Navigation Links
Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma
Date:2/17/2009

SEATTLE, Feb. 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that updated safety and efficacy data from the phase III trial of pixantrone provides further support for a robust clinical benefit for pixantrone when used as single agent therapy in the treatment of multiple relapsed aggressive non-Hodgkin's lymphoma (NHL). On an intent-to-treat analysis, pixantrone recipients who achieved a complete remission did so during the first 2 cycles of therapy, compared to 4 cycles among standard chemotherapy recipients, (1.9 months vs. 3.6 months, pixantrone vs. standard chemotherapy). The duration of response in the patients was similar in the 37% of pixantrone patients who had either a partial or complete response compared to the 14% of comparator patients with a major response. However, the overall progression free survival (PFS) was significantly longer in the pixantrone arm (4.7 months vs. 2.6 months, hazard ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy). Thirty-two percent (32%) of pixantrone patients received all 6 cycles of therapy, with 84% receiving 5 of 6 cycles of treatment. Pixantrone recipients had a low incidence of severe neutropenia complicated by either fever or documented infections, or severe vomiting or diarrhea. Pixantrone patients also experienced a low incidence of hair loss, a very common side effect of other drugs in this class. Overall, the incidence of serious adverse events was similar between pixantrone and the control arm. The pixantrone patients had a higher incidence of leucopenia and neutropenia and numerically more severe cardiac events (4 vs 2) than in the control arm. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).

"We were impressed to see that 84% of patients received at least 5 cycles of pixantrone therapy with a median total dose of 1,475 mg, despite having had significant prior therapy with doxorubicin, an agent in a similar class with cumulative cardiotoxicity," noted Jack Singer, M.D., Chief Medical Officer at CTI. "The rapid time-to-response data coupled with the relatively low incidence of traditional anthracycline toxicities and a safety profile that compares favorably to standard chemotherapy, positions pixantrone to live up to the promise of providing patients with relapsed aggressive NHL a meaningful clinical benefit."

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.

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.

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 http://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. 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 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
     E: media@ctiseattle.com
    http://www.CellTherapeutics.com/press_room

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

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

Related medicine technology :

1. Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkins Lymphoma Trial
2. Isis Announces That OGX-011 Has Shown Overall Survival Advantage in Prostate Cancer Compared to Standard Therapy in a Randomized Phase 2 Study
3. Nebulized Perforomist(TM) Inhalation Solution Provided Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI
4. TAXUS(R) Express(R) Stent Shows Similarly Low Re-Intervention Rates in Patients With Diabetes Compared to Non-Diabetics in Arrive Registry Program
5. Takedas Investigational PPI TAK-390MR Demonstrated Higher Healing Rates Compared to Lansoprazole as the Severity of Erosive Esophagitis Grade Increased, a New Integrated Analysis Showed
6. New Findings Show Efficacy of REMICADE(R) Compared With Azathioprine in Treatment of Crohns Disease According to First-of-its Kind Study
7. Continuous Treatment With Abbotts HUMIRA(R) Achieves Superior Long-Term Efficacy for Psoriasis Patients Compared to Interrupting Treatment
8. Nationwide Survey Shows Infertility Patients Prefer ENDOMETRIN(R) Compared With Other Progesterone Supplements
9. Spherics, Inc. Announces Reduced Cognitive Impairment of Novel Extended Release Topiramate (SRx-502) as Compared to Topamax(R)
10. Prasugrel Significantly Reduced New or Recurrent Heart Attacks in Both Acute and Longer-Term Settings Following PCI, Compared with Clopidogrel
11. Prasugrel Head-to-Head Study Showed Reduced Cardiovascular Events in Diabetes Patients by 30 Percent Compared with Clopidogrel
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on ... today announced that patient enrollment in its ongoing ... Duchenne) has exceeded 50% of its 24-patient target. ... in the third quarter of 2016, and to ...
(Date:6/23/2016)... the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in Bogota. Colombia ... ... Sandra ... ... Astellas is a pharmaceutical company ...
(Date:6/23/2016)... June 23, 2016  Experian Health, the ... transforming the patient payment and care experience, ... new products and services that will enhance ... cycle offerings. These award-winning solutions will enable ... remain compliant in an ever-changing environment and ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due ... up a new, often overlooked aspect of head lice: the parasite’s ability to live away ... a common occurrence, but a necessary one in the event that lice have simply gotten ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... ... BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a ... an hour by 2020 and then adjusting it yearly to increase at the same rate ... assure the wage floor does not erode again, and make future increases more predictable. , ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... feeding the Frederick area economy by obtaining investment capital for emerging technology companies. ... 2½ years that have already resulted in more than a million dollars of ...
Breaking Medicine News(10 mins):