D-Pharm / metal ion chelators
REHOVOT, Israel, March 11 /PRNewswire/ -- D-Pharm Ltd. announced today initial results from its Phase II Acute Stroke Study with D-Pharm's proprietary drug candidate, DP-b99. The Phase II study was performed as a randomized, double-blind, placebo-controlled trial. The purpose of the study was to determine whether DP-b99 could be safely used in patients within a 12-hour time window following a stroke incident and to provide important pharmacokinetics and dosing information for future pivotal efficacy trials. Initial analysis of the data indicates that DP-b99 may be safely administered in this patient population. Rates of mortality, serious adverse events and overall adverse events were not higher in the DP-b99 group compared to placebo and no major side effects were attributed to the treatment. Although the study was not powered for efficacy evaluation, noteworthy improvements were observed in the clinical neurological scale scores 2, 7 and 30 days after the stroke.
Dr. Itzchak Angel, Vice President for R&D at D-Pharm commented: "The results seem to confirm previous preclinical and clinical studies showing very comfortable safety and pharmacokinetics profiles of the compound. The study was performed on a limited number of patients and we were pleasantly surprised to see a promising trend in the neurological outcome measured." Alex Kozak, the Company's President and CEO added: "We are very encouraged by the results of this study and we are planning to aggressively continue the clinical development of DP-b99."
About the MAC technology
D-Pharm's MAC drug discovery platform is based on lipid modification of metal ion chelators. MAC drugs are designed to bind metal ions such as copper, zinc, calcium and iron selectively within cell membranes and membrane milieus, rendering the action localized and safe. The company's most advanced MAC based products include DP-b99 in Phase II for acute stroke and DP-109 in preclinical development for Parkinson's and Alzheimer's disease.
About DP-b99
DP-b99 is a MAC based product, designed and developed by D-Pharm as a neuroprotective agent for treatment of acute stroke. It showed a remarkable safety profile in Phase I clinical trials, even when administered at 100 times the expected effective dose. DP-b99 functions at several levels in the neurodegeneration process; modulates neuronal excitability, reduces metal ion dependent, cell damaging enzymatic activities and restricts intracellular diffusion of metal ions. The product is highly efficacious in pre-clinical stroke models, both in reducing the brain infarct volumes, and in the recovery of neurological function.
About Stroke
Stroke is one of the world's most prevalent pathologies, rated as the third leading cause of death and second leading cause of neurological morbidity in the US, Europe, and Japan. After a stroke victim arrives at the hospital emergency room, clinicians must diagnose and initiate treatment within a six-hour window, during the medical crisis.
About D-Pharm
D-Pharm (http://www.dpharm.com ) is a biopharmaceutical company pioneering the development of lipid-based therapeutics. D-Pharm is engaged in both drug targeting and drug discovery based on the company's technological platforms: (i) Regulated Activation of Prodrugs (D-RAP(TM)); (ii) Membrane Activated Chelators (MAC); and (iii) LipidoMimetix(TM). This has enabled the Company to generate a rich pipeline of innovative drugs for the treatment of CNS disorders, cancer, and autoimmune diseases. The company's business strategy is to develop its products through "proof of principle in man" and to seek partners for advanced clinical development and commercialization. |
