CELL THERAPEUTICS, INC. (Exact Name of Registrant As Specified in Its Charter)

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): January 23, 2009 CELL THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)

Washington 001-12465 91-1533912 (State or other jurisdiction of (Commission (I.R.S. Employer incorporation or organization) File Number) 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 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing. On January 23, 2009, Cell Therapeutics, Inc. (the “Company”) received an Additional Staff Determination (the “Determination Letter”) from The NASDAQ Stock Market (“NASDAQ”) stating that the staff had concluded that the Company’s recent issuance of 38,185,911 shares of common stock (the “Shares”) in connection with an amendment to the “earn-out” provision (the “Amendment”) of the Acquisition Agreement, dated as of July 27, 2007, by and among the Corporation, Cactus Acquisition Corp., Saguaro Acquisition Corporation LLC, Systems Medicine, Inc. (“SMI”) and Tom Hornaday and Lon Smith, in their capacities as representatives of the SMI stockholders (the “Stockholder Representatives”), whereby the Company acquired Systems Medicine, Inc. in a stock-for-stock merger, did not comply with the shareholder approval requirements set forth in NASDAQ Marketplace Rule 4350(i)(1)(C). Marketplace Rule 4350(i)(1)(C) requires shareholder approval in connection with an acquisition if the issuance or potential issuance is greater than 20% of the pre-acquisition shares outstanding.

In response to the concerns raised by the NASDAQ staff, the Company entered into a Cancellation Agreement dated January 23, 2009 with the Stockholder Representatives to cancel the Amendment and rescind the issuance of the 38,185,911 shares and to reinstate the original terms of the “earn-out” provision without modification.

The Determination Letter also indicated that the Company has at times not complied with Marketplace Rule 4310(c)(17), which requires companies to submit a “Listing of Additional Shares” form to NASDAQ no later than 15 days prior to entering into a transaction that involves the issuance of additional securities, including the form that was submitted in connection with the Amendment, and based upon the Company’s history of non-compliance with certain of NASDAQ’s corporate governance criteria, indicated that the Staff had raised public interest concerns under Marketplace Rule 4300.

As previously disclosed in the Company’s Current Report on Form 8-K filed on January 8, 2009, the NASDAQ Listing Qualifications Panel (the “Panel”) recently granted the Company’s request to transfer the listing of its common stock from The NASDAQ Global Market to The NASDAQ Capital Market, subject to the Company evidencing compliance with all applicable requirements for continued listing on The NASDAQ Capital Market, including the $35 million market value of listed securities requirement or its alternatives, by February 12, 2009. The Determination Letter provided formal notice that the Panel will consider the additional matters raised by the Staff in rendering a determination regarding the Company’s continued listing on The NASDAQ Capital Market. Pursuant to Marketplace Rule 4804(c), the Company will present its views with respect to those matters for the Panel’s review no later than January 30, 2009.

On January 26, 2009, the Company issued a press release relating to the matters described herein, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 8.01 Other Events On January 27, 2009, the Company issued a press release announcing that after communication with the Food and Drug Administration (FDA), it expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to treat relapsed aggressive non-Hodgkin’s lymphoma in the first quarter of 2009. The full text of the press release is attached hereto as Exhibit 99.2.

On January 28, 2009, the Company issued a press release announcing preliminary progression-free survival (PFS) results from its pivotal phase III EXTEND (PIX301) trial of pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin’s lymphoma (NHL) treated with pixantrone experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, p < 0.01, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. PFS was a prospectively defined secondary endpoint in the study. The full text of the press release is attached hereto as Exhibit 99.3.

By settlement agreement dated as of January 28, 2009, the Company agreed to pay within three court days a total amount of $494,500 to settle all outstanding claims for attorneys’ fees and expenses (such claims were previously disclosed to total $1.4 million) by the qui tam Relator, in connection with an investigation by the United States Attorney’s Office into certain of the Company’s prior marketing practices relating to TRISENOX® (arsenic trioxide). This agreement fully and finally resolves all remaining claims in this civil action. The Company’s separate action seeking indemnification for all losses incurred in the qui tam action is pending in the Ninth Circuit Court of Appeals.

As of January 28, 2009, the Company has 295,943,993 shares of its common stock, no par value, issued and outstanding.

Item 9.01 Financial Statements and Exhibits (d) Exhibits

Exhibit No. Description

99.1 Press Release of Cell Therapeutics, Inc. dated January 26, 2009 regarding NASDAQ Additional Staff Determination.

99.2 Press Release of Cell Therapeutics, Inc. dated January 27, 2009 regarding Pixantrone Pre-NDA Communication.

99.3 Press Release of Cell Therapeutics, Inc. dated January 28, 2009 regarding Pixantrone Preliminary Progression-Free Survival Results.

-2- SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CELL THERAPEUTICS, INC.

Date: January 29, 2009 By: /s/ Louis A. Bianco Louis A. Bianco Executive Vice President, Finance and Administration

-3- EXHIBIT INDEX

Exhibit No. Description

99.1 Press Release of Cell Therapeutics, Inc. dated January 26, 2009 regarding NASDAQ Additional Staff Determination.

99.2 Press Release of Cell Therapeutics, Inc. dated January 27, 2009 regarding Pixantrone Pre-NDA Communication.

99.3 Press Release of Cell Therapeutics, Inc. dated January 28, 2009 regarding Pixantrone Preliminary Progression-Free Survival Results.

-4- Exhibit 99.1

501 Elliott Ave. W. #400 T 206.282.7100 Seattle, WA 98119 F 206.272.4010

CELL THERAPEUTICS RECEIVES ADDITIONAL NASDAQ NOTIFICATION

January 26, 2009 Seattle— Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) announced today that the Company received an Additional Staff Determination letter (the “Determination Letter”) from the Listing Qualifications Staff (the “Staff”) of The NASDAQ Stock Market indicating that the Company did not comply with Marketplace Rule 4350(i)(1)(C) when the Company amended the acquisition agreement with Systems Medicine, Inc. (“SMI”) and issued additional common shares to SMI shareholders. Marketplace Rule 4350(i)(1)(C) requires shareholder approval for the issuance of common stock in connection with an acquisition if the issuance is greater than 20 percent of the pre-acquisition shares outstanding.

On January 6, 2009, as disclosed in the Company’s Form 8-K filed with the SEC on January 8, 2009, the Company entered into the First Amendment to Acquisition Agreement (the “Amendment”), which amended the Acquisition Agreement with SMI, dated as of July 24, 2007, whereby the Company acquired SMI in a stock-for-stock merger. Pursuant to the Amendment, the “earn-out” provision of the Acquisition Agreement was amended to provide that the Company shall pay accredited SMI stockholders an immediate substitute “earn-out” payment of $5 million, to be paid in common stock at a value of $0.13 per share (the closing market price on the date of the Amendment), in lieu of the former potential milestone payments of $5 million and $10 million tied to certain FDA milestones for Brostallacin. As a result, the Company issued 38,186,911 shares of its common stock to SMI stockholders, which is in excess of 20% of the Company’s pre-transaction shares outstanding as of July 24, 2007, the date of the original Acquisition Agreement.

The violation was inadvertent and unintentional. Upon learning of the Staff’s position that the issuance of shares resulting from the Amendment violated Marketplace Rule 4350(i)(1)(C) , the Company took immediate action to rescind the issuance of such shares.

As disclosed on January 7, 2009, the NASDAQ Listing Qualifications Panel (the “Panel”) recently granted the Company’s request to transfer the listing of its common stock from The NASDAQ Global Market to The NASDAQ Capital Market, subject to the Company evidencing compliance with all applicable requirements for continued listing on The NASDAQ Capital Market, including the $35 million market value of listed securities requirement or its alternatives, by February 12, 2009. The Determination Letter provided formal notice that the Panel will consider the additional matters raised by the Staff in rendering a determination regarding the Company’s continued listing on The NASDAQ Capital Market. Pursuant to Marketplace Rule 4804(c), the Company will present its views with respect to those matters for the Panel’s review no later than January 30, 2009. As part of that submission, the Company plans to request continued listing on The NASDAQ Capital Market; however, there can be no assurance that the Panel will grant the Company’s request.

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.

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. These risks and uncertainties include, without limitation, that the Company may continue to be unable to meet the continued listing requirements for The NASDAQ Capital Market, and that it may be unsuccessful in obtaining a favorable determination from the Panel regarding the Company’s continued listing on The NASDAQ Capital Market; as well as other risk and uncertainties that could affect the Company’s business operations and the development of the Company’s products including the Company’s need to raise additional capital, risks associated with preclinical and clinical developments in the biopharmaceutical industry in general including, without limitation, the potential failure of a product to prove safe and effective for treatment of a specific condition, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, and costs of developing, producing and selling the product(s). You should also review 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, 8-K, and 10-Q. 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: [email protected] www.CellTherapeutics.com/press_room

Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F : 206.272.4434 E: [email protected] www.CellTherapeutics.com/investors Exhibit 99.2

501 Elliott Ave. W. #400 T 206.282.7100 Seattle, WA 98119 F 206.272.4010

PIXANTRONE PRE-NDA COMMUNICATION FROM FDA PROVIDES CELLTHERAPEUTICS BASIS TO BEGIN ROLLING NDA SUBMISSION

January 27, 2009 Seattle—Cell Therapeutics (CTI) (NASDAQ and MTA: CTIC) announced today that after communication with the Food and Drug Administration ( FDA), CTI expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to treat relapsed aggressive non-Hodgkin’s lymphoma ( NHL) in the first quarter of 2009. If granted priority review a decision on the NDA could occur before the end of 2009.

“This communication from the FDA is a significant milestone for the Company and for patients with relapsed aggressive NHL as this could be the first drug approved for this unmet medical need,” noted James A. Bianco, M.D. Chief Executive Officer of CTI. “With the potential for three drug approvals in 2009 we are on track to meet our objective of cash flow break even in the fourth quarter of this year.”

The EXTEND clinical trial was a phase III single-agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin’s lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician.

CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increased the overall response rate (CR/uCR+PR) with (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). CR/uCR and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.

The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004 and pixantrone has received fast track designation for this indication. About Pixantrone Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.

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. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the results of complete safety information, the ability of the company to file a rolling NDA in the first quarter of 2009,determination by the FDA that the PIX301 trial is insufficient to support an NDA filing and that the FDA would grant priority review, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the Company’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, 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, 8-K, and 10-Q. 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.

Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: [email protected] www.CellTherapeutics.com/press_room

Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F : 206.272.4434 E: [email protected] www.CellTherapeutics.com/investors Exhibit 99.3

501 Elliott Ave. W. #400 T 206.282.7100 Seattle, WA 98119 F 206.272.4010

PIXANTRONE INCREASES PROGRESSION-FREE SURVIVAL BY 81% COMPARED TO STANDARD CHEMOTHERAPEUTIC AGENTS IN PHASE III RELAPSED AGGRESSIVE NON-HODGKIN’S LYMPHOMA TRIAL

January 28, 2009 Seattle—Cell Therapeutics (CTI) (NASDAQ and MTA: CTIC) announced today preliminary progression-free survival (PFS) results from its pivotal phase III EXTEND (PIX301) trial of pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin’s lymphoma (NHL) treated with pixantrone experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, p < 0.01, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. PFS was a prospectively defined secondary endpoint in the study.

“We always believed the effectiveness of pixantrone would translate into a meaningful difference for patients with relapsed aggressive NHL and these dramatic and significant differences in PFS in this tough to treat group of patients provides that evidence,” stated James A. Bianco, M.D. Chief Executive Officer of CTI. “Pixantrone is the first agent in this patient population to demonstrate a significant and meaningful PFS advantage. We believe these data will support a priority review designation on our New Drug Application (NDA) once we share them with the Food and Drug Administration (FDA).”

The Company had previously announced that its pivotal phase III (PIX 301) EXTEND trial had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02) with no patients in the standard chemotherapy arm achieving a confirmed complete remission. Additionally, pixantrone treatment also significantly increased the overall response rate (CR/CRu+PR) (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). PFS, CR/CRu and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.

The most common serious toxicities (>5%) seen in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety information is not yet available for the study, however, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee and no serious concerns were raised. The EXTEND clinical trial is a phase III single-agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin’s lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician. The trial was designed to examine the complete remission or unconfirmed complete remission rate, overall survival and progression-free survival. The study received Special Protocol Assessment approval from the FDA in 2004 and pixantrone has received fast track designation for this indication.

The Company announced on January 27, 2009 that after a pre-NDA communication with the FDA, it expects to begin submission of a rolling NDA and request priority review for pixantrone to treat relapsed aggressive NHL in the first quarter of 2009.

About Pixantrone Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.

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. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the results of complete safety information, the ability of the company to file a rolling NDA in the first quarter of 2009,a determination by the FDA that the PIX301 trial is insufficient to support an NDA filing and that the FDA would grant priority review, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the Company’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, 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, 8-K, and 10-Q. 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. Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: [email protected] www.CellTherapeutics.com/press_room

Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F : 206.272.4434 E: [email protected] www.CellTherapeutics.com/investors