Healthcare Industry News:  rituximab 

Biopharmaceuticals Oncology FDA

 News Release - May 17, 2007

Cell Therapeutics, Inc. Receives FDA Special Protocol Assessment (SPA) Comments on the Design of Phase III Trial of Pixantrone in Relapsed Indolent NHL

Fast track-designated trial may expand use into larger segment of lymphoma population

SEATTLE, May 17 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) announced today it received feedback from the U.S. Food and Drug Administration (FDA) and is in agreement with requests from the agency for the design of its trial for relapsed or refractory indolent non- Hodgkin's lymphoma (NHL) patients. Pixantrone for relapsed or refractory indolent NHL received fast-track designation by the FDA earlier this month.

"We are pleased that the FDA acknowledged that pixantrone may address unmet medical needs for patients with relapsed indolent NHL, and that the agency is working with us on designing a pivotal trial which, if successful, would provide the basis for expanding the indication for pixantrone into this larger segment of the lymphoma population," said James A. Bianco, president and CEO of CTI."

The PIX303 trial will examine the time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have failed up to five prior treatments for relapsed or refractory NHL. The trial is expected to enroll 300 patients beginning in the second quarter of 2007 with interim data by mid-2008.

Pixantrone Clinical Trials in Indolent NHL

Prior results demonstrated that the addition of pixantrone to a fludarabine/rituximab-based regimen in relapsed or refractory indolent NHL yielded a 70 percent confirmed response/unconfirmed response (CR/uCR) rate. In that phase I/II study the estimated median duration of response was 25 months (range 2.3 to 43 months) and the estimated progression-free survival (PFS) rate at three years was 50.4 percent. A phase III trial of rituximab compared to rituximab plus pixantrone in relapsed or refractory indolent NHL had a 61 percent overall improvement in time to tumor progression (TTP) compared to rituximab alone (395 days vs. 245 days). In that randomized trial, the median TTP estimate for pixantrone/rituximab was 13.2 months compared to 8.1 months for rituximab alone (hazard ratio 0.13, log rank p<0.001). The overall response rate in the pixantrone/rituximab arm was 75 percent versus 33 percent in the rituximab arm with a CR rate of 30 percent in the pixantrone/rituximab arm versus 11 percent in the rituximab arm.

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. Except as may be required by Italian law, 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.


Source: Cell Therapeutics

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