D-Pharm’s drug DP-b99 to control stroke damages could hit markets by 2013

DP-b99, an experimental medicine to control neurological damages caused by stroke, may reach the market earlier than expected –in 3 to 4 years’ time, reports said quoting D-Pharm’s senior officials.

Trial data of DP-b99 analyzed has found that the drug has doubled the number of patients who completely recovered from strokes caused by blood clots.

If the final phase of clinical trial, which the drug is currently undergoing, could repeat the positive outcome,the U.S. Food and Drug Administration may relax D-Pharm from conducting another trial with the drug to establish the findings.

DP-b99 seeks to address an array of brain damaging processes occurring in stroke patients. The drug uses D-Pharm’s proprietary Membrane Activated Chelator (MAC) platform technology.

D-Pharm completed testing of DP-b99 in pre-clinical and then in Phase I and Phase II clinical studies.

In a 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.

In December 2009, D-Pharm Ltd started enrollment of patients with acute ischemic stroke into its Phase III clinical study of DP-b99 (MACSI).

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.

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.

Stroke accounts for 5.7 million deaths annually, Worldwide, according to the World Stroke Organization.

Nearly 795,000 people suffer a new or recurrent stroke each year in the U.S alone, according to the American Stroke Association.
D-Pharm 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.