TEL AVIV, Israel - D-Pharm Ltd. said it completed preclinical toxicological studies for DP-b99, establishing this neuroprotectant drug candidate as safe with a wide therapeutic window to improve neuronal survival in stroke and traumatic brain injury and for prophylaxis against neurological damage associated with open-heart surgery.

The comments were made here at the Fifth Annual Growth & Technology Conference of Robertson Stephens Evergreen by molecular biologist Itzchak Angel, D-Pharm's vice president of research and development. Phase I clinical studies of DP-b99 are planned to begin by the end of 1999 in Europe.

D-Pharm, of Rehovot, and Compugen Ltd. were singled out as the two biotech companies ready to go public as early as next year by Robertson Stephens International vice president Peter Hoffmann-Fischer, who heads the life sciences section of the London-based investment bank.

He noted that although both companies are young, founded in 1993, both are scientifically and technologically advanced, with excellent management and "able to choose when and if they want to go public."

DP-b99 passed all of the standard preclinical toxicology studies with no significant effect on any cardiovascular, respiratory or hematological variables measured, and no toxic side effects, even at doses up to 500-fold above the therapeutically effective dose.

The pharmacological studies of DP-b99 demonstrated "remarkable beneficial effects over a long therapeutic window," as long as eight hours after the ischemic insult, "in a uniquely curative, postponed mode of treatment of global and focal brain ischemia, with no major adverse side effects, an issue that has plagued other stroke drug development programs," Angel told BioWorld International.

DP-b99 controls apoptotic processes by regulating intracellular ionic homeostasis. In the vicinity of the plasma membrane, DP-b99 is a metal chelator modulating calcium as well as zinc, iron and copper ion levels.

"Yet, uniquely, unlike any other metal ion chelators, DP-b99 has no cardiotoxicity and does not affect cardiovascular functions," said Angel, which could position it for prophylaxis against neurological damage associated with open-heart surgery.