D-Pharm Receives Agreement Letter on Special Protocol Assessment for DP-b99 Study - a Pivotal Phase III Trial in Acute Ischemic Stroke Patients

REHOVOT, Israel, April 15, 2010 - D-Pharm Ltd (DPRM: TASE) announced that it has reached an
agreement with the U.S. Food and Drug Administration (FDA) under the Special
Protocol Assessment (SPA) procedure for a pivotal phase 3 trial (MACSI) of
its neuroprotective agent DP-b99 in acute ischemic stroke patients. The SPA
agreement letter indicates that "the design and planned analysis of the study
adequately address the objectives necessary to support a regulatory
submission" of the drug for marketing approval, a New Drug Application (NDA).

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

Dr. Gilad Rosenberg, D-Pharm's VP Clinical Development commented: "The
FDA thoroughly reviewed this protocol and issued an SPA agreement letter -
the same FDA that will have to eventually rule whether DP-b99 may receive
marketing authorization in the USA. Their agreement to the protocol attests
to the adequacy of the MACSI trial design, and confirms that the MACSI
results, if positive, will be able to support a New Drug Application
submission. As such, the SPA agreement represents an auspicious development
of major significance."

About the Phase 3 MACSI Trial

The MACSI trial is a double blind, randomized, placebo controlled,
parallel group, multicenter and multinational phase 3 pivotal study to
compare, using mRS "Shift Analysis" at Day 90, the therapeutic effects of
1mg/kg/day intravenous DP-b99 over 4 consecutive days versus placebo, in
subjects with moderately severe, likely hemispheric, acute ischemic stroke.
Treatment will be initiated within nine hours of acute ischemic stroke onset.
The safety and tolerability of DP-b99 will be assessed, as well as
post-stroke recovery according to mRS and NIHSS Day 90 scores.

The study will enroll 770 patients, with recruitment started at some of
the 140 clinical sites in Europe, USA, Canada, Brazil, South Africa, Israel
and South Korea.

About the SPA

Special Protocol Assessment (SPA) is an instrument of the FDA for
evaluating protocols and reaching agreement with sponsors on the design of
clinical trials that can be used for drug approval. In our case, it applies
to a clinical protocol for a trial from which the data will form the primary
basis for a claim of efficacy. In general, the SPA can significantly reduce
development time since the design of the pivotal protocol has been approved
in advance by the Regulator.

About DP-b99

DP-b99, by virtue of its ability to modulate pathological levels of zinc
in the vicinity of membranes, is a multi-targeted compound for the treatment
of stroke that addresses an array of brain damaging processes occurring in
stroke patients. DP-b99 represents a family of proprietary Membrane Activated
Chelator (MAC) compounds that have potential efficacy in the treatment of a
wide variety of neurodegenerative disorders.

D-Pharm successfully completed extensive testing of DP-b99 in
pre-clinical and then in Phase 1 and Phase 2 clinical studies. Both
preclinical and clinical studies indicate a favorable efficacy and safety
profile for DP-b99. In the Phase 2b trial in 150 ischemic stroke patients,
DP-b99 increased by two-fold the percentage of patients that completely
recovered from ischemic stroke. The first patient was enrolled into the MACSI
study, on schedule, in December 2009.

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 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 (Ph. 3) for treatment of
acute ischemic stroke patients and DP-VPA (Ph. 2) for treatment of epilepsy,
bipolar disorder and prophylaxis of migraine; and preclinical drug-candidates
for Alzheimer's disease and cancer.

    Contact: Tami Horovitz
    D-Pharm Ltd.
    thorovitz@dpharm.com
    Tel: +972-89385100

Contact: Tami Horovitz, D-Pharm Ltd., thorovitz at dpharm.com, Tel: +972-89385100