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:12/17/2014)... -- , The new Dompé ... information concerning the biopharmaceutical Group,s national and international clinical research ... the recently launched institutional website that is receiving accolades from ... a new chapter in the fascinating story of Drug Discovery ... panoramic hub on the world of clinical research, ranging from ...
(Date:12/17/2014)... N.J. , Dec. 17, 2014  IGI Laboratories, ... today the closing of its offering of $125 million ... 2019 (the "Notes").  The Notes were offered and sold ... under the Securities Act of 1933, as amended (the ... a fixed rate of 3.75% per year, payable semiannually ...
(Date:12/17/2014)... and RALEIGH, N.C. ... Marketing Communications, LLC (CTMC), and Integrated Clinical Trial ... recruitment and retention for clinical trials announce that ... Clinical Trial Marketing Services (i-CTMS). i-CTMS will provide ... services to pharmaceutical, biotechnology and medical device companies. ...
Breaking Medicine Technology:Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 2Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 2IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 4Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 2Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 3
... HAIKOU, China , April 22 /PRNewswire-Asia-FirstCall/ ... (OTC Bulletin Board: KURU), a,leading bio-pharmaceutical company in ... peptide-based drugs and small molecule drugs, today,announced the signing ... of preferred stock and warrants with Caduceus Asia ...
... CardioGenics Inc. (OTC Bulletin Board: CGNH), a developer of technology and ... spotlighted in three publications during the month of April: Today,s Medical ... Transcript . , , ... the April 2010 print and online editions of Today,s ...
Cached Medicine Technology:Kun Run Biotechnology, Inc. Executes Purchase Agreements for Approximately $8 Million Private Placement 2Kun Run Biotechnology, Inc. Executes Purchase Agreements for Approximately $8 Million Private Placement 3Kun Run Biotechnology, Inc. Executes Purchase Agreements for Approximately $8 Million Private Placement 4CardioGenics to be Spotlighted in Three Publications During Month of April 2CardioGenics to be Spotlighted in Three Publications During Month of April 3CardioGenics to be Spotlighted in Three Publications During Month of April 4
(Date:12/19/2014)... December 19, 2014 The ... to developing educational events, tools and resources for ... Cooking School , the world’s leading online cooking ... every human being needs: Culinary Rx. As an ... course, Culinary Rx, scheduled for debut spring 2015, ...
(Date:12/19/2014)... Eufaula, Oklahoma, located just 9 miles ... state’s largest lake with more than 600 miles of ... a little more than 3,000 residents, hosted its annual ... 6th of December. , Featuring Santa, Christmas lights and ... on Main Street. Narconon Arrowhead’s parade float participated ...
(Date:12/19/2014)... Abilene, TX (PRWEB) December 20, 2014 ... XC, a new injectable filler from respected cosmetic brand ... can occur naturally with age. The Medspa at Hendrick ... new development in skin care technology to its clients. ... filler gel to be FDA-approved to treat the mid-face ...
(Date:12/19/2014)... News) -- The intestinal bacteria that cause inflammatory bowel ... be inherited, researchers report. The findings, published recently ... in efforts to prevent the disease and treat the ... authors added. "The intestinal bacteria, or ,gut microbiome, ... a big impact on your health for the rest ...
(Date:12/19/2014)... Injectable drug users who also use cocaine and amphetamines ... substance users, a new study finds. "We know ... suicide attempt and completed suicide," Didier Jutras-Aswad, a psychiatry ... university news release. "However, there are many different profiles ... substance users were actually more likely to attempt suicide." ...
Breaking Medicine News(10 mins):Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 2Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 3Health News:The Plantrician Project and the Rouxbe Cooking School Join Forces to Develop Culinary Rx – a Plant-Prescription Course 4Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 3Health News:Breakthrough New Injectable Dermal Filler Voluma XC Offered by The MedSpa at Hendrick 2Health News:Crohn's, Colitis May Have Genetic Underpinnings, Study Finds 2Health News:Cocaine, Amphetamines May Up Injection Drug Users' Suicide Risk 2
... a novel therapy that uses magnetic pulses to treat ... promising alternative to medication. , The therapy is called ... presented today (April 29, 2009) during the annual American ... , In a previous randomized controlled clinical study by ...
... after Bariatric SurgeryCHEYENNE, Wyo., April 29 Workers with ... than 100 diseases and conditions than other employees, and ... one-quarter of the diseases studied, according to a study ... of the Journal of Occupational and Environmental Medicine ...
... April 29 The University HealthSystem Consortium (UHC) ... and Web-based resource center to help its academic ... economic downturn. "The challenges of the current economic ... sharing on proven cost reduction initiatives and ideas. ...
... customers scheduled to travel through May 16 DENVER, April 29 ... the Swine Flu virus in parts of Mexico, Frontier Airlines ... all customers scheduled to travel to/from Cancun, Cozumel, ... through May 16, 2009, who bought tickets on or before ...
... Corporation (NYSE: SYK ) announced an increase ... of Howard L. Lance as a member of its ... with the slate of the Company,s seven current Directors ... held today.Mr. Lance is currently Chairman, President and Chief ...
... OTC, Vision and Beauty Sales Outpace Industry - Net Income ... to $5.6 Million BELLEVUE, Wash. April 29 drugstore.com ... retailer of health, beauty, vision, and pharmacy products, today announced ... 2009. The company reported record quarterly net sales of ...
Cached Medicine News:Health News:New therapy based on magnetic stimulation shows promise for non-drug treatment for migraine 2Health News:New Study Shows Morbidly Obese Workforce Has Higher Prevalence of 100+ Diseases and Conditions 2Health News:New Study Shows Morbidly Obese Workforce Has Higher Prevalence of 100+ Diseases and Conditions 3Health News:New Study Shows Morbidly Obese Workforce Has Higher Prevalence of 100+ Diseases and Conditions 4Health News:New Study Shows Morbidly Obese Workforce Has Higher Prevalence of 100+ Diseases and Conditions 5Health News:University HealthSystem Consortium Launches Tactics for Tough Times Initiative to Help Members With Issues Such as Capacity and Medication Management 2Health News:Frontier Airlines Extends Mexico Travel Policy for Customers With Concerns About Swine Flu 2Health News:Stryker Announces Election of New Director 2Health News:drugstore.com Reports Highest Net Revenues in Company History 2Health News:drugstore.com Reports Highest Net Revenues in Company History 3Health News:drugstore.com Reports Highest Net Revenues in Company History 4Health News:drugstore.com Reports Highest Net Revenues in Company History 5Health News:drugstore.com Reports Highest Net Revenues in Company History 6Health News:drugstore.com Reports Highest Net Revenues in Company History 7Health News:drugstore.com Reports Highest Net Revenues in Company History 8Health News:drugstore.com Reports Highest Net Revenues in Company History 9Health News:drugstore.com Reports Highest Net Revenues in Company History 10Health News:drugstore.com Reports Highest Net Revenues in Company History 11Health News:drugstore.com Reports Highest Net Revenues in Company History 12Health News:drugstore.com Reports Highest Net Revenues in Company History 13Health News:drugstore.com Reports Highest Net Revenues in Company History 14
... Allograft is processed from 100% cortical bone, ... The graft is machined with a textured ... graft migration. The intermedulary canal accommodates autograft ... Allografts contain a relief orientation in either ...
Lumbar Allograft with Osteoactive advantage. Promotes bone formation and faster incorporation. Derived from the proven technology behind Grafton DBM. Maintains structural integrity and strength....
... Anteater Titanium Microdiscectomy System offers ... spinal surgery. The boss anteater titanium ... herniated intervertebral discs provides for less ... The retractor is designed to provide ...
Meyerding Laminectomy Retractors, self-retaining....
Medicine Products: