Navigation Links
Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission
Date:1/26/2009

sed 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 http://www.celltherapeutics.com.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or
'/>"/>

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

0

GOOD

Page: 1 2 3

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:
*Name:
*Comment:
*Email:
(Date:5/22/2013)... , May 22, 2013  Modern Medical ... Manager™ (ODM).  Launched in November 2012 in a ... care program to stop the rising opioid abuse ... proactive, customized program designed to protect employees, physicians ... maintaining the necessary balance to provide pain relief ...
(Date:5/22/2013)... 2013 STEPh, Inc., a full service medical ... their web site ( http://www.stephreports.com ) dedicated ... About STEPh Reports STEPh Reports are comprehensive ... Each STEPh Report assesses the competitive landscape by individual ... company, and specific key issues.  STEPh Reports are written ...
(Date:5/22/2013)... -- MEDIFIRST SOLUTIONS, INC. (OTCQB: MFST) would like to ... company developments. As Medifirst continues to expand its business, ... Integrating social media into its investor relations strategy, the ... updates on Twitter.  The Facebook homepage is Medifirst Solutions ... Says CEO Bruce J. Schoengood , ...
Breaking Medicine Technology:Modern Medical Introduces Opioid Abuse Solution to the Workers' Compensation Industry 2Scientific and Technical Evaluation of Pharmaceuticals, Inc. [STEPh, Inc.], Launches New Competitive Intelligence Web Site 2Medifirst Solutions, Inc. Announces Update To Shareholders 2
... , , ... OPTR ) today announced that new data highlighting ... vancomycin-resistant enterococci (VRE) acquisition from Optimer,s North American phase 3 ... Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. , ...
... HONG KONG, Sept. 15 Data from multiple clinical trials ... stent, and preclinical data from Combo Bio-engineered Sirolimus Eluting Stent ... symposium, TCT 2009, in San Francisco. , , ... Center in Amsterdam will provide the final 12-month outcomes from ...
Cached Medicine Technology:Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI) 2Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI) 3Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI) 4Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI) 5Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI) 6Data From Multiple Clinical Trials of OrbusNeich's Genous(TM) Bio-engineered R stent(TM) to be Presented at TCT 2009 2Data From Multiple Clinical Trials of OrbusNeich's Genous(TM) Bio-engineered R stent(TM) to be Presented at TCT 2009 3
(Date:5/23/2013)... May 23, 2013 Footwear etc. is pleased ... Vista Collection of sandals containing cork footbeds. Known for its ... consistently good sales for many years, and with this new ... summer. , Dansko Shoes and Sandals are ... Collection is no exception. Containing leather and patent leather uppers ...
(Date:5/23/2013)... 2013 Long-Term Care Insurance shopping ... rate at which applicants for Long Term Care Insurance are ... , The decision to buy a Long Term Care ... willing and able to purchase protection are increasingly being turned ... any price. A variety of chronic conditions appear to ...
(Date:5/23/2013)... 2013 AttorneyOne.com, a recognized authority on ... actively providing expert opinion in view of the recent ... According to court documents, on March 5, 2013 a ... (case no. 3:2013cv50102) alleging that her husband suffered massive ... Pharmaceuticals, is mainly used as a blood thinner for ...
(Date:5/22/2013)... 23, 2013 Most women dread cellulite ... several factors, including estrogen being a factor in the ... fatty deposits stored and smashed together which create that ... must take a multi-pronged action," says Kathy Heshelow, founder ... Specific products like Cellulite Whisperer ® that work ...
(Date:5/22/2013)... Existing research shows that bicyclists who wear helmets have ... researchers at Boston Children,s Hospital found that simply having ... decrease in deaths and injuries for children younger than ... , The cross-sectional study, conducted by William P. Meehan ... Mannix, MD, MPH of Boston Children,s Hospital, and Christopher ...
Breaking Medicine News(10 mins):Health News:Footwear etc. Announces the New Collection of Dansko Cork Sandals 2Health News:More Baby Boomers Rejected by Long Term Care Insurance Companies 2Health News:More Baby Boomers Rejected by Long Term Care Insurance Companies 3Health News:New Lawsuit on Pradaxa Brain Hemorrhage: Now, AttorneyOne Can Provide Advice 2Health News:Get Cellulite Under Control Now with Cellulite Whisperer® Products Introduced by Sublime Beauty® 2Health News:Rate of bicycle-related fatalities significantly lower in states with helmet laws 2
... for combating prostate cancer was developed by researchers of ... received the Barenholz Prize for Creativity and Originality in ... its donor, Yehezkel Barenholz, the Dr. Daniel G. Miller ... School, was presented recently during the 70th meeting of ...
... a novel way of increasing stem cells in blood, ... bone marrow transplant. ,The recent research ... to help patients bounce back sooner after treatment for ... is available in detail in the current issue of ...
... the link between levels of urate in the blood and ... of Public Health (HSPH) have found that high levels of ... disease. ,Urate is a normal component of ... might also have beneficial effects because it is a potent ...
... world's leading wine producer, has fostered just one revolution in ... The slow pace of change has been offset however by ... that in Britain -- sometimes called the "scourge of the ... ,Holding back innovations in both French packaging and branding has ...
... Bush administration proposal was met with opposition as Children's ... the proposal will limit the eligibility of low-income families ... Children's Health Insurance Program. ,The families who ... to the policy debate on the floor of Congress. ...
... Governments measures to address Indigenous child abuse, initially in the ... the AMA to play the key role in addressing this ... that the AMA is seeking a briefing from the Prime ... the proposals so work can commence as soon as practicable. ...
Cached Medicine News:Health News:Novel Method to Inhibit Prostate Cancer 2Health News:Fishing for a Speedy Recovery After Chemotherapy or Marrow Transplant 2Health News:Fishing for a Speedy Recovery After Chemotherapy or Marrow Transplant 3Health News:Urate Reduces the Risk of Parkinsons Disease 2Health News:Wine Packaging: Bag-in-box, Plastic Bottles, Cork Comeback? 2Health News:Wine Packaging: Bag-in-box, Plastic Bottles, Cork Comeback? 3Health News:Childrens Health Program Covering More Adults Than Children 2Health News:Childrens Health Program Covering More Adults Than Children 3Health News:Indigenous Child Abuse 2
Disposable Cannula Cuffless Tracheostomy Tubes...
... KIMBERLY-CLARK BALLARD Adult TRACH ... to take place at the ... Available in T-Piece, Double Swivel ... Features dual lavage/irrigation port. Offers ...
... KIMBERLY-CLARK BALLARD Adult TRACH CARE ... T-Piece, Elbow and Double Swivel ... from vials; 12 vials per ... multiple tracheostomy sizes, French sizes ...
... BALLARD Adult TRACH CARE ... endotracheal intubated patients. Rounded ... provide smooth surface interface. ... locking thumb port. Offers ...
Medicine Products: