Navigation Links
New Pixantrone Data Presented at Meetings at American Society of Hematology Conference
Date:12/6/2010

once the survival and PFS data are mature. The summary update presented at ASH meeting is available for viewing on the Company's website www.celltherapeutics.com.

About the PIX301 EXTEND trial: PIX301 is the largest and only randomized trial comparing single agent pixantrone to a list of physician's choice of standard chemotherapy to patients with relapsed or refractory aggressive NHL who have failed two or more lines of therapy. There are currently no approved or effective agents for these patients. The successful PIX301 study results formed the basis of the Company's recent MAA submission to the EMA which was validated and accepted for review on November 17th, 2010.

In addition on December 2, 2010 the Company filed a formal appeal with the U.S. Food and Drug Administration (the "FDA") under the FDA's dispute resolution proceedings. The basis for the appeal is based on the Company's belief that the FDA diverged from accepted statistical principles and practices when the FDA applied a more stringent statistical significance level in concluding that the PIX301 primary analysis required an adjustment for type 1 error as if an interim analysis had been conducted. This was not the case in the PIX301 trial where only a single final analysis was undertaken. The Company expects to have a response to the appeal in the first quarter of 2011.

About PIX203 trial design: The PIX203 trial is a first-line randomized phase II study of the CHOP-R versus CPOP-R in high risk and elderly patients with previously untreated DLBCL  The study evaluates replacing doxorubicin in the standard CHOP-R combination regimen with pixantrone as part of the CPOP-R regimen. The objective of the study was to demonstrate non-inferior complete response rates to standard doxorubicin-based therapy while producing significantly less severe acute and chronic cardiac toxicities. The Company plans to submit the results of this study for
'/>"/>

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

Page: 1 2 3 4 5 6

Related biology technology :

1. EMEA Validates Cell Therapeutics, Inc.s (CTI) Expanded Pixantrone Pediatric Investigation Plan (PIP)
2. Cell Therapeutics, Inc. (CTI) Advances Pixantrone Filing Process in Europe; Submits Pediatric Investigation Plan (PIP)
3. Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval
4. Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkins Lymphoma
5. Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial
6. Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009
7. Alder Biopharmaceuticals Announces That Data From Multiple Studies of ALD518 (BMS945429), an Investigational Antibody Therapeutic in Rheumatoid Arthritis Patients, to be Presented at Annual Meeting of the American College of Rheumatology
8. Week-24 Interim Results From Phase 2b PILLAR Study to be Presented as Late-Breaker at AASLD
9. Investigational Data Presented for INTUNIV™ (guanfacine) Extended-Release Tablets When Coadministered With Stimulants Showed ADHD Symptom Improvement in Overall, Morning and Evening Assessments
10. Amgen Highlights Data to Be Presented at American Society for Bone and Mineral Research (ASBMR) Meeting
11. Data on VIVUS QNEXA to be Presented in Six Posters at The Obesity Societys Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2015)... April 28, 2015 The Pistoia Alliance, ... work together to lower barriers to innovation in R&D, ... project. , The Ontologies Mapping project has been ... practices for ontology management in life sciences R&D. The ... of standardized guidelines, tools and services to enable the ...
(Date:4/28/2015)... According to a 2013 report from ... medical treatment from burn injuries per year. Despite several ... formation of scars with subsequent contractures remains a major ... there is no adequate treatment. Contractures are a permanent ... can cause permanent deformity. , Synedgen has developed ...
(Date:4/28/2015)... 28, 2015 Reproductive endocrinologist Dr. Kaylen ... 7 couples battling infertility in this country, testified on behalf ... as the first state in the nation to consider creating ... to couples who desire to receive them. , Infertility affects ... that infertility is one of the few medical diseases that ...
(Date:4/27/2015)... HEIDELBERG , Alemania, April 27, 2015 ... patente para un nuevo receptor utilizando tecnología de descubrimiento ... no cubierta en el tratamiento de millones de pacientes ... anunciado hoy que ha recibido una patente en Europa ... el descubrimiento de Molecular Health de que EPHB4 es ...
Breaking Biology Technology:Pistoia Alliance Announces Start of Ontologies Mapping Project 2Synedgen Burn Treatment Results Presented at Premier Wound Conference 2Synedgen Burn Treatment Results Presented at Premier Wound Conference 3Texas Fertility Center Supports a Groundbreaking HB1145 that Facilitates Embryo Donation in Texas 2Texas Fertility Center Supports a Groundbreaking HB1145 that Facilitates Embryo Donation in Texas 3Molecular Health obtiene la patente para un nuevo receptor 2Molecular Health obtiene la patente para un nuevo receptor 3
... 6 , 3Q09 Corporate Highlights: ... to Astellas Pharma Europe Ltd. Made significant progress ... VP Sales; Senior Director, Marketing; and Director, Commercial Operations ... Committee chairman , Upcoming 2009 Milestones: ...
... Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced ... REOLYSIN(R) in patients with sarcomas metastatic to the lung ... Tissue Oncology Society Meeting held in Miami Beach, Florida, ... "A Phase II Study of Intravenous REOLYSIN (Wild-type Reovirus) ...
... ... place on February 22-24, 2010 in Philadelphia, has been announced. At this three day ... to share their experiences. , ... Minneapolis, MN (PRWEB) November 6, 2009 -- The agenda for Arrowhead’s ...
Cached Biology Technology:NeurogesX Reports Third Quarter 2009 Results 2NeurogesX Reports Third Quarter 2009 Results 3NeurogesX Reports Third Quarter 2009 Results 4NeurogesX Reports Third Quarter 2009 Results 5NeurogesX Reports Third Quarter 2009 Results 6NeurogesX Reports Third Quarter 2009 Results 7NeurogesX Reports Third Quarter 2009 Results 8NeurogesX Reports Third Quarter 2009 Results 9NeurogesX Reports Third Quarter 2009 Results 10Oncolytics Biotech(R) Inc. Collaborators Present Positive Phase II Sarcoma Trial Results at CTOS Annual Meeting 2Oncolytics Biotech(R) Inc. Collaborators Present Positive Phase II Sarcoma Trial Results at CTOS Annual Meeting 3Leaders in Biopharma and Molecular Diagnostics to Discuss Key Issues and Opportunities in Forming Partnerships at 2010 Personalized Medicine Partnerships Conference 2Leaders in Biopharma and Molecular Diagnostics to Discuss Key Issues and Opportunities in Forming Partnerships at 2010 Personalized Medicine Partnerships Conference 3
(Date:4/14/2015)... OXFORD, Conn. , April 14, 2015 ... "Company"), a biometric authentication company focused on the growing ... has been nominated for the 2015 New York Design ... The Design100, New York City Design Awards are ... are based on over 2,500 ratings from the marketplace, ...
(Date:4/13/2015)... -- higi, a leading cloud-based consumer engagement platform that provides ... their communities around health and wellness, announced today the ... ... convenient vehicle to receive validated health information from consumers. ... API will allow higi,s trusted partners, on a user ...
(Date:4/9/2015)... Synaptics Inc. (NASDAQ: SYNA ), a leading ... will report financial results for the third quarter of ... close of market. The company will host a corresponding ... PT (5:00 p.m. ET), during which management may discuss ... live call, analysts and investors should dial 888-438-5524 (conference ...
Breaking Biology News(10 mins):NXT-ID's Wocket Smart Wallet Nominated for 2015 New York Design Awards in 'Product Design- Technology' 2NXT-ID's Wocket Smart Wallet Nominated for 2015 New York Design Awards in 'Product Design- Technology' 3higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 2higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 3Synaptics to Report Third Quarter Results on April 23 2
... decades, crop breeders have increasingly relied on the wild and ... resistance, drought tolerance, and other traits. But just like all ... at risk of decline and extinction due to habitat loss, ... two speakers will describe the latest efforts to identify and ...
... Ohio The discovery of genetic differences affecting up ... guesswork out of prescribing the correct dose of 25 ... The scientists found two genetic variants that alter ... or metabolizing, drugs ranging from the painkiller codeine to ...
... 10 per cent of the UK is left handed ... world. But why exactly someone is left or right handed ... Nottingham,s Professor John Armour and Dr Angus Davison, in collaboration ... genetic determinant, in influencing handedness. The researchers conducted ...
Cached Biology News:Protecting the weedy and wild kin of globally important crops 2New genetic discovery could reduce the guesswork in drug dosing 2New genetic discovery could reduce the guesswork in drug dosing 3New genetic discovery could reduce the guesswork in drug dosing 4What makes us left or right handed? New study rules out strong genetic factors 2