DP-b99 Phase III MACSI Study Protocol Published in International Journal of Stroke

By D-pharm Ltd, PRNE
Monday, June 13, 2011

REHOVOT, Israel, June 14, 2011 -

D-Pharm Ltd., (TASE: DPRM) announced today publication, on-line,
in the International Journal of Stroke the protocol for its
ongoing, Phase III, Membrane Activated Chelator Stroke Intervention
(MACSI) study. In this study, DP-b99 is being tested for safety and
for the ability to improve outcome in moderately severe acute
ischemic stroke patients. The article is available on-line at the
following link href="onlinelibrary.wiley.com/doi/10.1111/j.1747-4949.2011.00608.x/abstract">
and will appear in the journal’’s August, 2011 print edition.

(Logo: href="www.newscom.com/cgi-bin/prnh/20100415/386828">www.newscom.com/cgi-bin/prnh/20100415/386828

Dr. Gilad Rosenberg, D-Pharm’’s V.P. of Clinical Development
commented; “DP-b99 is the most advanced industry-developed
neuroprotective agent in clinical development. Benefitting from the
MACSI Steering Committee’’s many years of experience in clinical
stroke research, we have gone to a great effort to include an
innovative trial design that incorporates many of the lessons
learned from past studies.”

The MACSI study is one on the largest randomized, double blind,
placebo-controlled Phase III stroke studies currently ongoing. Its
primary objective is to evaluate the safety and therapeutic effects
of intravenous 1.0mg/kg/day DP-b99, initiated within nine-hours of
stroke onset in patients with moderately severe hemispheric acute
ischemic stroke. The primary efficacy outcome is the mRS score at
day 90 which will be compared between treatment groups using a
‘shift’, or distribution, analysis.

The MACSI study is enrolling 770 patients, with recruitment in
over 100 clinical sites in North America, Europe, South America,
South Africa and Israel. The protocol, now published, was agreed
with the U.S. FDA under the Special Protocol Assessment (SPA)
procedure and the DP-b99 development program has been granted Fast
Track status by the U.S. FDA.

According to the MACSI protocol, a Data Safety Monitoring Board
(DSMB), should periodically review safety data from patients
enrolled into the study. The DSMB, which includes independent
experts in stroke, neurology and biostatistics, recently
recommended to the MACSI Steering Committee that the study continue
in its present design without changes to the protocol.

About DP-b99

DP-b99 is a unique broad-spectrum neuroprotective drug that
addresses an array of brain damaging processes occurring in stroke
patients. Both preclinical and clinical Phase I and II studies
indicate a favorable efficacy and safety profile for DP-b99. In the
Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased
by two-fold the percentage of patients that recovered from ischemic
stroke. DP-b99 may be administered within a nine hour therapeutic

About Stroke

Every year around 1.5 million people in the U.S., Western Europe
and Japan suffer an acute stroke. Stroke is a leading cause of
death in the western world and around 50% of stroke survivors
suffer from some form of severe disability. According to the
American Heart Association (AHA) the annual economic burden of
stroke in the U.S. was around $70B in 2009. Currently, between 2-5%
of stroke patients receive tissue plasminogen activator (tPA), the
only drug currently approved for treatment of acute stroke in the

About D-Pharm

D-Pharm (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 ischemic stroke
patients and DP-VPA, a novel drug for treatment of epilepsy,
bipolar disorder and prophylaxis of migraine. DP-VPA, a prodrug of
valproic acid, is in Phase II clinical development. 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

D-Pharm was established in 1993 at the initiative of Dr. Alex
, President and CEO. In August 2009 the Company completed
the first offering of its shares on the Tel Aviv stock exchange.
The largest shareholder in the company is Clal Biotechnology
Industries (46%).


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

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


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