8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report: (Date of earliest event reported): February 17, 2012

CELL THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Washington	001-12465	91-1533912
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification Number)

501 Elliott Avenue West, Suite 400

Seattle, Washington 98119

(Address of principal executive offices)

Registrant’s telephone number, including area code: (206) 282-7100

Not applicable

(Former name or former address, if changed since last report).

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure.

A copy of Cell Therapeutics, Inc.’s (the “Company”) press release, entitled “European Medicines Agency’s Committee for Medicinal Products for Human Use Issues Positive Opinion for Conditional Approval on Marketing Authorization Application for Pixuvri^™” is furnished and not filed pursuant to Item 7.01 as Exhibit 99.1 hereto. Such information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On February 17, 2012, the Company announced that Pixuvri^™ (pixantrone dimaleate) has been granted a positive opinion for conditional approval from the European Medicines Agency’s (the “EMA”) Committee for Medicinal Products for Human Use (“CHMP”). CHMP recommended Pixuvri for conditional approval as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive non-Hodgkin’s B-cell lymphomas. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, the Company will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

Cautionary Statement Regarding Forward-Looking Statements

This Current Report on Form 8-K contains “forward-looking” statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, regarding CHMP’s positive opinion recommending conditional approval of the marketing authorization application for Pixuvri. Such forward-looking statements are based on current expectations, are predictive in nature, and involve known and unknown risks and uncertainties that may cause the Company’s actual outcomes and results to differ materially from those projected or contemplated in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that that Pixuvri may not be approved as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive non-Hodgkin’s B-cell lymphomas, that the European Commission may not adopt CHMP’s recommendation regarding Pixuvri, that the conditional marketing authorization may not be renewed and that the Company may not be able complete a post-marketing study aimed at confirming the clinical benefit previously observed. 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Press Release, dated February 17, 2012, entitled “European Medicines Agency’s Committee for Medicinal Products for Human Use Issues Positive Opinion for Conditional Approval on Marketing Authorization Application for Pixuvri™.”

SIGNATURE

Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CELL THERAPEUTICS, INC.
Date: February 17, 2012	By:	/s/ JAMES A. BIANCO, M.D.
		James A. Bianco, M.D.
		Chief Executive Officer

EXHIBIT INDEX

Exhibit Number	Description
99.1	Press Release, dated February 17, 2012, entitled “European Medicines Agency’s Committee for Medicinal Products for Human Use Issues Positive Opinion for Conditional Approval on Marketing Authorization Application for Pixuvri™.”

EX-99.1

Exhibit 99.1

 

European Medicines Agency’s Committee For

Medicinal Products For Human Use Issues Positive

Opinion For Conditional Approval On Marketing

Authorization Application For Pixuvri^TM

Potentially the First Drug to be Approved as Monotherapy for the Treatment of

Adult Patients with Multiple Relapsed or Refractory Aggressive Non-Hodgkin B-Cell Lymphomas (NHL)

February 17, 2012 Seattle—Cell Therapeutics, Inc. (“CTI”) (NASDAQ and MTA: CTIC) announced today that Pixuvri^TM (pixantrone dimaleate) has been granted a positive opinion for conditional approval from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”). Based on the CHMP’s recommendation, CTI expects that a conditional marketing authorization for Pixuvri should be granted by the European Commission within the next few months. CHMP recommended Pixuvri for conditional approval as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (“NHL”).

If the CHMP’s recommendation is formally adopted by the European Commission, Pixuvri would be approved for marketing in the 27 countries that are members of the E.U., as well as the European Economic Area. The decision by the European Commission is typically issued approximately two to three months after the CHMP opinion and generally follows the recommendation from the CHMP. If the opinion is confirmed by the European Commission, Pixuvri would be the first drug approved for patients in this setting.

“We are very pleased with the CHMP’s positive recommendation recognizing the clinical benefit of Pixuvri in addressing a significant unmet medical need for patients with multiple relapsed or refractory aggressive B-cell NHL, and we believe that Pixuvri will add an important treatment option for physicians and provide a meaningful impact on patients,” stated James A. Bianco, CEO of CTI.

501 Elliott Ave. W. #400 Seattle, WA 98119 T 206.282.7100 F 206.284.6206

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“There are currently no proven effective therapies for these advanced NHL patients. Our goal for this late stage patient population is to control disease progression and symptoms as a cure is no longer an option. We are encouraged by the PFS noted in the PIX301 study and the opportunity this agent provides in treating this difficult to treat group of patients,” said Bertrand Coiffier, M.D., Ph.D., Professor of Hematology at the Department of Hematology, Hospices Civils de Lyon and the University Lyon 1 in Lyon, France.

Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

The CHMP has accepted PIX306, CTI’s ongoing randomized controlled phase 3 clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab in 2^nd line patients with aggressive B-cell NHL who failed front-line CHOP-R and who are not eligible for autologous stem cell transplant (“ASCT”) or as 3^rd or 4^th line therapy in aggressive B-cell NHL. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.

For more information visit the EMA website at http://www.ema.europa.eu.

About Non-Hodgkin Lymphoma

NHL is caused by the abnormal proliferation of lymphocytes, cells key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms—aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly. The World Health Organization’s International Agency for Research on Cancer’s 2008 GLOBOCAN database most recent estimates state that in European Union approximately 74,162 people will be diagnosed with NHL and 31,371 are estimated to die from NHL every year.

There are many subtypes of NHL, but aggressive NHL is one of the more common types of NHL and accounts for about 60% of cases. Initial therapy for aggressive NHL with anthracycline-based combination therapy cures up to 60% of patients. Of the remaining patients, approximately half will respond to second-line treatment, but few are cured and there is no effective therapy for patients relapsing after or refractory to second-line treatment.

About Pixuvri (pixantrone)

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to

501 Elliott Ave. W. #400 Seattle, WA 98119 T 206.282.7100 F 206.284.6206

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anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines — rather than intercalation with DNA — pixantrone alkylates DNA — forming stable DNA adducts with particular specificity for CpG-rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone in an effort to prevent the binding of iron and perpetuation of superoxide production — both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline-like potency in the treatment of relapsed/refractory B-cell NHL without unacceptable rates of cardiotoxicity.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.

Sign up for email alerts and get RSS feeds at our Web site,

http://www.CellTherapeutics.com/investors_alert

This press release includes forward-looking statements that involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of CTI’s securities. Specifically, the risks and uncertainties that could affect the development of Pixuvri include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with Pixuvri in particular, including, without limitation, the potential failure of Pixuvri to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the FDA and/or the EMA, that Pixuvri may not be the first drug approved as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive NHL, that a conditional marketing authorization for Pixuvri may not be granted by the European Commission within the next few months or at all, that CTI may not be able to complete the PIX306 clinical trial of Pixuvri-rituximab versus gemcitabine-rituximab in patients with aggressive B-cell NHL, who failed front-line CHOP-R and who are not eligible for ASCT (2nd line) or failed ASCT (3rd or 4th line) by June 2015 or at all as required by the EMA or have the results of such trial available by June 2015 or at all, that CTI may not be able complete a post-marketing study aimed at confirming the clinical benefit observed in the PIX 301 trial, that full marketing authorization for Pixuvri may not be obtained, that the EMA and/or the European Commission may not formally adopt the CHMP’s recommendation regarding Pixuvri, that Pixuvri may not be approved for marketing in all of the E.U. Member States and the European Economic Area members, that the EMA may request additional information from CTI regarding Pixuvri, CTI’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling Pixuvri, and the risk factors listed or described

501 Elliott Ave. W. #400 Seattle, WA 98119 T 206.282.7100 F 206.284.6206

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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. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

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Media Contact:

Dan Eramian

T: 206.272.4343

C: 206.854.1200

E: deramian@ctiseattle.com

www.CellTherapeutics.com/press_room

Investors Contact:

Ed Bell

T: 206.282.7100

Lindsey Jesch Logan

T: 206.272.4347

F: 206.272.4434

E: invest@ctiseattle.com

www.CellTherapeutics.com/investors

Medical Information Contact:

T: 800.715.0944

E: info@askarm.com

501 Elliott Ave. W. #400 Seattle, WA 98119 T 206.282.7100 F 206.284.6206