Healthcare Industry News:  rituximab 

Biopharmaceuticals FDA

 News Release - May 7, 2007

Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients

Proposed Phase III Trial Has the Potential to Demonstrate an Effect on a Serious or Life Threatening Aspect of This Disease

SEATTLE, May 7 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) announced today it received fast track designation from the U.S. Food and Drug Administration (FDA) for pixantrone, a novel anthracenedione, being investigated for the potential treatment of relapsed or refractory indolent non-Hodgkin's lymphoma (NHL). In granting fast track, the FDA noted that "relapsed or refractory indolent NHL is a serious and life threatening condition and is generally considered incurable. Results from a phase I and phase III study in patients with relapsed and/or refractory indolent non-Hodgkin's lymphoma suggest that pixantrone is active in this disease." The FDA also noted that the proposed phase III trial in combination with fludarabine and rituximab "has the potential to demonstrate an effect on a serious or life threatening aspect of this disease."

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.

"With fast track designation already granted for pixantrone in aggressive NHL, this designation for indolent NHL is an important step in the development of this product and may help us bring this potentially life-saving drug to patients more quickly," stated James A. Bianco, M.D., President and CEO of CTI.

CTI is awaiting feedback from the FDA on the design of its PIX303 trial, which 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, submitted under the FDA's Special Protocol Assessment procedure, is expected to enroll 300 patients beginning in the second quarter with interim data by mid-2008

Pixantrone Clinical Trials

Pixantrone has been studied extensively in aggressive NHL patients, including two ongoing studies, a phase III single agent trial, known as EXTEND and a phase II combination study, known as RAPID. The EXTEND trial explores the role of single agent treatment as a salvage regimen in patients with relapsed aggressive NHL who have failed at least two prior treatment regimens. Patients are randomized to receive either pixantrone or another single-agent drug of physician's choice currently used for the treatment of this patient population. An interim look is planned for the summer of 2007.

The RAPID trial is a first-line phase II study in aggressive NHL patients that will evaluate pixantrone as part of the CPOP-R combination regimen (cyclophosphpamide, pixantrone, vincristine, prednisone and rituximab) compared to the standard treatment regimen, CHOP-R (cyclophosphpamide, doxorubicin, vincristine, prednisone and rituximab). This study will explore the potential cardiac safety benefits of pixantrone in chemotherapy na´ve patients when compared directly to doxorubicin.

Fast Track Designation

Fast track designation means the FDA will facilitate and expedite the development and review of the application for the approval of a new drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need. An expedited review as defined by the FDA user fee performance goals provides for a review within six months.

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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