Fast Track-Designated Study Approved Under FDA Special Protocol Assessment
Process Could Expand Indication to Indolent NHL
SEATTLE, Sept. 12 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) today announced the launch of its phase III clinical trial, known as PIX303, of pixantrone for patients with indolent non-Hodgkin's lymphoma (NHL) who have relapsed following first-line therapy. The Company has a Special Protocol Assessment (SPA) in place with the U.S. Food and Drug Administration (FDA) for PIX303. The trial will examine progression-free survival (PFS), which is the rate at which a patient's lymphoma recurs or progresses, following treatment with pixantrone, fludarabine, and rituximab (FP-R) compared to treatment with fludarabine and rituximab (F-R), a commonly used second-line regimen in relapsed indolent NHL. The randomized, multi-center, multi-national trial is expected to enroll 300 patients, to be completed over a 12 to 16 month period. Dependant on the rate of progression, an interim analysis is targeted in 2009 and, if successful, could serve as a potential supplemental indication for pixantrone. Pixantrone has received fast track designation from the FDA for this indication.
"We have previously shown in a randomized controlled trial that the addition of pixantrone to rituximab significantly increased median time to progression over rituximab alone (13.0 months versus 8.1 months for rituximab alone; p<0.001) in relapsed indolent NHL patients," said James A. Bianco, M.D., President and CEO of CTI. "That data, coupled with the marked increase in PFS when pixantrone was added to a fludarabine-based regimen, provides a strong rationale for proceeding with this trial which could expand the application into the larger indolent NHL market."
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 a 60 percent overall improvement in TTP compared to rituximab alone. [SC1] The median TTP estimate for the pixantrone/rituximab recipients was 13.0 months compared to 8.1 months for rituximab alone (hazard ratio 0.13, log rank p<0.001).
Pixantrone in Aggressive NHL
Pixantrone is the subject of two ongoing studies in aggressive NHL, a phase III single agent trial, known as EXTEND (PIX301) and a phase II/III combination study, known as RAPID (PIX203). 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.
The RAPID trial is a first-line randomized phase II/III study of the CHOP-R versus CPOP-R in previously untreated aggressive NHL patients. The study is evaluating replacing doxorubicin in the standard CHOP-R combination regimen (cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab) with pixantrone as part of the CPOP-R regimen (cyclophosphamide, pixantrone, vincristine, prednisone and rituximab). The objective of the study is to demonstrate similar objective response rates to the standard doxorubicin-based therapy with significantly less severe cardiac toxicities and other doxorubicin-related toxicities on the CPOP-R arm of the study. A total of 280 patients are expected to be enrolled.
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 simplify administration compared to the currently marketed anthracyclines. The main adverse events associated with pixantrone in clinical trials to date include myelosuppression and alopecia.
According to the SEER CanQuest Database and the American Cancer Society, in 2005 the prevalence of indolent NHL in the U.S. was 282,025 with 24,490 newly diagnosed patients. The prevalence of aggressive NHL in the U.S. was 99,880 with 31,900 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, our ability and time needed to enroll, treat and evaluate eligible patients in our clinical trials, 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.
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|SOURCE Cell Therapeutics, Inc.|
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