Pixantrone* is a novel aza-anthracenedione derivative with unique structural and physio-chemical properties. Unlike related compounds, pixantrone forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixantrone was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite – both of which are the putative mechanisms for anthracycline-induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow pixantrone to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.
The pivotal Phase 3 EXTEND, or PIX301, randomized clinical trial evaluated pixantrone for patients with relapsed or refractory aggressive NHL was published in Lancet Oncology in May 2012. Also in May 2012, PIXUVRI® (pixantrone) was granted conditional marketing authorization by the European Commission as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. There are no drugs approved for this indication in the United States.
In connection with the conditional marketing authorization, CTI is conducting an ongoing randomized, controlled Phase 3 clinical trial, known as PIX-R or PIX306, that currently is enrolling patients.
Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant.