SEATTLE, May 16 /PRNewswire-FirstCall/ -- Preliminary results of a phase I/II study of pixantrone combined with fludarabine, dexamethasone, and rituximab for treatment of patients with relapsed indolent non-Hodgkin's lymphoma (NHL) will be presented today at the Rodman & Renshaw 3rd Annual Global Healthcare Conference in Monte Carlo, Monaco. The phase I/II study of the pixantrone combination regimen, known as FPD-R, produced a 95 percent overall response rate (ORR) with 77 percent of patients experiencing complete disappearance of their tumors (complete remission). Cell Therapeutics, Inc. (CTI) is also studying pixantrone in an ongoing phase III study in aggressive NHL, known as the EXTEND trial.
In the phase I/II study, of the 22 patients evaluable for response, 95 percent achieved an objective response, including 77 percent who achieved complete response/unconfirmed complete response (CR/CRu) with 18 percent achieving a partial response (PR). At two years, overall survival is 85 percent, 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 percent), febrile neutropenia (8 percent), lymphopenia (76 percent), thrombocytopenia (20 percent) and anemia (4 percent).
"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."
The webcast with slides will be available at www.cticseattle.com.
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.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.cticseattle.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the potential failure of pixantrone to prove safe and effective for treatment of non-Hodgkin's lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Cell Therapeutics, Inc.CONTACT: investors, Leah Grant, +1-206-282-7100, or invest@ctiseattle.com,or www.cticseattle.com/investors.htm, or media, Susan Callahan,+1-206-272-4472, or media@ctiseattle.com, or www.cticseattle.com/media.htm,both of Cell Therapeutics, Inc., fax, +1-206-272-4434
Web site: http://www.cticseattle.com//
