Cell Therapeutics vor Tounaround?
Cell Therapeutics (NASDAQ: CTIC) auf ihre Pixantrone Phase-III-Studie in der 1. Juni. Bei $ 1,23 seine Marktkapitalisierung noch immer zu finden rund $ 560 Millionen. Das kann sich geändert haben durch ein Angebot, aber die 52-Wochen-Bereich wird als $ 0.05 bis $ 6.50. "Die Volatilität ist unser zweiter Name!"
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| Boardmail an "Heron" |
Wertpapier: CTI BioPharma |
Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
ORLANDO, Fla., June 1 /PRNewswire-FirstCall/ -- 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.
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| Boardmail an "al56hg" |
Wertpapier: CTI BioPharma |
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| Boardmail an "al56hg" |
Wertpapier: CTI BioPharma |
da werde ich sagen erstemal eine kleine position aufbauen und zukaufen kannst du immer.
viel glück.
Ich sehe gute Chancen auf 2 Euro (Zeitrahmen Ende 2009).
Das ist aber keine Empfehlung, nur meine eigene bescheidene Meinung.....
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| Boardmail an "al56hg" |
Wertpapier: CTI BioPharma |
Also die 2 Euro sehe ich bereits für nächste Woche..........
Aber leider werd ichs nicht miterleben, da ich ab Sonntag eine Woche Bella Italia besuchen werde............
Overview of 11 peer review publications presented in 'Future Oncology'
SEATTLE, June 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reports a summary of peer reviewed publications spanning preclinical, Phase I and Phase II clinical studies with pixantrone was reviewed in the May 2009 edition of Future Oncology (Volume 5, Issue 4) which is now available on line. The article, "Pixantrone: a promising drug in the treatment of non-Hodgkin lymphomas," was written by Drs. Barry W. Hancock and Loaie M. El-Helw of the Weston Park Hospital, Sheffield UK.
The review focuses on the impressive preclinical anti-tumor activity demonstrated in hematologic cancers over standard anthracyclines and the rational design modifications to the chemical compound believed to be responsible for enhanced DNA damage and binding to topoisomerase II enzyme, a key target for anthracycline mediated tumor death. These modifications are also hypothesized by the authors to underlie the drugs' low cardiotoxicity profile in preclinical animal studies when compared to standard anthracycline drugs.
Five phase I/II studies in which pixantrone was added to standard chemotherapy regimens for treating relapsed aggressive and indolent NHL were also reviewed in the article. Pixantrone, when added to standard multi-agent chemotherapy regimens produced encouragingly high rates of overall response (58-74%) including high rates of complete responses (37-57%). As previously reported, neutropenia was the dose limiting toxicity when used as a single agent.
"In both preclinical and early clinical studies pixantrone exhibited lower cardiac toxicity and better anti-tumor activity than that observed with alternative anthracyclines, as it is devoid of the putative cardiac toxicity generating chemical structure," said Barry W. Hancock, M.D., Professor of Medical Oncology, Weston Park Hospital, Shefield.
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.htm
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 for treatment of relapsed aggressive NHL as determined by the FDA, the failure of pixantrone to have a low cardiotoxicity profile or to produce low cardiac toxicity, the failure of pixantrone to produce high rates of overall response including high rates of complete responses , 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: 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
Date : 06/10/2009 @ 1:30AM
Source : PR Newswire
Stock : (CTIC)
Quote : 1.67 0.0 (0.00%) @ 9:11AM
Overview of Pixantrone Phase III Clinical Data Presentation at American Society of Clinical Oncology 2009 Annual Meeting Now Ava
SEATTLE, June 10 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that a summary of the pixantrone Phase III clinical data that were presented at American Society of Clinical Oncology (ASCO) 2009 Annual Meeting on June 1, 2009 is now available at Clinical Care Options website http://www.clinicaloptions.com/. Clinical Care Options is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs. The ASCO summaries are "quick read" reviews of key oral sessions and poster presentations, which are handpicked by leading experts in oncology and hematology for the Clinical Care Options website.
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/.
Media Contact:
Dan Eramian T: 206.272.4343 C: 206.854.1200 E: 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: http://www.celltherapeutics.com/investors
Medical Information Contact:
T: 800.715.0944 E:
DATASOURCE: Cell Therapeutics, Inc.
CONTACT: Media, Dan Eramian , +1-206-272-4343, cell, +1-206-854-1200,
, or Investors, Ed Bell, +1-206-282-7100, or Lindsey
Jesch Logan, +1-206-272-4347, fax, +1-206-272-4434, , all
of Cell Therapeutics, Inc.
Web Site: http://www.celltherapeutics.com/
http://www.clinicaloptions.com/
On Monday June 15, 2009, 1:30 am EDT
SEATTLE, June 15 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has been included on a list of preliminary additions to the Russell 3000® Index and Russell Global® Index posted by Russell Investments on June 12, 2009 on www.russell.com. Russell Investments will reconstitute its family of U.S. and global equity indexes on June 26, 2009.
"We are pleased to be on the preliminary list for addition to the Russell 3000® Index and Russell Global® Index as we believe it reflects the progress we have made and the potential we have going forward," said James A. Bianco, M.D., CEO of Cell Therapeutics, Inc. "The awareness of CTI among institutional investors and the investment community should increase if CTI is included in the Russell indexes as we continue with our objective to build CTI into a leading biopharmaceutical company."
Annual reconstitution of Russell's U.S. indexes captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization. Membership in the Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. Membership in the Russell Global® Index, which remains in place for one year, means automatic inclusion in the appropriate large-cap, small-cap, all-cap indexes as well as the applicable style, sector and country indexes. Russell determines membership for its equity indexes primarily by objective, market capitalization rankings and style attributes.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. An industry-leading $4 trillion in assets currently are benchmarked to them. These investment tools originated from Russell's multi-manager investment business in the early 1980s when the company saw the need for a more objective, market-driven set of benchmarks in order to evaluate outside investment managers.
About Russell
Russell Investments provides strategic advice, world-class implementation, state-of-the-art performance benchmarks and a range of institutional-quality investment products. Russell had more than $136 billion in assets under management as of March 31, 2009, and serves individual, institutional and advisor clients in more than 40 countries. Founded in 1936, Russell is a subsidiary of The Northwestern Mutual Life Insurance Company.
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