Healthcare Industry News: rituximab
News Release - December 12, 2006
Cell Therapeutics, Inc. (CTI) Announces Pixantrone Combination Regimen Produces High Response RatesCPOP Combination Therapy With Pixantrone Results in 73 Percent Overall Response Including 47 Percent Complete Response
ORLANDO, Fla., Dec. 12 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC ) today announced results from a phase II study of CPOP combination therapy with pixantrone for patients with relapsed aggressive NHL. The results, presented at the 48th Annual Meeting of the American Society of Hematology (ASH), showed a 73 percent overall response rate (ORR), including 47 percent experiencing complete disappearance of their tumors (complete response, CR). These patients had received prior first-line regimens containing anthracyclines and due to dose limitations for potential cardiotoxicity were not eligible to be retreated with standard anthracyclines.
"These data suggest that in the relapsed setting where patients have already received prior regimens containing anthracyclines, the CPOP combination has substantial activity with a notable complete remission rate and a low rate of serious cardiac events," said Andreas Engert, M.D., Professor for Internal Medicine, Hematology and Oncology, University Hospital of Cologne and principal investigator on the study.
Pixantrone in Combination with Cyclophosphamide, Vincristine, and Prednisone (CPOP) in Patients with Relapsed Aggressive NHL (Publication #529)
In an oral session, Peter Borchmann, M.D., Ph.D., Senior Consultant, Hematology and Oncology, University Hospital of Cologne and investigator on the study, presented results from a phase II clinical trial of pixantrone combination therapy, known as CPOP, in patients with relapsed aggressive NHL -- all of whom had received prior regimens containing anthracyclines. In the CPOP regimen, pixantrone replaces doxorubicin in the standard CHOP regimen.
Of the 30 patients evaluable for response, 73 percent (22 patients) achieved an objective response, including 47 percent (14 patients) experiencing a complete response (CR) and 26 percent (8 patients) achieving a partial response (PR). The median duration response was 10.2 months (95 percent confidence interval: range 6.7 to 23 months). The predominant side effects (grade 3/4) were hematologic including neutropenia (97 percent), leukopenia (90 percent), lymphopenia (53 percent), anemia (30 percent), thrombocytopenia (20 percent), and febrile neutropenia (20 percent). Preliminary results from this study were announced in March 2006.
About the CPOP Study
This trial examined the safety and potential efficacy of pixantrone when substituted for doxorubicin in the CHOP regimen among patients who failed prior doxorubicin-containing CHOP therapy for aggressive NHL. Patients received a median of six cycles of therapy (range one to 6). Dosing for the CPOP regimen was pixantrone at 150 mg/m(2) on day l, cyclophosphamide at 750 mg/m(2) on day l, vincristine at 1.4 mg/m(2) on day l, and prednisone at 100 mg on days 1 through 5, each three-week cycle.
About the CHOP Regimen
The CHOP chemotherapy regimen (a combination of cyclophosphamide, vincristine, prednisone and doxorubicin) in combination with rituximab for CD20+ patients is the standard-of-care treatment for newly diagnosed (first-line) aggressive NHL. Response rates following CHOP in first-line aggressive NHL can reach 70 percent and the regimen is potentially curative in up to 40 percent of patients. The prognosis is poor for patients who have a recurrence of the disease (relapsed patients). Despite its impressive anti- tumor activity, CHOP often cannot be used to retreat the 60 to 65 percent of patients who will relapse following CHOP, due to the cumulative cardiotoxicity associated with one of its constituent agents, doxorubicin; a chemotherapy agent which belongs to the anthracycline family. The maximum lifetime recommended dose of doxorubicin is 450 mg/m(2). During first-line treatment with CHOP most patients receive between 300 and 400 mg/m(2) of doxorubicin.
"The data presented at ASH suggest that in the relapsed setting for both aggressive and indolent NHL, the use of pixantrone offers patients a high probability of achieving a complete response with an acceptable safety profile, even in pretreated patients," said Scott C. Stromatt, M.D., Executive Vice President of Clinical Development and Regulatory Affairs at CTI. "We look forward to further results from our ongoing pixantrone trials."
CTI is also studying pixantrone in two ongoing trials -- a phase III single agent study for relapsed aggressive NHL known as the EXTEND trial and a phase II combination study (CPOP-R versus CHOP-R) for first-line treatment of aggressive NHL, known as the RAPID trial. Interim results for the EXTEND trial are scheduled late in the first half of 2007.
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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