Navigation Links
Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission

SEATTLE, Jan. 27 /PRNewswire-FirstCall/ -- Cell Therapeutics (CTI) (Nasdaq and MTA: CTIC) announced today that after communication with the Food and Drug Administration (FDA), CTI expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to treat relapsed aggressive non-Hodgkin's lymphoma (NHL) in the first quarter of 2009. If granted priority review a decision on the NDA could occur before the end of 2009.

"This communication from the FDA is a significant milestone for the Company and for patients with relapsed aggressive NHL as this could be the first drug approved for this unmet medical need," noted James A. Bianco, M.D. Chief Executive Officer of CTI. "With the potential for three drug approvals in 2009 we are on track to meet our objective of cash flow break even in the fourth quarter of this year."

The EXTEND clinical trial was a phase III single-agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma 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 announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (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 8/70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increased the overall response rate (CR/uCR+PR) with (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). CR/uCR and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.

The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004 and pixantrone has received fast track designation for this indication.

About Pixantrone

Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.

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

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 results of complete safety information, the ability of the company to file a rolling NDA in the first quarter of 2009, determination by the FDA that the PIX301 trial is insufficient to support an NDA filing and that the FDA would grant priority review, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the Company'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 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 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: 206.272.4345
     Lindsey Jesch Logan
     T : 206.272.4347
     F : 206.272.4434

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

Related medicine technology :

1. Cell Therapeutics Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint
2. Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial
3. Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL
4. Pixantrone to be Studied in Phase I/II Trial for Aggressive Multiple Sclerosis
5. Pixantrone Shows Activity in a Preclinical Study of Experimental Autoimmune Myasthenia Gravis (EAMG)
6. Pixantrone Versus Doxorubicin in CHOP-R Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Preliminary Results Presented at American Society of Hematology (ASH) Annual Meeting
7. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
8. American College of Cardiology and Center of Excellence for Simulation Research of Western Michigan University (CESR) Partner for in situ Simulation to Improve Team Communication and Door-to-Balloon (D2B) Time
9. Richard E.T. Smith, Ph.D. Joins Pharmasset as Vice President of Investor Relations and Corporate Communications
10. Argonauta Assist(TM)ance: Argonauta Communications Strives to Enhance Site-Based Recruitment Efforts
11. New Survey Explores the Impact of Insulin Injections and Communications Between Patients and Healthcare Providers
Post Your Comments:
(Date:11/25/2015)... 2015 Developmental, commercial, and regulatory/legal ... profitability of pharmaceutical products, says GBI Research ... regulatory/legal strategies all play a key role in boosting ... . --> Developmental, commercial, ... in boosting the profitability of pharmaceutical products, says ...
(Date:11/24/2015)... NEW DELHI , November 25, 2015 ... fear invoked due to repeated failure of IVF cycles. ... Rani Bhatia was totally dejected and had lost all hopes that ... the first Indian miracle child conceived after failure of ... to abroad (UK) before they decided to take one last ...
(Date:11/24/2015)... HILL, N.C. , Nov. 24, 2015  In ... research projects in an effort to quickly uncover new ... position. --> --> ... launch a market research project and ensure that all ... company and industry standards. Another major barrier to efficiently ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 25, 2015 , ... In an ongoing Clinical Study conducted by an independent ... UV Angel is evaluating the efficacy of its product and its disinfection protocol. This ... beds) from May 2014 through October 2015 at a 360-bed, acute-care, academic medical center ...
(Date:11/25/2015)... ... November 25, 2015 , ... "When I underwent breast reconstruction ... incredibly uncomfortable," said an inventor from Bronx, N.Y. "In order to meet my ... RECOVERY BRA for added comfort and support. The bra is easier to put ...
(Date:11/25/2015)... ... ... Since its launch in 2012, the Regenestem brand ( ... to patients with chronic degenerative medical conditions. Now, the U.S. Patent and Trademark ... Organizations are required to hold a registered trademark in order to make licensing ...
(Date:11/24/2015)... ... ... Dr. Todd S. Afferica, a noted general dentist in Norcross, GA ... Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many of his dental procedures. ... traditional cutting tools, such as the scalpel and high-speed drill, which can both cause ...
(Date:11/24/2015)... ... , ... In an article published November 12th by Obesity News ... or are not eligible for bariatric surgery. The article explains that candidates for weight ... 100 pounds overweight, or have a BMI of 35 and over with at least ...
Breaking Medicine News(10 mins):