-----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, Hn9fmsNhe71UGKuLEJmIw9uj/IWT6RCZXe0bL4vA6llGO16rJ1ExLe4tKnQTCjRk FnCoVC4DjXWgn/EGppKPGg== 0001193125-10-272425.txt : 20101202 0001193125-10-272425.hdr.sgml : 20101202 20101201203840 ACCESSION NUMBER: 0001193125-10-272425 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20101201 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101202 DATE AS OF CHANGE: 20101201 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: 101226051 BUSINESS ADDRESS: STREET 1: 501 ELLIOTT AVE W STREET 2: STE 400 CITY: SEATTLE STATE: WA ZIP: 98119 BUSINESS PHONE: 2062827100 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): December 2, 2010 (December 1, 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.

The following information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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.

On December 1, 2010, Cell Therapeutics, Inc. (the “Company”) announced that it will host an investor and analyst meeting to present new pixantrone data and discuss the Company’s planned PIX306 clinical trial of pixantrone on December 4, 2010 in Orlando, Florida.

A copy of the Company’s press release, entitled “Pixantrone Phase III End of Study Results to be Presented at the 52nd Annual Meeting of the American Society of Hematology” is furnished and not filed pursuant to Item 7.01 as Exhibit 99.1 hereto. Interested parties will be able to view the materials to be presented at the meeting and access the audio webcast (both live and on-demand) by visiting the Company’s website at: http://www.celltherapeutics.com and completing the registration page. The live presentations are scheduled to begin at 12:45 p.m. Eastern time on December 4, 2010. The archived webcast of the presentations will be available commencing at 5:30 p.m. Eastern time on December 4, 2010 on the Company’s website.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

Number

  

Description

99.1    Press Release, dated December 1, 2010, entitled “Pixantrone Phase III End of Study Results to be Presented at the 52nd Annual Meeting of the American Society of Hematology.”


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: December 2, 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 December 1, 2010, entitled “Pixantrone Phase III End of Study Results to be Presented at the 52nd Annual Meeting of the American Society of Hematology.”
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

www.CellTherapeutics.com

Pixantrone Phase III End of Study Results to be Presented at the

52nd Annual Meeting of the American Society of Hematology

Company to Host Investor and Analyst Meeting on Saturday, December 4, 2010

SEATTLE, December 1, 2010 — Cell Therapeutics, Inc. (“CTI”) (Nasdaq and MTA: CTIC) announced today that Ruth Pettengell, M.D. of St. George’s Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial will present end of study results for the pixantrone phase III trial in relapsed/refractory aggressive non-Hodgkin’s lymphoma (“NHL”) at the 52nd Annual Meeting of the American Society of Hematology on Sunday, December 5, 2010 in Orlando, Florida.

The presentation is scheduled for Sunday, December 5, 2010 during the “Lymphoma: Chemotherapy, excluding Pre-Clinical Models” session that will be held from 6:00 p.m.-8:00 p.m. Eastern time. The presentation, abstract #2833, is titled, “Phase 3 Trial of Pixantrone Dimaleate Compared with Other Agents as Third-Line, Single-Agent Treatment of Relapsed Aggressive Non-Hodgkin’s Lymphoma (EXTEND): End of Study Results.” The abstract is available at www.hematology.org.

Investor and Analyst Meeting

Separately, CTI will host an investor and analyst meeting to present new pixantrone data and discuss CTI’s planned PIX306 clinical trial of pixantrone on Saturday, December 4, 2010 in Orlando, Florida.

Speakers at the event will include Ruth Pettengell, M.D., Mitchell Smith, M.D., Ph.D., Director of the Lymphoma Service, Fox Chase Cancer Center in Philadelphia, Pennsylvania, and James A. Bianco, M.D., Chief Executive Officer of CTI. The presentations will begin at 12:45 p.m. Eastern time / 9:45 a.m. Pacific time / 6:45 p.m. Central European time and conclude at approximately 2:00 p.m. Eastern time / 11:00 a.m. Pacific time /8:00 p.m. Central European time. The presentations will be webcast live with slides. Webcast and conference call details are as follows:

Saturday, December 4, 2010

Webcast accessible at www.celltherapeutics.com.


Conference Call Numbers

12:45 p.m. Eastern/ 9:45 a.m. Pacific/6:45 p.m. Central European Time:

1-877-941-2333 (US Participants)

1-480-629-9723 (International)

Call-back numbers for post-listening available at 5:30 p.m. Eastern Time:

1-800-406-7325 (US Participants)

1-303-590-3030 (International)

Passcode: 4390987

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. CTI believes that these structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, CTI believes 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.

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 http://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 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 for the treatment of relapsed or refractory aggressive NHL and/or other tumors as determined by the U.S. Food and Drug Administration (the “FDA”) and/or the European Medicines Agency (the “EMA”), that the FDA may not accept CTI’s proposed design for the protocol of CTI’s PIX306 clinical trial and/or may request additional clinical trials, that if CTI conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that the FDA may not approve CTI’s special protocol assessment for pixantrone, 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 http://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 mailto:invest@ctiseattle.com

www.CellTherapeutics.com/investors

Medical Information Contact:

T: 800.715.0944

E: info@askarm.com

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