The trial enrolled patients within the first 9 hours following appearance of stroke symptoms. The data indicate that the effect of DP-b99 on recovery was uniform across the full 9h window, confirming the wide therapeutic window for DP-b99.
The favorable safety and tolerability profile of DP-b99 was confirmed and is in line with D-Pharm's previous clinical experience from the Phase I and IIa studies. There were no significant differences in the number or type of serious adverse events, mortality rate or death causes between the DP-b99 and placebo groups.
These results show that DP-b99 doubled the chances to recover from ischemic stroke, has at least a 9hr therapeutic window and is safe. D-Pharm is planning to commence a pivotal Phase III study of DP-b99 in 2008.
About D-Pharm Ltd.
D-Pharm (www.dpharm.com) is a biopharmaceutical company pioneering the development of lipid-like therapeutics and has generated a rich product pipeline from its drug targeting and discovery technologies, Regulated Activation of Prodrugs (D-RAPTM) and Membrane Active Chelators (MAC). The company expects to discuss the further development of DP-b99 with regulatory authorities in the coming months.
D-Pharm's pipeline includes DP-VPA, a new chemical entity that is a modified and targeted version of valproic acid for epilepsy, bipolar disorder treatment and migraine prophylaxis, currently in Phase II development. DP-460 is in preclinical development intended as an oral, disease-modifying therapy for Alzheimer's disease.
For further information please contact: Tami Horovitz, PhD. Tel: +972-8-9385100
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