Ibex Completes Phase Ia Neutralase Trials

IBEX Technologies of Montreal in Canada has completed the first Phase Ia trial of its lead compound Neutralase (heparinase I). The drug is intended for the reversal of heparin treatment following bypass surgery.

The dose-escalating safety and pharmacokinetic study was conducted in the UK and enrolled 32 healthy volunteers, who were administered up to three times the expected clinical dose. Full details of the results will be presented at a scientific meeting later in the year, according to the firm. IBEX intends to conduct a further two Phase I trials, the first one beginning in the fall, which may provide some preliminary efficacy data for the product. Neutralase is the first in-house drug from IBEX to reach the clinic.

Product Rationale Heparin is used as an anticoagulant in each of the 500,000 bypass operations performed annually, and following completion of the operation it must be neutralized to restore normal clotting and thereby limit blood loss. According to the company, the current mainstay drug for heparin neutralization, protamine, has a number of serious medical and safety limitations which are overcome by heparinase I, and market research has indicated that the majority of US clinicians who administer protamine would prefer a safer alternative.