SEATTLE, June 22 /PRNewswire-FirstCall/ --
Updated follow-up phase III EXTEND (PIX 301) clinical trial data enhances previously reported superior response rates for pixantrone over comparator including in high risk patient subgroups
Additional Clinical Studies Also Highlighted at Pan Pacific Conference
Cell Therapeutics, Inc. (“CTI”) announced today that an overview of CTI’s pixantrone clinical studies in aggressive and indolent NHL including follow-up data and subgroup analyses of high risk patients from the phase III EXTEND PIX 301 clinical trial of pixantrone (the “PIX 301 EXTEND trial”) is being presented at the Pan Pacific Lymphoma conference by Dr. Richard Van der Jagt of the Ottawa General Hospital.
Pixantrone PIX 301 EXTEND Trial Follow-up Data and Subgroup Analyses
Initial follow-up data in the PIX 301 EXTEND trial demonstrated that three additional patients in the pixantrone arm achieved a CR and one additional patient achieved a CRu during the follow-up period of patients that received chemotherapy on the control arm. Including the treatment and follow-up period, pixantrone had a significantly higher complete remission rate compared to the patients who received standard chemotherapy (CR/CRu rate=24% (17 of 70 patients) for pixantrone vs. CR/CRu rate=7% (5 of 70 patients) for standard chemotherapy; p=0.009). No patient in the standard chemotherapy arm achieved a confirmed complete remission at this point. The ORR was also significantly higher for patients treated with pixantrone and was 40% (28 of 70 patients) for pixantrone vs. 14.3% (10 of 70 patients) for standard chemotherapy with p=0.001. The follow-up period of this study is ongoing. CTI expects an additional update during late 2009.
In subgroup analyses, higher response rates in the pixantrone treatment group compared to comparator group were observed consistently across all of the following subgroups: age (<65 or >= 65 years old); whether the patient was refractory to last therapy; or whether the international prognostic index (IPI) score, a predictor of risk of disease recurrence and overall survival, was greater than or equal to 2. Patients greater than or equal to 65 years of age that received pixantrone achieved a CR/CRu rate of 26.1% (6 of 23 patients) and an ORR of 47.8% (11 of 23 patients) compared to no patients achieving a CR/CRu rate and an ORR of 5.6% (1 of 18 patients) for those that received standard chemotherapy. Furthermore, patients whose disease had relapsed and who had received pixantrone achieved a CR/CRu rate of 28.8% (8 of 28 patients) and an ORR of 50.0% (14 of 28 patients) compared to a CR/CRu rate of 6.7% (2 of 30 patients) and an ORR of 16.7% (5 of 30 patients) for those that received standard chemotherapy. Those patients whose disease was refractory to prior therapy and received pixantrone achieved a CR/CRu rate of 15% (6 of 40 patients) and an ORR of 30.0% (12 of 40 patients) compared to a CR/CRu rate of 5.0% (2 of 40 patients) and an ORR of 12.5% (5 of 40 patients) for those that received standard chemotherapy. Finally, in patients with an IPI score of greater than or equal to two, those patients that received pixantrone achieved a CR/CRu rate of 18.0% (9 of 50 patients) and an ORR of 32%(16 of 50 patients) compared to a CR/CRu rate of 5.9% (3 of 51 patients) and an ORR of 15.7% (8 of 51 patients) for those that received standard chemotherapy.
“It is gratifying that we are seeing more patients convert to complete remission after the initial assessment period with pixantrone compared to other agents. These additional late responders are likely to have a positive impact on analyses of progression free and overall survival and will be provided to the U.S. Food and Drug Administration during the 120-day update,” stated James A. Bianco, M.D., Chief Executive Officer of CTI. “We plan to request priority review of the NDA from the FDA as we believe that pixantrone would provide patients and physicians with a compelling new option in treating this disease.”
Review of Pixantrone Clinical Studies in Indolent non-Hodgkin’s lymphoma
Additionally, data from two previously reported clinical trials investigating pixantrone combined with other agents in indolent NHL is being reviewed. In one trial, PIX 302, patients that received pixantrone plus rituximab achieved higher CR and ORR rates, (CR=35% (7 of 20 patients); ORR=75% (15 of 20 patients)) as well as a longer TTP (13.2 months) than those who only received rituximab alone (CR=11% (2 of 18 patients); ORR=33% (6 of 18 patients); TTP=8.1 months) in relapsed/refractory indolent NHL. In a separate study, AZA I06, pixantrone and the FPD-R regimen achieved high response rates (CR/CRu=70% (19 of 27 patients); ORR=89% (24 of 27 patients) in relapsed/refractory indolent NHL, nearly all of whom had received aggressive first-line therapy with CHOP-R.
The Pan Pacific Lymphoma Conference poster is available at http://www.celltherapeutics.com/investor_updates.
About the PIX 301 EXTEND Trial
The PIX 301 EXTEND trial was a phase III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician.
CTI previously announced that its pivotal PIX 301 EXTEND trial of pixantrone had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) compared to patients treated with standard chemotherapy (14 of 70 patients (20.0%) for the pixantrone arm compared to four of 70 patients (5.7%) for the standard chemotherapy arm, p=0.02) with no patients in the standard chemotherapy arm achieving a confirmed complete remission while on study.
The most common grade 3, 4 adverse event observed on the pixantrone arm was neutropenia in 41.2% of patients versus 19.4% on the comparator arm. However, the incidence of grade 3, 4 febrile neutropenia was only 7.4% versus 3.0% in the comparator arm. Grade 3, 4 infections had a similar incidence in both study arms (18% vs. 13%). Although the grade 3, 4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a slightly higher incidence of serious cardiac disorders in patients treated with pixantrone than among patients who received comparator agents (8.8% vs. 4.5%). Events considered cardiac disorders included cardiac arrest, congestive heart failure, myocardial infarction, cyanosis, pericardial effusion, and tachycardia.
In April 2009, CTI began a rolling submission of a New Drug Application (the “NDA”) with the FDA for pixantrone to treat relapsed or refractory aggressive NHL. CTI expects to complete the submission this month and will request priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009.
Pixantrone is also now available in Europe on a named-patient basis.
About Pixantrone
Pixantrone (BBR 2778), is a novel major groove binder with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.
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.CellTherapeutics.com.
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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 and the trading price of CTI’s securities, including whether CTI will become profitable and the development of pixantrone. 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 (including the failure to achieve the overall response rate, complete remissions and progression-free survival and the possibility of significant grade 3, 4 adverse effects, including cardiac disorders) for the treatment of relapsed, refractory indolent or aggressive NHL as determined by the FDA, the potential that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in six months or in the fourth quarter of 2009, CTI’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI’s filings with the Securities and Exchange Commission including, without limitation, CTI’s most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise
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