Navigation Links
CTI Issues Statement Regarding Tosedostat Clinical Trial
Date:6/24/2013

SEATTLE, June 25, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today issued the following statement regarding the notification of the U.S. Food and Drug Administration (the "FDA") partial clinical hold on tosedostat (IND 075503), the Company's aminopeptidase inhibitor under development for the treatment of blood-related cancers, that is being studied in an investigator-sponsored trial and not by CTI. CTI's primary development programs are the ongoing Phase 3 trial of pacritinib, the Company's JAK2/FLT3 inhibitor being evaluated for patients with myelofibrosis, and the post-approval commitment study of PIXUVRI® (pixantrone).

This is a partial clinical hold of only part of the clinical work requested under the investigational new drug ("IND") application. Under a partial clinical hold, although a specific protocol or part of a protocol is not allowed to proceed, other parts of such protocol or other protocols are allowed to proceed under the IND. With this partial clinical hold, the Company may not enter new patients onto any of the ongoing tosedostat protocols until agreement is reached with the FDA.

After a study has been placed on partial clinical hold, the sponsor provides additional information and discusses the adverse event with the FDA to understand whether or not it was associated with the drug or due to another cause. The Company has begun work to comply with the FDA request and expects to be able to submit these data to the FDA in the coming weeks. For additional information, please refer to the Current Report on Form 8-K filed by the Company on June 24, 2013.

