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:9/19/2014)... , September 19, 2014 ... by Equipment Type (Benchtop, Mobile, Industrial, & Laboratory), ... Technology (Tray-style, Manifold, & Rotary) & Geography - ... MarketsandMarkets, defines and segments the lyophilization market on ... with analyses and projections of the market size ...
(Date:9/19/2014)... Fla. , Sept. 19, 2014  The body ... with the publication of two papers this past week.  ... – Head and Neck Surgery , finds that ... and subjective measures of sleep disordered breathing, leading the ... reduction in obstructive sleep apnea severity and improvement of ...
(Date:9/19/2014)... and CAMBRIDGE, Mass. , Sept. 19, ... (PGDx), a provider of advanced cancer genome analysis ... a leader in discovering and developing highly selective ... the first-ever comprehensive genomic study of malignant mixed ... of the female reproductive system, also known as ...
Breaking Medicine Technology:Lyophilization Market Worth $5,121.5 Million by 2019 2Lyophilization Market Worth $5,121.5 Million by 2019 3New Data shows Reductions in obstructive sleep apnea (OSA) severity and improvement of quality of life with Inspire therapy 2New Data shows Reductions in obstructive sleep apnea (OSA) severity and improvement of quality of life with Inspire therapy 3New Data shows Reductions in obstructive sleep apnea (OSA) severity and improvement of quality of life with Inspire therapy 4First Discovery Of Actionable Genetic Alterations In A Deadly Cancer Reported By Personal Genome Diagnostics And Blueprint Medicines 2First Discovery Of Actionable Genetic Alterations In A Deadly Cancer Reported By Personal Genome Diagnostics And Blueprint Medicines 3First Discovery Of Actionable Genetic Alterations In A Deadly Cancer Reported By Personal Genome Diagnostics And Blueprint Medicines 4
... Medical, Inc., the wholly-owned operating subsidiary of Patient ... the recently released 2011-2012 U.S. News and World ... of the SurgiCount Safety-Sponge® System, a clinically proven ... common surgical errors, retained surgical sponges.  Only 17 ...
... A new policy recommendation released on 20 July by ... of serological (blood) tests to diagnose active tuberculosis (TB). ... are different to QuantiFERON, which measures responses of white ... Active tuberculosis occurs when the TB organism has overcome ...
Cached Medicine Technology:SurgiCount Medical Announces Expanded Honor Roll Hospital Users, Landmark Product Usage Milestones Achieved 2SurgiCount Medical Announces Expanded Honor Roll Hospital Users, Landmark Product Usage Milestones Achieved 3Cellestis Responds to World Health Organization Guidance on Use of Blood Tests for Active Tuberculosis 2Cellestis Responds to World Health Organization Guidance on Use of Blood Tests for Active Tuberculosis 3Cellestis Responds to World Health Organization Guidance on Use of Blood Tests for Active Tuberculosis 4
(Date:9/19/2014)... leading Dartmouth researcher, working with The Melanoma Genetics Consortium, ... today in the Journal of the National Cancer ... of melanoma. , "For the first time, we have ... telomeres play a part in the risk of developing ... PhD, School of Medicine at the University of Leeds ...
(Date:9/19/2014)... (PRWEB) September 19, 2014 According to ... of the embattled blood-thinner Xarelto, named as defendants in ... Common Pleas, have moved the court to dismiss those ... not have sufficient connection with Philadelphia.* The cases include, ... al. (No. 140304328; Pa. Comm. Pls., Philadelphia Cty.), which ...
(Date:9/19/2014)... News) -- U.S. military troops deployed to sunny climates ... to a new study. Many returning troops ... some cases, military personnel developed blisters on their skin ... size of their moles since being deployed overseas. ... skin cancer, the study authors noted. "The past ...
(Date:9/19/2014)... 2014 (HealthDay News) -- Pregnant women who live in leafy, ... birth weight babies, a new study suggests. Researchers analyzed ... found that expectant mothers who lived in a neighborhood with ... percent lower risk of very preterm birth (before 30 weeks) ... (30 to 36 weeks). Babies born to mothers who ...
(Date:9/19/2014)... 19, 2014 (HealthDay News) -- The U.S. Food and Drug ... Thursday. Trulicity is part of a class of once-a-week injectable ... type 2 diabetes. "Trulicity is a new treatment ... treatment regimens to control blood sugar levels in the overall ... of the FDA,s Office of Drug Evaluation II, said in ...
Breaking Medicine News(10 mins):Health News:Melanoma risk found to have genetic determinant 2Health News:Xarelto Makers Seek Dismissal of Cases Brought in Philadelphia, Notes Rottenstein Law Group LLP 2Health News:Xarelto Makers Seek Dismissal of Cases Brought in Philadelphia, Notes Rottenstein Law Group LLP 3Health News:Some U.S. Troops May Face Greater Skin Cancer Risk 2Health News:Do Greener Neighborhoods Produce Healthier Babies? 2Health News:FDA Approves Another Weekly Injectable Drug for Type 2 Diabetes 2
... a former psychiatric patient has been jailed for life for ... year in a Glasgow's Pollok Park. , ,He attacked ... from a psychiatric hospital where a judge had ordered he ... Robertson, a father of three from Glasgow, befriended James Smith ...
... consuming over eight cups of coffee a day risk spontaneous ... death was twice as likely among heavy coffee drinkers relative ... ,Adjusting for other risk factors weakened the association somewhat, ... of fetal death, Dr. Bodil Hammer Bech of the University ...
... findings that are being presented during the American Society ... Philadelphia, Pennsylvania, say that women are not being adequately ... Through analyses of the recently conducted renal trials showed ... may be the reason why the US Food and ...
... answer for may help cancer, researchers say.,A complex ... growth of tumours in tests in mice, reports online ... used by researchers in Gordon Jayson Manchester’s Christie’s Hospital ... During the tests, the sugar molecules were divided and ...
... have found a new model that shows how tumor ... the presence of microenvironment of tumor cells. // The ... cell to malignant cell is understood with the help ... new insights into the influence of the tumor cell ...
... training of new doctors in Britain. According to the Department of ... lack of cadavers and experts said more would be hit if ... ,The government has blamed rising medical student numbers, TV shows and ... years, the number of bodies being donated has fallen from 670 ...
Cached Medicine News:Health News:Man Bludgeons Friend, Gets Life Term 2Health News:Coffee In Pregnancy May Be Risky: Study 2Health News:New Model for understanding Tumor Metastasis 2
BD Vacutainer® Heparin Tubes are spray-coated with either lithium heparin or sodium heparin and are used for plasma determinations in chemistry....
VACUETTE paediatric tubes have decreased sample volumes and are ideal for small childrens' veins and geriatric patients....
... Coagulation tubes contain a buffered ... available with a citrate concentration ... 0.129 mol/l (3.8%). The mixing ... solution to 9 parts blood. ...
... are available in two versions. ... a clotting activator and is ... serum is required for testing ... is suitable where the testing ...
Medicine Products: