Navigation Links
Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th

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

  • Randomized phase III; PIX 302-Pixantrone plus rituximab significantly improves CR rate (35% vs. 11%), ORR (75% vs. 33%) and time to progression (TTP) (13.2 vs. 8.1 months) compared to rituximab alone in relapsed indolent NHL
  • Phase II; AZA I06- Pixantrone plus fludarabine, and rituximab (FPD-R regimen) produces high CR/CRu (70%) and ORR (89%) in multiple relapsed indolent NHL

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) 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

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

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 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

    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 medicine technology :

1. Preclinical Study Presented at AACR Annual Meeting Shows Peregrines Anti-PS Immunocytokines Can Generate Protective Immune Responses in a Highly Aggressive Breast Cancer Model
2. Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
3. Micromets BiTE Antibody Blinatumomab (MT103/MEDI-538) Demonstrates Durable Responses in Patients with Relapsed Non-Hodgkins Lymphoma
4. SARS Vaccine Achieves Neutralizing Responses in First U.S. Human Trial
5. Vical Pandemic Influenza Vaccines Achieve T-Cell Responses and Cross-Clade Reactivity in Humans
6. Use it or Lose it: A New Theory About Preserving Erectile Function After Prostate Surgery
7. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
8. Post-Hoc Data Show Daily Activity Participation, Independence and Sleep Quality Improved in Adults with Moderate to Severe Rheumatoid Arthritis After Treatment with ORENCIA(R) (Abatacept)
9. Biological Psychiatry Publishes Study Showing VYVANSE Demonstrated Significant Efficacy for Treatment of ADHD for up to 12 Hours After Administration
10. AHF Seeks White House Clarification After Press Room Flap Over CDCs HIV Numbers
11. New Implantable Lenses Can Reduce the Need for Glasses After Cataract Surgery
Post Your Comments:
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and Company ... results for the third quarter of 2017 on Tuesday, ... call on that day with the investment community and ... The conference call will begin at 9 a.m. ... access a live webcast of the conference call through ...
(Date:10/2/2017)... , Oct. 2, 2017 The Rebound mobile ... the struggle to reverse the tide of prescription drug addiction. ... regulating their medicine intake and stepping down their dosage in ... to launch in December 2017; the first 100,000 people to ... more at ...
(Date:9/27/2017)... for their devotion to personalized service, SMP Pharmacy Solutions announces ... the South Florida Business Journal,s 50 Fastest-Growing Companies, and listed ... national specialty pharmacy has found its niche.  To that end, ... honored by SFBJ as the 2017 Power Leader in Health ... his award in October, Bardisa said of the three achievements, ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Ellevate Network, ... in business to advocate for action towards gender equality at their inaugural Summit in ... around the globe, and reached a social audience of over 3 million. To watch ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... LA (PRWEB) , ... October 12, 2017 , ... Planet ... in the U.S., announced today its plans to open a flagship location in Covington, ... occupy the former Rooms To Go store next to Office Depot in the Holiday ...
(Date:10/12/2017)... ... 12, 2017 , ... The American College of Medical Informatics (ACMI) will present ... the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium ... Collen, a pioneer in the field of medical informatics, this prestigious award is presented ...
Breaking Medicine News(10 mins):