Recent Tosedostat Publication
In March 2013, Lancet Oncology published results from the OPAL Phase 2 study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML). The trial showed that once-daily oral tosedostat resulted in a disease contro
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Lilly Issues Alert for Illegal Scams Involving Fraudulent Checks and Online Job Requests
2. Celsion Corporation Issues Statement Regarding Misleading Blog Entry
3. Zydus Pharmaceuticals USA Inc. Issues Voluntary Nationwide Recall of Warfarin 2 mg Tablets, Lot MM5767, Expiration Date June 2014, Due to Oversized Tablets
4. Endeavor Power Corporation Issues Corrections on two of its earlier Press Releases dated January 9, 2013 and March 8, 2013
5. Neiman Center Issues Policy Brief Outlining Innovative Health Care Payment Models to Provide Cost-Effective Specialty Care for Patients
6. ISPE Patient Initiative Issues Survey Regarding Patient Experience with Clinical Materials
7. Ampio Pharmaceuticals Issues Statement Regarding Misleading Blog
8. American Academy of Ophthalmology Issues Statement on Provisions to Pharmaceutical Compounding Quality and Accountability Act
9. Royalty Pharma Issues Investor Presentation Highlighting The Strategic And Financial Advantages Of Its Offer To Acquire Elan For $12.50 Per Share In Cash
10. BD Issues 2012 Sustainability Report
11. TNI BioTech, Inc. Corporations CEO Issues Letter to Shareholders Discussing Recent Events
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/29/2015)... -- Research and Markets ( http://www.researchandmarkets.com/research/p37spr/north_america ) has announced ... MRI Market - Growth, Trends And Forecasts (2014 - ... key players in the industry are GE , Hitachi ... Medical Systems MRI is a ... its higher sensitivity and use of non-ionizing radiations. Open ...
(Date:5/29/2015)... CAMBRIDGE, Massachusetts and SPARTANBURG, South ... The Guardian Research Network and Molecular Health have ... access and molecular diagnostic decision support to the majority ... The Guardian Research Network will collaborate with Molecular Health ... molecular testing to identify cohorts from hundreds of thousands ...
(Date:5/29/2015)... BRAINTREE, Mass. , May 29, 2015  Haemonetics ... Kent Davies , Chief Operating Officer, will present at ... New York on June 23 rd , ... public may access Mr. Davies, presentation live via webcast ... Haemonetics (NYSE: HAE ) is a global ...
Breaking Medicine Technology:North America Open System MRI Market 2014-2019 with GE, Hitachi Medical, Philips Healthcare, Siemens Healthcare and Toshiba Medical Dominating 2New Collaboration to Dramatically Expand Therapeutic Clinical Trial Access for Cancer Patients Across the United States 2New Collaboration to Dramatically Expand Therapeutic Clinical Trial Access for Cancer Patients Across the United States 3New Collaboration to Dramatically Expand Therapeutic Clinical Trial Access for Cancer Patients Across the United States 4
... Reportlinker.com announces that a new market ... The Outlook for Pharmaceuticals ... Market growth in the mature ... the coming years by the health needs ...
... (Nasdaq: MSHL ), an oncology company focused ... metabolism, announced today that it has submitted an Investigational ... Drug Administration (FDA) to initiate clinical testing for oncology ... "I am extremely proud of our clinical ...
Cached Medicine Technology:The Outlook for Pharmaceuticals in Western Europe 2The Outlook for Pharmaceuticals in Western Europe 3The Outlook for Pharmaceuticals in Western Europe 4The Outlook for Pharmaceuticals in Western Europe 5Marshall Edwards Submits Investigational New Drug Application for Oncology Drug Candidate ME-344 2Marshall Edwards Submits Investigational New Drug Application for Oncology Drug Candidate ME-344 3
(Date:5/29/2015)... Florida (PRWEB) May 29, 2015 Designed ... Bodybuilding.com teamed up to create an all new, exclusive ... are a formulated with the latest and greatest, high ... and proven to be effective. The 24/7 Series can ... to cross-fitters and even the casual fitness enthusiasts. There ...
(Date:5/29/2015)... Javlin continues to fulfill its worldwide ... a larger team, with the intention to better serve ... in the U.S. and Canada. , Javlin Inc., the ... growth in 2014 with its strongest earnings to date, ... platform, CloverETL. To accelerate further progress and ensure exceptional ...
(Date:5/29/2015)... This is a professional and ... Naproxen industry.The report provides a basic overview of ... chain structure. The Naproxen market analysis ... trends, competitive landscape analysis, and key regions development ... as manufacturing processes and cost structures are also ...
(Date:5/29/2015)... Michigan (PRWEB) May 29, 2015 Vulvodynia ... and can cause significant physical, sexual, and psychological distress. ... altering disorder of Vulvodynia. The actual diagnosis is often ... in Endometriosis, they realize that this problem can be ... experiencing any of these symptoms, they need to schedule ...
(Date:5/29/2015)... San Rafael, CA (PRWEB) May 29, 2015 ... USA Ultimate (USAU) to bring the Denver youth ultimate community ... that fosters learning and individual improvement. The mission of the ... environment for boys and girls to improve, build character, and ... a program for boys and girls of all skill and ...
Breaking Medicine News(10 mins):Health News:BPI Sports and Bodybuilding.com Partner Up to Bring an Innovative New Line of Supplements 2Health News:BPI Sports and Bodybuilding.com Partner Up to Bring an Innovative New Line of Supplements 3Health News:Growth of Data Integration Platform CloverETL Continues in North America 2Health News:Naproxen Market Analysis For Global & China Regions 2020 Research Forecasts 2Health News:US Sports Camps, Nike Sports Camps, and USA Ultimate Host Third Summer of Ultimate Camp in Denver 2
... answered a central question in cancer biology: whether normal ... are immature cells that can renew themselves and give ... of body tissues. In recent years, researchers have developed ... stem cells. , Like a brand-name product instantly ...
... Ariz., Dec. 17 Pyramid Developers, a leader in ... master planned projects has joined with Scottsdale based Dr. Theresa ... for "Of the Place, Of the People" reflecting the focus ... creation of health and wellness focused sustainable communities. , ...
... Canadians are becoming aware of the prevalence of mental ... well equipped are we to help the many people ... the December issue of the Canadian Journal of ... for mental health and substance use services to adequately ...
... LifeBanc, the nonprofit,organ and tissue recovery organization for Northeast ... conference announcing the first,near total face transplant in the ... The following statement is from LifeBanc Chief Executive Officer ... keeping with LifeBanc,s mission of helping to improve and ...
... CITY, Dec. 17 Dynatronics Corporation (Nasdaq: ... directors and the execution of an agreement with a ... strategic planning and improved corporate profitability. On December 15, ... Capital Partners for consulting services through its principal, Mark ...
... Policymakers, the media, and the public should focus on 20 ... and well-being of Americans, says a new report from the ... compared over time, these 20 indicators will also help Americans ... effectiveness of public health and care systems, the report says. ...
Cached Medicine News:Health News:Molecular marker identifies normal stem cells as intestinal tumor source 2Health News:Pyramid Developers and Dr. Ramsey's Center for Natural Healing Announce Formation of Community Health and Wellness Planning Collaborative. 2Health News:Pyramid Developers and Dr. Ramsey's Center for Natural Healing Announce Formation of Community Health and Wellness Planning Collaborative. 3Health News:Pyramid Developers and Dr. Ramsey's Center for Natural Healing Announce Formation of Community Health and Wellness Planning Collaborative. 4Health News:National rates of co-occurring substance use and mental disorders call for better service integration 2Health News:National rates of co-occurring substance use and mental disorders call for better service integration 3Health News:LifeBanc Assists Cleveland Clinic in First Near Total Face Transplant in the United States 2Health News:Dynatronics Announces Changes to Board and Launches Operational Improvement Process 2Health News:Stakeholders and public should use 20 specific health indicators 2Health News:Stakeholders and public should use 20 specific health indicators 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: