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Cell Therapeutics, Inc., a biopharmaceutical company, develops, acquires, and commercializes oncology products for cancer treatment. Its development portfolio includes Pixantrone, a phase III trial product, for non-Hodgkin’s lymphoma; Brostallicin, which is in first-line Phase II study for the treatment of sarcoma; and OPAXIO, a chemotherapeutic agent for the potential treatment of non-small cell lung, ovarian, and other cancers. It has collaboration and licensing arrangements with Novartis International Pharmaceutical, Ltd.; and PG-TXL Company, L.P. The company was founded in 1991 and is headquartered in Seattle, Washington

SEATTLE, March 1 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee ("ODAC") will review CTI's New Drug Application ("NDA") for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL") on March 22, 2010. The meeting was to take place on February 10, 2010, but the FDA postponed the meeting because of severe weather conditions in the Washington, D.C. area. Following the vote at the rescheduled ODAC meeting, the FDA is expected to make a final decision on approval of CTI's NDA for pixantrone by April 23, 2010.

"Our team is well-prepared to deliver an evidenced-based presentation to the ODAC panel, which we expect will provide a persuasive argument to the clinicians on the panel for the approval of pixantrone," said James A. Bianco, M.D., CEO of CTI. "The ODAC meeting is an important milestone in the review process, and we look forward to discussing the efficacy and safety data for pixantrone with the members of the panel and the FDA review team." Dr. Owen O'Connor, Chief of Hematology Oncology at NYU Cancer Institute, and Dr. John Leonard, Chief of Lymphoma Myeloma at Weill Corner Cancer Center will be presenting on behalf of CTI.

ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. The FDA regulations indicate that although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA.

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 and the trading price of the securities of CTI. 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 as determined by the FDA (including ODAC), that the FDA may postpone the ODAC meeting again, 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

F: 206.272.4434

E: deramian@ctiseattle.com

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: invest@ctiseattle.com

www.celltherapeutics.com/investors

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SEATTLE, March 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that the U.S. Food and Drug Administration ("FDA") has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures the CTI's drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product. CTI has a New Drug Application ("NDA") under review at the FDA for pixantrone to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. As previously announced, the FDA's Oncologic Drugs Advisory Committee ("ODAC") will review the NDA for pixantrone on March 22, 2010 and the FDA is expected to make a final decision on approval by April 23, 2010.

"FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved," said Craig W. Philips, President of CTI.

About Nerviano Medical Sciences (NMS)

Nerviano Medical Sciences is the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.

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/.

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 for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA (including ODAC), that the FDA may postpone the ODAC meeting again, that the FDA may not approve the NDA for pixantrone, 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

F: 206.272.4434

E: deramian@ctiseattle.com

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: invest@ctiseattle.com

www.celltherapeutics.com/investors

SAN DIEGO--(BUSINESS WIRE)--Robbins Umeda LLP has commenced an investigation into possible breaches of fiduciary duty and other violations of state law by certain officers and directors of Cell Therapeutics, Inc. ("Cell Therapeutics" or the "Company") (NASDAQ: CTIC - News). Cell Therapeutics develops, acquires, and commercializes oncology products for the treatment of cancer. The Company was founded in 1991 and is headquartered in Seattle, Washington.

Robbins Umeda LLP's investigation concerns whether the Company's directors and officers caused the Company to issue materially false and misleading statements. Specifically, the investigation will determine whether these directors and officers misrepresented the efficacy and safety of one of the Company's products, Pixantrone.

In addition, certain of Cell Therapeutics' officers and directors may have also failed to ensure that the Company's Pixantrone trials complied with the U.S. Food and Drug Administration's Special Protocol Assessment by which the drug was tested. Possible violations of the special protocol include not enrolling an adequate amount of patients with aggressive non-Hodgkin's lymphoma.

A lawsuit alleging violations of the Securities Exchange Act of 1934 has been filed on behalf of shareholders who purchased or otherwise acquired Cell Therapeutics stock between May 5, 2009 and February 8, 2010, against the Company and certain of its officers. Securities class actions like this can potentially cause additional damage to the Company.

If you purchased your Cell Therapeutics stock prior to May 5, 2009, continue to hold your shares, and would like more information about your rights as a shareholder, please contact attorney Lauren Levi at 800-350-6003 or by e-mail at llevi@robbinsumeda.com.

Robbins Umeda LLP is a California-based law firm, which has significant experience representing investors in shareholder derivative actions, securities fraud class actions, and merger-related shareholder class actions. For more information about the firm, please go to http://www.robbinsumeda.com.

Im glad that we reccomended to our member in chat to dumo this one when the lawsuit news started coming out.

A U.S. Food and Drug Administration advisory panel unanimously recommended against approval of Cell Therapeutics' drug pixantrone, reports said.

The FDA advisory panel, in a 9-0 vote, said "the company's single trial was not adequate to support approval of the drug," according to Reuters.

A spokesman for Seattle-based Cell Therapeutics (NASDAQ: CTIC) was not immediately available for comment.

The FDA does not necessarily have to heed the advisory panel in deciding whether it will approve pixantrone, but the agency often follows panels' recommendations.

Pixantrone is under review by the FDA to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. Cell Therapeutics has said it expects a final FDA decision on approval by April 23.

Earlier this month, an accounting firm said it has “substantial doubt” about Cell Therapeutics’ ability to continue as a going concern. The accounting firm said the biotech firm had "sustained loss from operations over the audit periods, incurred an accumulated deficit, and has substantial monetary liabilities in excess of monetary assets as of Dec. 31, 2009."

GAITHERSBURG, Md., March 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration's (the "FDA") Oncologic Drugs Advisory Committee ("ODAC") panel voted unanimously that clinical trial data was not adequate to support approval of pixantrone for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL"). Currently, there are no approved drugs for patients with relapsed or refractory aggressive NHL that have received two or more prior therapies. Pixantrone would be the first drug approved by the FDA for this indication. The FDA is not bound by the recommendations of its advisory committee and the agency is expected to make a decision whether to approve pixantrone for this use by April 23, 2010.

"We continue to believe that pixantrone should be considered as a treatment option for patients with relapsed/refractory aggressive NHL. There is a significant medical need to bring safe and effective therapies to this very sick patient population," said James A. Bianco, M.D., CEO of CTI. "We are committed to working closely with the FDA to address the committee's comments as quickly as we can."

About Pixantrone

Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.

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 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 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 for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA, 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.

STEVENSON, MD--(Marketwire - 03/24/10) - Brower Piven, A Professional Corporation announces that a class action lawsuit has been commenced in the United States District Court for the Western District of Washington on behalf of purchasers of the common stock of Cell Therapeutics, Inc. ("Cell Therapeutics" or the "Company") (NASDAQ:CTIC - News) during the period between May 5, 2009 and February 8, 2010, inclusive (the "Class Period").

No class has yet been certified in the above action. Members of the Class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. If you wish to choose counsel to represent you and the Class, you must apply to be appointed lead plaintiff no later than May 11, 2010 and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement and how much of a settlement to accept for the Class in the action. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in the Company during the Class Period. You are not required to have sold your shares to seek damages or to serve as a Lead Plaintiff. You may contact Brower Piven (through hoffman@browerpiven.com or 410/415-6616) to answer any questions you may have in that regard.

The complaint accuses the defendants of violations of the Securities Exchange Act of 1934 by virtue of the Company's failure to disclose during the Class Period ) that the Special Protocol Assessment ("SPA") with the United States Food and Drug Administration ("FDA") for pixantrone was invalidated in March 2008 because the Company's pixantrone study enrolled a large number of patients who did not suffer from aggressive non-Hodgkin's lymphoma and that the Company's pixantrone drug was cardiotoxic. According to the complaint, after, on February 8, 2010, the FDA posted its assessment of pixantrone in advance of its February 10, 2010 advisory meeting stating, among other things, that the Company's SPA was invalidated in March 2008 and that the Company's pixantrone study results were not meeting the FDA's standards for approval, the value of Cell Therapeutics shares declined significantly.

If you have suffered a net loss for all transactions in Cell Therapeutics, Inc. common stock during the Class Period, you may obtain additional information about this lawsuit and your ability to become a lead plaintiff by contacting Brower Piven at http://www.browerpiven.com/, by email at hoffman@browerpiven.com, by calling 410/415-6616, or at Brower Piven, A Professional Corporation, 1925 Old Valley Road, Stevenson, Maryland 21153. Attorneys at Brower Piven have combined experience litigating securities and class action cases of over 40 years. If you choose to retain counsel, you may retain Brower Piven without financial obligation or cost to you, or you may retain other counsel of your choice. You need take no action at this time to be a member of the class.

Cell Therapeutics, Inc. Acquires Exclusive Marketing and Co-Development Rights in the Americas to Chroma Therapeutics' Tosedostat - Conference Call



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