D-Pharm Receives Top-line Results From Cardiac Safety Study With DP-b99

By D-pharm Ltd, PRNE
Monday, August 9, 2010

REHOVOT, Israel, August 10, 2010 - D-Pharm Ltd (DPRM: TASE) announced today successful top-line results from
a thorough electrocardiographic (ECG) study of DP-b99 in healthy volunteers.
This ECG study, conducted in parallel with the ongoing MACSI phase 3 study in
acute ischemic stroke patients, demonstrated the electrocardiographic safety
of DP-b99 administered at doses three times higher than are currently
administered in MACSI. In the ECG study, DP-b99 had no effect on the QT
segment of the ECG, in contrast to a positive control that clearly prolonged
the QTc interval. This study, mandated by the ICH (International Conference
on Harmonisation) guidelines that govern the regulatory process in the USA,
Europe, Japan and most other countries, was particularly important given that
DP-b99 is a new chemical entity and represents an entirely novel therapeutic
class.

(Logo:
www.newscom.com/cgi-bin/prnh/20100415/386828 )

The study was a randomized, positive-controlled, double-blind,
placebo-controlled, four-way crossover study to define the ECG effects of a
clinical and a supra-therapeutic dose of DP-b99 in 32 healthy male and female
volunteers.

Dr. Gilad Rosenberg, D-Pharm's VP Clinical Development commented: "I'm
delighted that we've achieved this important milestone. Not only has the
electrocardiographic safety of DP-b99 been unequivocally demonstrated at the
clinical dose, but also at a supra-therapeutic dose."

DP-b99 is currently being tested in a pivotal phase 3 trial,
MACSI, in acute ischemic stroke patients. The protocol for the trial was
agreed with the U.S. FDA under the Special Protocol Assessment (SPA)
procedure. The MACSI study is enrolling 770 patients, with recruitment
ongoing at many, of over 100, clinical sites in North America, Europe, South
America
, South Africa, Israel and South Korea. For more details see:
clinicaltrials.gov/ct2/show/NCT00893867?term=MACSI&rank=1

About D-Pharm Ltd.

D-Pharm (www.dpharm.com) is a technology-driven biopharmaceutical
company focused on the discovery and development of innovative proprietary
drugs for the treatment of central nervous system disorders and cancer.
D-Pharm is a leader in design and development of lipid-like medicine and its
products are new chemical entities (NCEs) derived from its proprietary
platform technology. The drug development pipeline includes two products in
advanced stages of clinical development: DP-b99 (phase 3) for treatment of
acute ischemic stroke patients and DP-VPA (phase 2) for treatment of
epilepsy, bipolar disorder and prophylaxis of migraine; and preclinical
drug-candidates for Alzheimer's disease and 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.

    Contact:
    Tami Horovitz
    thorovitz@dpharm.com
    Tel: +972-8-9385100

Photo:
www.newscom.com/cgi-bin/prnh/20100415/386828

Contact: Tami Horovitz, thorovitz at dpharm.com, Tel: +972-8-9385100

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