation Links
D-Pharm (TASE: DPRM) Announces Enrollment of First Patient in DP-b99 Phase III Efficacy Study, MACSI
Date:12/31/2009

REHOVOT, Israel, December 31 /PRNewswire-FirstCall/ -- D-Pharm Ltd (TASE: DPRM) announced enrollment of patients with acute ischemic stroke into its Phase III clinical study of DP-b99 (MACSI). The first patient has been enrolled at the Wolfson Medical Center, Israel. The MACSI trial involves numerous medical centers in the US, Canada, Europe, Israel, South Africa, South Korea and Brazil. DP-b99 is D-Pharm's most advanced product developed for protection of brain cells suffering from restricted blood and oxygen supply (ischemia).

The MACSI study is as international, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. The trial will compare the stroke outcome in a group of patients treated with placebo (an inactive substance) to patients treated with 1 mg/kg/day of DP-b99 for 4 consecutive days. The study is expected to enroll, in total, 770 patients at 120 - 140 clinical sites worldwide.

Recently D-Pharm met with the FDA to discuss the Special Protocol Assessment (SPA) and will continue the dialog with the FDA towards the final agreement.

Dr. Gilad Rosenberg, D-Pharm's V.P. Clinical Development stated, "We're very pleased that this important clinical milestone has been achieved on schedule. The challenge is now to effectively activate the additional clinical sites to ensure a patient recruitment rate sufficient to complete the study on time, as planned."

For the global development of DP-b99, D-Pharm Ltd. will collaborate with its partners Yungjin Pharmaceuticals in S. Korea and Wanbang Biopharmaceuticals in China. Stroke is a leading cause of serious long-term disability and the second most common cause of death worldwide. The number of acute ischemic stroke patients in the US, Western Europe and Japan is around 1.5 million; including the territories of S. Korea and China may almost double this figure.

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 D-Pharm Ltd.

D-Pharm (http://www.dpharm.com) 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.

Disclaimer

Statements in this press release that are not historical facts are forward-looking information, as defined in the Securities Law, based on information available to D-Pharm at the time of this press release. The estimations could, some or all, be unrealized, or could be realized in significantly different ways than expected.

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


SOURCE D-Pharm Ltd


'/>"/>
SOURCE D-Pharm Ltd
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. D-Pharm Completes Pre-IND Meeting With the FDA for Treatment of Acute Stroke With DP-b99
2. D-Pharm Secures Funding From Israels Chief Scientists Office
3. D-Pharm Receives FDA Clearance to Commence a Phase III Trial of DP-b99 in Acute Stroke Patients
4. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
5. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
6. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
7. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
8. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
9. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... , ... December 01, 2016 , ... ... long-term client Nanowear on their recent FDA Class II 510(k) clearance for their ... significant hurdle in commercializing remote cardiac monitoring devices that rely on cloth-based nanosensors. ...
(Date:12/2/2016)... a world leader in rapid infectious disease tests, introduced the Company,s newest product, the ... (Photo: http://photos.prnewswire.com/prnh/20161201/444905 ) Continue Reading ... ... , , bioLytical was invited by the ... INSTI HIV Self Test to 350 pharmacy representatives in Nairobi ...
(Date:11/30/2016)... Biotest Pharmaceuticals Corporation (BPC), a leading manufacturer ... addition of its newest plasma collection center located at ... The 15,200 square foot state-of-the-art facility officially opened its ... the total number of BPC,s plasma collection centers to ... Chief Executive Officer said "We are pleased to become ...
(Date:11/30/2016)... November 2016   Merck , ein ... Unterzeichnung einer Reihe von Vereinbarungen mit Evotec ... AG Screeningleistungen für Mercks Palette genetischer Reagenzien ... auf diese Bibliotheken in Kombination mit Evotecs ... Weg zur Ermittlung und Erforschung neuer Arzneimitteltargets.    ...
Breaking Biology Technology:
(Date:11/29/2016)... Nearly one billion matches per second with DERMALOG,s high-speed AFIS    ... ... DERMALOG is Germany's largest Multi-Biometric supplier: The ... Identification Systems) ... Germany's largest Multi-Biometric supplier: The company's Fingerprint Identification System is part of ...
(Date:11/22/2016)... According to the new market research report "Biometric ... Signature, Voice), Multi-Factor), Component (Hardware and Software), Function (Contact and Non-contact), Application, ... is expected to grow from USD 10.74 Billion in 2015 to reach ... and 2022. Continue Reading ... ...
(Date:11/19/2016)... , Nov. 18, 2016 Securus Technologies, ... solutions for public safety, investigation, corrections and monitoring, announced ... smaller competitor, ICSolutions, to have an independent technology judge ... the most modern high tech/sophisticated telephone calling platform, and ... customers that they do most of what we do ...
Breaking Biology News(10 mins):