Navigation Links
Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Date:6/23/2009

Completed NDA submission could lead to marketing approval in Q4-2009

SEATTLE, June 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has completed the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTI requested priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009. Pixantrone is currently available in Europe on a named-patient basis.

"This is a major milestone for CTI and is the cornerstone of a turnaround strategy for us in meeting our goals of becoming a profitable operating business," said James A. Bianco, M.D., Chief Executive Officer of CTI. "With more than 76,000 pages and 500,000 hyperlinks this submission represents the hard work of many CTI employees dedicated to making a difference in the lives of patients with cancer. This also represents a significant advance in the treatment of patients with relapsed/refractory aggressive NHL, a patient population which the FDA has acknowledged represents an unmet medical need."

About the PIX 301 EXTEND Trial

CTI's EXTEND (PIX 301) clinical 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 as selected by the physician.

CTI previously announced that its pivotal PIX 301 EXTEND trial 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 out of 70 patients (20.0%) for the pixantrone arm compared to four out of 70 patients (5.7%) for the standard chemotherapy arm, p=0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to eight out of 70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increased the overall response rate (ORR) (26 out of 70 (37.1%) for the pixantrone arm compared to ten out of 70 (14.3%) for the control arm, p=0.003). Additionally, pixantrone experienced a statistically significant improvement in median progression-free survival (PFS), compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, p=0.007, respectively). PFS, CR/CRu and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.

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.

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.

Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_news.htm

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, 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 events, including cardiac disorders) for the treatment of relapsed or refractory 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
    E: deramian@ctiseattle.com
    www.CellTherapeutics.com/press_room

    Investors Contact:
    Ed Bell
    T: 206.282.7100
    Lindsey Jesch
    T: 206.272.4347
    F: 206.272.4434
    E: invest@ctiseattle.com
    www.CellTherapeutics.com/investors

    Medical Information Contact:
    T: 800.715.0944
    E: info@askarm.com


'/>"/>
SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Prime Therapeutics Receives TIPPS Certification
2. Adams Respiratory Therapeutics to Celebrate 10th Anniversary of its Incorporation on September 12
3. Transition Therapeutics Announces Fiscal 2007 Year End Financial Results
4. Lorus Therapeutics announces election of three new Directors and appoints a new Chairman
5. Deane F. Johnson Center for Neurotherapeutics to Launch First Mobile Medical Unit on October 4th
6. Russell Investment Group Advises Protalix Biotherapeutics of Index Adjustment
7. Adams Respiratory Therapeutics Announces FDA Approval of Grape-Flavored Delsym(R)
8. Prime Therapeutics Announces URAC Accreditation
9. Cell Therapeutics, Inc. (CTI) to Present at BIO Investor Forum
10. Horizon Therapeutics, Inc. Scheduled to Present at Upcoming BioPartnering Europe Meeting
11. Sontra Medical Corporation Changes Name to Echo Therapeutics, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... February 10, 2016 , ... For additional information contact Phyllis ... Pioneering book "Better with Age: The Ultimate Guide to Brain Training" by award-winning author ... memory. The book’s publication date is March 16, 2016. A free review copy ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... digital self-scheduling readily available to physicians. The integration will enable Allscripts users ... select appointments via Everseat’s free mobile app. , The partnership gives Everseat substantial ...
(Date:2/10/2016)... CA (PRWEB) , ... February 10, 2016 , ... Workrite ... and most versatile series of monitor mounts ever. , “Our goal was to ... and easy to install system that we have ever created.” said Darren Hulsey, Product ...
(Date:2/10/2016)... ... ... Anxiety of older Americans over steep cost increases of prescription drugs is at ... to The Senior Citizens League (TSCL). Since last fall, TSCL has ... costs. “The implications are chilling, particularly for people with chronic health problems,” says ...
(Date:2/10/2016)... ... February 09, 2016 , ... Ross A. Clevens, MD, ... to welcome a new addition to their growing practice. Beginning this month, Teresa ... nurse practitioner performing cosmetic procedures including injectables, fillers and laser treatments. ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... , Feb. 10, 2016  CVS Health (NYSE: ... people living in Santa Clara County, CA ... B on the Santa Clara University campus. CVS Pharmacy ... to protect patients against the disease. Students at Santa ... to get vaccinated. In addition, anyone who has had ...
(Date:2/10/2016)... , Feb. 10, 2016  Oxis International Inc. (OTC/QB: ... OXS-1550, was described as a "clinical trial triumph" after ... went into complete cancer remission. Daniel ... Minnesota Masonic Cancer Center. --> Daniel ... Minnesota Masonic Cancer Center. --> An ...
(Date:2/10/2016)... 2016  LexisNexis® Risk Solutions, a leading provider ... launch of LexisNexis Provider Performance Monitor , ... and optimize the quality and efficiency of provider ... scores. By measuring provider performance through Provider Performance ... better outcomes, improve the patient experience and reduce ...
Breaking Medicine Technology: