ZICHRON YAAKOV, Israel ¿ D-Pharm gained approval to start Phase I clinical trials in Germany for DP-b99, its neuroprotective drug candidate. DP-b99 is being developed as a first-line therapy to improve neuronal survival in stroke and traumatic brain injury, as well as for prophylaxis against neurological damage associated with open-heart surgery. DP-b99 will be administered intravenously, in single and repeated doses, to healthy volunteers, both young and elderly.

¿We believe that DP-b99 will lead to a major breakthrough in stroke therapy, comprising a novel mechanism of action targeting apoptosis, or programmed cell death, which underlies the spread of neurological damage subsequent to a hypoxic shock,¿ said Itzhak Angel, D-Pharm¿s vice president for research and development. DP-b99 was effective in animal models up to eight hours after the onset of ischemia, ¿promising effective treatment for patients even if administered hours after the stroke insult,¿ Angel added.

¿DP-b99 has the potential to become a blockbuster drug,¿ said Alex Kozak, D-Pharm president and CEO. ¿We expect DP-b99 to provide for the unmet needs of the stroke market by offering a unique combination of efficacy, at all stages of post-hypoxic neuronal degeneration, concomitant with a remarkable safety profile and lack of cardiotoxic effects.¿

DP-b99 is a member of a novel drug class, Membrane-activated chelators (Mac), designed to control apoptotic processes by regulating intracellular homeostasis of divalent metal ions. DP-b99 selectively exerts chelating properties in the vicinity of the cell membranes, modulating intracellular calcium, zinc, iron and copper levels. Unlike other metal ion chelators, DP-b99 does not cause cardiotoxicity or affect cardiovascular and respiratory functions, even when administered in doses up to 500-fold greater than required to achieve efficacy, as shown in hemodynamic studies in dogs.

Separately, D-Pharm disclosed last week the incorporation of a subsidiary in the United States to be known as D-Pharm US Inc. (DPI), located in Chapel Hill, N.C. The new company will focus on providing business development as well as other liaison services to D-Pharm and will be headed by Albert Lauri tano, who was vice president, business development at ICAgen Inc., of Research Triangle Park, N.C., before taking similar roles at Amylin Pharma ceuticals Inc. in San Diego and Novo Nordisk Pharma ceuticals Inc. in Princeton, N.J.

Yaffa Beck, D-Pharm¿s COO and executive vice president, said, ¿We expect his extensive experience in both the biotech and pharmaceutical industry will make an important contribution to our business development and spearhead the efforts to globalize our operation.¿