D-Pharm Receives Top-line Results From Cardiac Safety Study With DP-b99
REHOVOT, Israel, August 10, 2010 /PRNewswire-FirstCall/ -- 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.
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: http://clinicaltrials.gov/ct2/show/NCT00893867?term=MACSI&rank=1
About D-Pharm Ltd.
D-Pharm (http://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.
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.
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SOURCE D-Pharm Ltd