Navigation Links
FDA Sets Meeting Date in Early June to Discuss Re-submission of Pixantrone NDA for Accelerated Approval
Date:5/19/2011

SEATTLE, May 20, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ: CTICD and MTA: CTIC) announced today that it will meet with the U.S. Food and Drugs Administration's (the "FDA") Office of Oncology Drug Products in early June  to discuss the re-submission of CTI's New Drug Application ("NDA") for pixantrone for accelerated approval to treat patients with relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL"). This meeting follows CTI's receipt of the FDA's Office of New Drugs' (the "OND") response to CTI's appeal as announced on May 3, 2011, which allows CTI the opportunity to resubmit the NDA to the FDA with additional information for consideration of accelerated approval of the NDA based on the PIX 301 trial. In the FDA's response to CTI's appeal, the FDA requested that CTI submit  two items—an additional review of radiographs by an  independent panel and additional information regarding circumstances of stopping the clinical trial prior to achieving the planned accrual  to assure reviewers that efficacy assessments were not involved in the decision to stop accrual early.

About Pixantrone

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines--rather than intercalation with DNA---- pixantrone alkylates DNA-- forming stable DNA adducts with particular specificity for CpG rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone in an effort to prevent the binding of iron and per
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. Chromos obtains interim order in connection with arrangement, announces annual and special meeting of shareholders and confirms mailing of information circular
2. Sinovac Biotech Ltd. Schedules 2007 Annual Meeting of Shareholders
3. 3SBio Inc. to Hold Annual General Meeting
4. Accuray Incorporated to Host Investor and Analyst Meeting at ASTRO
5. USP's 2008 Annual Scientific Meeting to Convene Scientific Experts from Around the World
6. Sinovac Adjourns Annual General Meeting
7. Ondine Announces Presentation of Positive Clinical Trial Results at the American Academy of Periodontologys 94th Annual Meeting
8. Acologix Presents Preclinical Data on Cartilage Regeneration by AC-100 at the 30th ASBMR Annual Meeting
9. 3SBio Inc. Announces Results of Annual General Meeting
10. Ardea Biosciences to Present Data on Gout and Inflammation Programs at the 2008 ACR/ARHP Annual Scientific Meeting
11. Sangui Bio Tech International Inc. Shareholders Meeting Delayed to Include FY 2008 Report
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/31/2014)... 2014 2014 Market Research ... professional and in-depth research report on the ... information, including Polyacrylamide definition, classification, application, and ... overview. This research covers the international market ... global industry analysis covering macroeconomic environment & ...
(Date:8/29/2014)... based on electrons, but one of the most promising ... circuits based on light (photons) instead of electrons. First, ... stream of single photons and control their direction. Researchers ... to achieve this control, but now scientists at the ... stream of photons emitted one at a time and ...
(Date:8/29/2014)... Aug. 29, 2014 /PRNewswire/ - iCo Therapeutics ("iCo" ... reported financial results for the six months ended ... expressed in Canadian dollars and presented under International ... 2014 Highlights , Announced top-line results ... primary endpoint for subjects enrolled in the Phase ...
(Date:8/29/2014)... (PRWEB) August 29, 2014 A major ... the biotech start-up dense realm of Boston-Cambridge, is gaining ... able investors. James Sherley, the Director of Boston’s Adult ... the local and national visibility of his company an ... 2013. , In addition to a social media marketing ...
Breaking Biology Technology:International Polyacrylamide Industry & Copper Iodide Market Data Analysis Now Available at DeepResearchReports.com 2International Polyacrylamide Industry & Copper Iodide Market Data Analysis Now Available at DeepResearchReports.com 3Breakthrough in light sources for new quantum technology 2iCo Therapeutics Announces Second Quarter 2014 Financial Results 2iCo Therapeutics Announces Second Quarter 2014 Financial Results 3iCo Therapeutics Announces Second Quarter 2014 Financial Results 4The Adult Stem Cell Technology Center, LLC Participates in Multiple Stem Cell and Regenerative Medicine Conferences Before Year End 2The Adult Stem Cell Technology Center, LLC Participates in Multiple Stem Cell and Regenerative Medicine Conferences Before Year End 3The Adult Stem Cell Technology Center, LLC Participates in Multiple Stem Cell and Regenerative Medicine Conferences Before Year End 4
... , , , , , , ... , 1691112, 100 g, ... Inserts/Product , Instructions , , German , ... version - 54 K , , US Material Safety , Data Sheets, ...
... , , , Template , ... outcome of the PCR. For instance, , large amounts of RNA ... of the PCR. Also, impure templates may contain polymerase inhibitors that , ... always use a purification product specifically designed to purify DNA such , ...
... , , , PCR principles , , ... , , Setting up the , ... , , Thermal , Cycling ... Enzymes , Choice of RT-PCR Enzymes , , ...
Cached Biology Technology:PCR reaction components 2PCR reaction components 3PCR reaction components 4PCR reaction components 5PCR reaction components 6Roche Diagnostics Corporation 2
(Date:9/2/2014)... In the battle between our immune systems and ... bacteria-killing viruses known as phages. In a new study, ... Health, Haiti,s National Public Health Laboratory, and elsewhere, report ... their virulence in order to survive. Importantly, the study ... cholera,s mutational escape from phage predation occurs during human ...
(Date:9/2/2014)... the truth; everyone has a tipping point. We all want ... the benefit is great enough. Now, scientists have confirmed the ... , The result was published online this week in ... be honest, even if lying is beneficial," said Lusha Zhu, ... Virginia Tech Carilion Research Institute , where she works ...
(Date:9/2/2014)... Sam Kean stops by Reactions this week to debunk ... that, despite what "Shark Week" may lead you to ... http://youtu.be/KhFygIoW_MA . , Kean,s book, "The Disappearing Spoon: ... History of the World from the Periodic Table of ... 10-episode video series produced for the newly launched American ...
Breaking Biology News(10 mins):War between bacteria and phages benefits humans 2War between bacteria and phages benefits humans 3Scientists find possible neurobiological basis for tradeoff between honesty, self-interest 2Scientists find possible neurobiological basis for tradeoff between honesty, self-interest 3Scientists find possible neurobiological basis for tradeoff between honesty, self-interest 4
... Single person submersibles have been called in to help ... that may hold vital clues to the history of life ... environmental geochemist in the Faculty of Science, says the objects ... microbialites because they are covered with microbes. Some of these ...
... risks from the use of nanomaterials will be explored ... project supported by a $400,000 grant from the U.S.Department ... Nanomaterials are becoming more prevalent in our lives each ... less than one one-thousandth the width of a human ...
... Canadell from CSIRO and the Global Carbon Project, and ... of tons of carbon dioxide (CO2) absorbed annually by ... change mitigation worth hundreds of billions of dollars. ... challenges in quantifying changes in the size of those ...
Cached Biology News:Mini subs to probe odd structures in BC lake 2Growing use of nanomaterials spurs research to investigate possible downsides 2Growing use of nanomaterials spurs research to investigate possible downsides 3Tropical forest sustainability: A climate change boon 2
... ,Schistosomal glutathione-S-transferase (GST) is commonly ... proteins in E. coli (1). The GSTTag ... production and in some cases the solubility ... a soluble, properly folded form, GSTTag fusion ...
... peptide whose sequence is from the C-terminal end of the mouse retinoic ... amino acids 429 to 448 of RAR*. The sequence of PEP-005 ... - S - P - S - S - V - E ... - S - P - L - L - Q (The ...
... applications for the use of small interfering ... via the RNA interference (RNAi) pathway have ... molecular biology fields. siRNA for experimental use ... or enzymatically, and then transfected into the ...
... The HybArray 12™ is an automated ... microarrays. The system automates both the hybridization ... onto glass slides. A single instrument can ... time in pairs and has multi-protocol software, ...
Biology Products: