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

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 ( 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.


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

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
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:
(Date:6/27/2016)... June 27, 2016 /PRNewswire/ - BIOREM Inc. (TSX-V: BRM) ("Biorem" ... by its major shareholders, Clean Technology Fund I, LP ... States based venture capital funds which together ... (on a fully diluted, as converted basis), that they ... their entire equity holdings in Biorem to TUS Holdings ...
(Date:6/27/2016)... , ... June 27, 2016 , ... ... their findings on what they believe could be a new and helpful biomarker ... new research. Click here to read it now. , Biomarkers are ...
(Date:6/27/2016)... , ... June 27, 2016 , ... ... bring innovative medical technologies, services and solutions to the healthcare market. The company's ... of various distribution, manufacturing, sales and marketing strategies that are necessary to help ...
(Date:6/27/2016)... PHILADELPHIA , June 27, 2016  Liquid ... today announced the funding of a Sponsored Research ... study circulating tumor cells (CTCs) from cancer patients.  ... changes in CTC levels correlate with clinical outcomes ... therapies. These data will then be employed to ...
Breaking Biology Technology:
(Date:4/15/2016)... , April 15, 2016 ... "Global Gait Biometrics Market 2016-2020,"  report to their ... ) , ,The global gait biometrics market ... 13.98% during the period 2016-2020. Gait ... which can be used to compute factors that ...
(Date:3/31/2016)... Florida , March 31, 2016 ... ) ("LegacyXChange" or the "Company") LegacyXChange ... potential users of its soon to be launched online ... ( ) will also provide potential ... use of DNA technology to an industry that is ...
(Date:3/23/2016)... 2016 Einzigartige ... und Stimmerkennung mit Passwörtern     ... MESG ), ein führender Anbieter digitaler Kommunikationsdienste, ... SpeechPro zusammenarbeitet, um erstmals dessen Biometrietechnologie einzusetzen. ... Möglichkeit angeboten, im Rahmen mobiler Apps neben ...
Breaking Biology News(10 mins):