D-Pharm (TASE: DPRM) Announces Enrollment of First Patient in DP-b99 Phase III Efficacy Study, MACSI
By D-pharm Ltd, PRNEWednesday, December 30, 2009
REHOVOT, Israel, December 31 - 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 (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 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.
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
For further information please contact: Tami Horovitz, Tel: +972-8-9385100, Fax: +972-8-9300795, Email: thorovitz at dpharm.com
Tags: D-Pharm Ltd, Israel, Rehovot