Healthcare Industry News:  rituximab 

Biopharmaceuticals Oncology

 News Release - December 11, 2006

'Impressive' Complete Remission and 'Durable' Survival Data in Relapsed Indolent NHL Patients Identifies New Potential Registration Trial for Pixantrone

Cell Therapeutics, Inc. (CTI) to Request Meeting With FDA to Discuss Special Protocol Assessment for Phase III Trial

ORLANDO, Fla., Dec. 11 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) today announced results from a phase I/II study of patients with relapsed indolent non-Hodgkin's lymphoma (NHL) that may identify a potential registration trial for pixantrone. Among the 27 patients evaluable for response, study results showed the FPD-R regimen with pixantrone produced an 89 percent overall response rate (ORR), including 63 percent of patients experiencing a complete disappearance of their disease (complete response, CR). The results were presented at the 48th Annual Meeting of the American Society of Hematology (ASH). The estimated median duration of response was 25 months and the estimated progression-free survival rate at three years was 50.4 percent. CTI plans to request a meeting with the United States Food and Drug Administration (FDA) to discuss a Special Protocol Assessment for a phase III trial utilizing this regimen in indolent NHL.

"The use of pixantrone in the FPD-R combination produced impressive, durable responses," said Luis Fayad, M.D., Associate Professor of Medicine, Clinical Medical Director, Department of Lymphoma/Myeloma, The University of Texas M. D. Anderson Cancer Center and principal investigator on the study. "Given the results observed in this study, more studies with this regimen are warranted."

Pixantrone in Combination with Fludarabine, Dexamethasone and rituximab (FPD-R) in the Treatment of Patients with Relapsed/Refractory Indolent NHL (Poster #936)

In a poster session, Dr. Fayad presented results from a phase I/II study of pixantrone combined with fludarabine, dexamethasone, and rituximab for treatment of patients with relapsed indolent NHL.

Of the 27 patients evaluable for response, 89 percent (24 patients) achieved an objective response, including 70 percent (19 patients) who achieved complete response/unconfirmed complete response (CR/uCR) and 19 percent (5 patients) achieving a partial response (PR). The estimated median duration of response was 25 months (range 2.4 to 43 months) and the estimated progression-free survival rate at three years was 50.4 percent. No serious cardiotoxicity was observed. The primary toxicities (grade 3/4) were hematologic including lymphopenia (89 percent), neutropenia (82 percent), leukopenia (79 percent), thrombocytopenia (21 percent) and febrile neutropenia (11 percent). Preliminary results of this study were announced in May 2006.

About the FPD-R Study

This trial examined 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 five cycles (range 1 to 8) of therapy. Cycles were every 28 days. Dosing was rituximab at 375 mg/m2 on day l, fludarabine at 25 mg/m2 on days 2 through 4, dexamethasone at 20 mg per day on days 1 through 5 and pixantrone starting at 80 mg/m2 (first three patients) to 120 mg/m2 on day 2.

About the FND-R Regimen

The FND-R chemotherapy regimen (a combination of fludarabine , mitoxantrone, dexamethasone, rituximab) is one of a number of regimens that include fludarabine available to patients who relapse with low-grade NHL. It has a notably high overall and complete response rate and is reasonably well tolerated. Despite its impressive anti-tumor activity, FND-R often cannot be used to re-treat patients who relapse due to the cumulative cardiotoxicity associated with mitoxantrone. Pixantrone is a member of the same class of compounds as mitoxantrone but in animal studies demonstrates less cardiotoxcity when given to animals that received prior anthracycline therapy. The current study demonstrates that substituting pixantrone for mitoxantrone, yields a highly active therapeutic regimen with acceptable levels of cardiotoxicity even in patients who have received prior anthracycline therapy at close to lifetime limiting doses.

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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