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:7/10/2014)... BURLINGTON, Mass. , July 10, 2014 /PRNewswire/ ... three-quarters of surveyed infectious disease (ID) specialists are ... Medicines Company,s Orbactiv (oritavancin) for use as OPAT, ... to prescribe these agents to their hospital inpatients. ... percent) of OPAT patients are initiated on OPAT ...
(Date:1/15/2014)... , Jan. 15, 2014 Sono-Tek Corporation (OTC BB: ... ended November 30, 2013, compared to sales of $2,202,000 for ... Once again, this quarter has also shown growth over the ... first quarter of this fiscal year. Markets that experienced sales ...
(Date:1/15/2014)... 15, 2014 As health officials across the Midwest warn ... pharmacies in Michigan will offer free ... enabling Meijer pharmacists to administer tests and, in some cases, ... physician participating in the study. The ...
Breaking Medicine Technology:Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3Sono-Tek Announces Third Quarter Results 2Sono-Tek Announces Third Quarter Results 3Sono-Tek Announces Third Quarter Results 4Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 2Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 3
... YORK, Nov. 14, 2011 Reportlinker.com announces that ... its catalogue: Test-Volume-Sales-Forecasts-and-Supplier-Shares-by-Country.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic title=,The ... Japan Test ... 2011 Prostatic Acid Phosphatase Testing Market: US, Europe, ...
... Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage ... today that Punit Dhillon, President and CEO, will be ... in Irvine, California. (Logo: http://photos.prnewswire.com/prnh/20110314/MM64943LOGO ) ... Forum Hyatt Regency Irvine 17900 Jamboree Road Irvine, ...
Cached Medicine Technology:The 2011 Prostatic Acid Phosphatase Testing Market: US, Europe, Japan 2The 2011 Prostatic Acid Phosphatase Testing Market: US, Europe, Japan 3The 2011 Prostatic Acid Phosphatase Testing Market: US, Europe, Japan 4The 2011 Prostatic Acid Phosphatase Testing Market: US, Europe, Japan 5OncoSec to Present at Medical Device Investor Forum 2
(Date:7/13/2014)... 2014 Epidemiologists forecast an increase in ... from 8,062 diagnosed incident cases in 2013 to 11,568 ... Rate (AGR) of 4.35%, during the forecast period. In ... diagnosed incident cases of aGVHD in the 6MM, with ... lowest number of diagnosed incident cases of aGVHD, with ...
(Date:7/13/2014)... ability to identify odors might indicate the development ... of the eye could indicate the build-up of ... brain, according to the results of four research ... Conference 2014 (AAIC 2014) in Copenhagen. , In ... identify odors was significantly associated with loss of ...
(Date:7/13/2014)... Wright & Schulte LLC has learned that ... July of 2015, in U.S. District Court, District of ... discovery process in the South Carolina federal court ... the multidistrict litigation (MDL). The complaints pending in the ... allege that they took the statin medication to lower ...
(Date:7/13/2014)... Celebrity fitness trainer and former World ... partnership with Aqua Health Labs for their flagship product ... . The collaboration was recently announced live on ESPN ... , actor, model, and a two time World Super ... he has prepared stars including Demi Moore, Hilary Swank ...
(Date:7/13/2014)... Hope Palliative & Hospice Care announced today that ... the Tamarack Senior Living Community in Palatine, IL. The group, ... the 3rd Wednesdays of every month. This group will ... located at 55 S. Greeley St. Palatine, IL 60067. ... no cost for the group. , “A grief support ...
Breaking Medicine News(10 mins):Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 3Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 4Health News:Smell and eye tests show potential to detect Alzheimer's early 2Health News:Smell and eye tests show potential to detect Alzheimer's early 3Health News:Smell and eye tests show potential to detect Alzheimer's early 4Health News:Smell and eye tests show potential to detect Alzheimer's early 5Health News:Smell and eye tests show potential to detect Alzheimer's early 6Health News:Smell and eye tests show potential to detect Alzheimer's early 7Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 2Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 3Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 4Health News:Celebrity Fitness Expert Supports Revolutionary New Health Supplement 2Health News:Hope Hospice Announces Grief Support Group at the Tamarack Senior Living Community 2
... By Mary Brophy Marcus HealthDay Reporter ... that,s typically used to treat the flu and Parkinson,s ... patients, a new study indicates. Traumatic brain injury ... to rehabilitation facilities after hospitalization were given amantadine hydrochloride. ...
... but long ago shelved after newer, modern antiretroviral therapies became ... uses its natural immunity to fight the viruswork that could ... published online this month by the journal PNAS , ... at the University of California, San Francisco (UCSF) presented the ...
... Feb. 29 (HealthDay News) -- Sports-related concussions are common in ... type of head injury, according to an expert. While ... immediate CT scan or MRI, concussion damage occurs at the ... scans of the brain, said Dr. Howard Derman, director of ...
... 29, 2012 - Scientists at the Toronto Western Research ... that protects the brain against the damaging effects of ... been in development for a few years. At this ... development among drugs created to reduce the brain,s vulnerability ...
... Scientists have combined two new "designer" forms of aspirin into ... its forebears in controlling the growth of several forms of ... so named because it releases nitric oxide (NO) and hydrogen ... Medicinal Chemistry Letters . Khosrow Kashfi, Ravinder Kodela and ...
... WEDNESDAY, Feb. 29 (HealthDay News) -- People worried about ... their life and their work performance, and their commitment ... questionnaires completed by 321 workers with an average age ... commercial distribution companies, or were temporary work agency employees. ...
Cached Medicine News:Health News:Drug Seems to Speed Recovery After Traumatic Brain Injury 2Health News:Drug Seems to Speed Recovery After Traumatic Brain Injury 3Health News:Drug Seems to Speed Recovery After Traumatic Brain Injury 4Health News:Old drug reveals new tricks 2Health News:Old drug reveals new tricks 3Health News:Sports Concussion: Myths and Facts 2Health News:Canadian scientist develops world's most advanced drug to protect the brain after a stroke 2
... instrument and custom filter wheels with ... The standard filter set includes: FAM/SYBR ... Red (585nm-610nm), Cy5 (635nm-665nm) and Cy3 ... analysis software, Beacon Designer oligo software, ...
... rapid, real-time thermal cycler used for identifying ... much of the testing process, and making ... the fastest, easiest to use, and most ... SmartCycler delivers highly accurate and consistent test ...
... SmartCycler System is a rapid, real-time thermal ... biological samples. By automating much of the ... individually programmable, it is the fastest, easiest ... on the market. The SmartCycler delivers highly ...
... The Applied Biosystems 7300 Real-Time ... real-time PCR capabilities with exceptional budget ... you to perform gene expression analysis, ... assays with internal positive controls ...
Medicine Products: