Navigation Links
FDA Provides Guidance for Design of Cell Therapeutics' Pixantrone Pivotal Trial
Date:3/9/2011

SEATTLE, March 10, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced the final clinical trial design of a randomized pivotal trial of pixantrone for the treatment of diffuse large B-cell lymphoma ("DLBCL") following discussions with the  U.S. Food and Drug Administration's (the "FDA") Division of Hematologic Products (the "DHP") .  The new clinical trial, referred to as the PIX-R or PIX 306 trial, will compare a combination of pixantrone plus rituximab to a combination of gemcitabine plus rituximab in patients with relapsed or refractory DLBCL who have received one to three prior lines of therapy, utilizing progression free survival ("PFS") and Overall Survival ("OS")as co-primary endpoints of the study. The PIX-R trial, is targeting to enroll approximately 350 patients over 18 months and will include patients who have failed at least one line of previous therapy and patients who are not candidates for myeloablative chemotherapy and stem cell transplant. During its discussions with the DHP the Company was advised that only OS would be acceptable for a formal Special Protocol Assessment ("SPA") agreement, however the DHP noted that the Company could conduct a study utilizing PFS along with OS as co-primary endpoints which would be an acceptable design outside of the formal SPA process. Regulatory acceptability will depend on the magnitude of the difference between the trial study arms as well as a risk and benefit analysis.

"CTI has worked with the DHP since August on an appropriate clinical trial design that may serve as either a post-marketing commitment trial or as a follow-on pivotal trial depending on the outcome of an appeal of CTI's new drug application for pixantrone based on the PIX 301 trial at the FDA's Office of New Drugs," stated James A. Bianco, M.D., CEO of Cell Therapeutics.

"We believe that pre-clinical data and results from a randomized clinical trial have already demonstrated syn
'/>"/>

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

Page: 1 2 3 4 5

Related biology technology :

1. Amicus Therapeutics Provides Positive Data Update from Phase 2 Long-Term Extension Study of Amigal™ for Fabry Disease
2. China-Biotics, Inc. Provides Preliminary FY2011Third Quarter Revenue
3. Savient Pharmaceuticals Provides Business Update
4. Celladon Corporation Announces MYDICAR® Enzyme Replacement Therapy for Advanced Heart Failure Provides Sustained Clinical Improvements in Patients for 12 Months Compared with Placebo
5. Celsion Reports Third Quarter 2010 Financial Results and Provides Business Update
6. Lexicon Pharmaceuticals Provides Clinical Pipeline Update and Reports 2010 Third Quarter Financial Results
7. Generex Provides Additional Details for October 21st Live Video Webcast
8. Generex Provides Additional Reverse Stock Split Information for the Consideration of Stockholders
9. PDL BioPharma Provides Clarification Regarding Redemption of Its 2.75% Convertible Subordinated Notes
10. PDL BioPharma Provides Third Quarter 2010 Revenue Guidance of Approximately $86 Million and Update to its Correspondence With Genentech
11. NeoStem Provides Second Quarter Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... Bina Technologies, Inc. (Bina, Redwood ... have been acquired by Roche (SIX: RO, ROG; OTCQX: ... company that provides a big data platform for centralized ... for the academic and translational research markets.  Bina will ... continue to focus on development of their innovative genomic ...
(Date:12/19/2014)... Today, TiFiber, Inc. announced ... and future company headquarters in Fort Smith, Arkansas ... that safely and effectively control dangerous microorganisms. Fort ... historic, strong support for manufacturing, but also due ... technology-based companies such as TiFiber. , In ...
(Date:12/19/2014)... iLab Solutions, the global leader in core facility ... the new Director of Institutional Implementations and Sarah Becker ... new leadership positions were created to support iLab’s mission ... continues to meet the needs of its growing customer ... been deployed at over 450 core facilities across more ...
(Date:12/19/2014)... 18, 2014  Decision Resources Group finds that the ... will grow moderately through 2023 as the aging population, ... of dental biomaterials all spur procedure volumes. Growth will ... China and India ... within reach for a larger proportion of the population. ...
Breaking Biology Technology:Bina Technologies is acquired by Roche. 2Bina Technologies is acquired by Roche. 3Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 2Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 3Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 4iLab Solutions Announces Two New Leadership Positions to Meet the Needs of Its Growing Customer Base 2Asia Pacific Dental Biomaterial Market Will Grow Strongly Through 2023 2Asia Pacific Dental Biomaterial Market Will Grow Strongly Through 2023 3
... This release is available in German . ... RFID tags (Radio Frequency Identification) are increasingly finding their way ... or goods and identify them automatically by radio frequency. The ... the label. Smart labels can be affixed to goods under ...
... , SANTA CRUZ, Calif., Nov. 24 Two more ... online job board and careers site for life science professionals. ... job board, joining 28 other major life science training Institutions. ... post-graduates in the life sciences. While there are hundreds of ...
... ... field remains the only one to show consistent growth during the U.S. recession. However, clinics ... actually cut medical personnel, instead of just administrators. , ... (Vocus) November 24, 2009 -- Health care employment continued growing in ...
Cached Biology Technology:Intelligence inside metal components 2Two Major Universities Join Nation's Leading Postgrad Bio Job Board 2The MedZilla Report for October 2009 - Health Care Employment Grows Again in October Even As Clinics, Specialty Centers Close 2The MedZilla Report for October 2009 - Health Care Employment Grows Again in October Even As Clinics, Specialty Centers Close 3The MedZilla Report for October 2009 - Health Care Employment Grows Again in October Even As Clinics, Specialty Centers Close 4
(Date:12/11/2014)... , Dec. 09, 2014 Research and Markets ... ( http://www.researchandmarkets.com/research/9ql3kr/biometrics_market ) has announced ... India 2015-2019" report to their offering. ... market is the adoption of multimodal biometric systems. ... of an individual for verification and identification purposes. ...
(Date:12/11/2014)... Minn. , Dec. 10, 2014  Data ... physiologic monitoring, has released a new series of ... of preclinical toxicology researchers. M series, part of ... toxicologists collect the best possible physiologic data when ... Adding functional endpoints to toxicology studies has ...
(Date:12/10/2014)... RALEIGH, N.C. , Dec. 9, 2014  Valencell, ... announced it is seeing a staggering demand from its ... demand, the Company revealed, is not solely coming from ... industries as well. "A wearable is only ... a result, accuracy is the ultimate driver in long-term ...
Breaking Biology News(10 mins):Biometrics Market in India 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2New telemetry implants expected to change how large animal toxicology studies are conducted 2Wearable Technology Products Demand Highly Accurate Biometric Technology 2
... about 140 million years ago, dinosaurs had been munching ... happened then is one of evolution,s greatest success stories, ... transform the planet: The first flowers appeared, competing for ... their pollen to other flowers to ensure the plant,s ...
... Charitable Foundation has made a $2 million donation to The ... the Florida campus. In recognition of the gift, the Founders ... been named the Esther B. O,Keeffe Founders Suite. ... I wholeheartedly thank the Esther B. O,Keefe Charitable Foundation," said ...
... CHAMPAIGN, lll. Doctors can now get a ... chronic ear infections, thanks to a new medical imaging ... could usher in a new suite of non-invasive, 3-D ... team, led by University of Illinois electrical and computer ...
Cached Biology News:Got nectar? To hawkmoths, humidity is a cue 2Got nectar? To hawkmoths, humidity is a cue 3Got nectar? To hawkmoths, humidity is a cue 4Got nectar? To hawkmoths, humidity is a cue 5Esther B. O'Keeffe Foundation gives $2 million to the Scripps Research Institute 2Nowhere to hide: New device sees bacteria behind the eardrum 2Nowhere to hide: New device sees bacteria behind the eardrum 3
...
... DNA Engine Opticon 2 real-time PCR detection ... for fluorescence excitation (470-505 nm) and two ... 540-700 nm). The Opticon 2 system is ... which includes a thermal gradient feature. This ...
... The Mini-PROTEAN II multiscreen apparatus is used ... 7 cm) gels. The apparatus can screen up ... to cut the blot into strips. The apparatus ... templates that accommodate one or two 8 x ...
... allows detection of SYBR Green I or ... range of fluorophores in the second channel ... for a multitude of applications such ... thermal cycler offers precision thermal control and ...
Biology Products: