• We have completed a Phase IIa, multicenter, open-label study designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra administration, for the prevention of GvHD in subjects with hematologic malignancies undergoing allogeneic sibling HLA-matched HSCT. The study was designed for dose-escalation in four sequential cohorts (35, 70, 140 and 210 X106 cells/kg), included 13 eligible patients, and was conducted at three sites in Israel. Patients received conventional myeloablative conditioning and prophylaxis regimen that was prescribed according to the normal standard of care.
  • Our preclinical data and clinical data from our Phase IIa trial appeared to indicate that Allocetra was well-tolerated at all doses administered for up to six months, which was the observed duration of the trial.  Ten severe adverse events were reported, seven of which were assessed as not related to Allocetra and three of which were assessed as unlikely to be related to Allocetra.  We did not observe or receive reports of any definite or probable adverse effects related to Allocetra.  Although scientific literature notes that 30% to 50% of patients with acute GvHD are expected to advance to the most severe grades of GvHD (i.e., Grades II-IV) and the overall incidences of acute GvHD Grades II through IV and Grades III or IV in the trial were 23% and 15%, respectively, none of the six patients treated with the two highest doses of Allocetra in the study advanced to such grades.  In fact, the number of overall adverse effects decreased with Allocetra dose escalation.  In addition, although incidences of acute, low-grade (i.e., Grade I) GvHD increased to 50% and we observed mild chronic GvHD in these patients, we believe this shows that Allocetra does not suppress the immune system, but rather permits its natural activity, which can result in decreased relapse rates with little to no risk to the patient.  In the trial, Allocetra injections were not associated with prolongation of time to engraftment, duration of hospitalization, chimerism delay (i.e., the time it takes for donor immune cells to become immunologically effective in the patient’s body), increased mortality rate or serious infections when compared with similar patients described in scientific literature.
  • We are planning a pivotal Phase III clinical trial, one-year (per-patient), multicenter, randomized, double-blind, placebo-controlled, of Allocetra for prevention of acute GvHD after HSCT in matched-related patients with hematological malignancies, or types of cancer that affect blood, bone marrow and lymph nodes. This study will consist of approximately 220 patients with the primary end point of the incidence of acute Grades II to IV GvHD at day 180 and that the secondary end points would include, without limitation, hospitalization period, quality of life, time to engraftment, rate of relapse, rate of survival, and steroid consumption.