-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, O7eueMKkXZPqCKIXjef15S6z0qQJJMd6kepwsqvX59zj++eTs4Rp4zxbW12aau3r 3B7ain6v3B4oIAVlHX4t9A== 0001193125-10-190709.txt : 20100817 0001193125-10-190709.hdr.sgml : 20100817 20100817060554 ACCESSION NUMBER: 0001193125-10-190709 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20100817 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100817 DATE AS OF CHANGE: 20100817 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELL THERAPEUTICS INC CENTRAL INDEX KEY: 0000891293 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 911533912 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12465 FILM NUMBER: 101021695 BUSINESS ADDRESS: STREET 1: 501 ELLIOTT AVE W STREET 2: STE 400 CITY: SEATTLE STATE: WA ZIP: 98119 BUSINESS PHONE: 2062707100 MAIL ADDRESS: STREET 1: 501 ELLIOTT AVE W STREET 2: STE 400 CITY: SEATTLE STATE: WA ZIP: 98119 8-K 1 d8k.htm FORM 8-K Form 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): August 17, 2010

 

 

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.

On August 17, 2010, Cell Therapeutics, Inc. (the “Company”) issued a press release in Italy entitled “Cell Therapeutics Provides Additional Information on Pixantrone Pediatric Investigation Plan (PIP) at CONSOB’s Request.” An English translation of the press release is furnished and not filed pursuant to Item 7.01 as Exhibit 99.1 hereto.

The information provided pursuant to this Item 7.01 shall not be deemed “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 filing or other document filed by the Company pursuant to the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof and regardless of any general incorporation language in such filings or documents, except to the extent expressly set forth by specific reference in such a filing or document. The information furnished pursuant to this Item 7.01 shall instead be deemed “furnished.”

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following exhibit is furnished with this report on Form 8-K:

 

Exhibit
Number

  

Description

99.1    Press Release, dated August 17, 2010, entitled “Cell Therapeutics Provides Additional Information on Pixantrone Pediatric Investigation Plan (PIP) at CONSOB’s Request.”


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: August 17, 2010   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 August 17, 2010, entitled “Cell Therapeutics Provides Additional Information on Pixantrone Pediatric Investigation Plan (PIP) at CONSOB’s Request.”
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

LOGO   

501 Elliott Ave. W. #400

Seattle, WA 98119

  

T 206.282.7100

F 206.284.6206

Cell Therapeutics Provides Additional Information on

Pixantrone Pediatric Investigation Plan (PIP) at CONSOB’s Request

SEATTLE, August 17, 2010—Cell Therapeutics, Inc. (“CTI” or the “Company”) (NASDAQ and MTA: CTIC) provides the following information at CONSOB’s request pursuant to Article 114, paragraph 5, of the Legislative Decree no. 58/1998.

The validation of the Pediatric Investigation Plan (“PIP”) for pixantrone is part of the PIP assessment process in which the European Medicines Agency (the “EMEA”) reviews the PIP application and verifies that the PIP application is complete and the contents meet the EMEA’s requirements for filing. Following the validation, the EMEA Pediatric Committee (the “PDCO”) will review and comment or approve the contents of PIP. According to the general timeline of the EMEA’s PIP review process, if the EMEA has comments to the PIP, CTI would anticipate receiving them 30 days after the EMEA’s validation of the PIP application. Based on the EMEA’s expected timeline, CTI would then expect the PDCO to reach an opinion 60 days after validation of the PIP application. If the PIP is approved, CTI would then submit the Marketing Authorization Application (“MAA”) for pixantrone to the EMEA. CTI expects to be able to submit the MAA during the second half of 2010.

About 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 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 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 aggressive lymphoma without unacceptable rates of cardiotoxicity.

www.CellTherapeutics.com


Page 2 of 2   PIP Validation Release

 

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 http://www.celltherapeutics.com/.

Sign up for email alerts and get RSS feeds at CTI’s 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 trading price of CTI’s securities. 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 potential failure of pixantrone to prove safe and effective and/or less toxic and effective for the treatment of relapsed or refractory, aggressive NHL and/or other tumors as determined by the EMEA, that the EMEA may not accept the PIP, that CTI cannot guarantee the timing or outcome of PDCO’s opinion or the EMEA’s review of the PIP application or response to CTI, that CTI may not file the MAA later this year, that CTI’s MAA may not be approved by the EMEA by next year, that the current plans for the pediatric program may change, that the pediatric program may not determine the comparative safety and effectiveness of pixantrone compared to doxorubicin in pediatric lymphoid cancers, and CTI’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 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.

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

 

www.CellTherapeutics.com

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-----END PRIVACY-ENHANCED MESSAGE-----