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New Pixantrone Data Presented during Meetings during American Society of Hematology Conference

December 6, 2010

Posted on: Monday, 6 Dec 2010, 00:30 CST

SEATTLE, Dec. 6, 2010 /PRNewswire-FirstCall/ — Cell Therapeutics, Inc. (“the Company”) (Nasdaq and MTA: CTIC) now announced new pixantrone finish of investigate (“EOS”) follow adult formula from a Company’s pivotal proviso III PIX301 trial, that formula form a basement for a Company’s new Marketing Authorization Application (the “MAA”) now underneath examination by a European Medicines Agency (“EMA”).

The end-of-study formula showed continued alleviation in a trial’s primary and delegate endpoints with increasing statistical certainty around a endpoint results. At EOS, CR/CRu (Complete Response (“CR”)/Complete Response unconfirmed) rate increasing to 24% in a pixantrone arm compared to 7% among comparator recipients (p=0.009) while ORR (Overall Response Rate) increasing to 40% contra 14% for comparator recipients (p=0.001). The median era of CR/CRu was 9.6 months for a pixantrone organisation compared to 4.0 months for a comparator group. Pixantrone patients gifted a 40% rebate in a risk of genocide or course over a dual year investigate regard and follow adult duration compared to customary chemotherapy (p=0.005, HR=0.60) and a 21% rebate in a altogether risk for failing (p= 0.25, HR =0.79). The many common category 3, 4 inauspicious eventuality celebrated on a pixantrone arm was neutropenia in 41.2% of patients contra 19.4% on a comparator arm. However, a occurrence of critical infections was allied between arms. Deaths due to an inauspicious eventuality were matching between both arms; there were some-more LVEF reductions in pixantrone arm, however usually dual were category 3 and all were asymptomatic. The formula were presented by Principal Investigator, Ruth Pettengell, M.D. of St. George’s Hospital, University of London, a lead questioner for a proviso III PIX301 EXTEND trial.

“The finish of investigate formula strengthen a certainty and fortitude opposite a primary and delegate measures of efficacy,” remarkable Dr. Pettengell. “The bulk of finish and durable responses and PFS demonstrated by pixantrone are now not practicable regulating customary of care and we would acquire a event to implement this new drug for a benefit of a patients.”

The print from a conference is accessible during www.celltherapeutics.com/investor_updates.

To denote that a sip and report employed in a PIX301 hearing and due for a follow on PIX306 study, is an suitable sip and exposure for maximizing efficiency while minimizing side effects, a Company had an consultant pharmacokinetic exposure reserve and efficiency research conducted on information from all of a proviso I, II and III trials including relapsed adverse patients with plain growth malignancies. At an financier assembly during ASH those information were presented demonstrating that a sip of pixantrone used in PIX301 and due for PIX306 is an suitable sip demonstrating a poignant association between exposure to pixantrone and extended anti-tumor response (Progression-Free Survival (“PFS”)) while minimizing a risk for side effects (neutropenia). The PIX306 hearing is now designed to be a randomized, single-blind investigate comparing pixantrone + rituximab to multiple gemcitabine + rituximab in patients with relapsed or adverse assertive B-cell non-Hodgkin’s lymphoma (“NHL”) who are not possibilities for myeloablative chemotherapy and branch dungeon transplant.

A outline standing refurbish on a PIX203 front line hearing of CPOP-rituximab contra CHOP-rituximab in high risk and aged DLBCL was also presented during an questioner assembly during ASH. Given that median PFS has not nonetheless been reached for a CPOP-R arm and a median OS has not nonetheless been reached for both treatment arms a Company usually supposing a brief refurbish on studious demographics, while summarizing pivotal efficiency and reserve endpoints of a study. The Company anticipates submitting a PIX203 information for display during systematic meetings once a presence and PFS information are mature. The outline refurbish presented during ASH assembly is accessible for observation on a Company’s website www.celltherapeutics.com.

About a PIX301 EXTEND trial: PIX301 is a largest and usually randomized hearing comparing singular representative pixantrone to a list of physician’s choice of customary chemotherapy to patients with relapsed or adverse assertive NHL who have unsuccessful dual or some-more lines of therapy. There are now no authorized or effective agents for these patients. The successful PIX301 investigate formula shaped a basement of a Company’s new MAA acquiescence to a EMA that was certified and supposed for examination on Nov 17th, 2010.

In further on Dec 2, 2010 a Company filed a grave interest with a U.S. Food and Drug Administration (the “FDA”) underneath a FDA’s brawl fortitude proceedings. The basement for a interest is formed on a Company’s faith that a FDA diverged from supposed statistical beliefs and practices when a FDA practical a some-more difficult statistical stress turn in final that a PIX301 primary research compulsory an composition for form 1 blunder as if an halt research had been conducted. This was not a box in a PIX301 hearing where usually a singular final research was undertaken. The Company expects to have a response to a interest in a initial entertain of 2011.

About PIX203 hearing design: The PIX203 hearing is a first-line randomized proviso II investigate of a CHOP-R contra CPOP-R in high risk and aged patients with formerly untreated DLBCL The investigate evaluates replacing doxorubicin in a customary CHOP-R multiple fast with pixantrone as partial of a CPOP-R regimen. The pattern of a investigate was to denote non-inferior finish response rates to customary doxorubicin-based therapy while producing significantly reduction serious strident and ongoing cardiac toxicities. The Company skeleton to contention a formula of this investigate for display during systematic meetings once median presence is reached in both treatment arms, to date median PFS has not nonetheless been reached in a CPOP-R arm.

About Pixantrone

Pixantrone is a novel aza-anthracenedione that has graphic constructional and physio-chemical properties that make a anti-tumor activity singular in this category of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II though distinct anthracyclines–rather than intercalation with DNA–pixantrone alkylates DNA–forming fast DNA adducts, with sold specificity for CpG rich, hyper-methylated sites. The Company believes that these constructional differences resulted in significantly extended anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, a Company believes a constructional motifs on anthracycline-like agents that are obliged for a era of oxygen giveaway radicals and a arrangement of poisonous drug-metal complexes have also been mutated in pixantrone to forestall a contracting of iron and duration of superoxide production–both of that are a putative resource for anthracycline prompted strident cardiotoxicity. These novel pharmacologic differences might concede re-introduction of anthracycline like intensity in a treatment of relapsed/refractory assertive lymphoma but unsuitable rates of cardiotoxicity.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical association committed to building an integrated portfolio of oncology products directed during creation cancer some-more treatable. For additional information, greatfully revisit www.CellTherapeutics.com.

Sign adult for email alerts and get RSS feeds during a Web site, http://www.CellTherapeutics.com/investors_alert

This press recover includes forward-looking statements that engage a series of risks and uncertainties, a outcome of that could materially and/or adversely impact tangible destiny formula and a marketplace price of a Company’s securities. Specifically, a risks and uncertainties that could impact a growth of pixantrone embody risks compared with preclinical and clinical developments in a biopharmaceutical attention in general, and with pixantrone in particular, including, but limitation, a intensity disaster of pixantrone to infer protected and effective for a treatment of relapsed or adverse assertive NHL and/or other tumors as dynamic by a FDA and/or a EMA, that a FDA might not accept a Company’s due pattern for a custom of a Company’s PIX306 clinical hearing and/or might ask additional clinical trials, that if a Company conducts an additional clinical trial, it might not denote a reserve and efficacy of pixantrone, that a Company can't envision or pledge a gait or embankment of enrollment of a clinical trials, that a Company can't pledge when it will trigger a new clinical hearing for pixantrone, that a FDA might not approve a Company’s special custom assessment, that a Company can't envision a outcome of a interest to a FDA, that a Company’s interest might not be successful, that a EMA might not approve a Company’s MAA after review, a Company’s ability to continue to lift collateral as indispensable to account a operations, rival factors, technological developments, costs of developing, producing and offered pixantrone, and a risk factors listed or described from time to time in a Company’s filings with a Securities and Exchange Commission including, but limitation, a Company’s many new filings on Forms 10-K, 10-Q and 8-K. Except as might be compulsory by law, a Company does not intend to refurbish or change a forward-looking statements either as a outcome of new information, destiny 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

SOURCE Cell Therapeutics, Inc.

Source: PR Newswire

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