Healthcare Industry News:  rituximab 

Biopharmaceuticals Oncology FDA

 News Release - March 13, 2007

Cell Therapeutics, Inc. (CTI) Files for Special Protocol Assessment (SPA) for Pixantrone in Relapsed Indolent Non-Hodgkin's Lymphoma (NHL)

Encouraging Complete Remission Rates and Durable Survival in Phase II Support Potential Registration in Indolent NHL

SEATTLE, March 13 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) today announced it has filed for a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of its phase III trial of pixantrone for patients with indolent non- Hodgkin's lymphoma (NHL). The trial, PIX303, will examine the complete remission rates and time to disease progression of 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 indolent NHL. The trial is expected to enroll 300 patients.

"The impressive complete remission rates and durable survival data in our phase II combination study for indolent NHL patients provides the rationale for conducting a phase III study and we look forward to feedback and guidance from the FDA on the study design," said James A. Bianco, M.D., President and CEO of CTI. "Pixantrone has shown encouraging activity in both indolent and aggressive NHL especially in the relapsed setting, paving a route for a potential registration across both types of NHL thus potentially doubling the size of the market potential in lymphoma."

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.

Pixantrone in Indolent NHL

Preliminary results from a phase I/II study of pixantrone combined with fludarabine, dexamethasone, and rituximab for patients with relapsed indolent NHL were presented at the American Society of Hematology (ASH) annual meeting in December, 2006. Among the 27 patients evaluable for response, study results showed the FPD-R regimen with pixantrone produced an 89 percent overall response rate (ORR) by the Cheson criteria, including 70 percent of patients experiencing a complete response/unconfirmed complete response (CR/uCR; 63 percent, CR and seven percent, u/CR). The estimated median duration of response was 25 months and the estimated progression-free survival rate at three years was 50.4 percent. In addition, pixantrone was studied in a randomized clinical trial for indolent NHL patients comparing pixantrone in combination with rituximab to rituximab alone, with time to progression (TTP) as the primary efficacy endpoint. The study of 38 relapsed or refractory patients receiving the combination of rituximab and pixantrone had an 87 percent overall improvement in TTP compared to rituximab alone. The median TTP estimate for the pixantrone/rituximab recipients was 13.2 months compared to 8.1 months for rituximab alone (hazard ratio 0.13, log rank p<0.001). The one- and two-year progression-free survival estimates were 66 percent and 44 percent for the pixantrone/rituximab recipients compared to zero percent for the rituximab recipients for both measurement intervals (p<0.001 and 0.003, respectively).

Pixantrone in Aggressive NHL

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.

About NHL

According to the SEER CanQuest Database and the American Cancer Society, in 2005 the prevalence of aggressive NHL in the U.S. was 99,880 with 31,900 newly diagnosed patients. The prevalence of indolent NHL in the U.S. was 282,025 with 24,490 newly diagnosed patients.

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 http://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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