Navigation Links
Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

First Randomized Trial to Demonstrate Superior Clinical Benefit in Relapsed/Refractory Aggressive NHL

ORLANDO, Fla., June 1 /PRNewswire-FirstCall/ --

Intent to treat Analysis results per FDA agreed upon Statistical Analysis Plan

  • Significant Increase in Complete Remission Rates 20% vs. 5.7%; p=0.021
  • Significant Increase in Overall Response Rate 37.1% vs. 14.3%; p=0.003
  • Significant increase in percent of all patients whose response lasted greater than or equal to four months 25.7% vs. 8.6%; p=0.012
  • Significant Increase in Progression Free Survival 4.7 months vs. 2.6 months; p=0.007
  • Positive trend in Overall Survival even though data not fully mature with median 8.1 month vs. 6.9 month; p=0.544

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that at the 2009 American Society for Clinical Oncology ("ASCO") Annual Meeting for the first time since the top-line data were released, complete pivotal phase III results of CTI's EXTEND (PIX 301) clinical trial of pixantrone (the "PIX 301 EXTEND trial") in relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") were presented by Principal Investigator, Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial who presented the study at ASCO.

"Anthracycline-related drugs can be effective salvage agents in aggressive NHL, but our use of them is limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs," said Dr. Pettengell. "These results represent a breakthrough in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naive patients as a potential alternative to currently available standard anthracycline drugs."

The PIX 301 EXTEND (Expanding the reach of antrhacyclines with piXanTronE in relapsed or refractory aggressive NHL Disease) 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.

In the PIX 301 EXTEND trial 57% of the randomized patients were refractory to prior treatments with 50% of patients having failed three prior chemotherapy treatments. More than 70% of the patients on both arms were considered intermediate to high risk by the International Prognostic Index score (>=2). The median prior doxorubicin equivalent dose was approximately 300 mg/m2, the dose that is associated with six cycles of CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy, the standard of care for first line therapy in this disease. Fifty-three percent of pixantrone patients received four or more cycles of therapy compared to a median of three cycles in the comparator arm. The median doxorubicin equivalent dose at the end of therapy was 513 mg/m2 (with a range of 115 mg/m2 to 1003mg/m2). Data from repeated evaluations of Left Ventricular Ejection Fraction ("LVEF") by MUGA (Multi Gated Acquisition Scan) scan demonstrated no consistent dose related decline as has been described for doxorubicin with median LVEF values at a baseline of 58% and at the end of treatment of 59%. Consistent across the primary and subgroup analyses, treatment with pixantrone resulted in superior clinical benefits over standard of care chemotherapy treatment.

"We are pleased that the PIX 301 EXTEND trial of pixantrone demonstrated a long-lasting clinical benefit in this heavily pretreated relapsed/refractory group of patients with aggressive NHL and look forward to completing the New Drug Application submission later this month," said James A. Bianco, M.D., Chief Executive Officer of CTI. "Given the lack of approved therapies for this resistant group of patients with aggressive NHL, we believe pixantrone offers a valuable therapy for this unmet medical need."

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.

The ASCO poster is available at

In April 2009, CTI began a rolling submission of a New Drug Application ("NDA") with the U.S. Food and Drug Administration (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

Sign up for email alerts and get RSS feeds at our Web site,

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 (or increase remission rates or progress free survival) for treatment of relapsed or refractory aggressive NHL as determined by the FDA, the possibility that the NDA submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 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, 8-K, and 10-Q. 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.

    Media Contact:
    Dan Eramian
    T: 206.272.4343
    C: 206.854.1200

    Investors Contact:
    Ed Bell
    T: 206.282.7100
    Lindsey Jesch
    T: 206.272.4347
    F: 206.272.4434

    Medical Information Contact:
    T: 800.715.0944

SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Discussions With FDA on Pixantrone EXTEND (PIX301) Trial Provide Path for NDA Submission
2. Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009
3. Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial
4. Clinical Data Acquires Epidauros Biotechnologie AG, Significantly Enhancing Proprietary Genetic Biomarker Portfolio
5. Phase 2 Data Show Daclizumab Significantly Reduced Multiple Sclerosis Lesions in Patients Receiving Interferon Beta Therapy
6. Study Data Results Showed Desvenlafaxine Significantly Reduced Moderate to Severe Vasomotor Symptoms in Menopausal Women Versus Placebo
7. UCB Announces New Data Showing Investigational Drug Lacosamide Significantly Reduced Seizures in Refractory Epilepsy Patients
8. New Phase 3 Data Showed PRISTIQ Significantly Reduced Symptoms of Major Depressive Disorder Versus Placebo
9. Taxotere(R)-Based Chemotherapy Significantly Improved Overall Survival Compared With Standard Anthracycline-Based Chemotherapy in Early Stage Breast Cancer
10. Cord Blood America CEO Matthew Schissler Says Operations Significantly Streamlined
11. Treatment with Paliperidone ER May Be Associated with Significantly Reduced Use of Mental Health Resources
Post Your Comments:
(Date:11/25/2015)... November 25, 2015 The ... is a professional and in-depth study on the ...      (Logo: ) , ... industry including definitions, classifications, applications and industry chain ... the international markets including development trends, competitive landscape ...
(Date:11/24/2015)... Nov. 24, 2015 Cepheid (NASDAQ: CPHD ... at the following conference, and invited investors to participate ...      Tuesday, December 1, 2015 at 11.00 a.m. ...      Tuesday, December 1, 2015 at 11.00 a.m. ... New York, NY      Tuesday, December ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... event of the year and one of the premier annual events for pharmaceutical ... ran from 8–11 November 2015, where ISPE hosted the largest number of attendees ...
(Date:11/24/2015)... ... ... This fall, global software solutions leader SAP and AdVenture Capital brought together ... their BIG ideas to improve health and wellness in their schools. , Now, the ... title of SAP's Teen Innovator, an all-expenses paid trip to Super Bowl 50, and ...
Breaking Biology Technology:
(Date:11/17/2015)... Paris from 17 th until 19 ... from 17 th until 19 th November 2015. ... invented the first combined scanner in the world which scans ... now two different scanners were required: one for passports and ... the same surface. This innovation is an ideal solution for ...
(Date:11/17/2015)... Calif. , Nov. 17, 2015  Vigilant Solutions ... has joined its Board of Directors. ... Board after recently retiring from the partnership at TPG ... 107 companies with over $140 Billion in revenue.  He ... improvement across all the TPG companies, from 1997 to ...
(Date:11/16/2015)... , Nov 16, 2015  Synaptics Inc. (NASDAQ: ... interface solutions, today announced expansion of its TDDI ... touch controller and display driver integration (TDDI) ... smartphones. These new TDDI products add to the ... resolution), TD4302 (WQHD resolution), and TD4322 (FHD resolution) ...
Breaking Biology News(10 mins):