The phase 1/2 study of the pixantrone combination regimen, known as FPD-R, produced a 95% overall response rate (ORR) with 77% of patients experiencing complete disappearance of their tumors (complete remission). Cell Therapeutics, Inc. is also studying pixantrone in an ongoing phase 3 study in aggressive NHL, known as the EXTEND trial.

In the phase I/II study, of the 22 patients evaluable for response, 95% achieved an objective response, including 77% who achieved complete response/unconfirmed complete response (CR/CRu) with 18% achieving a partial response (PR). At two years, overall survival is 85%, with a median failure-free survival of 25 months (range, three to 29 months). Predominant side effects (grade 3/4) were primarily hematological including neutropenia (76%), febrile neutropenia (8%), lymphopenia (76%), thrombocytopenia (20%) and anemia (4%).

"Although many regimens induce responses in patients with relapsed indolent NHL, many of the remissions are of relatively short duration," noted Jack W. Singer, M.D. Chief Medical Officer at CTI. "These data suggest that use of pixantrone with fludarabine, dexamethasone and rituximab not only offers a very high response rate, but impressive durability."

About Pixantrone and the FPD-R Regimen
This trial examines the safety and potential efficacy for pixantrone when substituted for mitoxantrone in the FND-R regimen (fludarabine, mitoxantrone, dexamethasone, rituximab) for patients who had failed prior treatment.

Patients received a median of 5.5 cycles of therapy. Cycles were every 28 days. Dosing was rituximab at 375 mg/m² dl, fludarabine at 25 mg/m²/d d1-3, dexamethasone at 20 mg/d PO, d1-5 and pixantrone starting at 80 mg/m² to 120 mg/m².

About Pixantrone
Pixantrone is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplified administration compared to the currently marketed anthracyclines.


SOURCE: Cell Therapeutics, Inc.

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