D-Pharm Receives Nod From DSMB to Continue the DP-b99 MACSI Phase III Study in Stroke Patients

By D-pharm Ltd, PRNE
Tuesday, July 19, 2011

REHOVOT, Israel, July 20, 2011 -


 

D-Pharm Ltd., (TASE: DPRM) announced today that the Data and
Safety Monitoring Board (DSMB) for the Membrane Activated Chelator
Stroke Intervention (MACSI) study recommended that the study
continue as planned. The DSMB conducted a comprehensive unblinded
review of safety data from the first 200 patients that completed
follow-up in the MACSI study, as well as a review of all serious
adverse event (SAE) data from previous DP-b99 clinical studies.

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

In the Phase III MACSI study, DP-b99 is being tested for safety
and for the ability to improve outcome in moderately severe acute
ischemic stroke patients.

Dr. Alex Kozak, D-Pharm’s CEO, commented; “The outcome of this
in depth safety review by an unblinded, unbiased team of
independent experts is most reassuring and I’m delighted that the
MACSI study can continue uninterrupted.”

According to the MACSI protocol, the DSMB reviews safety data
once every 100 patients complete the study’s follow-up period.
Additionally, the DSMB has reviewed data across the whole
development program of DP-b99.  The DSMB, which includes
independent experts in stroke neurology and biostatistics, has
recommended to the MACSI Steering Committee that the study continue
in its present design without changes to the protocol.
According to plan, the DSMB will next meet upon
completion of enrollment and follow-up of the
first 300 patients in the study.

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
up to 170 clinical sites in North America, Europe, South America,
South Africa and Israel. The protocol, published recently in the
International Journal of Stroke, 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.

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
window.

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
U.S.

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
cancer.

D-Pharm was established in 1993 at the initiative of Dr. Alex
Kozak
, 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%).

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

.

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