Navigation Links
Independent Radiology Assessment Panel Results Confirm Statistical Significance of Response and Progression Endpoints of Cell Therapeutics' Pixantrone PIX301 Pivotal Trial
Date:9/27/2011

SEATTLE, Sept. 28, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that a second independent radiology assessment of response and progression endpoint data from CTI's PIX301 clinical trial of pixantrone confirmed the statistical robustness of the PIX301 efficacy data that was previously submitted by CTI to the U.S. Food and Drug Administration ("FDA") in CTI's new drug application ("NDA") for pixantrone.

This second independent assessment was recommended by the FDA's Office of New Drugs ("OND") as part of CTI's appeal of the Complete Response Letter ("CRL") for the NDA, which CTI received from the FDA's Office of Oncology Drug Products.

"The review conducted by a second independent panel of three radiologists confirmed the statistically and clinically significant results the first independent panel reported for the PIX301 study response and progression endpoints," noted James A. Bianco, M.D., CEO of CTI. "We now have two separate independent response assessment panels reporting significant results for complete response/complete response unconfirmed, overall response rate and progression-free survival at both end of treatment and end of study assessment periods as well as among the histologically confirmed aggressive non-Hodgkin's lymphoma ("NHL") subset of patients. We look forward to sharing these confirmatory results with the Division of Oncology Drug Products ("DODP") in our resubmission of the pixantrone NDA."

The review and the review process was conducted based on the recommendations by OND in order to determine that efficacy had been established by confirming confidence in the endpoint ascertainment and reliability of the primary results.

Based on the results of this second independent assessment panel's review, CTI plans on resubmitting the pixantrone NDA as early as October 2011 for accelerated approval.  The DODP previously confirmed that the review of the NDA would be complet
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Video: New Research Discovers Independent Brain Networks Control Human Walking
2. Facet Solutions AFRS(TM) Demonstrates Biomechanical Advantages Over Dynamic Stabilization in Independent Testing
3. Independent Clinical Results Confirm Up to a 7-Centimeter Reduction in Body Circumference Using UltraShape(TM) Non-Invasive Fat Reduction and Body Contouring System
4. Independent Physician Surveys Show if Approved, MF101 Could Become First-Line Treatment for Menopause Symptoms
5. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R) Following Second Interim Review
6. Longevinex(R) Found to be Superior to Green Tea Molecule in Independent Human Study
7. Independent Studies Report on Possible Roles for Cylexs Immune Cell Function Assay in Monitoring of Heart and Lung Transplant Recipients
8. Seven Presentations by Two Independent Research Groups Highlight Advantages of Pressure Cycling Technology (PCT) at Scientific Symposia in Philadelphia, Boston, and New York City
9. Video: Major Independent Trial Demonstrates Significant Anticancer Benefit of Zometa(R) in Women With Early-Stage Breast Cancer
10. Promise of Vicals CMV Vaccine Noted by Independent Experts
11. ASPIRE Independent Review Board Announces 10 Ways to Protect Participants Rights in Clinical Drug Trials and Optimize Results From Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)...  Unichem Pharmaceuticals ( USA ), Inc. ... 25 mg 1000-count bottle to the consumer level. This ... to the identification of a Clopidogrel tablet found in ... risk associated with mistakenly taking a Clopidogrel tablet instead ... experiencing Clopidogrel,s side effects which include bleeding and/or bruising. ...
(Date:7/30/2015)... 30, 2015  Amgen (NASDAQ: AMGN ) today announced ... director of Warburg Pincus LLC, to the Amgen Board of ... Fred Hassan and the deep, global experience he brings ... Robert A. Bradway , chairman and chief executive officer of Amgen. ... serve Amgen well." Mr. Hassan has been Partner ...
(Date:7/30/2015)... -- Growth of the U.S. nonprescription market is primarily driven ... to the OTC market. Due to an increasingly favorable ... activity over the next five years with several all ... entering the market into existing categories. If ... those with low to moderate likelihood), the market is ...
Breaking Medicine Technology:Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets 2Amgen Announces Appointment Of Fred Hassan To Board Of Directors 2Amgen Announces Appointment Of Fred Hassan To Board Of Directors 3Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 2Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 3
... VALLEY, Calif., Oct. 11, 2011 SensoScientific Inc, ... the Healthcare Industry, announced that its WI-FI ... are now available to more than ... of Premier healthcare members.   ...
... 11, 2011 Reportlinker.com announces that ... available in its catalogue: ... in BRICS (Brazil, Russia, India, China, ... http://www.reportlinker.com/p0652980/Peripheral-Vascular-Devices-Market-Outlook-in-BRICS-Brazil-Russia-India-China-South-Africa-to-2017.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Cardiovascular_Devices ...
Cached Medicine Technology:SensoScientific Awarded Contract by Premier Health Care Alliance for its Breakthrough WI-FI Temperature Monitoring System 2Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 2Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 3Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 4Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 5Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 6Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 7Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 8Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 9Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 10Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 11Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 12Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 13Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 14Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 15Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 16Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 17Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 18Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 19Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 20Peripheral Vascular Devices Market Outlook in BRICS (Brazil, Russia, India, China, South Africa) to 2017 21
(Date:7/31/2015)... ... 2015 , ... When the weather turned hot and warm-season turfgrasses, such as ... called Leisure Time(TM) zoysia . It's nicknamed LTZ(TM) for short. Incidentally, both names ... new type of sod, Super-Sod is giving away red Adirondack chairs with the Leisure ...
(Date:7/31/2015)... ... 31, 2015 , ... Precision Aesthetics is New York’s only Thermage skin tightening ... first provider of Exilis non-surgical fat reduction in New York. Due to its ... large International clientele. Many patients travel to New York to get their non-surgical ...
(Date:7/31/2015)... ... July 31, 2015 , ... Sculpted Contours Luxury Medical Aesthetics announces the arrival ... Zeltiq Aesthetics released this new applicator in the United States as an upgrade to ... thighs. The original applicator required a 2 hour treatment time. The new ...
(Date:7/31/2015)... (PRWEB) , ... July 31, 2015 , ... Coco Libre ... athletes, judges, media, and VIPs at the 2015 Vans US Open of Surfing, July ... water that can claim “no added sugar” on the market, is a natural choice ...
(Date:7/31/2015)... CA (PRWEB) , ... July 31, 2015 , ... According ... and cosmetic experts gathered to see if they could reach a consensus on the ... breast augmentation and facelifts. Overall, the group reached 90 percent consensus on a series ...
Breaking Medicine News(10 mins):Health News:Super-Sod Introduces Leisure Time(TM) Zoysia Grass with an Adirondack Chair Promotion 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 3Health News:Coco Libre Brings Eco-conscious Hydration to Vans US Open of Surfing 2Health News:Article on Plastic Surgery Consensus Highlights the Duties of Veteran Plastic Surgeons, says Beverly Hills Physicians 2Health News:Article on Plastic Surgery Consensus Highlights the Duties of Veteran Plastic Surgeons, says Beverly Hills Physicians 3
... Services Administration (SAMHSA) has awarded a four-year $1.6 million ... for the Study of Violence Against Children (CSVAC). The ... nation, is going to organizations helping children and adolescents ... the nation,s capacity to provide help to children of ...
... Whether she is giving a,keynote address or visiting on ... optimism and possibility. "Only in America could someone ... a warm laugh, "I,m a physically disabled woman whose,father ... three temples,and I,m running for Town Council as a ...
... Would Allow Condom Distribution in CA Correctional,Facilities, LOS ... (SCHAC) and the California HIV Alliance,will hold a press ... front,of L.A. Central Jail, 441 Bauchet Street, LA, CA ... Inmate and Community Public Health &,Safety Act" (Swanson, D, ...
... for Poverty Research has received a major research grant ... (MOWAAF) to study the economic and demographic causes, consequences, ... Ziliak, Gatton Endowed Chair of Microeconomics and director of ... the Gatton College of Business and Economics, will serve ...
... 28 "The actions of the,Connecticut Catholic Conference ... president of American Life League. "It,s bad enough ... to claim that,the Church has never officially ruled ... Catholic Conference released a statement that allows,personnel at ...
... Cross Blue Shield of Michigan is,partnering with the Michigan ... cities to help enroll eligible uninsured children in MIChild. ... community leaders and small,business owners to help get the ... be asked to send their staffs to upcoming MIChild,enrollment ...
Cached Medicine News:Health News:Center gets national funding for child trauma research 2Health News:Center gets national funding for child trauma research 3Health News:Humor and Hope Sustain NJ Woman Through Disabling Movement Disorder, Election Campaign 2Health News:Community Leaders to Host Press Event at L.A. Central Jail Urging Governor to Sign AB 1334 2Health News:Center for Poverty Research to study senior hunger in America 2Health News:Connecticut Catholic Conference Wrong to Allow 'Plan B' in Catholic Hospitals 2Health News:Blue Cross Blue Shield of Michigan Launches Effort in Five Michigan Cities with Department of Community Health to Enroll Uninsured Children in MIChild 2
... designed to help you achieve one important ... procedure. All needles are engineered for exceptional ... for smooth entry and exit. A broad ... an ideal match with procedural needs and ...
... implant is a combination of innovative design, ... makes TheraSeed® treatment an ideal choice for ... that every TheraSeed® implant order is backed ... required by clinicians who must meet the ...
... Every Bard BrachyStar® Needle is designed to ... efficient and clinically effective brachytherapy procedure. All ... ultra-sharp tips and polished surfaces for smooth ... needle configurations and sizes assures an ideal ...
... is a combination of innovative design, consistently ... BrachySource I-125 implant an ideal choice for ... that every BrachySource I-125 implant order is ... is required by clinicians who must meet ...
Medicine Products: