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:9/2/2014)... , Sept. 2, 2014  Amgen ... the submission of a Marketing Authorization Application ... via the centralized procedure for talimogene laherparepvec ... with melanoma that is regionally or distantly ... administered as an intralesional injection that is ...
(Date:9/2/2014)... FRANCISCO, Calif. , Sept. 2, 2014   Veracyte, ... Bonnie H. Anderson , president and chief executive officer, ... Morgan Stanley Global Healthcare Unplugged Conference 2014 on Monday, September ... York . The live audio webcast and ... http://investor.veracyte.com . Please connect to the website at least ...
(Date:9/2/2014)... Redspin, Inc., a leading provider of HIPAA ... an IT security advisory specifically for senior executives in ... presiding over the most dynamic period in the history ... Redspin,s President and CEO. "The goal of our advisory ... understand why they need to elevate IT security to ...
Breaking Medicine Technology:Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 2Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 3Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 4Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 5Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency 6Veracyte to Present at the Morgan Stanley Global Healthcare Unplugged Conference 2014 2
... importance of dedicated information management systems for radiation ... most recent version of its MOSAIQ® Oncology Information ... Systems Society,s 2012 conference (HIMSS12), Feb. 20-24, in ... comprehensive OIS that centralizes traditional radiation oncology, particle ...
... Feb. 16, 2012  Cardium Therapeutics (NYSE Amex: ... previously announced sale of 17,857,143 shares of its common ... of approximately $5.0 million, before deducting placement agent,s fees ... investors participating in the offering purchased the shares at ...
Cached Medicine Technology:Elekta Highlights Latest Version of MOSAIQ Oncology Information System at HIMSS12 Meeting 2Cardium Announces Closing of $5.0 Million Equity Financing 2Cardium Announces Closing of $5.0 Million Equity Financing 3
(Date:9/2/2014)... Humility of Mary Health Partners will offer a ... Health Center, 1044 Belmont Ave. , The workshop includes an ... common health problems as well as tips on caring for ... on when to seek medical attention. , The morning ... Room; the evening session runs from 5:30 to 6:30 p.m. ...
(Date:9/2/2014)... 02, 2014 A little bit of ... sometimes the onset of irritability, sadness, or apathy can ... September 2014 Harvard Health Letter. , "Mood-related ... stresses. If they occur for long periods, cause significant ... to seek help," says Dr. Nancy Donovan, an instructor ...
(Date:9/2/2014)... Eric Jimenez and Leah Ashley announced ... revolutionary makeup application device. Designed to improve and accelerate ... the palm of women’s hands to help them get ... Me’s success lies in its patented technology. With a ... 15,000 pulses per minute, the device applies foundation evenly ...
(Date:9/2/2014)... B. E. Smith, the only full-service leadership solutions ... to lead a national chief executive officer ... Sioux Falls, S.D. The top executive search firm in ... more than 900 healthcare executives into organizations. , ... and nationally recognized leader in patient-centered care. It is ...
(Date:9/2/2014)... Syracuse, NY (PRWEB) September 02, 2014 ... A. Gadlage, M.D. & Associates in Duluth, GA and ... the EarQ team at the 2014 National ... in Cancun, Mexico. , While interacting with the former ... maintaining hearing health, the team provided free hearing screenings, ...
Breaking Medicine News(10 mins):Health News:HMHP Offers ‘Health at Home’ Workshop 2Health News:When a Mood Swing Signals Trouble, From the September 2014 Harvard Health Letter 2Health News:Color Me Launches With Ulta Beauty Revolutionary Makeup Application Device Gets Women Flawless in a Flash 2Health News:Color Me Launches With Ulta Beauty Revolutionary Makeup Application Device Gets Women Flawless in a Flash 3Health News:Sioux Falls Specialty Hospital Retains B. E. Smith to Recruit New CEO 2Health News:Sioux Falls Specialty Hospital Retains B. E. Smith to Recruit New CEO 3Health News:The EarQ Team Brings Hearing Health Awareness to the 2014 National Basketball Retired Players Association Annual Convention in Cancun 2
... a few glasses of wine enough to disrupt normal development, ... Just a few glasses of wine over a short period ... the Medical College of Georgia. , The initial signs ... include facial malformations such as a flat and high upper ...
... Benefit Muscular Dystrophy Research , ... Iselin, NJ (PRWEB) ... [Sanford-Brown Iselin] (SBI), in New Jersey, raised $11,000 for muscular ... the event are in support of local non-profit www.ryansquest.org ...
... to recent news,about Michigan,s first identified case of chronic ... issued the following statement., With hunting season fast ... a deer on a Kent County farm understandably has,created ... great state of Michigan. The deer farming industry in ...
... Surgery Seems to be the Provider of Choice for Recent,Big ... Next?, Months of constant cameras, mirrors all around and ... a major impact on how you feel,about the way you ... reality. Upon leaving the house contestants may undoubtedly spend,hours watching ...
... to $19 million, NATICK, Mass., Aug. 29 ... the U.S. District Court of,Marshall, Texas found two patents ... conduct during the prosecution of the patents,before the United ... previously found that certain Boston Scientific balloon,catheters and stent ...
... leadership and State delegations as a possible solution to national health ... ... 2008 -- If there has been any one consistent message offered ... the party platform initiative to resolve our national health care issues., ...
Cached Medicine News:Health News:Alcohol in Early Pregnancy May Prompt Fetal Cell Death 2Health News:Sanford-Brown Institute - Iselin Raises $11,000 for Ryan's Quest 2Health News:Deer Farm Industry in Michigan Issues Statement on the Recent Chronic Wasting Disease Case Identified on a Kent County Deer Farm 2Health News:MYA Makes Big Brother Stars Amazing! 2Health News:MYA Makes Big Brother Stars Amazing! 3Health News:Court Rejects Two Medtronic Patents 2Health News:Court Rejects Two Medtronic Patents 3Health News:AMD Global Telemedicine Inc. Invited to Attend Democratic National Convention 2
...
The Tew cranial/spinal retractor is designed for posterior fossa or intraspinal microsurgery where retraction is required. Clinical applications are: Posterior fossa microsurgery and intraspinal micr...
The Doro Halo retractor system is designed for all neurosurgical applications where retraction of the brain tissue and an armrest is required....
The Budde Halo brain retractor is designed for use in all intercranial procedures where retraction of delicate brain tissue is required....
Medicine Products: