Navigation Links
Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkin's Lymphoma (NHL)
Date:9/11/2007

Fast Track-Designated Study Approved Under FDA Special Protocol Assessment

Process Could Expand Indication to Indolent NHL

SEATTLE, Sept. 12 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) today announced the launch of its phase III clinical trial, known as PIX303, of pixantrone for patients with indolent non-Hodgkin's lymphoma (NHL) who have relapsed following first-line therapy. The Company has a Special Protocol Assessment (SPA) in place with the U.S. Food and Drug Administration (FDA) for PIX303. The trial will examine progression-free survival (PFS), which is the rate at which a patient's lymphoma recurs or progresses, following treatment with pixantrone, fludarabine, and rituximab (FP-R) compared to treatment with fludarabine and rituximab (F-R), a commonly used second-line regimen in relapsed indolent NHL. The randomized, multi-center, multi-national trial is expected to enroll 300 patients, to be completed over a 12 to 16 month period. Dependant on the rate of progression, an interim analysis is targeted in 2009 and, if successful, could serve as a potential supplemental indication for pixantrone. Pixantrone has received fast track designation from the FDA for this indication.

"We have previously shown in a randomized controlled trial that the addition of pixantrone to rituximab significantly increased median time to progression over rituximab alone (13.0 months versus 8.1 months for rituximab alone; p<0.001) in relapsed indolent NHL patients," said James A. Bianco, M.D., President and CEO of CTI. "That data, coupled with the marked increase in PFS when pixantrone was added to a fludarabine-based regimen, provides a strong rationale for proceeding with this trial which could expand the application into the larger indolent NHL market."

Pixantrone in Indolent NHL

Preliminary results from a phase I/II study of pixantrone combined with fludarabine, dexamethasone, and rituximab for patients with relapsed indolent NHL were presented at the American Society of Hematology (ASH) annual meeting in December 2006. Among the 27 patients evaluable for response, study results showed the FPD-R regimen with pixantrone produced an 89 percent overall response rate (ORR) by the Cheson criteria, including 70 percent of patients experiencing a complete response/unconfirmed complete response (CR/uCR; 63 percent, CR and seven percent, u/CR). The estimated median duration of response was 25 months and the estimated progression-free survival rate at three years was 50.4 percent.

In addition, pixantrone was studied in a randomized clinical trial for indolent NHL patients comparing pixantrone in combination with rituximab to rituximab alone, with time to progression (TTP) as the primary efficacy endpoint. The study of 38 relapsed or refractory patients receiving the combination of rituximab and pixantrone had a 60 percent overall improvement in TTP compared to rituximab alone. [SC1] The median TTP estimate for the pixantrone/rituximab recipients was 13.0 months compared to 8.1 months for rituximab alone (hazard ratio 0.13, log rank p<0.001).

Pixantrone in Aggressive NHL

Pixantrone is the subject of two ongoing studies in aggressive NHL, a phase III single agent trial, known as EXTEND (PIX301) and a phase II/III combination study, known as RAPID (PIX203). 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 physician's choice currently used for the treatment of this patient population.

The RAPID trial is a first-line randomized phase II/III study of the CHOP-R versus CPOP-R in previously untreated aggressive NHL patients. The study is evaluating replacing doxorubicin in the standard CHOP-R combination regimen (cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab) with pixantrone as part of the CPOP-R regimen (cyclophosphamide, pixantrone, vincristine, prednisone and rituximab). The objective of the study is to demonstrate similar objective response rates to the standard doxorubicin-based therapy with significantly less severe cardiac toxicities and other doxorubicin-related toxicities on the CPOP-R arm of the study. A total of 280 patients are expected to be enrolled.

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 simplify administration compared to the currently marketed anthracyclines. The main adverse events associated with pixantrone in clinical trials to date include myelosuppression and alopecia.

About NHL

According to the SEER CanQuest Database and the American Cancer Society, in 2005 the prevalence of indolent NHL in the U.S. was 282,025 with 24,490 newly diagnosed patients. The prevalence of aggressive NHL in the U.S. was 99,880 with 31,900 newly diagnosed patients.

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 http://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, our ability and time needed to enroll, treat and evaluate eligible patients in our clinical trials, 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

E: media@ctiseattle.com

http://www.cticseattle.com/media.htm

Investors Contact:

Leah Grant

T: 206.282.7100

F: 206.272.4434

E: invest@ctiseattle.com

http://www.cticseattle.com/investors.htm

Medical Information Contact:

T: 800.715.0944

E: info@askarm.com


'/>"/>
SOURCE Cell Therapeutics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
2. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
3. Mersana Therapeutics, Inc. to Present Preclinical Data on XMT-1001 at American Association of Cancer Research Annual Meeting
4. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
5. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
6. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)... AMSTERDAM , Sept. 25, 2017   ... Trial Master File solutions, today—from the IQPC Trial ... Amsterdam , NL)—announced that EastHORN Clinical Services ... its clinical programs and TMF management. EastHORN, a ... Montrium,s eTMF platform to increase transparency to enable ...
(Date:9/23/2017)... -- Janssen Biotech, Inc. (Janssen) announced today that it ... Food and Drug Administration (FDA) for the Biologics License ... of moderately to severely active rheumatoid arthritis (RA). The ... to further evaluate the safety of sirukumab in the ... "We are disappointed by ...
(Date:9/22/2017)... 2017 AVACEN Medical (AVACEN) announced that its ... helping those with the widespread pain associated with fibromyalgia ... in Essex, England commented, "I ... experiencing no sleep at all, tremendous pain, with every ... recommend [the AVACEN 100] enough, how this has and ...
Breaking Medicine Technology:
(Date:10/13/2017)... Shelton, CT (PRWEB) , ... October 13, 2017 , ... ... and long-term care services, staged a mock evacuation of the facility as part of ... Department, Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... , ... Talented host, actor Rob Lowe, is introducing a ... episode of "Success Files," which is an award-winning educational program broadcasted on PBS ... in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve in ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian ... On The Brink” is the creation of published author, William Nowers. Captain Nowers ... a WWII veteran, he spent thirty years in the Navy. Following his career ...
(Date:10/12/2017)... Orleans, LA (PRWEB) , ... October 12, 2017 , ... ... centers in the U.S., announced today its plans to open a flagship location in ... will occupy the former Rooms To Go store next to Office Depot in the ...
Breaking Medicine News(10 mins):