Navigation Links
Cell Therapeutics Announces Removal of the Partial Clinical Hold on Tosedostat
Date:1/2/2014

SEATTLE, Jan. 2, 2014 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the partial clinical hold on tosedostat (IND 075503) has been removed and all studies underway may continue. Tosedostat is a first-in-class selective inhibitor of aminopeptidases, which are required by tumor cells to provide amino acids necessary for growth and tumor cell survival, and is under development for the treatment of blood-related cancers. Tosedostat is currently being studied in the United States and European Union in investigator-sponsored and cooperative group-sponsored Phase 2 trials in elderly patients with newly diagnosed and relapsed acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).

"We are pleased that the FDA has responded favorably to the tosedostat clinical trial data provided and removed the partial clinical hold to allow further development of tosedostat in ongoing and future studies," said John Pagel, MD, PhD, Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center; Associate Professor, Medical Oncology Division, University of Washington School of Medicine; and Principal Investigator in the tosedostat first-line AML/MDS trial.

About AML and MDS

Approximately 14,590 new cases of AML were expected to be diagnosed in the United States in 2013.1 As of January 2008 an estimated 30,993 people were living with (or were in remission from) AML.2 Although AML can occur at any age, adults aged 60 years and older are more likely to develop the disease than younger people. AML is a cancer characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. AML may develop from the progression of other diseases such as myelodysplastic syndrome (MDS), a blood cancer that also affects the bone marrow leading to a decrease in circulating red blood cells. AML is the most common acute leukemia affecting adults, and its incidence increases with age. The symptoms of AML are caused by replacement of normal bone marrow with leukemic cells, which causes a drop in red blood cells, platelets, and normal white blood cells leading to infections and bleeding. AML progresses rapidly and is typically fatal within weeks or months if left untreated. Although a substantial proportion of younger individuals who develop AML can be cured, AML in the elderly typically responds poorly to standard therapy with few complete remissions.

About Tosedostat

Tosedostat is an oral aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in Phase 1–2 clinical trials. CTI has an exclusive marketing and co-development agreement with Chroma Therapeutics Ltd. for drug candidate tosedostat in North, Central and South America.

About Cell Therapeutics, Inc.

CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable.  CTI is headquartered in Seattle, WA.  For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com.

Forward Looking Statements

This press release contains "forward-looking" statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the number of expected cases of AML and the potential benefits of tosedostat. Such statements are subject to risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of tosedostat include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with tosedostat in particular including, without limitation, the potential failure of tosedostat to prove safe and effective as determined by the FDA and/or the European Medicines Agency; determinations by regulatory, patent, and administrative governmental authorities; competitive factors; technological developments; costs of developing and producing tosedostat; and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission, including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. CTI can give no assurances that any results or events projected or contemplated by its forward-looking statements will in fact occur and CTI cautions you not to place undue reliance on these statements. CTI undertakes no duty to update these forward-looking statements to reflect any future events, developments or otherwise.

References:

  1. American Cancer Society, Cancer Facts & Figures 2013. Available at http://tinyurl.com/kl6vs5h . Accessed June 2013.
  2. The Leukemia and Lymphoma Society, Acute Myeloid Leukemia, Rev. 2011. Available at http://tinyurl.com/d72ycja. Accessed February 2013.

Contacts:
Monique Greer
+1 206-272-4343
mgreer@ctiseattle.com  

Ed Bell
+1 206-282-7100
ebell@ctiseattle.com  

In Europe:
CTI Life Sciences Limited, Milan Branch
Laura Villa
+39 02 89659706
lvilla@cti-lifesciences.com
CTI_EUInvestors@CTI-Lifesciences.com


'/>"/>
SOURCE Cell Therapeutics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics, Inc. (CTI) to Report First Quarter Financial Results on April 20
2. Faruqi & Faruqi, LLP Encourages Investors Who Suffered Substantial Losses Investing in Chelsea Therapeutics International, Ltd. to Contact the Firm
3. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
4. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
5. Zacks Industry Outlook Highlights: Eli Lilly, Forest Labs, ViroPharma, Novartis and United Therapeutics
6. Oxford BioTherapeutics Appoints Senior Industry Leader to Head its New Clinical Development Operations in Basel, Switzerland
7. Nektar Therapeutics Reports Financial Results for the First Quarter of 2012
8. Cara Therapeutics Licenses Novel Kappa Opioid Agonist, CR845, to Chong Kun Dang Pharmaceutical Corporation For South Korean Market
9. Frost & Sullivan: High Uptake of New Drug Therapies and Aging Population Expansion Keep the U.S. Retinal Therapeutics Market Buoyant
10. Zenobia Therapeutics, Inc. And BioBlocks, Inc. Announce Sale Of A Joint Fragment Library Ideal For Screening By All Popular Methods
11. New Forecast Shows Global Protein Therapeutics Market to Reach $143.4 Billion by 2015
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... -- Hutchison China MediTech (Chi-Med) (HCM) ... highly lucrative global oncology and immunology markets. HCM ... or best-in-class tyrosine kinase inhibitor (TKI) drugs, some ... HCM,s profitable Chinese healthcare business continues to benefit ... of the mid-to-late-stage pipeline during 2016-17 (including US ...
(Date:5/26/2016)... ALBANY, New York , May 26, 2016 ... Transparency Market Research "Medical Waste Management Market - U.S. Industry ... the medical waste management market in the U.S. was valued ... expand at a CAGR of 3.4% from 2015 to 2023 ... report provides exhaustive analysis of current and emerging needle free ...
(Date:5/26/2016)... 2016 Since its commercial introduction ... essential life science tool for conducting genetic studies in ... reveals in its new report that the industry sits ... powered by a range of new applications in the ... http://photos.prnewswire.com/prnh/20140723/694805 ) , Since the ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... In response to ... who are unaware of the plight of aphasia. In collaboration with the American ... Awareness” campaign. , The link between stroke and aphasia is relatively unknown, but ...
(Date:5/27/2016)... NY (PRWEB) , ... May 27, 2016 , ... Aimed ... inspiring human interest stories, which come courtesy of leaders in the nursing and health ... industry, from leading advocates and associations—namely Abilene Christian University. , As the nursing ...
(Date:5/26/2016)... ... ... Despite last week’s media reports hinting at a June rate hike after ... 2017 for an interest rate increase, according to Rajeev Dhawan of the Economic Forecasting ... Open Market Committee (FOMC) dot charts are of interest to the press for their ...
(Date:5/26/2016)... , ... May 26, 2016 , ... ... discovery of thousands of defective respirators, according to court documents and SEC filings. ... of William and Becky Tyler v. American Optical Corporation, Case No. BC588866, Los ...
(Date:5/26/2016)... ... May 26, 2016 , ... Connor Sports, through its Connor ... for the Tamika Catchings Legacy Tour that will commemorate the Indiana Fever ... basketball surfaces in all forms and levels of the game, Connor Sports has committed ...
Breaking Medicine News(10 mins):