3SOF

CTIC - Momentum.......
Cell Therapeutics, Inc. markets lymphoma drug, Zevalin, in the United States.



52wk Range: 0.05 - 9.60
Volume: 44,275,582
Avg Vol (3m): 6,103,500

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
116.57%above 13-day MA
90.12%above 50-day MA
RS Rating: 88  

Fundamentals
Key Data:
Market Cap (M): $38.62  
P/E Ratio: NA  
PEG Ratio: N/A  
Next Earnings: 05/07/2009
Last Analyst Rating: Hold

Profile: 




Cell Therapeutics, Inc.
501 Elliott Avenue West
Suite 400
Seattle, WA 98119
United States - Map
Phone: 206-282-7100
Fax: 206-284-6206
Web Site: http://www.cticseattle.com

DETAILS   
Index Membership: N/A
Sector: Healthcare
Industry: Biotechnology
Full Time Employees: NaN


BUSINESS SUMMARY   
Cell Therapeutics, Inc. markets lymphoma drug, Zevalin, in the United States. Zevalin is an FDA-approved radioimmunotherapeutic for treating lymphoma. The company also develops, acquires, and commercializes novel treatments for cancer. In addition, Cell Therapeutics develops XYOTAX for the treatment of non-small cell lung cancer and ovarian cancer; Pixantrone, a novel compound in the class of drugs known as anthracyclines, for non-Hodgkin's lymphoma; and Brostallicin, which is in first-line Phase II study for the treatment of sarcoma. The company has collaboration and licensing arrangements with Novartis International Pharmaceutical, Ltd. and PG-TXL Company, L.P. It has a joint venture with Spectrum Pharmaceuticals, Inc. to commercialize and develop Zevalin(R) in the United States. The company was founded in 1991 and is headquartered in Seattle, Washington.

CTIC - DD info

Thanks to Justin. CTIC has been on fire today.

Here' some DD from Justin on CTIC:

Here's some links to some of the PR's I looked at before getting in at .08 plus some recent ones, their fiances are tight, but IMO that makes it even better for a buyout Hope these help!

http://www.xconomy.com/seattle/2009/03/16/cell-therapeutics-lead-drug-linked-to-severe-heart-side-effect/

^^The part about NVS having an exclusive offer Pixantrone

http://www.xconomy.com/seattle/2008/11/11/cell-therapeutics-lymphoma-drug-wipes-out-tumors-in-pivotal-trial/

^^ Information on Pixantrone trials and success

http://investors.celltherapeutics.com/phoenix.zhtml?c=92775&p=irol-newsArticle&ID=1249098&highlight=

^^ Phase III trials. 81% survial

"In January 2009, CTI announced that pixantrone met its primary endpoint of progression-free survival (PFS), and 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."

^^ Quote from: http://investors.celltherapeutics.com/phoenix.zhtml?c=92775&p=irol-newsArticle&ID=1260883&highlight=

IMO today (tuesday) is the telling day for CTIC. Depending on the results of the shareholders meeting today will decide a lot of things. If the Revers split gets approved (hoping not!! most have voted no, at least those saying so on boards...) But a reverse split won't affect things to much except increase in share price.

IMO Pixantrone is to "good" for anyone to let fail, that's what makes CTIC so appealing to me I hope this information helps!

Justin

Press Release Source: Cell Therapeutics, Inc.
Cell Therapeutics, Inc. Reports Outcome of Special Meeting of Shareholders
Wednesday March 25, 2009, 1:30 am EDT


SEATTLE, March 25 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) announced today the results from its Special Meeting of Shareholders held on Tuesday, March 24, 2009.

At the meeting, shareholders approved the proposal to increase the number of shares of authorized stock (including an increase in the number of shares of authorized common stock), the proposal to increase the number of shares available for issuance under its 2007 Equity Incentive Plan and the proposal to increase the number of shares available for issuance under its 2007 Employee Purchase Plan. The proposal to allow the Board of Directors to implement a reverse split if and when the Board deems such action appropriate was not approved by the shareholders.

"We appreciate the support of our shareholders as it is important both from an operational and a strategic perspective as we move our products and programs toward approval," said James A. Bianco, M.D., CEO of CTI. "With excellent phase III data for pixantrone for aggressive relapsed non-Hodgkin's lymphoma we plan to complete the New Drug Application (NDA) submission in the second quarter of 2009 and we believe that this product would truly make a significant impact on this difficult to treat patient population. While we now have approval for additional authorized shares, we intend to continue to pursue product partnerships to generate operating capital."

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, our ability to submit an NDA in the first half of 2009 for pixantrone and gain approval in 2009, the potential failure of pixantrone to prove safe and effective for treatment of non-Hodgkin's lymphoma, our ability to identify and negotiate product partnerships, our ability to raise additional capital to fund our continued operations, determinations by regulatory, patent and administrative governmental authorities including but not limited to decisions regarding the review and approval of applications submitted to the FDA or the EMEA, 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:
    Cell Therapeutics, Inc.
    Dan Eramian
    T: 206.272.4343
    C: 206.854.1200
    Lindsey Jesch
    T : 206.272.4347
    F : 206.272.4434
    E: [email protected]
    www.CellTherapeutics.com/press_room

    Investors Contact:
    Cell Therapeutics, Inc.
    Ed Bell
    T: 206.272.4345
    F: 206.272.4434
    E: [email protected]
    www.CellTherapeutics.com/investors

52wk Range: 0.05 - 9.60
Volume: 103,796,730...........
Avg Vol (3m): 7,259,330

Technicals
13-day MA Cross Above 50-day MA....
Most Actives
Percentage Gainer

Last Price Quote is:
395.80%above 13-day MA
445.63%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $38.62 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/07/2009
Last Analyst Rating: Hold

Press Release Source: Cell Therapeutics, Inc.
Genes Identified That Enhance Tumor Cell Sensitivity to CTI's Cancer Drug Brostallicin
Tuesday April 21, 2009, 1:30 am EDT

Identifies potential clinical trial strategies for personalized approach to cancer treatment.

SEATTLE, April 21 /PRNewswire-FirstCall/ -- Systems Medicine, LLC (SM), a wholly-owned subsidiary of Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC), presented data from a preclinical study, which utilized RNA interference (RNAi) and bioinformatics to identify genetic markers - "contexts of vulnerability" - that enhance the anti-tumor response to the experimental drug candidate brostallicin, at the 2009 American Association for Cancer Research (AACR) annual meeting in Denver, Colorado. "Contexts of vulnerability" refers to the genetic configuration in a patient's tumor that makes it susceptible to a specific drug thus providing the genetic rationale for targeted therapy. The study's objective was to identify molecular determinants of brostallicin's anti-tumor response that could guide clinical development and drug combination studies by incorporating an integrated pharmacogenomics approach. The study was conducted by SM in collaboration with the Translational Genomics Research Institute's Pharmaceutical Genomics Division in Scottsdale, Arizona.

"This study has identified certain patient groups which might be more likely to benefit from therapy with brostallicin and have been invaluable in assisting us in identifying promising clinical development strategies for future development of this novel drug candidate," said Jack Singer, M.D., Chief Medical Officer of CTI. "Ultimately, we believe this approach should shorten the clinical development time and increase the success rate by bringing us closer to being able to offer the right drug to the appropriate patient."


Brostallicin is a small-molecule chemotherapeutic agent with a unique mechanism of action -- it binds to the minor grooves located in the DNA double helix. To identify genes associated with cellular response to brostallicin, a high-throughput RNA interference screen was performed in selected ovarian cancer cell lines. RNA interference is a cellular process that results in the targeted knockdown of specific genes. The current screen assayed the effect of over 7,000 individual gene knockdowns, representing the "druggable" genome, on brostallicin response.

The identified genes, representing unique contexts of vulnerability to brostallicin, converged on cellular concepts relating to DNA repair and chromosome modification. These findings were further extended and confirmed in breast cancer cell lines, wherein the knockdown of specific genes involved in these concepts, mentioned above, resulted in an increased response to brostallicin.

To substantiate the brostallicin response observed in the RNAi studies, drugs that target selected genetic targets were tested for synergistic activity in combination with brostallicin. The outcome of this validation work has identified important contexts and rational drug combinations that will be critical for the clinical development of brostallicin.

To review the poster and see more detailed information about the study, please go to http://www.celltherapeutics.com/investor_updates

About Brostallicin

Brostallicin, a novel synthetic second-generation DNA minor groove binder, has shown potent cancer killing activity and has demonstrated synergism in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical experimental tumor models. Brostallicin binds covalently to DNA within the DNA minor groove, interfering with DNA division and leading to tumor cell death. More than 200 patients have been treated with brostallicin in single-agent and combination studies. Brostallicin had predictable and predominantly hematologic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma met its pre-defined activity and safety hurdles and resulted in a first-line phase II study that is currently being conducted by the European Organization for Research and Treatment of Cancer (EORTC).

About Systems Medicine (SM)

In July 2007, CTI acquired Systems Medicine, a privately held oncology company, in a stock-for-stock merger. SM applies a systems biology approach to drug development, combining pharmacogenomics and bioinformatics with experienced preclinical, clinical, and regulatory expertise to find and exploit a specific cancer's 'context of vulnerability.' Specifically, SM defines the molecular and genetic alterations (context) that cause cancer cells to be particularly sensitive (vulnerable) to a drug or combination of drugs--the "context of vulnerability."

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/news_subscription_service

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 brostallicin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with brostallicin in particular, including, without limitation, the potential failure of the preclinical results to predict results in clinical trials, the potential failure of the clinical results to predict the safe and effective treatment of cancer, the potential failure of brostallicin to prove safe and effective for treatment of solid tumors particularly ovarian or colon cancers, determinations by regulatory, patent, and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing, and selling brostallicin, and the risk factors listed or described from time to time in the CTI's filings with the Securities and Exchange Commission including, without limitation, the 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: [email protected]
    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: [email protected]
    www.CellTherapeutics.com/investors

    Medical Information Contact:
    T: 800.715.0944
    E: [email protected]

Cell Therapeutics (CTIC): CTIC recently presented data from a preclinical study that identifies genetic markers for an enhanced anti-cancer effect for brostallicin, which is currently in Phase 2 clinical development as a new type of synthetic cancer drug (a DNA minor groove binding agent) and has the potential to be a highly selective cancer treatment that is synergistic with standard chemo drugs and newer targeted therapies. CTIC owns the exclusive, worldwide rights to brostallicin and has completed six clinical trials for the drug, with results for three of the trials still pending.
CTIC has agreements with Novartis (NVS) for both pixantrone and Opaxio which provide for $17.5M in potential pixantrone milestone payments ($7.5M licensing option for NVS + $10M approval milestone payment for pixantrone) and $25M for an Opaxio approval milestone in Europe. The Company expects to receive an opinion on the Marketing Authorization Application for Opaxio in Europe during 2H09 and recently initiated a rolling NDA submission with the FDA for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTIC expects to complete the submission during 2Q09 and will request a priority review (six month) that could lead to an approval decision from the FDA before year-end.


52wk Range: 0.05 - 8.50
Volume: 48,998,479
Avg Vol (3m): 14,138,200

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
19.40%above 13-day MA
58.26%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $98.26 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/07/2009
Last Analyst Rating: Hold

Press Release Source: Cell Therapeutics, Inc.
Pixantrone Now Available in Europe on a Named-Patient Basis
On Tuesday May 5, 2009, 1:30 am EDT

Cell Therapeutics and IDIS Partner to Accelerate Patient Access to Pixantrone through Program

SEATTLE, May 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced that pixantrone is now available on a named-patient basis in Europe. Pixantrone will be supplied by IDIS to healthcare professionals for the treatment of individual patients with aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed after standard therapies or is refractory to them. We know of no therapy that has previously been shown to be effective treatment for such patients.

"CTI has worked hard to make pixantrone available in Europe at the prescriber's request as it provides an option for these difficult to treat aggressive NHL patients," noted Craig Philips, President of CTI. "We continue to work toward potential approval of pixantrone at the end of 2009 in the United States and expect to complete the submission of the New Drug Application to the Food & Drug Administration this quarter."

"Our experience with pixantrone has been positive with patients achieving a complete response where such a result was not achievable with other treatments," said Prof. Pier Luigi Zinzani, M.D., Institute of Hematology and Oncology, University of Bologna. "I am pleased that it is now available on a named-patient basis as it has the potential to address a significant unmet need in this heavily pretreated patient population."

A named-patient program is a compassionate use drug supply program under which physicians can legally supply investigational drugs to qualifying patients. Under a named-patient program, investigational drugs can be administered to patients who are suffering from serious illnesses prior to the drug being approved by the European Medicines Evaluation Agency. "Named-patient" distribution refers to the distribution or sale of a product to a specific healthcare professional for the treatment of an individual patient. In Europe, under the named-patient program the drug is most often purchased through the national health system.

Contact Information for Program:

Licensed healthcare professionals in Europe treating individual patients with relapsing or refractory aggressive non-Hodgkin's lymphoma interested in pixantrone should contact:


    IDIS Limited
    Tel: +44 (0) 1932 824 123
    Fax: +44 (0) 1932 824 323
    Email: [email protected]

    Additionally, more information can be found at
    http://www.celltherapeutics.com/pixantrone_europe

About Pixantrone

Pixantrone (BBR 2778), is a novel major groove binder 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. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities without sacrificing anti-cancer activity. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.

About IDIS

IDIS is the world leader in the development and implementation of named-patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. IDIS supports customers in over 100 countries, supplying more than 400 different medicines per month and responding to more than half a million requests on a named-patient basis to medical professionals worldwide. For more information on IDIS please visit their website at http://www.idispharma.com.

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. 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 failure to receive anticipated number of requests for pixantrone to treat specific patients, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the possibility that the New Drug Application submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 2009, 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

•Cell Therapeutics, Inc. (CTI) to Report 2009 First Quarter Financial Results on May 7

SEATTLE, May 5 /PRNewswire-FirstCall/ -- On Thursday, May 7, 2009, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of Cell Therapeutics, Inc.'s (CTI) (Nasdaq and MTA: CTIC) management team will host a conference call to discuss the Company's 2009 first quarter achievements and financial results.

Conference Call Numbers
        Thursday, May 7
        8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
        1-888-561-1799 (US Participants)
        1-480-629-9867 (International)

        Call-back numbers for post-listening available at 11:30 a.m. Eastern:
        1-800-406-7325 (US Participants)
        1 303 590 3030 (International)
        Passcode: 4066143#


Live audio webcast at http://www.celltherapeutics.com will be archived for post listening approximately two hours after call ends.

Cell Therapeutics (NASDAQ:CTIC) announced today that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed or is refractory to standard treatment options. On 4/14/09, CTIC began a rolling submission of a NDA to the FDA for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTI expects to complete the submission during 2Q09 and will request priority review (six month) which if granted could lead to an approval decision from the agency during 4Q09.

Busted through the 200-day MA.......
Great run today... Hope a better one  tomorrow!
Europe will drive it up.Pixantrone being used is a HUGE buy signal if I ever saw one.

52wk Range: 0.05 - 7.20
Volume: 162,805,548 ... 
Avg Vol (3m): 15,628,100

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
191.32%above 13-day MA
308.31%above 50-day MA
RS Rating: 99 

Fundamentals
Earnings Expected on May 7

Key Data:
Market Cap (M): $154.16 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/07/2009
Last Analyst Rating: Hold

Alert...CTIC - Earnings Watch...

CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.

Place it on a watch list and watch its movement.
Then the story will unfold before your eyes...
Your list lets you know whats hot and whats not
The making of your $$$....

buy on the pullbacks...


52wk Range: 0.05 - 6.90
Volume: 95,218,079
Avg Vol (3m): 19,666,700

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
95.56%above 13-day EMA
261.22%above 50-day EMA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $531.21 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/17/2009
Last Analyst Rating: Hold

The Golden Cross!
Deja Vu....... base built for another launch
Ready for some more... Way more buying going on right now than selling.
Friday was a strong day...Very Strong!
Great support @ $1.50

52wk Range: 0.05 - 6.40
Volume: 44,874,727
Avg Vol (3m): 26,027,500

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
21.94%above 13-day MA
90.29%above 50-day MA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $660.55 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/17/2009
Last Analyst Rating: Hold

ORLANDO, Fla., June 1, 2009 /PRNewswire-FirstCall via COMTEX/ -- Intent to treat Analysis results per FDA agreed upon Statistical Analysis Plan


 
    --  Significant Increase in Complete Remission Rates 20% vs. 5.7%; p=0.021 
    --  Significant Increase in Overall Response Rate 37.1% vs. 14.3%; p=0.003 
    --  Significant increase in percent of all patients whose response lasted 
        greater than or equal to four months 25.7% vs. 8.6%; p=0.012 
    --  Significant Increase in Progression Free Survival 4.7 months vs. 2.6 
        months; p=0.007 
    --  Positive trend in Overall Survival even though data not fully mature 
        with median 8.1 month vs. 6.9 month; p=0.544 

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that at the 2009 American Society for Clinical Oncology ("ASCO") Annual Meeting for the first time since the top-line data were released, complete pivotal phase III results of CTI's EXTEND (PIX 301) clinical trial of pixantrone (the "PIX 301 EXTEND trial") in relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") were presented by Principal Investigator, Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial who presented the study at ASCO.

"Anthracycline-related drugs can be effective salvage agents in aggressive NHL, but our use of them is limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs," said Dr. Pettengell. "These results represent a breakthrough in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naive patients as a potential alternative to currently available standard anthracycline drugs."

The PIX 301 EXTEND (Expanding the reach of antrhacyclines with piXanTronE in relapsed or refractory aggressive NHL Disease) trial was a phase III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL 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.

In the PIX 301 EXTEND trial 57% of the randomized patients were refractory to prior treatments with 50% of patients having failed three prior chemotherapy treatments. More than 70% of the patients on both arms were considered intermediate to high risk by the International Prognostic Index score (>=2). The median prior doxorubicin equivalent dose was approximately 300 mg/m2, the dose that is associated with six cycles of CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy, the standard of care for first line therapy in this disease. Fifty-three percent of pixantrone patients received four or more cycles of therapy compared to a median of three cycles in the comparator arm. The median doxorubicin equivalent dose at the end of therapy was 513 mg/m2 (with a range of 115 mg/m2 to 1003mg/m2). Data from repeated evaluations of Left Ventricular Ejection Fraction ("LVEF") by MUGA (Multi Gated Acquisition Scan) scan demonstrated no consistent dose related decline as has been described for doxorubicin with median LVEF values at a baseline of 58% and at the end of treatment of 59%. Consistent across the primary and subgroup analyses, treatment with pixantrone resulted in superior clinical benefits over standard of care chemotherapy treatment.

"We are pleased that the PIX 301 EXTEND trial of pixantrone demonstrated a long-lasting clinical benefit in this heavily pretreated relapsed/refractory group of patients with aggressive NHL and look forward to completing the New Drug Application submission later this month," said James A. Bianco, M.D., Chief Executive Officer of CTI. "Given the lack of approved therapies for this resistant group of patients with aggressive NHL, we believe pixantrone offers a valuable therapy for this unmet medical need."

The most common grade 3, 4 adverse event observed on the pixantrone arm was neutropenia in 41.2% of patients versus 19.4% on the comparator arm. However, the incidence of grade 3, 4 febrile neutropenia was only 7.4% versus 3.0% in the comparator arm. Grade 3, 4 infections had a similar incidence in both study arms (18% vs. 13%). Although the grade 3, 4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a slightly higher incidence of serious cardiac disorders in patients treated with pixantrone than among patients who received comparator agents (8.8% vs. 4.5%). Events considered cardiac disorders included cardiac arrest, congestive heart failure, myocardial infarction, cyanosis, pericardial effusion, and tachycardia.

The ASCO poster is available at http://www.celltherapeutics.com/investor_updates.

In April 2009, CTI began a rolling submission of a New Drug Application ("NDA") with the U.S. Food and Drug Administration (the "FDA") for pixantrone to treat relapsed or refractory aggressive NHL. CTI expects to complete the submission this month and will request priority review which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009.

Pixantrone is also now available in Europe on a named patient basis.

About Pixantrone

Pixantrone (BBR 2778), is a novel major groove binder 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 www.CellTherapeutics.com.

Sign up for email alerts and get RSS feeds at our Web site, http://www.celltherapeutics.com/investors_news

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 potential failure of pixantrone to prove safe and effective (or increase remission rates or progress free survival) for treatment of relapsed or refractory aggressive NHL as determined by the FDA, the possibility that the NDA submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 2009, 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, 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: 206.282.7100 
    Lindsey Jesch 
    T: 206.272.4347 
    F: 206.272.4434 
    E: [email protected] 
    www.CellTherapeutics.com/investors 
    Medical Information Contact: 
    T: 800.715.0944 
    E: [email protected] 

SOURCE Cell Therapeutics, Inc.



http://www.celltherapeutics.com 

Copyright (C) 2009 PR Newswire. All rights reserved