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:9/1/2015)... - The unique breadth ... at ESC Congress 2015 provide s ... of manag ing AF in everyday clinical practice across ... first-ever two-year outcomes from the Global Anticoagulant Registry in the Field - Atrial ... most frequent major event in more than 17,000 newly diagnosed AF patients, far ...
(Date:9/1/2015)... Sept. 1, 2015  Based on its ... market, Frost & Sullivan recognizes Pie Medical ... & Sullivan Award for Technology Leadership. ... designed innovative and easy-to-use imaging solutions—its CAAS ... reproducible quantitative results for cardiovascular diagnosis and ...
(Date:9/1/2015)... 2015  Abbott (NYSE: ABT ) announced today positive ... trial comparing the safety and effectiveness of Abbott,s fully ... Abbott,s market-leading, permanent drug eluting stent. The trial was ... and enrolled 400 people with coronary artery disease, ... will be featured at a late-breaking session today at ...
Breaking Medicine Technology:Global Atrial Fibrillation Registry Presents Two-Year Outcomes Data In More Than 17,000 Newly Diagnosed AF Patients 2Global Atrial Fibrillation Registry Presents Two-Year Outcomes Data In More Than 17,000 Newly Diagnosed AF Patients 3Global Atrial Fibrillation Registry Presents Two-Year Outcomes Data In More Than 17,000 Newly Diagnosed AF Patients 4Global Atrial Fibrillation Registry Presents Two-Year Outcomes Data In More Than 17,000 Newly Diagnosed AF Patients 5Global Atrial Fibrillation Registry Presents Two-Year Outcomes Data In More Than 17,000 Newly Diagnosed AF Patients 6Global Atrial Fibrillation Registry Presents Two-Year Outcomes Data In More Than 17,000 Newly Diagnosed AF Patients 7Global Atrial Fibrillation Registry Presents Two-Year Outcomes Data In More Than 17,000 Newly Diagnosed AF Patients 8Global Atrial Fibrillation Registry Presents Two-Year Outcomes Data In More Than 17,000 Newly Diagnosed AF Patients 9Frost & Sullivan Applauds Pie Medical Imaging for Highly Innovative Quantitative Software for Cardiovascular Diagnosis 2Frost & Sullivan Applauds Pie Medical Imaging for Highly Innovative Quantitative Software for Cardiovascular Diagnosis 3Frost & Sullivan Applauds Pie Medical Imaging for Highly Innovative Quantitative Software for Cardiovascular Diagnosis 4Frost & Sullivan Applauds Pie Medical Imaging for Highly Innovative Quantitative Software for Cardiovascular Diagnosis 5Abbott Announces Positive Results of Its Naturally Dissolving Stent from ABSORB Japan Study 2Abbott Announces Positive Results of Its Naturally Dissolving Stent from ABSORB Japan Study 3Abbott Announces Positive Results of Its Naturally Dissolving Stent from ABSORB Japan Study 4
... Masimo (Nasdaq: MASI ) announced ... Welfare (MHLW) regulatory clearance of its noninvasive and ... the Masimo rainbow SET® platform.  Representing a breakthrough ... hemoglobin level in real-time, SpHb tracks and trends ...
... As US doctors consider the switch from paper charts to ... have teamed up to provide an absolutely free EMR ... only ad-supported EMR platform for medical providers in a sector ... for a five provider practice in the first year. Since ...
Cached Medicine Technology:Masimo Noninvasive and Continuous Hemoglobin Receives Market Clearance in Japan 2Masimo Noninvasive and Continuous Hemoglobin Receives Market Clearance in Japan 3Masimo Noninvasive and Continuous Hemoglobin Receives Market Clearance in Japan 4Can an Ad-Supported EMR Fuel Healthcare's Technology Revolution? 2Can an Ad-Supported EMR Fuel Healthcare's Technology Revolution? 3Can an Ad-Supported EMR Fuel Healthcare's Technology Revolution? 4
(Date:9/1/2015)... ... September 01, 2015 , ... MediNatura™, the exclusive U.S. ... for physician assistants (PAs) practicing in orthopedics. The workshop, titled “Treatment of Osteoarthritis ... Dr. Erick Salado, an orthopedic surgeon at South Florida Bone and Joint Institute, ...
(Date:9/1/2015)... ... September 01, 2015 , ... The ... Systems, has become a leader in podiatric, surgical and wound care ... Superwounds Conferences place top national speakers at the podium and across the table ...
(Date:8/31/2015)... Knoxville, TN (PRWEB) , ... September 01, 2015 , ... ... function and other clinically relevant measures for physical therapy patients. The Registry is being ... President of FOTO, Inc. stated "We are happy to be selected to contribute FOTO ...
(Date:8/31/2015)... ... 2015 , ... Sculpted Contours Luxury Medical Aesthetics proudly announces that Kathy King, ... Modern Luxury’s The Atlantan Magazine. , This award for the Sculpted Contours ... Her idea and vision to bring to Atlanta a true luxury experience in a ...
(Date:8/31/2015)... ... August 31, 2015 , ... ... at Western University of Health Sciences to learn more about its integrated approach ... of Dental Sciences and Institute of Cellular Medicine at Newcastle University, and Susan ...
Breaking Medicine News(10 mins):Health News:New Hope for Patients Seeking Treatment of Osteoarthritis Knee Pain 2Health News:New Hope for Patients Seeking Treatment of Osteoarthritis Knee Pain 3Health News:PRESENT e-Learning Systems Announces their 2016 Podiatry and Wound Care Medical Education Conference Schedule 2Health News:FOTO Selected as Official Registry Partner with Physical Therapy Outcomes Registry 2Health News:Sculpted Contours Owner Selected One of Atlanta's Women of Power and Influence by Modern Luxury's The Atlantan Magazine 2Health News:Sculpted Contours Owner Selected One of Atlanta's Women of Power and Influence by Modern Luxury's The Atlantan Magazine 3Health News:Western Diabetes Institute Collaborates with UK team 2Health News:Western Diabetes Institute Collaborates with UK team 3Health News:Western Diabetes Institute Collaborates with UK team 4
... have cautioned against exempting mental health units from the ... cause the decline in the health of people// suffering ... preventable illness and premature death in the United Kingdom, ... effects of smoking. , ,The Health Act ...
... Minister, Andy Kerr, praised the services of NHS 24 ... but added that the confidence on the Scotland's// health ... service dealing with out-of-hours health inquiries had come under ... due to crucial time delays in the service rendered ...
... Poultry imports, which is seeing an extension in the ban ... of pork will be prohibited, more so from the areas ... products will include domestic birds, wild birds, unprocessed meat and ... wild birds. India has also laid an embargo on import ...
... special drive to check fever has been launched by the ... being reported in the city in the last 5// days. ... will go house-to-house to give medicines.” ,The ... led to hundreds of people being admitted to the hospitals ...
... its proven benefits to health, which is as good as ... on tea consumption, researchers say with conviction that four to ... a potential heart attack. ,The main ingredient ... are antioxidants known to offset cell damage. Tea is also ...
... In spite of laws that require limiting of the amount ... to 'black lung' or pneumoconiosis, according to a report from// ... ,The Coal Workers' Health Surveillance Program has identified 30 miners ... 11 were diagnosed with advanced disease according to the report ...
Cached Medicine News:Health News:Smoking Ban should Include Mental Health Units 2Health News:NHS 24 Helpline Service Improved Remarkably Says Health Minister 2Health News:US Miners Still Prey to Black lung Disease 2
Hemagglutination slide test for the qualitative and quantitative detection of Rheumatoid Factor in serum or synovial fluid....
Hemagglutination slide test for the differential qualitative detection and quantitative determination of infectious mononucleosis and other heterophile antibodies in serum or plasma....
Color-enhanced hemagglutination slide test for the rapid qualitative and semi-quantitative detection of infectious mononucleosis heterophile antibodies in serum or plasma....
... Inverness Medical Professional Diagnostics is a leading ... IFA and DFA test menu that includes ... STDs as well as miscellaneous conjugates and ... you a wide assortment of substrates and ...
Medicine Products: