Navigation Links
Pixantrone Combination Therapy for First-line Treatment of,Aggressive Non-Hodgkin's Lymphoma Results in Reduction in Severe,Toxicities Including Heart Damage When Compared to,Doxorubicin-based Therapy

Positive interim results prompt request for meeting with FDA

SEATTLE, July 11, 2007 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) announced today that interim results of its phase II/III trial comparing CPOP-R, in which pixantrone is substituted for doxorubicin in standard CHOP-R first-line treatment of patients with aggressive non-Hodgkin's lymphoma (NHL), resulted in essentially all patients on both arms achieving a major objective anti-tumor response (complete response or partial response). The preliminary results showed that patients who received pixantrone had a reduction in severe (grade 3/4) side effects when compared to patients treated with standard doxorubicin-based therapy. The Company intends to report data from this trial, known as RAPID, at the American Society of Hematology (ASH) annual meeting in December.

Despite pixantrone patients receiving more treatment cycles, a three-fold reduction in the incidence of severe heart damage (LVEF decline >15 percent) was seen as well as clinically significant reductions in infections and thrombocytopenia. In addition a significant reduction in febrile neutropenia was also observed. Febrile neutropenia is a life-threatening complication of chemotherapy which often requires hospitalization and antibiotic therapy and may lead to death from infection while the patient's infection-fighting white blood cells are low due to neutropenia. The RAPID study is expected to complete enrollment in 2008.

"We are excited by these results demonstrating that pixantrone is living up to the promise of preventing the severe cardiac damage that accompanies the use of standard doxorubicin treatment while retaining the potent anti-lymphoma activity of this class of drug," said James A. Bianco, M.D., President and CEO of CTI. "Pending results from this and other studies, these findings could have major implications for treating patients with breast cancer, lym phoma, and leukemia, where debilitating cardiac damage from doxorubicin might be prevented. We look forward to discussing these results and our planned interim analysis of the PIX301 (EXTEND) pivotal trial with the FDA. We believe the RAPID data coupled with the EXTEND data may provide sufficient clinical information for review of pixantrone in aggressive NHL."

Details of the RAPID Trial

The RAPID (Replacing Adriamycin with Pixantrone to Improve Safety in NHL Disease) trial is a 280-patient randomized controlled phase II/III combination study investigating whether the substitution of pixantrone for doxorubicin in the first-line treatment of patients with advanced aggressive NHL can provide a comparable major response rate while reducing known doxorubicin-related toxicities. This multi-center international trial randomizes newly diagnosed patients to either the standard of care regimen CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab) or an investigational regimen which replaces doxorubicin with pixantrone, CPOP-R (cyclophosphamide, pixantrone, vincristine, prednisone, and rituximab) monthly for six cycles. Patients are evaluated for response to therapy every two cycles and evaluated every two months following completion of therapy.

Cardiac function, as determined by serial multi-gated nuclear scans (MUGA), is evaluated prior to initiation of therapy and then at the completion of every two cycles of therapy. Thus far, routine prophylactic administration of G-CSF was utilized equally across treatment arms in approximately half of study participants. The interim analysis was conducted after approximately 60 patients completed at least four cycles of therapy to determine if the dose of pixantrone (150 mg/m2) was adequate to induce major objective responses comparable to the doxorubicin arm as well as to evaluate potential differences in major toxicities.

Pixantrone in Clinical Studies

There are currently tw o clinical studies of pixantrone in aggressive NHL patients, RAPID and a phase III single agent trial, known as EXTEND. 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 the physician's choice currently used for the treatment of this patient population. An interim look for the EXTEND trial is planned for later this year.

The Company is awaiting feedback from the FDA on the design of a new phase III trial of pixantrone for patients with indolent NHL. The trial, PIX303, will examine the complete remission rates and time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have received at least one prior treatment for NHL. The trial is expected to enroll 300 patients.

About Pixantrone

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 permit 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 ad ditional information, please visit

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 the final results of the RAPID clinical study of pixantrone to have the same or similar results to the interim analysis, or the potential failure of pixantrone to prove safe and effective for treatment of non-Hodgkin's lymphoma or other cancers, 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.

    Media Contact:

    Dan Eramian

    T: 206.272.4343

    C: 206.854.1200

    Susan Callahan

    T: 206.272.4472

    F: 206.272.4434


    Investors Contact:

    Leah Grant

    T: 206.282.7100

    F: 206.272.4434


al Information Contact:

    T: 800.715.0944


CONTACT: Dan Eramian, +1-206-272-4343, cell, +1-206-854-1200, or SusanCallahan, +1-206-272-4472, fax, +1-206-272-4434, , orinvestors, Leah Grant, +1-206-282-7100, fax, +1-206-272-4434,, of medical, 1-800-715-0944, , all ofCell Therapeutics, Inc.

Web site:

Ticker Symbol: (NASDAQ-NMS:CTIC)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
2. Publication on Pixantrone Preclinical Studies Demonstrates Reduced Cardiotoxicity Compared to Equiactive Doses of Doxorubicin and Mitoxantrone
3. Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients
4. New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV
5. Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib Combination Studies
6. An Investigational Study Released at ADA Showed that Initial Combination Therapy with Januvia (sitagliptin) and Metformin Led to Improvement in Markers of Beta Cell Function in Patients with Type 2 Diabetes
7. Late Breaking Data Released at ADA Showed that the Investigational Use of Januvia and Metformin as Initial Combination Therapy Provided Significant Glucose Lowering Efficacy over 54 Weeks in Patients with Type 2 Diabetes
8. Poniard Pharmaceuticals Announces Promising Data From Interim Safety Analysis of Phase 1 Combination Trials of Picoplatin in Colorectal and Prostate Cancers
9. Peregrine Pharmaceuticals Reports Positive Top-Line Results in Bavituximab Combination Therapy Trial in Advanced Cancer Patients
10. Intarcia Therapeutics Announces Presentation of Final Results From a Phase 2 Combination Study for the Treatment of Hepatitis C at the Digestive Disease Week Conference
11. Data Presented at ASH Demonstrate Nebivolol Lowers Blood Pressure as Long-Term Monotherapy and in Combination Therapy
Post Your Comments:
(Date:10/9/2015)... Oct. 9, 2015 Regulatory affairs groups within medical ... --> --> These specialized groups are charged ... of global regulations pertaining to the development and marketing of ... groups largely rely on their own internal effectiveness and efficiencies ... --> --> Optimal ...
(Date:10/9/2015)... 9, 2015 ® ... einer Kolonoskopie im Rahmen eines Screenings, einer ... NOCT-Studie bewertete auch die Compliance, Sicherheit, Patientenakzeptanz ... ® ) an erwachsenen Patienten vergleicht, die ... einer beobachtenden oder einer diagnostischen Kolonoskopie unterziehen. ...
(Date:10/9/2015)... , October 9, 2015 ... of major players. --> India ... --> announces addition of 3 ... and 2020 forecasts for global markets as well ... along with analysis of major players. ...
Breaking Medicine Technology:
... in Mice Transgenic for Human TNFa, LAUSANNE, ... (Debiopharm), a global independent biopharmaceutical,development company specialising ... presentation of preclinical results that,validate the mechanism ... vaccine, that inhibits inflammatory processes in animal,models ...
... 2007 /PRNewswire-FirstCall/ --,InB:Biotechnologies, Inc. ("BioTech"), a wholly-owned ... strong positive,results in studies of vaccines against ... proprietary AIPwLV(TM) vaccine technology. The,studies were conducted ... (CMB), the Contract Research Organization led by ...
Cached Medicine Technology:
(Date:10/9/2015)... ... , ... Smoke alarms can save lives. In fact, according to the National ... reported home fires in half. As part of Fire Prevention Week, Amica Insurance ... maintained. , Half of home fire deaths result from fires reported between 11 p.m. ...
(Date:10/9/2015)... ... 2015 , ... Matrix IT Medical Tracking Systems LLC, a ... world’s first sterile field scanner. , The TRACTUS platform was developed, ... Unique Device Identifier (UDI) Final Rule, which will require manufacturers to directly mark ...
(Date:10/9/2015)... New Orleans, LA (PRWEB) , ... October 09, ... ... firm with offices serving New Orleans and the surrounding communities, is initiating a ... shelter and medical care for unwanted animals in southern Louisiana. , Animal ...
(Date:10/9/2015)... City, UT (PRWEB) , ... October 09, 2015 , ... ... Mental Illness Awareness Week. For many teenagers facing mental illness, the stigma associated with ... they need. , ViewPoint Center understands the importance of supporting teens with ...
(Date:10/9/2015)... ... October 09, 2015 , ... Amada ... recently opened its newest office in Maryland – its Bethesda location. ... background as a project management technology consultant to many of the largest construction ...
Breaking Medicine News(10 mins):
... The new Centers for Medicare & Medicaid Services ... for three hospital-acquired infections (HAIs) will be the ... and professionals sponsored by the Association for Professionals ... New CMS Regulation: Implications for Infection Prevention & ...
... Care Investment Trust Inc.,(NYSE: CRE ) today announced ... CIT, to Care,s Board of Directors, which increases the,number ... his capacity as President of Corporate Finance at CIT, ... business unit leaders,in assessing their go-to-market models, developing integrated ...
... the medical-surgical industry,s most ... CHICAGO, April 17 GHX today unveiled ... customizable, real-time access to the,medical-surgical industry,s most ... GHX Market Intelligence*. With GHX,MiShare, manufacturers can ...
... Sign language interpreting is one of the highest-risk professions ... by Rochester Institute of Technology. The research indicates that ... high-risk tasks conducted in industrial settings, including assembly line ... increase in the mental and cognitive stress of the ...
... based,organizations and Babies,R,Us to help prepare local moms for the arrival of ... ... local moms-to-be, April,showers takes on a whole new meaning as Anthem Blue ... Resource Center,(CRC) in Evansville, Indiana., Amid the traditional theme of pink ...
... the Pipeline, LIVINGSTON, N.J., April 17 ... that its wholly-owned,subsidiary, Genotec Nutritionals, Inc., a New ... the distribution of its branded,products and through custom ... several large transactions for the manufacture of,fish oil ...
Cached Medicine News:
... The Self-Cath Closed System is a ... method for safe, simple catheterization designed ... tract infections. It includes a ... The new EasyOff tear tab makes ...
... The Self-Cath Closed System is a ... method for safe, simple catheterization designed ... tract infections. It includes a ... The new EasyOff tear tab makes ...
... Self-Cath family of 100% ... a variety of options ... Each catheter is made ... PVC and has smooth ...
... The Self-Cath family ... offers patients a variety ... self-catheterization. Each catheter ... medical grade PVC and ...
Medicine Products: