REHOVOT, Israel, December 31 /PRNewswire-FirstCall/ -- 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.
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 (http://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.
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: email@example.com
SOURCE D-Pharm Ltd
|SOURCE D-Pharm Ltd|
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