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 control rate of 51 percent. Subset analyses suggested the greatest benefit occurred in the difficult-to-treat patients with prior myelodysplastic syndrome (MDS) or those that had received prior hypomethylating therapy (HMA). Adverse events were mild, predictable and manageable.

About Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (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 CTI
Cell Therapeutics, Inc. (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, statements concerning our anticipated product development and our ability to submit the above-referenced tosedostat data to the FDA in the coming weeks. 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 the Company's securities. Specifically, the risks and uncertainties that could affect our ability to address FDA requests or the development of tosedostat more generally 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; the risk that the FDA may expand its information request or initiate a complete clinical hold or take other actions; and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission, including, without limitation, the Company's most recent filings on Forms 10-K, 10-Q and 8-K. The Company can give no assurances that any results or events projected or contemplated by its forward-looking statements will in fact occur and the Company cautions you not to place undue reliance on these statements. The Company 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:

CTI Media and Investor Contacts:

Monique Greer
+1 206.272.4343
mgreer@ctiseattle.com

Ed Bell
+1 206.282.7100
invest@ctiseattle.com

In Europe

CTI Life Sciences Limited, Milan Branch
Laura Villa
E: CTI_EUInvestors@CTI-Lifesciences.com
T: +39 02 89659700
http://www.celltherapeutics.com/italiano


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

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:6/24/2016)... and SAN CLEMENTE, Calif. , June ... -based mobile pulmonary function testing company, is now able to ... devices developed by ndd Medical Technologies , Inc. ... done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ... , can get any needed testing done in the comfort of ...
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... Ill. , June 23, 2016  In a startling report ... are failing their residents by lacking a comprehensive, proven plan to ... a definitive ranking of how states are tackling the worst ... to only four states – Kentucky , ... Vermont . Of the 28 failing states, three ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, ... the latter, setting the bar too high can result in disappointment, perhaps even self-loathing. ... toward their goal. , Research from PsychTests.com reveals that behind the ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Global law firm ... 2016 Legal Elite. The attorneys chosen by their peers for this recognition are considered ... Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite ...
(Date:6/24/2016)... Rhinebeck, NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of ... of companies that call for a minimum wage raise to $12 an hour by 2020 ... wage. This will restore the lost value of the minimum wage, assure the wage floor ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, affiliated ... Weintraub as a prominent plastic surgeon and the network’s newest partner. , ... most handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands ...
Breaking Medicine News(10 mins):