BTI-322 murine monoclonal antibody targeting CD2 on the surface of T cells data

Investigators reported positive follow-up results of two Belgian Phase I/II trials of BTI-322. As presented at the International Conference of the Transplantation Society in Barcelona, Spain, the prevention trial compared the incidence of rejection in 20 control transplant patients who received standard triple drug therapy (cyclosporine A, azathioprin and steroids) and 18 patients who received a 10-day course of 5 mg/day of BTI-322 in addition to standard therapy. At six months, 12 of 20 controls (60 percent) had acute first rejection episodes versus 4 of 18 treated patients (22 percent, p=0.018). Adverse events included blood pressure variation in 1 patient and bronchospasm in 2 patients, both of which were associated with the first dose, limited in duration and manageable.

In the second study, BTI-322 at doses of 10, 5 or 2.5 mg/day was given to 11 patients experiencing a first rejection event, as well as to 10 patients experiencing a rejection event, most of whom had failed conventional rescue therapy or suffered multiple rejection episodes. A total of 10 of 11 patients in the first group and 8 of 10 in the second group responded to therapy. ...