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 (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.
Contact: Email: Tami Horovitz thorovitz@dpharm.com
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.