CTI BioPharma Corp. (Nasdaq: CTIC), today announced that Clinical Cancer Research, a journal of the American Association for Cancer Research, has published results from a Phase 1 study led by Joseph Pidala, MD, PhD (Moffitt Cancer Center), and Brian C. Betts, MD (Masonic Cancer Center at the University of Minnesota), evaluating pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, for the prevention of acute graft-versus-host disease (GVHD). The results demonstrated that pacritinib, combined with sirolimus and low-dose tacrolimus (PAC/SIR/TAC), has a promising safety profile and exhibits preliminary therapeutic activity in preventing acute GVHD after allogeneic hematopoietic cell transplantation. The article, titled "Pacritinib Combined with Sirolimus and Low-Dose Tacrolimus for GVHD Prevention after Allogeneic Hematopoietic Cell Transplantation: Preclinical and Phase 1 Trial Results," is available online (http://clincancerres.aacrjournals.org/content/early/2021/03/17/1078-0432.CCR-20-4725). The Phase 2 portion of the trial (NCT02891603) designed to evaluate the therapeutic effect of pacritinib in combination with sirolimus and low-dose tacrolimus for GVHD prevention is ongoing at Moffitt Cancer Center and the Masonic Cancer Center at the University of Minnesota.
The Phase 1 portion of the trial (NCT02891603) evaluated the safety of pacritinib when administered with sirolimus plus low-dose tacrolimus after allogeneic hematopoietic cell transplantation (alloHCT). A 3+3 dose escalation design identified PAC 100 mg twice a day as the minimum biologically active and well-tolerated dose for further study. At this dose, one out of six study participants treated with the investigational regimen had Grade 2-4 acute GVHD. Chronic GVHD was rare, with only two participants developing mild disease per NIH consensus criteria, which resolved without systemic immune suppression.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.