Navigation Links
Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
Date:12/3/2010

decision not to approve an NDA, by raising the matter with the supervisor of the FDA office that made the decision. The formal dispute resolution process exists to encourage open, prompt discussion of scientific (including, medical) disputes and procedural (including, administrative) disputes that arise during the drug development, new drug review, and post-marketing oversight processes of the FDA.

Based on the guidance documents available from the FDA, CTI expects an FDA decision on the appeal in the first quarter of 2011.

CTI continues to prepare for the initiation of an additional pixantrone clinical study in the U.S. that would serve as either a post-approval confirmatory study or as a second registration study for approval in the U.S. This trial, referred to as PIX306, was submitted for a Special Protocol Assessment ("SPA") review by the FDA.

Also, CTI filed a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for approval of pixantrone in Europe which was accepted for review on November 17, 2010.

About PixantronePixantrone 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 to prevent the binding of iron and perpetuation of superoxide production--both of which are the putative mechanism for anthracycline i
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
3. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
4. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
5. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
6. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
7. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
8. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
9. TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated with Schizophrenia
10. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
11. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/16/2015)... , April 16, 2015  Alexza Pharmaceuticals, Inc. (Nasdaq: ... March 31, 2015 on Wednesday, May 6, 2015, following the ... host an investor conference call and live webcast on the ... company update and discuss the financial results.  ... www.alexza.com , under the "Investors" link.  Please log onto the ...
(Date:4/16/2015)... 16, 2015 Mallinckrodt plc (NYSE: ... announced that it has completed its acquisition of ... $2.3 billion. The Ikaria acquisition extends Mallinckrodt,s footprint ... into neonatal critical care with INOMAX ® ... a highly vulnerable patient population. It also accelerates ...
(Date:4/16/2015)... April 16, 2015  Diplomat Pharmacy, Inc. (NYSE: ... to their senior leadership team as chief information ... for securing and properly monitoring Diplomat,s data, systems and ... and externally. Additionally, she will play key roles in ... "We are very excited to have someone of Shannon,s ...
Breaking Medicine Technology:Alexza to Report 2015 First Quarter Financial Results and Provide Corporate Update on Wednesday, May 6, 2015 2Alexza to Report 2015 First Quarter Financial Results and Provide Corporate Update on Wednesday, May 6, 2015 3Mallinckrodt Completes Acquisition Of Ikaria 2Mallinckrodt Completes Acquisition Of Ikaria 3Mallinckrodt Completes Acquisition Of Ikaria 4Mallinckrodt Completes Acquisition Of Ikaria 5Diplomat Names Shannon M. Beltrand as New CISO 2
(Date:4/17/2015)... ERGO-Pedic Products, LLC, which produces therapeutic ... products to help a broader range of people plagued ... the second most common visitors to doctors. , “The ... to help relieve sitting pain. Then, only a couple ... happy customers later, we began getting questions from those ...
(Date:4/17/2015)... Florida Hospital Wesley Chapel, Florida Hospital ... Carrollwood were all selected as Top Workplaces in Tampa ... County, is ranked number one for large businesses according ... conducted in partnership with an independent research firm. Florida ... that opened in October of 2012 with a vision ...
(Date:4/17/2015)... Washington, D.C. (PRWEB) April 17, 2015 ... today issued the following statement: “On Wednesday April 15th, ... bodies and adopted a resolution recognizing the Armenian Genocide, ... the memory of the one-and-a-half million innocent Armenian victims ... of Christians (IDC) extols the EU for this timely ...
(Date:4/17/2015)... MI (PRWEB) April 17, 2015 Enthusiasts of ... Grand Rapids, Saturday, April 25, 2015. The event will be ... Wine & Food (201 Monroe Ave NW, Grand Rapids, MI ... around the West Michigan area. Patrons are encouraged to savor ... elegance and fun. , This year’s event will feature seven ...
(Date:4/17/2015)... (PRWEB) April 17, 2015 Most dental ... dental restoration units are made overseas by foreign dental ... domestic labs remain unregulated in more than 40 states ... National Association of Dental Laboratories has created ... raise awareness among patients about the consequences that could ...
Breaking Medicine News(10 mins):Health News:Seat Cushion Company Credits Customer Driven Design For Two New Products 2Health News:Tampa Bay Times Selects Florida Hospital Wesley Chapel, Florida Hospital at Connerton Long Term Acute Care and Florida Hospital Carrollwood As Top Workplaces in Tampa Bay 2Health News:Tampa Bay Times Selects Florida Hospital Wesley Chapel, Florida Hospital at Connerton Long Term Acute Care and Florida Hospital Carrollwood As Top Workplaces in Tampa Bay 3Health News:Tampa Bay Times Selects Florida Hospital Wesley Chapel, Florida Hospital at Connerton Long Term Acute Care and Florida Hospital Carrollwood As Top Workplaces in Tampa Bay 4Health News:In Defense of Christians Condemns Armenian Genocide 2Health News:In Defense of Christians Condemns Armenian Genocide 3Health News:Children’s Leukemia Foundation of Michigan Presents 3rd Annual CRUSH Grand Rapids 2Health News:National Association Urges Transparency in Dental Industry 2
... active socially may help prevent Alzheimer's disease in the ... progressive brain disorder that gradually destroys a person's memory ... ,David Bennett and other researchers from the Rush University ... with an average age of about 80, none of ...
... Ban Ki-moon urged governments to join the anti-tuberculosis global ... years as// the disease has become extremely drug-resistant. ... World TB Day on Saturday. The World Health Organization ... drug resistant strain of tuberculosis, XDR-TB, which threatens to ...
... This is one study finding bound to be paid attention ... revelation that// long hours of watching TV or playing video ... ,According to lead researcher Stuart Biddle, professor of ... of more than 1,500 12- to 16-year-olds showed that teenagers ...
... of the review body described as the ‘ the ... to deal// with their protests against the Medical Training ... established to look at failures in the Medical Training ... Medical Careers (MMC) project. It has come under fierce ...
... medical advisor, a crackdown on private medical screening has been ... puts on the NHS and is also not regulated properly. ... National Screening Committee (NSC), told the medical magazine Pulse that ... the private health sector. The medical screening offered by the ...
... India continues to be free from the dreaded avian ... bordering// Myanmar, Pakistan and Bangladesh, the health ministry said ... from the avian influenza virus as on date. As ... have been put on alert," said a health ministry ...
Cached Medicine News:Health News:Your Kids may Not Be Fat Because of too Much TV or Video Games 2Health News:Junior Doctors of UK Stage Walkout 2
Lacrimal Cannula, Curved - Open End, 21gSize: 21g x 1-1/2"....
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Medicine Products: