Navigation Links
Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th
Date:6/21/2009

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 previously announced that its pivotal PIX 301 EXTEND trial of pixantrone 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 of 70 patients (20.0%) for the pixantrone arm compared to four of 70 patients (5.7%) for the standard chemotherapy arm, p=0.02) with no patients in the standard chemotherapy arm achieving a confirmed complete remission while on study.

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.

In April 2009, CTI began a rolling submission of a New Drug Application (the "NDA") with the FDA for pixantrone to treat relapsed or refractory aggressive NHL. CTI expects to complete the submission this month and will request priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009.


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

Page: 1 2 3 4 5 6

Related medicine technology :

1. Preclinical Study Presented at AACR Annual Meeting Shows Peregrines Anti-PS Immunocytokines Can Generate Protective Immune Responses in a Highly Aggressive Breast Cancer Model
2. Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
3. Micromets BiTE Antibody Blinatumomab (MT103/MEDI-538) Demonstrates Durable Responses in Patients with Relapsed Non-Hodgkins Lymphoma
4. SARS Vaccine Achieves Neutralizing Responses in First U.S. Human Trial
5. Vical Pandemic Influenza Vaccines Achieve T-Cell Responses and Cross-Clade Reactivity in Humans
6. Use it or Lose it: A New Theory About Preserving Erectile Function After Prostate Surgery
7. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
8. Post-Hoc Data Show Daily Activity Participation, Independence and Sleep Quality Improved in Adults with Moderate to Severe Rheumatoid Arthritis After Treatment with ORENCIA(R) (Abatacept)
9. Biological Psychiatry Publishes Study Showing VYVANSE Demonstrated Significant Efficacy for Treatment of ADHD for up to 12 Hours After Administration
10. AHF Seeks White House Clarification After Press Room Flap Over CDCs HIV Numbers
11. New Implantable Lenses Can Reduce the Need for Glasses After Cataract Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  Research and Markets ... the "Dental Consumables Market - Global Industry ... - 2018" report to their offering. ... ) Dental consumables are products which are ... impairments, for tooth restoration and in treatment of ...
(Date:1/15/2014)... , Jan. 15, 2014  Novation, the leading ... company, awarded several new IT value-added reseller (VAR) ... hospital organizations with IT goods and services at ... agreements, as well as value-added services such as ... New Novation agreements were awarded to ...
(Date:1/15/2014)... DUBLIN , January 15, 2014 ... that it has waived the Office of Fair Trading (OFT) ... the outstanding shares of ViroPharma Incorporated (NASDAQ: VPHM).   ... no longer conditional on OFT approval, and Shire expects to ... currently scheduled expiration time, subject to the satisfaction of all ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3
... 5, 2011 Reportlinker.com announces that a ... its catalogue: Acute Coronary ... http://www.reportlinker.com/p0567592/Acute-Coronary-Syndrome-ACS-Drug-Market .html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication What are ... of acute coronary syndrome? Our new report ...
... NEW YORK, July 4, 2011 ... research report is available in its ... for Dental Imaging Equipment 2011 (Digital ... and CBCT Scanners) ...
Cached Medicine Technology:Acute Coronary Syndrome (ACS) Drug Market 2Acute Coronary Syndrome (ACS) Drug Market 3Acute Coronary Syndrome (ACS) Drug Market 4Acute Coronary Syndrome (ACS) Drug Market 5Acute Coronary Syndrome (ACS) Drug Market 6Acute Coronary Syndrome (ACS) Drug Market 7Acute Coronary Syndrome (ACS) Drug Market 8Acute Coronary Syndrome (ACS) Drug Market 9Acute Coronary Syndrome (ACS) Drug Market 10Acute Coronary Syndrome (ACS) Drug Market 11Russian Market for Dental Imaging Equipment 2011 (Digital Intraoral X-Ray Systems, Extraoral X-Ray Systems and CBCT Scanners) 2Russian Market for Dental Imaging Equipment 2011 (Digital Intraoral X-Ray Systems, Extraoral X-Ray Systems and CBCT Scanners) 3Russian Market for Dental Imaging Equipment 2011 (Digital Intraoral X-Ray Systems, Extraoral X-Ray Systems and CBCT Scanners) 4Russian Market for Dental Imaging Equipment 2011 (Digital Intraoral X-Ray Systems, Extraoral X-Ray Systems and CBCT Scanners) 5Russian Market for Dental Imaging Equipment 2011 (Digital Intraoral X-Ray Systems, Extraoral X-Ray Systems and CBCT Scanners) 6
(Date:4/14/2014)... treat children with uncomplicated acute appendicitis is a reasonable ... fewer missed school days, according to a pilot study. ... Hospital and published online April 12 in the ... the first prospective study on nonoperative management of acute ... , Researchers enrolled 77 patients age 7 to 17 ...
(Date:4/14/2014)... 2014, Perth, Australia. Drug discovery company Proteomics International ... of a companion diagnostic (CDx) test with the ... The research team authenticated the panel of biomarkers ... samples. Seven biomarkers were validated at high stringency ... The mass spectrometry data was then cross-validated using ...
(Date:4/14/2014)... 2014) When it comes to the cost and ... Patients get the best care when they are treated ... extensive experience in their current job, according to a ... and Columbia Business School. The study was published in ... Applied Economics . , The review of more ...
(Date:4/13/2014)... STANFORD, Calif. A low-cost empowerment program for ... and sexual harassment of these girls, who live ... and are frequently attacked, a large new study ... Stanford University School of Medicine, Lucile Packard Children,s ... No Worldwide, validated the program,s effectiveness in combating ...
(Date:4/11/2014)... the processes that control brain cell production could pave ... brain-related disorders. , Scientists have gained new understanding of ... how and when nerve and brain cells are formed ... and keeps it healthy. Their findings could help explain ... which is a fundamental characteristic of many diseases including ...
Breaking Medicine News(10 mins):Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 2Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 3Health News:Longer nurse tenure on hospital units leads to higher quality care 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 3Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 4
... House effort to ensure that America,s military heroes receive care ... David Geffen School of Medicine at UCLA have pledged to ... care to help train physicians to meet the special needs ... Joining Forces, an initiative launched by first lady Michelle ...
... Ill. A program designed to boost cognition ... new experiences, researchers report, demonstrating for the first ... can change a personality trait once thought to ... describe openness as one of five major personality ...
... investigational drug called regorafenib slowed the progression of tumors and ... , an international phase III clinical trial found. The findings ... the American Society of Clinical Oncology in San Francisco ... , principal investigator of the trial in the United States. ...
... children with previously lethal health problems are surviving. ... A Children,s Hospital Boston study of more ... now shows that neurologically impaired children, though still ... account for increasing hospital resources, particularly within children,s ...
... -- Middle-aged men with blood pressure in the upper-normal range ... researchers say. Atrial fibrillation -- which affects more ... that can lead to stroke and other heart-related complications. High ... Previous research has shown that women with blood pressure ...
... today performed a minimally invasive surgical procedure to treat ... time in Canada. The procedure can significantly reduce high ... hypertension through drugs. These patients, numbering approximately 250,000 Canadians, ... attacks and stroke, which continues to kill thousands of ...
Cached Medicine News:Health News:UCLA joins forces with White House to meet unique needs of veterans, families 2Health News:UCLA joins forces with White House to meet unique needs of veterans, families 3Health News:UCLA joins forces with White House to meet unique needs of veterans, families 4Health News:Enhancing cognition in older adults also changes personality 2Health News:Drug improves survival of colorectal cancer patients, trial results show 2Health News:Neurologically impaired children dependent on children's hospitals 2Health News:'Upper Normal' Blood Pressure Linked to Heart Risk in Men 2Health News:Canada's first renal denervation procedure to reduce high blood pressure performed today 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: