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[Pitti72]

Press Release Source: Cell Therapeutics, Inc.


Cell Therapeutics, Inc. Closes $37.2 Million Offering
Thursday April 19, 7:00 am ET


SEATTLE, April 19 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) today confirmed that it has received approximately $37.2 million from the sale of 3% Convertible Preferred Stock and warrants in a previously announced registered offering to several institutional investors. CTI sold 37,200 shares of Series B convertible preferred stock, together with warrants, at a negotiated price of $1,000 per share of convertible preferred stock. The Preferred Stock is convertible into 5,527,488 shares of common stock, at a conversion price of $6.73. The Company also issued warrants to purchase up to 2,763,731 shares of common stock, with an exercise price of $6.48 per share.

[carpiediem]

Hallo Pitti,

schön dass du den Thread eröffnet hast.
Gibt es fundamentale Gründe für eine positive Zukunft?
Kaufe Aktien nur nach dem Chart.
Man kann es kaum glauben , hatte bei Cell ein falsches Zeitfenster und zu schnell geordert. Dann noch das geringe Handelsvolumen .
Welchen Vorteil sieht die Firma durch den Splitt?
Nach unten ist nun wieder viel Platz.
Mal sehen! Biotecs sind ein heißes Eisen!

Grüße carpe

[enkelchen]

Antwort auf Beitrag Nr.: 28.908.281 von carpiediem am 19.04.07 21:51:05

Dear Mr. xxx



XYOTAX

- NSCLC (non-small cell lung cancer): we are going to start PGT307 and/or PGT306 (depending on Novartis cost sharing), phase III clinical trial on women with normal estrogen levels. Interim results are planned mid 2008 for PGT307 and 2nd half 2008 for PGT306.

- Ovarian cancer: phase III maintenance trial (GOG212). Targeted interim analysis: 2nd half 2008.



Pixantrone

- Aggressive non-Hodgkin's lymphoma (NHL): PIX301, phase III clinical trial (EXTEND) with pixantrone as single agent, 3rd line. Interim analysis: summer 2007.

- Aggressive NHL: PIX203, phase II clinical trial (RAPID) with pixantrone in combination, 1st line. Interim analysis: fall 2007.

- Indolent NHL: we are going to start a phase III clinical trial, with pixantrone combined with fludarabine, dexamethasone and rituximab, 2nd line. Initial results are targeted for the 2nd half 2008.



Nearest results are therefore for the EXTEND trial (summer 2007) and for the RAPID trial (fall 2007) of pixantrone.



Please let me know if you need further information.

Kindest regards.





Elena Murador

Investor Relations & Communication



Cell Therapeutics Europe S.r.l.

Via L. Ariosto, 23

20091 Bresso (MI) - Italy

T [phone]

F [phone]

[e-mail]

www.cticseattle.com

[carpiediem]

Antwort auf Beitrag Nr.: 28.908.797 von enkelchen am 19.04.07 22:21:52

Thanks,

dann hoffen wir mal auf einen guten Sommer 2007!

[GuHu1]

Also gut dann wollen wir mal die news hier reinstellen.
wobi so new ist das auch nicht.

Cell Therapeutics, Inc. (CTI) Announces XYOTAX(TM) Has Fast Track Designation for Women With Advanced Lung Cancer Who Are Performance Status 2 (PS2)

SEATTLE, April 11 /PRNewswire-FirstCall/ -- Cell Therapeutics, (Nachrichten) Inc. (CTI) (Nasdaq: CTIC; MTAX) announced today that XYOTAX, a novel biologically- enhanced version of one of the most used cancer drugs, Taxol(R), qualifies for fast track designation for the treatment of PS2 (poor performance status) women with first-line advanced non-small cell lung cancer (NSCLC). The Company recently filed a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA) for the design of its phase III trial of XYOTAX for women with advanced NSCLC. The trial, PGT306, will focus exclusively on women with normal estrogen levels, the subset where XYOTAX demonstrated the greatest survival advantage in the STELLAR trials. The trial is expected to enroll 300 poor performance status (PS2) women who have advanced stage non- small cell lung cancer (NSCLC) and have not received prior chemotherapy. Only women with normal estrogen levels either as a result of pre-menopausal age or hormone replacement therapy will be randomized in the trial.

Fast track designation was initially granted on June 11, 2003 for XYOTAX for NSCLC PS2 patients (male and female). Confirmation from the FDA was obtained on January 24, 2006 that the existing fast track designation encompasses the treatment of female patients with advanced NSCLC with PS2. Fast track designation was granted because NSCLC in PS2 patients is incurable with available therapy offering only modest benefit, and XYOTAX has the potential to demonstrate improvement over available therapy in these patients.

"We also submitted a SPA to the FDA for PGT307, a phase III trial of combination therapy for women with advanced lung cancer. The trial will study XYOTAX in combination with carboplatin versus paclitaxel/carboplatin in female NSCLC patients with performance status of 0, 1 or 2," said James A. Bianco, M.D., President and CEO of CTI. "Pending FDA feedback, we anticipate that one or both of these trials would begin enrollment in the second quarter of 2007 with a targeted interim analysis in the first half of 2008."

Fast Track Designation

Fast track designation means the FDA will facilitate and expedite the development and review of the application for the approval of a new drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need. An expedited review as defined by the FDA user fee performance goals provides for a review within six months.

About XYOTAX

XYOTAX(TM) (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that XYOTAX metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.

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.cticseattle.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 XYOTAX include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX in particular including, without limitation, the potential failure of XYOTAX to prove safe and effective for treatment of non-small cell lung cancer, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX, 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 Italian law, CTI is under no obligation to (and expressly disclaims any such obligation 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 Susan Callahan T: 206.272.4472 F: 206.272.4434 E: [e-mail] http://www.cticseattle.com/media.htm Investors Contact: Cell Therapeutics, Inc. Leah Grant T: 206.282.7100 F: 206.272.4434 E: [e-mail] http://www.cticseattle.com/investors.htm

[grafbibi]

Antwort auf Beitrag Nr.: 28.989.134 von GuHu1 am 25.04.07 14:37:09

Nur zur Info



Press Release Source: Cell Therapeutics, Inc.


Cell Therapeutics, Inc. to Report 2007 Fourth Quarter Financial Results on May 2
Friday April 27, 7:00 am ET


SEATTLE, April 27 /PRNewswire-FirstCall/ -- On Wednesday, May 2, 2007, at 5:30 a.m. Pacific/8:30 a.m. Eastern/2:30 p.m. Central European Time members of Cell Therapeutics, Inc.'s (CTI) (Nasdaq: CTICD; MTAX: CTIC) management team will host a quarterly conference call to discuss the company's 2007 first quarter achievements and financial results.

Conference Call Numbers
Wednesday, May 2
5:30 a.m. Pacific/8:30 a.m. Eastern/2:30 p.m. Central European
1- 800-257-2101 (US Participants)
1- 303-262-2131 (International)

Live audio webcast at
www.cticseattle.com
will be archived for post listening
approximately two hours after call ends

Call-back numbers for post-listening available at 10:30 AM ET:
1- 800-405-2236 (US Participants)
1- 303-590-3000 (International)
Passcode: 11089224#

Media Contact:
Cell Therapeutics, Inc.
Dan Eramian
T: 206.272.4343
C: 206.854.1200
Susan Callahan
T: 206.272.4472
F: 206.272.4434
E: [e-mail]
www.cticseattle.com/media.htm

Investors Contact:
Cell Therapeutics, Inc.
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: [e-mail]
www.cticseattle.com/investors.htm

[Pitti72]

SEATTLE, am 27. April/PRNewswire-FirstCall/-am Mittwoch, dem 2. Mai 2007, um 5 Uhr 30. Pacific/8:30 vormittags. Eastern/2:30 nachmittags Mitglieder der Mitteleuropäischen Zeit von .'s von Cell Therapeutics, Inc (CTI) (Nasdaq: CTICD; MTAX: CTIC) Management-Team wird ein vierteljährliches Konferenzgespräch veranstalten, um 2007 der Gesellschaft die ersten Viertel-Ergebnisse und Finanzergebnisse zu besprechen.

Schönes langes Wochenende Euch

Pitti

[grafbibi]

Antwort auf Beitrag Nr.: 29.029.223 von grafbibi am 27.04.07 13:11:27

Nur zur Info !!!!

Anruf-Details
Zelle Therapeutik-Einkommen-Konferenz-Anruf (Q1 2007)
Festgelegt, um Wed, Mai 2, 2007, 8:30 morgens zu beginnen östlich
Überprüfen Sie zurück zur zeitlich geplanten Anlaßzeit für
die Sprechverbindung, zum in diesem Punkt zu erscheinen.
Fügen Sie Diesen Fall Ihrem Yahoo Hinzu! Kalender




Nachdem der Fall beendet hat, ist der Audio vorhanden
von dieser Seite, bis gesessen, Mai 3, 2008





Über Zelle Therapeutik (NasdaqGM:CTICD)

Cell Therapeutics, Inc. engagiert sich in der Entwicklung, im Erwerb und in der Kommerzialisierung der Behandlungen für Krebs. Die Firma bietet XYOTAX, ein Phase III klinisches chemotherapeutisches Probemittel an, das Anti- Krebs Mittel benanntes paclitaxel mit einem Polyglutamatpolymer-Plastik für die Behandlung des nicht-kleinen Zelle Lungenkrebses und der ovarian Krebse in den Frauen verbindet. Es liefert auch XYOTAX, ein Phase I klinisches Probeprodukt für die Behandlung der esophageal und gastrischen Krebse in den Frauen. Zusätzlich bietet die Firma pixantrone, eine Phase III klinische Probeanthracycline Ableitung für die Behandlung des Lymphoms der non-Hodgkins an; und CT-2106, ein Phase II Polyglutamat-camptothecin Molekül für die Behandlung der zurückgefallenen colorectal und ovarian Krebse. Die Firma arbeitet auch auf verschiedenen Drogezielen, einschließlich bisplatinum Mittel, Hemmnissen HIF-1/p300 und proteasome Hemmnissen mit indirekten Hemmungeigenschaften. Zelle Therapeutik hat Zusammenarbeit und genehmigende Vorbereitungen mit Novartis internationalem pharmazeutischem, Ltd.; PharmaBio Entwicklung; Nippon Shinyaku Co., Ltd.; Nippon Shinyaku Co., Ltd.; und PG-TXL Company, L.P. The Firma wurde 1991 gegründet und wird in Seattle, Washington gehabt.

[grafbibi]

Antwort auf Beitrag Nr.: 29.036.863 von grafbibi am 27.04.07 22:09:07

Original !!! Nur zur Info !!

Call Details
Cell Therapeutics Earnings Conference Call (Q1 2007)
Scheduled to start Wed, May 2, 2007, 8:30 am Eastern
Check back at the scheduled start time for
the audio link to appear in this spot.
Add This Event To Your Yahoo! Calendar




After the event has finished, the audio will be available
from this page until Sat, May 3, 2008





About Cell Therapeutics (NasdaqGM:CTICD)

Cell Therapeutics, Inc. engages in the development, acquisition, and commercialization of treatments for cancer. The company offers XYOTAX, a Phase III clinical trial chemotherapeutic agent, which links anti cancer agent called paclitaxel to a polyglutamate polymer for the treatment of non-small cell lung cancer and ovarian cancers in females. It also provides XYOTAX, a Phase I clinical trial product for the treatment of esophageal and gastric cancers in females. In addition, the company offers pixantrone, a Phase III clinical trial anthracycline derivative for the treatment of non-Hodgkin’s lymphoma; and CT-2106, a Phase II polyglutamate-camptothecin molecule for the treatment of relapsed colorectal and ovarian cancers. The company is also working on various drug targets, including bisplatinum agents, HIF-1/p300 inhibitors, and proteasome inhibitors with indirect inhibition properties. Cell Therapeutics has collaboration and licensing arrangements with Novartis International Pharmaceutical, Ltd.; PharmaBio Development; Nippon Shinyaku Co., Ltd.; Nippon Shinyaku Co., Ltd.; and PG-TXL Company, L.P. The company was founded in 1991 and is headquartered in Seattle, Washington.

[grafbibi]

Antwort auf Beitrag Nr.: 29.036.888 von grafbibi am 27.04.07 22:11:31

Nur zur Info



Press Release Source: Cell Therapeutics, Inc.


Cell Therapeutics, Inc. (CTI) Announces First Quarter 2007 Financial Results
Wednesday May 2, 7:00 am ET


SEATTLE, May 2 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTICD; MTAX: CTIC) reported financial results for the quarter ended March 31, 2007. Total operating expenses for the quarter totaled $23.6 million compared to $26.5 million for the comparable period in 2006. Net loss attributable to common shareholders for the quarter totaled $28.7 million ($0.76 per share) versus a net loss attributable to common shareholders of $51.9 million ($2.31 per share) for the quarter ended March 31, 2006. The Company ended the quarter with approximately $48.7 million in cash and cash equivalents, securities available-for-sale, and interest receivable, before taking into account gross proceeds of $37.2 million received from the recent convertible preferred stock and warrants offering and payment of a $10.6 million settlement expense in April 2007.
ADVERTISEMENT


"CTI is focused on re-entering the blood-related cancer market. The Company will look at acquiring one or more near-term products that could re- establish our commercial efforts in anticipation of a potential pixantrone NDA in 2008, depending on interim results from our pivotal trial later this year," said James A. Bianco, M.D., President and CEO of CTI. "With the planned expansion of pixantrone pivotal studies into indolent NHL, the initiation of a gender-specific trial in lung cancer with XYOTAX, and the exciting prospects of Aequus and our preclinical programs, 2007 promises to be a very exciting year for repositioning the Company for growth."

Recent Highlights

-- Raised approximately $57.2 million ($20.0 million and $37.2 million gross proceeds) from two convertible preferred stock and warrant offerings

-- Announced plans to form a new spin-off company, Aequus BioPharma, Inc. to develop a Genetic Polymer(TM) technology that was created at CTI to speed the manufacture, development and commercialization of novel biopharmaceuticals including follow-on biologics and siRNA

-- Submitted a protocol under Special Protocol Assessment ("SPA") guidelines to the U.S. Food and Drug Administration ("FDA") for a pivotal clinical trial, known as PIX303, for pixantrone combination chemotherapy in patients with indolent non-Hodgkin's lymphoma (NHL)

-- Submitted protocols under SPA guidelines to FDA for two pivotal clinical trials, known as PGT306 and PGT307, for XYOTAX(TM) (paclitaxel poliglumex) in women with lung cancer who have not received prior chemotherapy

-- Reported on preliminary results in an investigator-sponsored phase II study of XYOTAX(TM) in patients with taxane-resistant androgen independent prostate cancer showing 'encouraging' major responses, which were presented at a medical conference in February

-- Effected a one-for-four reverse stock split of common stock in an attempt to bring the capital structure and balance sheet in line with other pre-commercial stage companies and make the stock more available to a wider cross section of institutional fund investors

-- Received approval in a special meeting of shareholders to amend and restate the Company's articles of incorporation to increase the number of authorized shares; the current authorized shares are 100 million of common stock and 10 million of preferred stock

-- Settled government claims, arising from an investigation dating to 2004, of allegations regarding alleged overpayments by Medicare to doctors who prescribed the anti-cancer drug, TRISENOX, with a full release from liability and no admission of wrongdoing by CTI; CTI filed suit against the Lash Group alleging that it provided CTI negligent professional advice about Medicare reimbursements which created this liability.

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.cticseattle.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 forward- looking statements contained in this press release include statements about future financial and operating results and risks and uncertainties that could affect the development of CTI's products under development, including XYOTAX and pixantrone. These risks include, but are not limited to, preclinical, clinical, and sales and marketing developments in the biopharmaceutical industry in general and in particular including, without limitation, the enrollment and completion of planned and ongoing clinical trials, the timely submission and review of regulatory applications for XYOTAX and pixantrone, the potential failure of XYOTAX to prove safe and effective for or to be approved for use in the treatment of non-small cell lung and ovarian cancers, the potential failure of pixantrone to prove safe and effective for aggressive or indolent non-Hodgkin's lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX and pixantrone, risks related to private party claims arising out of the Department of Justice investigation, 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 Italian law, CTI is under no obligation to (and expressly disclaims any such obligation 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
Susan Callahan
T: 206.272.4472
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/media.htm

Investors Contact:
Cell Therapeutics, Inc.
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/investors.htm


Cell Therapeutics, Inc.

Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
(unaudited)

Three Months Ended
March 31,
2007 2006
Revenues:
License and contract revenue $20 $20
Total revenues 20 20
Operating expenses:
Research and development 15,286 15,764
Selling, general and administrative 8,130 10,563
Amortization of purchased intangibles 207 189
Total operating expenses 23,623 26,516
Loss from operations (23,603) (26,496)
Other income (expense):
Investment and other income, net 703 542
Interest expense (3,916) (8,628)
Foreign exchange gain 447 291
Make-whole interest expense (2,310) (20,166)
Gain on derivative liabilities 2,708 3,424
Settlement expense (143) (883)
Net loss (26,114) (51,916)
Preferred stock beneficial conversion
feature (2,594) -
Preferred stock dividends (31) -
Net loss attributable to common shareholders $(28,739) $(51,916)
Basic and diluted net loss per common share $(0.76) $(2.31)
Shares used in calculation of basic and
diluted net loss per common share (1) 37,588 22,500

Balance Sheet Data: (amounts in thousands)

March 31, December 31,
2007 2006
(unaudited)
Cash and cash equivalents, securities
available-for-sale and interest receivable $48,738 $54,407
Working capital 24,238 30,166
Total assets 94,355 101,821
Convertible debt 156,943 166,178
Accumulated deficit (989,847) (961,108)
Shareholders' deficit (106,909) (101,604)

(1) Amounts reflect a one-for-four reverse stock split of our common stock
effective April 15, 2007.

[carpiediem]

Sieht nicht gut aus!
Gibt es negative News??
Haben die den Splitt nur vorgenommen, um sich langsam wieder der 1 Euro Marke zu nähern.

[carpiediem]

Irgendetwas wollen die für 150 Millionen verscherbeln. Kann das jemand deuten? Ist der Sinkflug gerechtfertigt?

mfg carpe

[Pitti72]

Wenn ich das richtig gelesen habe,dann
wollen die für 150 Millionen Anteile
verkaufen.Erst der Splitt und dann das!
Das past doch wie die Faust auf s Auge.

Pitti

[carpiediem]

Antwort auf Beitrag Nr.: 29.699.404 von Pitti72 am 08.06.07 09:39:38

danke pitti,

habe das Teil aus Versehen gekauft - hab mich verlesen!
Eigene Blödheit!!
Bin dann nach dem Splitt nicht rausgekommen - zu hohes Limit!

Die ganze Sache stinkt ! Bin heute raus!
Sollte mich mich nicht wundern wenn wir bald die 1 Euro sehen.
Und tschüß
carpe

[GuHu1]

bin bei € 3,79 raus mit 20 % miesen!
schau mir den wert erstmal von der seitenlinie an.

[Pitti72]

Publication on Pixantrone Preclinical Studies Demonstrates Reduced Cardiotoxicity Compared to Equiactive Doses of Doxorubicin and Mitoxantrone
Tuesday June 26, 7:00 am ET
Interim results in a randomized phase II/III clinical trial anticipated later this year


SEATTLE, June 26 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) announced the publication of preclinical studies, which demonstrate that treatment with pixantrone (BBR 2778) resulted in minimal or no significant cardiotoxicity, while doxorubicin and mitoxantrone induced significant cardiac damage. The studies compared the cardiac side effects of equiactive doses of pixantrone to doxorubicin and mitoxantrone in mice pre-treated with a cardiotoxic dose of doxorubicin as well as in mice without prior treatment. The article was published in the June 2007 journal Investigational New Drugs.
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"In preclinical hematological tumor models pixantrone showed higher effectiveness and minimal or lack of cardiotoxicity as compared to mitoxantrone or doxorubicin. The findings reported in this article strongly support the clinical potential of pixantrone as a replacement for currently marketed anthracyclines. We hope our randomized phase II/III RAPID (PIX203) study in first-line aggressive NHL will confirm these preclinical results in patients and possibly diminish the most serious side effect associated with current standard treatments -- irreversible heart damage," said Gabriella Pezzoni, Ph.D., Scientific Director at Cell Therapeutics Europe S.r.l. (Milan).

In spite of their dose-dependent cardiotoxic effects, anthracyclines are still considered the standard of care because of their efficacy in several tumor types, including breast cancer, leukemia, and non-Hodgkin's lymphoma (NHL). Because of the irreversible nature of the cardiac damage that accompanies the use of currently marketed anthracyclines, patients who are treated with these agents are subject to a maximum cumulative life-time dose, which may result in premature discontinuation of therapy and limit the physician's ability to use this active class of anti-cancer drugs following disease relapse. Pixantrone, a novel anthracenedione analog, was developed to reduce treatment-related cardiotoxicity while retaining efficacy.

These findings suggest that pixantrone may have potential use in patients heavily pre-treated with anthracyclines, in patients with cardiac disorders, and in patients who might benefit from longer-term anthracycline therapy than can be administered with currently approved agents.

Details of the Preclinical Studies

The studies were designed to evaluate the potential cardiotoxicity of pixantrone in mice pre-treated with doxorubicin and to evaluate the potential cardiotoxicity of pixantrone as a single agent compared to doxorubicin and mitoxantrone. Mice pre-treated with a cardiotoxic dose of doxorubicin were then administered a saline placebo control, doxorubicin, pixantrone, or mitoxantrone. Mice that received a second cycle of doxorubicin or mitoxantrone developed marked or severe cardiotoxicity. Mice that received the placebo or pixantrone as the second cycle had slightly increased mean total cardiotoxicity score, indicating that earlier exposure to doxorubicin may continue to damage the heart. While cardiotoxicity observed in the mice treated with pixantrone was not statistically different compared to mice treated with placebo, it was statistically different from that observed in the groups treated with doxorubicin or mitoxantrone. In the mice pre-treated with doxorubicin, a second cycle of mitoxantrone or pixantrone resulted in mortality of 33 percent and 27 percent, respectively.

Mice that received two consecutive cycles of pixantrone as a single agent showed no significant cardiotoxicity and had a mean total toxicity score that was statistically similar to the placebo. The severity and extent of observed damage to heart tissue was minimal and considered reversible. However, mice receiving two cycles of doxorubicin or mitoxantrone experienced marked cardiac damage that was statistically worse than that observed in the pixantrone-treated mice. In addition, mortality ranged from 40 to 68 percent in mice receiving two cycles of doxorubicin to 68 percent in mice receiving two cycles of mitoxantrone. In mice receiving two cycles of pixantrone, the mortality rate was 0 percent.

Pixantrone in Clinical Studies

There are currently two clinical studies of pixantrone in aggressive NHL patients, including a phase III single agent trial, known as EXTEND and a phase II/III combination study, known as RAPID. The EXTEND trial explores the role of single agent treatment as a salvage regimen in patients with relapsed aggressive NHL who have failed at least two prior treatment regimens. Patients are randomized to receive either pixantrone or another single-agent drug of physician's choice currently used for the treatment of this patient population. An interim look is planned for the summer of 2007.

The RAPID trial is a first-line randomized phase II/III study of the CHOP-R versus CPOP-R in previously untreated aggressive NHL patients. The study is evaluating replacing doxorubicin in the standard CHOP-R combination regimen (cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab) with pixantrone as part of the CPOP-R regimen (cyclophosphamide, pixantrone, vincristine, prednisone, and rituximab). The objective of the study is to demonstrate similar objective response rates as the standard doxorubicin-based therapy with significantly less severe cardiac toxicities and other doxorubicin-related toxicities on the CPOP-R arm of the study. A total of 280 patients are expected to be enrolled.

The Company is awaiting feedback from the FDA on the design of a phase III trial of pixantrone for patients with indolent NHL. The trial, PIX303, will examine the complete remission rates and time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have received at least one prior treatment for NHL. The trial is expected to enroll 300 patients.

About Pixantrone

Pixantrone is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplify administration compared to the currently marketed anthracyclines.

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.cticseattle.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 potential failure of pixantrone to have the same cardiotoxicity profile in humans as demonstrated in preclinical studies or to prove safe and effective for treatment of non-Hodgkin's lymphoma or other cancer, determinations by regulatory, patent and administrative governmental authorities, 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 Italian law, CTI is under no obligation to (and expressly disclaims any such obligation 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

Susan Callahan
T: 206.272.4472
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/media.htm

Investors Contact:
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/investors.htm

Medical Information Contact:
T: 800.715.0944
E: [e-mail]

[Pitti72]

Antwort auf Beitrag Nr.: 30.327.673 von Pitti72 am 26.06.07 16:19:25

Publikation auf Pixantrone Preclinical Studien zeigt verringertes Cardiotoxicity, das mit Equiactive Dosen von Doxorubicin und von Mitoxantrone Dienstag Juni 26, 7:00 morgens UND Zwischenzeitsresultate in einem randomisierten Phase II/III klinischen Versuch verglichen wird, der später dieses Jahr vorweggenommen wird SEATTLE, Juni 26 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) verkündet der Publikation der preclinical Studien, die daß Behandlung mit pixantrone zeigen (BBR 2778) ergab minimales oder kein bedeutendes cardiotoxicity, während doxorubicin und mitoxantrone bedeutende Herzbeschädigung verursachen. Die Studien verglichen die Herznebenwirkungen der equiactive Dosen von pixantrone mit doxorubicin und von mitoxantrone in den Mäusen, die mit einer cardiotoxic Dosis von doxorubicin sowie in Mäusen ohne vorherige Behandlung vorbehandelt wurden. Der Artikel wurde in den Juni 2007 Journal neuen Untersuchungsdrogen veröffentlicht. REKLAMEANZEIGE "im preclinical hämatologischen Tumormodelle pixantrone zeigte höhere Wirksamkeit und minimal oder Mangel an cardiotoxicity verglichen mit mitoxantrone oder doxorubicin. Die Entdeckungen berichteten in dieser Unterstützung des Artikels stark über das klinische Potential von pixantrone als Wiedereinbau für z.Z. vermarktete anthracyclines. Wir hoffen, daß unsere randomisierte Phase II/III SCHNELLE (PIX203) Studie in first-line konkurrenzfähigem NHL diese preclinical Resultate bei Patienten bestätigt und vielleicht die ernsteste Nebenwirkung vermindert, die mit gegenwärtigen Standardbehandlungen verbunden ist -- irreversible Herzbeschädigung, "sagte Gabriella Pezzoni, Ph.D., wissenschaftlicher Direktor an der Zelle Therapeutik Europa S.r.l. (Mailand). Trotz ihrer mengenabhängigen cardiotoxic Effekte gelten anthracyclines noch als den Standard von Obacht wegen ihrer Wirksamkeit in einigen Tumorarten, einschließlich Brustkrebs, Leukämie und Lymphom der non-Hodgkins (NHL). Wegen der irreversiblen Natur der Herzbeschädigung, die den Gebrauch der z.Z. vermarkteten anthracyclines begleitet, sind Patienten, die mit diesen Mitteln behandelt werden, abhängig von einer maximalen kumulativen Lebenszeitdosis, die vorzeitige Unterbrechung der Therapie ergeben kann und die Fähigkeit des Arztes begrenzt, diese aktive Kategorie der krebsbekämpfenden Drogen nach Krankheitrückfall zu benutzen. Pixantrone, eine Roman anthracenedione Entsprechung, wurde entwickelt, um Behandlung-in Verbindung stehendes cardiotoxicity beim Behalten von von Wirksamkeit zu verringern. Diese Entdeckungen schlagen vor, daß pixantrone möglichen Gebrauch haben kann bei den Patienten, die schwer mit anthracyclines vorbehandelt werden, bei Patienten mit Herzstörungen und bei Patienten, die von der längerfristigen anthracycline Therapie als profitieren konnten, kann mit z.Z. genehmigten Mitteln ausgeübt werden. Details der Preclinical Studien Die Studien waren entworfen, um das mögliche cardiotoxicity von pixantrone in den Mäusen auszuwerten, die mit doxorubicin vorbehandelt wurden und das mögliche cardiotoxicity von pixantrone als einzelnes Mittel auszuwerten verglich mit doxorubicin und mitoxantrone. Den Mäusen, die mit einer cardiotoxic Dosis von doxorubicin vorbehandelt wurden, wurden dann einer salzigen Placebo Steuerung, einem doxorubicin, einem pixantrone oder ein mitoxantrone ausgeübt. Mäuse, die einen zweiten Zyklus von doxorubicin oder von mitoxantrone empfingen, entwickelten markiertes oder strenges cardiotoxicity. Mäuse, die das Placebo oder das pixantrone empfingen, da der zweite Zyklus etwas Mittelgesamtcardiotoxicity Kerbe erhöht hatte, anzeigend, daß frühere Aussetzung zum doxorubicin fortfahren kann, das Herz zu beschädigen. Während das cardiotoxicity beobachtet in den Mäusen, die mit pixantrone behandelt wurden, nicht statistisch verglichen mit den Mäusen unterschiedliches war, die mit Placebo behandelt wurden, war es statistisch zu dem unterschiedlich, das in den Gruppen beobachtet wurde, die mit doxorubicin oder mitoxantrone behandelt wurden. In den Mäusen, die mit doxorubicin vorbehandelt wurden, ergaben ein zweiter Zyklus von mitoxantrone oder pixantrone Sterblichkeit von 33 Prozent und von 27 Prozent, beziehungsweise. Mäuse, daß empfangen zwei nachfolgende Zyklen pixantrone, da ein einzelnes Mittel kein bedeutendes cardiotoxicity zeigte und eine Mittelgesamtgiftigkeitkerbe hatte, die statistisch dem Placebo ähnlich war. Die Schwierigkeit und der Umfang einer beobachteten Beschädigung des Herzgewebes waren minimaler und betrachteter Reversible. Jedoch erfuhren die Mäuse, die zwei Zyklen doxorubicin oder mitoxantrone empfangen, markierte Herzbeschädigung, die statistisch schlechter als die war, die in den pixantrone-behandelten Mäusen beobachtet wurde. Zusätzlich reichte Sterblichkeit von 40 bis 68 Prozent in den Mäusen, die zwei Zyklen doxorubicin bis zu 68 Prozent in den Mäusen empfangen, die zwei Zyklen mitoxantrone empfangen. In den Mäusen, die zwei Zyklen pixantrone empfangen, war die Sterblichkeitrate 0 Prozent. Pixantrone in den klinischen Studien Es gibt z.Z. zwei klinische Studien von pixantrone bei konkurrenzfähigen NHL Patienten, einschließlich einen Phase III einzelnen Mittelversuch, bekannt als VERLÄNGERN und eine Phase II/III Kombination Studie, bekannt als SCHNELL. Der VERLÄNGERNVERSUCH erforscht die Rolle der einzelnen Mittelbehandlung als Wiedergewinnungregierung bei Patienten mit zurückgefallenen konkurrenzfähigen NHL, die mindestens zwei vorherige Behandlungregierungen verlassen haben. Patienten werden randomisiert, um entweder das pixantrone oder eine andere Einzelnmittel Droge der Wahl des Arztes zu empfangen z.Z. benutzt für die Behandlung dieser geduldigen Bevölkerung. Ein Zwischenzeitsblick wird für den Sommer von 2007 geplant. Der SCHNELLE Versuch ist eine first-line randomisierte Phase II/III Studie des CHOP-R gegen CPOP-R bei vorher unbehandelten konkurrenzfähigen NHL Patienten. Die Studie wertet aus, doxorubicin in der Standard-CHOP-R Kombination Regierung (Cyclophosphamid, doxorubicin, vincristine, Prednison und rituximab) mit pixantrone als Teil der CPOP-R Regierung (Cyclophosphamid, pixantrone, vincristine, Prednison und rituximab) ersetzend. Die Zielsetzung der Studie ist, ähnliche objektive Ansprechgeschwindigkeiten als die doxorubicin-gegründete Standardtherapie mit erheblich weniger strenger Herzgiftigkeit und anderer doxorubicin-in Verbindung stehender Giftigkeit auf dem CPOP-R Arm der Studie zu demonstrieren. Eine Gesamtmenge von 280 Patienten werden erwartet eingeschrieben zu werden. Die Firma erwartet Rückgespräch von der FDA auf dem Design eines Phase III Versuches von pixantrone für Patienten mit indolent NHL. Der Versuch, PIX303, überprüft die komplette Erlaßrate und -zeit zur Krankheitweiterentwicklung für die Kombination Regierung des fludarabine, des pixantrone und des rituximab (FP-R) verglichen mit der Kombination von fludarabine und des rituximab (Franc) in der Behandlung der Patienten, die mindestens eine vorherige Behandlung für NHL empfangen haben. Der Versuch wird erwartet, um 300 Patienten einzuschreiben. Über Pixantrone Pixantrone ist ein Untersuchungsmittel unter Entwicklung für die mögliche Behandlung der verschiedenen hämatologischen Malignancies, der festen Tumoren und der immunologischen Störungen. Es wurde entwickelt, um die Tätigkeit und die Sicherheit der anthracycline Familie der krebsbekämpfenden Mittel zu verbessern. Anthracyclines sind gezeigt worden, um klinisch in einer Anzahl von Tumorarten sehr aktiv zu sein. JedochSIND sie normalerweise mit kumulativer Herzbeschädigung verbunden, die verhindert, daß sie in einem großen Anteil Patienten verwendet werden. Pixantrone ist entworfen worden, um das Potential für diese strengen cardiotoxicities zu verringern, sowie, Tätigkeit möglicherweise zu erhöhen und die Leitung zu vereinfachen, die mit den z.Z. vermarkteten anthracyclines verglichen wird. Über Zelle Therapeutik Inc.. Hauptsitz gehabt in Seattle, ist CTI eine biopharmaceutical Firma, die am Entwickeln einer integrierten Mappe der Onkologieprodukte festgelegt wird, die Krebs umgänglicher bildend angestrebt werden. Zu zusätzlicher Information besuchen Sie bitte http://www.cticseattle.com.

Bis dann Pitti

[GuHu1]

+ 20 % ??
was ist los?

[wallstreetcrash]

Antwort auf Beitrag Nr.: 30.512.692 von GuHu1 am 05.07.07 21:28:29

Hurra, Sie leben ja doch noch...

[Pitti72]

Auch auf der Bewegung, kletterte Cell Therapeutics (CTIC) 44 Cents oder 14.6%, bis $3.46. Die Firma sagte Dienstag, nachdem Marktende, das es einen neuen medizinischen Direktor für sein Programm XYOTAX/CT-2103 nannte, das einen Anwärter für ovarian Krebs und Lungenkrebs in Frauen miteinbezieht. Dr. Jay Umbreit übernimmt den Versuch PGT307 der Firma. Umbreit entwickelte vor kurzem pharmazeutische Produkte für PPD, eine globale Vertrag Forschung Organisation. Cell Therapeutics ist ein Teil des Nasdaq Biotechnologie-Index, der hinunter 1.35 war, oder 0.2%, bis 810.89.

[GuHu1]

Antwort auf Beitrag Nr.: 30.519.569 von wallstreetcrash am 06.07.07 12:04:31

Hurra, Sie leben ja doch noch...

da liegt wohl die betonung auf noch.

[GuHu1]

Antwort auf Beitrag Nr.: 30.520.821 von Pitti72 am 06.07.07 13:21:14

danke für die info

[Pitti72]

Pixantrone Combination Therapy for First-line Treatment of Aggressive Non-Hodgkin's Lymphoma Results in Reduction in Severe Toxicities Including Heart Damage When Compared to Doxorubicin-based Therapy
Wednesday July 11, 1:45 am ET
Positive interim results prompt request for meeting with FDA


SEATTLE, July 11 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) announced today that interim results of its phase II/III trial comparing CPOP-R, in which pixantrone is substituted for doxorubicin in standard CHOP-R first-line treatment of patients with aggressive non-Hodgkin's lymphoma (NHL), resulted in essentially all patients on both arms achieving a major objective anti-tumor response (complete response or partial response). The preliminary results showed that patients who received pixantrone had a reduction in severe (grade 3/4) side effects when compared to patients treated with standard doxorubicin-based therapy. The Company intends to report data from this trial, known as RAPID, at the American Society of Hematology (ASH) annual meeting in December.
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Despite pixantrone patients receiving more treatment cycles, a three-fold reduction in the incidence of severe heart damage (LVEF decline >15 percent) was seen as well as clinically significant reductions in infections and thrombocytopenia. In addition a significant reduction in febrile neutropenia was also observed. Febrile neutropenia is a life-threatening complication of chemotherapy which often requires hospitalization and antibiotic therapy and may lead to death from infection while the patient's infection-fighting white blood cells are low due to neutropenia. The RAPID study is expected to complete enrollment in 2008.

"We are excited by these results demonstrating that pixantrone is living up to the promise of preventing the severe cardiac damage that accompanies the use of standard doxorubicin treatment while retaining the potent anti-lymphoma activity of this class of drug," said James A. Bianco, M.D., President and CEO of CTI. "Pending results from this and other studies, these findings could have major implications for treating patients with breast cancer, lymphoma, and leukemia, where debilitating cardiac damage from doxorubicin might be prevented. We look forward to discussing these results and our planned interim analysis of the PIX301 (EXTEND) pivotal trial with the FDA. We believe the RAPID data coupled with the EXTEND data may provide sufficient clinical information for review of pixantrone in aggressive NHL."

Details of the RAPID Trial

The RAPID (Replacing Adriamycin with Pixantrone to Improve Safety in NHL Disease) trial is a 280-patient randomized controlled phase II/III combination study investigating whether the substitution of pixantrone for doxorubicin in the first-line treatment of patients with advanced aggressive NHL can provide a comparable major response rate while reducing known doxorubicin-related toxicities. This multi-center international trial randomizes newly diagnosed patients to either the standard of care regimen CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab) or an investigational regimen which replaces doxorubicin with pixantrone, CPOP-R (cyclophosphamide, pixantrone, vincristine, prednisone, and rituximab) monthly for six cycles. Patients are evaluated for response to therapy every two cycles and evaluated every two months following completion of therapy.

Cardiac function, as determined by serial multi-gated nuclear scans (MUGA), is evaluated prior to initiation of therapy and then at the completion of every two cycles of therapy. Thus far, routine prophylactic administration of G-CSF was utilized equally across treatment arms in approximately half of study participants. The interim analysis was conducted after approximately 60 patients completed at least four cycles of therapy to determine if the dose of pixantrone (150 mg/m2) was adequate to induce major objective responses comparable to the doxorubicin arm as well as to evaluate potential differences in major toxicities.

Pixantrone in Clinical Studies

There are currently two clinical studies of pixantrone in aggressive NHL patients, RAPID and a phase III single agent trial, known as EXTEND. The EXTEND trial explores the role of single-agent treatment as a salvage regimen in patients with relapsed aggressive NHL who have failed at least two prior treatment regimens. Patients are randomized to receive either pixantrone or another single-agent drug of the physician's choice currently used for the treatment of this patient population. An interim look for the EXTEND trial is planned for later this year.

The Company is awaiting feedback from the FDA on the design of a new phase III trial of pixantrone for patients with indolent NHL. The trial, PIX303, will examine the complete remission rates and time to disease progression for the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have received at least one prior treatment for NHL. The trial is expected to enroll 300 patients.

About Pixantrone

Pixantrone is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and permit simplified administration compared to the currently marketed anthracyclines.

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.cticseattle.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 potential failure of the final results of the RAPID clinical study of pixantrone to have the same or similar results to the interim analysis, or the potential failure of pixantrone to prove safe and effective for treatment of non-Hodgkin's lymphoma or other cancers, determinations by regulatory, patent and administrative governmental authorities, 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 Italian law, CTI is under no obligation to (and expressly disclaims any such obligation 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

Susan Callahan
T: 206.272.4472
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/media.htm

Investors Contact:
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/investors.htm

Medical Information Contact:
T: 800.715.0944
E: [e-mail]

[GuHu1]

Hmmm, verhält sich aber relativ stark auf dem niveau = Boden bei ca. € 2,50 ?

[wolfgangh02]

ist zwar schon etwas älter:
New York (aktiencheck.de AG) - Die Analysten von Rodman&Renshaw stufen die Aktie von Cell Therapeutics (ISIN US1509344040 (Nachrichten)/ WKN A0MNTK) unverändert mit "market outperform" ein. Das Kursziel werde bei 15 USD gesehen. (13.08.2007/ac/a/u)
Analyse-Datum: 13.08.2007

[Pitti72]

Press Release Source: Cell Therapeutics, Inc.


Cell Therapeutics, Inc. (CTI) to Submit Marketing Authorization Application for XYOTAX(TM) for First-line Non-small Cell Lung Cancer Ahead of Schedule
Tuesday December 18, 1:30 am ET
European regulatory authorities support filing strategy


SEATTLE, Dec. 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) reported today that it met with and received feedback from the rapporteur and co-rapporteur regarding its marketing authorization application (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103). The feedback supports submission of the MAA in the first quarter of 2008, earlier than the first half of 2008 that CTI was targeting. The rapporteur and co-rapporteur, who are assigned by the EMEA, are responsible for providing scientific advice on the evaluation of medicinal products. CTI plans to submit an MAA in Europe, based on the STELLAR 4 phase III clinical trial results, for XYOTAX as a single agent for first-line treatment of non-small cell lung cancer (NSCLC) in patients with poor performance status (ECOG performance status 2, PS2).
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"The meetings were very productive and we appreciate the advice the rapporteurs provided us on how best to report our data and supporting literature for the utility of the comparator drugs gemcitabine and vinorelbine," said Scott C. Stromatt, M.D., Executive Vice President, Clinical Development and Regulatory Affairs. "Based on their feedback and agreement on several critical components of the application, we believe we will be in a position to submit our MAA in the first quarter, months ahead of our previous target."

Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.

About PS2 NSC Lung Cancer

PS2 patients represent a subgroup of patients who are ambulatory and capable of self-care, but are unable to carry out any work activities, although they are up and about more than 50 percent of waking hours. PS2 non-small cell lung cancer (NSCLC) patients account for approximately 25 percent of all patients with NSCLC who require chemotherapy. There are presently no drugs approved to treat PS2 patients with advanced NSCLC. Current treatments for this group of patients are poorly tolerated, with most tolerating a median of two doses of chemotherapy and experiencing disease progression on average within six weeks. Most physicians will utilize single-agent gemcitabine or vinorelbine to treat these frail patients. Current treatments also have limited effectiveness, with median survival ranging from only ten weeks for single-agent treatment to just over 17 weeks for combination therapies.

About the STELLAR 4 Trial

The STELLAR 4 phase III clinical trial tested XYOTAX versus either gemcitabine or vinorelbine for the potential first-line treatment of poor performance status (PS2) patients with NSCLC. While the STELLAR 4 trial missed its primary endpoints of significant improvement in overall survival, it did demonstrate significant reductions in many of the clinically relevant toxicities associated with gemcitabine or vinorelbine. Based on the clinical benefit of lower severe toxicities, reduced use of hematopoietic growth factors and transfusions, enhanced convenience, and reduced medical resource utilization and associated costs, in 2006 CTI received a positive opinion from the Scientific Advice Working Party (SAWP) of the EMEA that a switch from the superiority endpoint to a non-inferiority endpoint is feasible if adequate justification is provided in the marketing application.

About XYOTAX(TM)

XYOTAX(TM) (paclitaxel poliglumex, CT-2103) is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that XYOTAX metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.

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.cticseattle.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 XYOTAX include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX in particular including, without limitation, the potential failure of XYOTAX to prove safe and effective or be approved for treatment of non-small cell lung cancer, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX, 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 Italian law, CTI is under no obligation to (and expressly disclaims any such obligation 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
Susan Callahan
T: 206.272.4472
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/media.htm

Investors Contact:
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/investors.htm

[Pitti72]

Cell Therapeutics, Inc. (CTI) Cuts Net Operating Expenses 35% and Expands Commercial Team to Support Zevalin(R) Sales and Applications Seeking Two Product Approvals in 2009
Wednesday January 30, 5:00 pm ET


2008 Projected Financial Highlights and Potential Milestones include:

- Grow Zevalin sales

- XYOTAX(TM) Marketing Authorization Application submission in Q1

- Pixantrone phase III results and New Drug Application submission

- Brostallicin phase II interim results

SEATTLE, Jan. 30 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) announced today that with the return of CTI to a commercial operating company through its acquisition of Zevalin® (Ibritumomab Tiuxetan), the company will focus its resources on increasing the sales of Zevalin in the United States and preparing the marketing applications for XYOTAX (paclitaxel poliglumex, CT-2103) and pixantrone (BBR 2778), while supporting the advancement of brostallicin to a phase III trial. The move will reduce the Company's projected net cash operating expenses to a forecasted $77 million in 2008. The primary reduction in operating expenses stems from deferring or curtailing some phase III clinical trials for pixantrone and XYOTAX until planned regulatory filings and the completion of phase III studies result in product approvals. CTI expects to file for approval of XYOTAX in Europe in March. The Company will expand its commercial infrastructure for Zevalin and possible future drug sales while achieving an overall reduction in headcount.

"We believe the best way to maximize shareholder value now is to focus our resources on our marketed and late-stage products," noted James A. Bianco, M.D., President and CEO of CTI.

"Recently published data describing the clinical benefit of Zevalin are compelling and support the potential to expand its application into first-line treatment of follicular non-Hodgkin's lymphoma, leading us to expand our commercial operations staffing from 11 percent to 21 percent of our total headcount with corresponding reductions elsewhere. We will continue to support our two lead drug candidates, XYOTAX and pixantrone. This year we will continue to prepare for submission of a marketing authorization application for XYOTAX and the evaluation of pivotal trial data for pixantrone. Our goal is to ensure that we succeed with Zevalin and are prepared for the future market introductions of XYOTAX and pixantrone."

"On a personal note, while we are adding staff in some areas, it is with great disappointment that we must reduce headcount elsewhere in order to meet these goals," Bianco added.

CTI has begun building a new sales and marketing department to support Zevalin sales. The company will be adding more than 13 positions for Zevalin and other potential drug sales. The Company has also increased staffing in regulatory and manufacturing in preparation for filing for approval of XYOTAX in Europe in March.

About ZEVALIN®

Zevalin (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia, and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit http://www.zevalin.com for more information.

About XYOTAX(TM)

XYOTAX(TM) (paclitaxel poliglumex, CT-2103) is an investigational, biologically-enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that XYOTAX metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.

About Pixantrone

Pixantrone is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplify administration compared to the currently marketed anthracyclines. The main adverse events associated with pixantrone in clinical trials to date include myelosuppression and alopecia.

About Brostallicin

Brostallicin, which was initially developed by Nerviano Medical Sciences, the largest pharmaceutical research and development facility in Italy, is a synthetic second-generation DNA minor groove binder with potent cancer killing activity in experimental tumors models. More than 200 patients have been treated with brostallicin in single-agent and combination studies, and it is now in a first-line phase II study that is currently being conducted by the European Organization for Research and Treatment of Cancer (EORTC).

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.cticseattle.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 marketing and development of ZEVALIN, or the development of XYOTAX, pixantrone and brostallicin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with ZEVALIN, XYOTAX, pixantrone and brostallicin in particular including, without limitation, the potential failure of these product candidates to prove safe and effective for treatment of non-small cell lung cancer, ovarian cancer, non-Hodgkin's lymphoma, and sarcoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling ZEVALIN, XYOTAX, pixantrone and brostallicin. In addition, we may not be able to achieve the sales projected for ZEVALIN in 2008. There is no guarantee that we will receive approval for additional uses of ZEVALIN, or that we will receive approval from any regulatory agency for any approved use of XYOTAX, pixantrone or brostallicin. If we are able to obtain such approval, we may not be able to successfully market and sell such products. You should also review 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
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/media.htm

Investors Contact:
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/investors.htm




--------------------------------------------------------------------------------
Source: Cell Therapeutics, Inc.

[asics01]

und schon wieder eine bioleiche

[Pitti72]

Cell Therapeutics Inc. meldete Verlust im vierten Quartal von $39 Million oder einen Verlust von 74 Cents pro Anteil, der mit einem Verlust von $35.6 Million vergleicht, oder einen Verlust von $1 pro Anteil ein das Jahr früher. Analytiker stimmten durch Thomson Financial ab, den Netz Verlust im vierten Quartal von 52 Cents pro Anteil erwartete. Für steuerliches 2007 meldete Zelle Therapeutik einen Verlust von $148.3 Million oder einen Verlust von $3.27 pro Anteil, der mit einem Verlust von $135.8 Million vergleicht, oder einen Verlust von $4.84 pro Anteil, 2006. Analytiker erwarteten einen steuerlichen Verlust 2007 von $2.71. Im Dezember führte die Firma seinen Erwerb $30 Million der Krebsdroge Zevalin von Biogen Idec Inc. durch und gesagt ihm fängt kommerzielles Marketing der Droge an. "nun da wir bedeutenden Fortschritt auf unserer Strategie der Vereinfachung unseres Kapitalaufbaus, des Verringerns von von Betriebskosten und der Verschiebung unserer Betriebsmittel auf kurzfristige Gelegenheiten gebildet haben, glauben wir, daß wir in einer viel stärkeren Position sind, zum der Einkommen zu erhöhen, unsere Spätstadium klinischen Programme durchzuführen und Wert für unsere Aktionäre und Patienten verursachen,", sagte Dr. James Bianco, Präsident und CEO, in einer Aussage.

[Pitti72]

Vieleicht doch keine Bioleiche!!!

LONDON (Reuters) - The European Medicines Agency said on Thursday it had recommended approval of Bayer's (BAYG.DE: Quote, Profile, Research) cancer drug Zevalin in treating follicular lymphoma.

The medicine is currently authorised for patients with follicular B-cell non-Hodgkin's lymphoma, in combination with rituximab.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

Frohe Ostern

[Pitti72]

News Release

Follicular lymphoma:
Zevalin® Receives Positive CHMP Opinion in Europe for First-Line
Consolidation Treatment

Berlin, March 20, 2008 – Bayer Schering Pharma AG has received a positive opinion
from the European Committee for Medicinal Products for Human Use (CHMP)
recommending Zevalin® ([90Y]-ibritumomab tiuxetan) as consolidation therapy after
remission induction in previously untreated patients with follicular lymphoma (FL) in
Europe. The benefit of Zevalin following rituximab in combination with chemotherapy has
not been established. The product would receive marketing authorization for all EU
member states as a treatment for this indication later this year upon a favorable review by
the European Commission. Zevalin is currently approved for adult patients with rituximab
relapsed or refractory CD20-positive follicular B-cell Non-Hodgkin’s Lymphoma (NHL) in
Europe. It combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and
the tumour-destroying power of localised yttrium-90 radiation. Follicular lymphoma is one
of the most common types of Non-Hodgkin’s Lymphoma (NHL), a tumor of the lymphatic
system.
“The CHMP’s recommendation represents an important milestone for Zevalin, as it
recognizes the potential value that consolidation therapy with Zevalin can offer to patients
with follicular lymphoma,” said Dr. Gunnar Riemann, member of the Board of
Management of Bayer Schering Pharma AG. “This therapy option will provide clinicians
with a treatment regimen that truly could help many of their patients to an extended
progression-free survival.”
The CHMP’s decision is based on data from the pivotal Phase III First-Line Indolent Trial
(FIT) that showed Zevalin, when used as first-line consolidation therapy, significantly
prolonged progression-free survival time from 13.5 months (control arm) to 37 months
Follicular lymphoma:
Zevalin® Receives Positive CHMP Opinion in Europe for First-Line
Consolidation Treatment
- 2/4 -
(p<0.0001). The data was presented for the first time at the 49th Annual Meeting of the
American Society of Hematology meeting in December 2007.
About Zevalin – First-line Consolidation Therapy
Consolidation therapy is a treatment regimen given after a patient responds to initial firstline
induction therapy (e.g. chemotherapy). The aim of consolidation therapy is to rapidly
improve the quality of a patient’s response, thereby extending the response duration.
About the FIT study
The Zevalin FIT study (First-line Indolent Trial) is a multinational, randomized, Phase III
trial to investigate Zevalin as first-line consolidation therapy, given as a single therapeutic
dose, in patients with advanced (stage III or IV) follicular lymphoma who achieved a
partial remission or a complete remission after receiving standard first-line chemotherapy
regimens. The objective of the FIT study is the evaluation of benefit and safety of
consolidation with Zevalin after first-line therapy in follicular lymphoma patients, one of the
most common types of Non-Hodgkin’s Lymphoma.
About Zevalin® — the immunotherapy with yttrium-90
Zevalin® is currently approved in more than 40 countries for the treatment of B-cell non-
Hodgkin’s lymphoma, including Europe, countries in Latin America and, amongst others in
Asia, Japan. In Europe, Zevalin has been approved for adult patients with rituximabrelapsed
or refractory CD20-positive follicular B-cell non-Hodgkin’s lymphoma since 2004.
Zevalin combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the
tumor-destroying power of localized yttrium-90 radiation. The radiolabeled antibodies can
specifically bind to the tumor, therefore killing targeted and also neighboring lymphoma
cells, and thus destroying the tumor through several layers of tumor cells. The treatment
ensures a high bio-availability at tumor sites and prevents the radioactivity from being
distributed through the body by circulating lymphocytes.
Bayer Schering Pharma AG has exclusive rights to Zevalin in all countries of the world
except the United States of America.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma is a type of malignant disease that occurs within the lymphatic
system. NHL is the fifth most common cancer after breast, prostate, lung and colon
cancer. It originates from lymphocytes, a type of white blood cells, which can be divided
- 3/4 -
into two main types, B lymphocytes and T lymphocytes (also called B-cells or T-cells).
Non-Hodgkin’s lymphomas can be divided into two general clinical categories: indolent
lymphomas, mainly typified as follicular lymphomas, which tend to grow relatively slowly;
and aggressive lymphomas, mainly typified as diffuse large B-cell lymphomas (DLBCL),
which grow more rapidly. Follicular lymphoma is one of the most common types of
indolent NHL, accounting for 70% of all indolent cases. The overall prevalence of NHL in
the European Union is approximately 230,000, with an annual incidence of about 70,000.
Approximately 18,500 new cases of FL are diagnosed annually in the USA. It is a longlasting
disease and is difficult to treat.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of health
care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is
one of the world’s leading, innovative companies in the healthcare and medical products
industry and is based in Leverkusen, Germany. The company combines the global
activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals
divisions. The pharmaceuticals business operates under the name Bayer Schering
Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will
improve human and animal health worldwide. Find more information at
www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its
research and business activities are focused on the following areas: Diagnostic Imaging,
Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions
in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to
make a contribution to medical progress and strives to improve the quality of life. Find
more information at www.bayerscheringpharma.de.
Contact:
Anna Schuberth, Phone: [phone]
E-mail: [e-mail]
as (2008-0126E)

[Pitti72]

Press Release Source: Cell Therapeutics, Inc.


Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL
Tuesday March 25, 2:30 am ET
Potential NDA Submission in 2009


SEATTLE, March 25 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced today that enrollment is complete in the phase III EXTEND (PIX301) clinical trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL). An analysis of the data is expected in the second half of 2008. Based on prior discussions with the U.S. Food and Drug Administration (FDA) the data could provide a registration path for pixantrone if final study results are adequate for submitting a New Drug Application (NDA) with the FDA in early 2009 with a potential approval in 2009. A total of 140 patients were enrolled in the study, 97 patients are currently evaluable according to Histological Intent to Treat, or HITT, criteria and will be included in the final analysis of the study.
ADVERTISEMENT


"PIX301 examines the effectiveness of pixantrone in patients with relapsed and refractory diffuse large B cell lymphoma, a population where current therapies seldom induce complete remissions," said Jack W. Singer, Chief Medical Officer at CTI. "Based on a blinded current independent assessment of events in the trial we believe we have an adequate sample size of eligible patients to meet the primary objective of the trial."

About the EXTEND (PIX301) Clinical Trial

The EXTEND clinical trial is a phase III single agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial was conducted at 130 sites in 17 countries. 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. The trial was designed to examine the complete response (CR) or unconfirmed complete response (uCR) rate, time to tumor progression, and overall survival. The study was powered based on a CR rate assumption of less than 5 percent for the control arm and a greater than 10 percent improvement in CR rate for the pixantrone arm. The study was conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) and pixantrone has received fast track designation for this indication.

About Pixantrone

Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. It is a novel DNA major groove binder that contains an aza- anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. A new chemical compound for the treatment of non- Hodgkin's lymphoma (NHL), and various other hematologic malignancies, solid tumors, and immunological disorders, pixantrone is being developed by CTI to improve the activity and safety in treating cancers usually treated with the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.

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. 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, determinations by regulatory, patent and administrative governmental authorities that the PIX301 trial is insufficient to demonstrate pixantrone's safety and effectiveness for commercial use, 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 Italian law, CTI is under no obligation to (and expressly disclaims any such obligation 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

Susan Callahan
T: 206.272.4472
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/media.htm

Investors Contact:
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: [e-mail]
http://www.cticseattle.com/investors.htm




--------------------------------------------------------------------------------
Source: Cell Therapeutics, Inc.

[Bombenleger]

Zevalin Revenues Lead Cell Therapeutics, Inc.'s First Quarter 2008 Financial Results
Thursday May 8, 1:30 am ET
Company resumes commercial operations with first product sales since 2005


SEATTLE, May 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reported financial results for the quarter ended March 31, 2008. Total revenues for the quarter were $3.4 million compared to $20,000 for the first quarter of 2007. Gross product sales of Zevalin® (Ibritumomab Tiuxetan) reached $3.8 million in the first quarter of 2008.
ADVERTISEMENT


Total operating expenses increased to $28.4 million for the quarter ended March 31, 2008 compared to $23.6 million for the same period in 2007 mainly as a result of increased expenses related to the creation of commercial infrastructure to support Zevalin and fees associated with capital structure advisory services. Net loss attributable to common shareholders for the quarter ended March 31, 2008, which includes a one-time inducement payment of $16.2 million to convert preferred shares into common shares, totaled $54.6 million ($0.77 per share) compared to $28.7 million ($0.76 per share) for the comparable period in 2007. The increase in net loss attributable to common shareholders was also due, in part, to an increase in interest expense and make-whole interest payments related to the 9% convertible senior notes and the loss recorded on the exchange of the 5.75% convertible senior subordinated and subordinated notes in 2008. This was offset by a gain on the derivative liability related to conversions of the 9% convertible senior notes. We also had a foreign exchange loss for the quarter ended March 31, 2008 compared to a gain for the same period in 2007.

The Company had approximately $15.3 million in cash and cash equivalents, securities available-for-sale, and interest receivable as of March 31, 2008. This does not include $6.2 million in restricted cash held in escrow and net proceeds, before fees and expenses, of approximately $22.9 million from the issuance on April 30, 2008 of preferred stock, convertible notes, and warrants. The Company also expects to receive an additional $5 million in gross proceeds from an additional sale of securities to the purchaser of the Series E preferred stock and 13.5% convertible senior notes prior to July 4, 2008, provided adequate shares are available for issuance of such securities at that time.

"In the second quarter we expect to see the positive financial impact of our strategy to focus resources on our late-stage development products and growing Zevalin sales. With our commercial team now in place to support Zevalin, we expect revenues to continue to increase over the next few quarters," said James A. Bianco, M.D., President and CEO of CTI. "In addition, over the last two quarters, we have been successful in cleaning up our balance sheet, retiring or exchanging approximately 74 percent of current debt and preferred securities. With the majority of the investments in OPAXIO and pixantrone behind us we look forward to the review of the MAA for OPAXIO and to final results of the pixantrone pivotal trial."


Recent Highlights
o Announced that the Company selected and received a positive opinion
from the European Medicines Agency (EMEA) on the new brand name
OPAXIO(TM) (paclitaxel poliglumex), which replaces the name XYOTAX(TM)

o Announced that the EMEA accepted for review CTI's Marketing
Authorization Application (MAA) for OPAXIO for first-line treatment of
patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern
Cooperative Oncology Group) performance status 2 (PS2)

o Announced completion of enrollment in the phase III EXTEND (PIX301)
clinical trial of pixantrone (BBR 2778) for patients with relapsed
diffuse large B-cell non-Hodgkin's lymphoma (NHL)

o Announced the appointment of Craig W. Philips, most recently Vice
President and General Manager of Bayer Healthcare Oncology, as
president of CTI with direct responsibilities for development and
commercial operations, effective August 1, 2008

o Restructured, or retired more than $66 million of current convertible
debt and preferred securities while raising over $50 million in gross
proceeds during the past two quarters


Conference Call Information

On Thursday, May 8, 2008, 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: CTIC and MTA: CTIC) management team will host a quarterly conference call to discuss the company's 2008 first quarter achievements and financial results.


Conference Call Numbers
Thursday, May 8
8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-877-835-3295 (US Participants)
1-303-262-2137 (International)

Call-back numbers for post-listening available at 11:30 a.m. Eastern:
1-800-405-2236 (US Participants)
1-303-590-3000 (International)
Passcode: 11114025#

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

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. Specifically, the risks and uncertainties include statements about future sales of Zevalin, reducing net operating expenses in 2008, the closing of an additional financing prior to July 4, 2008, the availability of adequate shares for future financings, and the development of OPAXIO, pixantrone, and brostallicin, which include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with OPAXIO, pixantrone, and brostallicin in particular, including, without limitation, the potential failure of these product candidates to prove safe and effective for treatment of non-small cell lung cancer, ovarian cancer, non-Hodgkin's lymphoma, and sarcoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling Zevalin, OPAXIO, pixantrone, and brostallicin, the Company's ability to continue to raise capital as needed to fund its operations, 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: [e-mail]
http://www.CellTherapeutics.com/media.htm

Investors Contact:
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: [e-mail]
http://www.CellTherapeutics.com/investors.htm



Three Months Ended
March 31,
2008 2007
Revenues:
Product sales $3,374 $-
License and contract revenue 20 20
Total revenues 3,394 20

Operating expenses:

Cost of product sold 890 -
Research and development 15,855 15,286
Selling, general and administrative 11,174 8,130
Amortization of purchased intangibles 397 207
Acquired in-process research and
development 36 -
Total operating expenses 28,352 23,623

Loss from operations (24,958) (23,603)
Other income (expense):
Investment and other income 260 703
Interest expense (12,929) (3,916)
Foreign exchange gain (loss) (2,237) 447
Make-whole interest expense (7,781) (2,310)
Gain on derivative liabilities 11,744 2,708
Loss on exchange of convertible notes (2,295) -
Settlement expense - (143)

Net loss before minority interest (38,196) (26,114)
Minority interest in net loss of subsidiary 32 -

Net loss (38,164) (26,114)
Preferred stock beneficial
conversion feature - (2,594)
Preferred stock dividends (242) (31)
Deemed dividends on conversion of
preferred stock (16,198) -

Net loss attributable to common
shareholders $(54,604) $(28,739)
Basic and diluted net loss per common share $(0.77) $(0.76)
Shares used in calculation of basic
and diluted net loss per common share 71,074 37,588



Balance Sheet Data: (amounts in thousands)

March 31, December 31,
2008 2007
Cash and cash equivalents, securities
available-for-sale (unaudited)
and interest receivable $15,341 $18,392
Restricted cash 6,165 -
Working capital (20,395) (30,909)
Total assets 78,636 73,513
Convertible debt 145,530 137,396
Accumulated deficit (1,164,017) (1,109,413)
Shareholders' deficit (124,100) (134,125)




--------------------------------------------------------------------------------
Source: Cell Therapeutics, Inc.

[Bombenleger]

Wie bewertet Ihr die Zukunft des Unternehmens?
Immerhin kommen jetzt Einnahmen rein.

[micky68]

was ist mit diesem Thread? schon 5 Monate lang kein Eintrag. Ist Cell Therapeutics eigentlich pleite oder so gut wie? bitte um aktuelle Antworten zum derzeiten Stand es Unternehmens!

[kardoss12]

Antwort auf Beitrag Nr.: 35.621.812 von micky68 am 19.10.08 15:03:08

cell therapeutics braucht dringend geld - investment.
der stock scouter rating ist jetzt leicht gestiegen auf 5

ich steige bis ende nov. 08 spekulativ - schrittweise ein

mfg
----------------------------------------------------------------

Cell Therapeutics Inc: Stock Rating Summary
StockScouter Rating: 5

Cell Therapeutics Inc, a micro-cap growth company in the health care sector, is expected to significantly underperform the market over the next six months with very high risk.

Analyst Ratings
Recommendations Current 1 Month Ago 2 Months Ago 3 Months Ago
Strong Buy 1 1 1 1
Moderate Buy 0 0 0 0
Hold 4 4 4 4
Moderate Sell 0 0 0 0
Strong Sell 0 0 0 0
Mean Rec. 2.60 2.60 2.60 2.60

[VaJo]

Antwort auf Beitrag Nr.: 36.062.172 von kardoss12 am 25.11.08 16:45:47

Schau dir mal den Partner von CIT, Spectrum Pharmaceuticals an. 100 Mio Cash in der Tasche, keine Schulden, einen Vertrag mit einem Big Pharma, ein Krebsmedikament am Markt und eine dicke Pipeline.

[VaJo]

Antwort auf Beitrag Nr.: 36.092.168 von VaJo am 27.11.08 15:48:30

... und die MK über 50% unter Cash
Also da würde ich lieber auf SPPI (Spectrum Pharmaceuticals) setzen, wenn ihr an den Erfolg von Zevalin glaubt.

CIT muss ja auch noch Royalities an Biogen abtreten und sich an den Entwicklungskosten bei Bayer Schering beteiligen.
Zudem ist fraglich ob Zevalin die Marke von 18.000 Anwendungen schafft. Den nur dann gibt es ja so wie ich das lese, die zusätzlichen 15 Mio Dollar von Spectrum.
Schafft Zevalin das nicht bleibt es bei der jetzigen Einmalzahlung Ende Januar.

[VaJo]

Um 18.00 Uhr ist heute der Konferenz Call (in 10 Minuten) bzgl. des Zevalin Deals. Dürfte für euch ganz interessant sein wie SPPI die Verkäufe ankurbeln möchte.

http://phx.corporate-ir.net/phoenix.zhtml?c=83249&p=irol-Eve…

[Bombenleger]

Spectrum Pharmaceuticals Announces ZEVALIN sBLA Granted Priority Review by the FDA; Target Decision (PDUFA) Date of April 2, 2009
Monday December 1, 7:00 am ET


IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News) today announced that its joint venture partner for ZEVALIN, Cell Therapeutics, Inc. (CTI) (NASDAQ:CTIC - News)(MTA:CTIC), received notice that the U.S. Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for the supplemental Biologics License Application (sBLA) for use of ZEVALIN® ([90Y]-ibritumomab tiuxetan) as first line consolidation therapy for patients with B-cell follicular non-Hodgkin’s lymphoma.
ADVERTISEMENT


Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. This does not represent any evaluation of the adequacy of the data submitted.

A Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 has been established by the FDA for a decision regarding the ZEVALIN sBLA.

If approved, ZEVALIN would be the first radioimmunotherapy available to patients as first-line consolidation therapy. It is estimated that there would be approximately 18,000 additional patients that currently receive first-line treatment which would potentially be eligible to use ZEVALIN under the proposed expanded label. Together with ZEVALIN's current approval as treatment for patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients that are rituximab-refractory or rituximab-naive, approval of ZEVALIN as first-line consolidation therapy will allow ZEVALIN to be used in several lines of NHL therapy.

Spectrum Pharmaceuticals and CTI recently entered into an agreement to form a 50/50 owned joint venture, RIT Oncology LLC, to commercialize and develop ZEVALIN in the United States. Radioimmunotherapy is commonly referred to as ‘RIT’ in medical literature. ZEVALIN, as a first-line consolidation treatment, is currently approved in Europe. CTI gained access to the First-line Indolent Trial (FIT) data through an agreement with Bayer Schering Pharma AG, Germany. These data were used to obtain approval for ZEVALIN as first-line consolidation treatment in Europe.

“ZEVALIN in the first-line consolidation setting could represent an important treatment option for B-cell follicular non-Hodgkin’s lymphoma patients,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals. “We recently assembled a strong sales force to launch our proprietary oncology drug FUSILEV. ZEVALIN is an excellent complementary product to FUSILEV. Our in-house medical expertise and experienced sales force together with CTI’s, through RIT Oncology LLC, will be ready to add considerable strength to clinical, marketing and sales activities to promote ZEVALIN and provide NHL patients with this drug as quickly as possible.”

ZEVALIN is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.

About First-Line Consolidation Therapy

Consolidation therapy aims to rapidly improve the quality of the response achieved with initial remission induction treatment. Induction therapy is a treatment designed as a first step toward reducing the number of cancer cells.

About the Phase 3 First-line Indolent Trial (FIT)

The multinational, randomized Phase 3 First-line Indolent Trial (FIT) evaluated the benefit and safety of a single infusion of ZEVALIN in 414 patients with CD20-positive follicular non-Hodgkin’s lymphoma who had achieved a partial response or a complete response after receiving one of the standard first-line chemotherapy regimens. The FIT trial demonstrated that when used as a first-line consolidation therapy for patients with follicular non-Hodgkin’s lymphoma, ZEVALIN significantly improved the median progression-free survival time from 13 months (control arm) to 37 months (ZEVALIN arm) (p<0.0001). The FIT trial results were presented for the first time in one oral and three poster presentations at the American Society of Hematology (ASH) conference in December 2007. The full publication can be downloaded ahead of print from the Journal of Clinical Oncology website at http://jco.ascopubs.org.

The primary investigators of the study concluded that ZEVALIN consolidation of first remission in advanced stage follicular non-Hodgkin’s lymphoma is highly effective, resulting in a total complete response (CR + CRu) rate of 87 percent and prolongation of median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with ZEVALIN’s use in approved indications. ZEVALIN-treated patients had reversible Grade 3 or 4 hematologic side effects including neutropenia in 67 percent, thrombocytopenia in 61 percent, and anemia in 3 percent of patients. Non-hematologic toxicities were 24 percent Grade 3, 5 percent Grade 4, and Grade 3/4 infection was 8 percent.

About ZEVALIN®

ZEVALIN® (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit www.ZEVALIN.com for more information.

About Non-Hodgkin’s Lymphoma

Non-Hodgkin’s lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms – aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute’s SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.

About Spectrum Pharmaceuticals

Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum's website at http://www.spectrumpharm.com.

Forward-looking statements -- This press release may contain forward- looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to Spectrum's business and its future, as well as its contemplated transaction with Cell Therapeutics, Inc, the safety and effectiveness of ZEVALIN, ZEVALIN's potential, that if approved for first line therapy in NHL, an additional 18,000 patients per year would be eligible to receive ZEVALIN in that setting, that ZEVALIN represents a complementary product that our sales force can provide to their accounts, that ZEVALIN in the first-line setting could represent an important treatment option for B-cell follicular non-Hodgkin’s lymphoma patients, that our sales force together with CTI’s will be ready to bring considerable sales, marketing, and clinical strength to promote ZEVALIN and provide NHL patients with this drug as quickly as possible and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates, may not prove safe or effective, the possibility that its existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that its existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that its efforts to acquire or in-license and develop additional drug candidates may fail, its lack of revenues, its limited marketing experience, its dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this press release speak only as of the date hereof. Spectrum does not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

ZEVALIN® is a registered trademark of Cell Therapeutics, Inc.

© 2008 Spectrum Pharmaceuticals, Inc.




Contact:
Spectrum Pharmaceuticals, Inc.
Russell Skibsted
SVP & Chief Business Officer
949-788-6700 x234
or
Paul Arndt
Manager, Investor Relations
949-788-6700 x216

--------------------------------------------------------------------------------
Source: Spectrum Pharmaceuticals, Inc.

[Bombenleger]

Cell Therapeutics, Inc. Announces Single Institutional Investor Purchases $32.65 Million of Senior Convertible Notes
Friday December 5, 1:00 am ET
Retires $30 Million of Previously Issued Convertible Notes


SEATTLE, Dec. 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI" or the "Company") (Nasdaq and MTA: CTIC) today announced that a single institutional investor shall purchase, for $32.65 million, newly issued 10% Convertible Senior Notes due 2011 (the "Notes"), with a conversion price of $0.137 per share.
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The new Notes would have a $32.65 million initial principal balance and feature a make-whole provision entitling the holder, upon any conversion of the Notes, to receive the interest payable through scheduled maturity, less any interest paid before conversion.

The Company has also agreed to repurchase from the investor, for approximately $29 million, approximately $30 million aggregate principal amount of outstanding 15% Convertible Senior Notes, Series B 18.33% Convertible Senior Notes and 9.66% Convertible Senior Notes (collectively, the "Repurchased Notes") that were issued in June, August and October 2008, respectively. For such repurchase, the Company will use approximately $16.4 million of the proceeds from the offering of the new Notes, plus funds to be released to the Company from the escrow account that was established to pay the make-whole and interest payments on the Repurchased Notes. Warrants to purchase approximately 5.15 million shares of common stock which are held by the investor are also being surrendered to the Company and will be cancelled. The Company expects to receive net proceeds of approximately $16.3 million from the new Notes (before payment of fees and expenses), after the repurchase of the Repurchased Notes and prior to depositing approximately $9.8 million in escrow for the new Notes' make-whole provision. The new Notes will rank equal in right of payment with all existing and future unsecured senior indebtedness of the Company.

In addition, the Company obtained a conditional put option to require the investor to purchase up to $6 million of its Series C 10% Convertible Notes (the "C Notes"), related to a tender offer for up to $124 million principal amount of the Company's outstanding convertible notes that the Company may commence in the near future. If the Company receives tenders of at least $62 million of its outstanding convertible notes, it has the option to require the investor to purchase $3 million principal amount of the C Notes, and if the Company receives tenders of at least $93 million of its outstanding convertible notes, it has the option to require the investor to purchase $6 million principal amount of the C Notes. The C Notes would have substantially the same terms as the Notes.

Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. (Nasdaq: RODM - News), acted as the exclusive placement agent for the transaction.

A prospectus supplement relating to the new Convertible Senior Notes to be issued in the offering has been filed with the Securities and Exchange Commission. Copies of the prospectus supplement and accompanying base prospectus may be obtained directly from Cell Therapeutics, Inc., 501 Elliott Avenue West, Suite 400, Seattle, Washington 98119.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.

This press release contains forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect future results. The risks and uncertainties include that the Company continues to have a substantial amount of debt outstanding and the quarterly interest expense associated with the debt is significant; the Company's operating expenses continue to exceed its net revenues and the Company will continue to need to raise capital to fund its operating expenses; as well as other risks listed or described from time to time in the Company's most recent filings with the SEC on Forms 10-K, 8-K and 10-Q. Except as required by law, the Company does not intend to update any of the statements in this press release upon further developments.


Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: [e-mail]
http://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: [e-mail]
http://www.CellTherapeutics.com/investors




--------------------------------------------------------------------------------
Source: Cell Therapeutics, Inc.

[Bombenleger]

Zevalin Consolidation in Patients With Complete Remission After Induction Therapy Results in Durable Remission of More Than 67 Months
Monday December 8, 1:30 am ET
Updated Phase III First-line Indolent Trial (FIT) Results Confirms Continued Significant Benefit over Chemotherapy Alone


SEATTLE, Dec. 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that extended follow-up data for the Zevalin® ([90Y]-ibritumomab tiuxetan) First-line Indolent (FIT) study presented at the American Society of Hematology (ASH) 50th Annual Meeting by Morschhauser, et al demonstrated the continued improvement in progression-free survival (PFS) following Zevalin consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieved a response to first line therapy over chemotherapy alone. Additionally, Zevalin consolidation did not adversely affect the use of various effective second-line treatments including stem cell transplants in patients who relapsed.
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"The FIT study follow-on results are quite impressive when one considers that the median progression free survival for the Zevalin recipients that achieved a complete remission (CR) after induction therapy has not yet been reached with an estimated 67 months compared to 30 months with chemotherapy alone," said James A. Bianco, M.D., CEO of Cell Therapeutics. "A single dose of consolidation that could allow patients with a CR from requiring additional treatment for their NHL for over 3 years represents a significant advancement in the treatment of this disease."

The multinational, randomized phase III FIT study evaluated the benefit and safety of a single infusion of Zevalin in patients with follicular B-cell non-Hodgkin's lymphoma who had achieved a partial remission (PR) or a complete remission / complete remission unconfirmed (CR/CRu) after receiving standard first-line chemotherapy regimens. Patients were randomized to either Zevalin consolidation or no further therapy. The FIT trial results were first presented at the December 2007 ASH annual meeting. The results were subsequently published in Journal of Clinical Oncology 2008 26(32):5156-64. At the 2008 ASH meeting, the investigators presented an additional 1-year follow-up (median follow-up of 42 months) of the FIT study that included 409 patients who achieved a CR/CRu or PR after induction therapy. Patients that achieved a CR after induction therapy achieved a median PFS of >67 months for the Zevalin arm compared to 30.8 in the control arm (HR 0.61[95% CI .41-.91]; p = 0.015). Patients that achieved a PR after induction therapy achieved a median PFS of 29.6 months for the Zevalin arm compared to 6.7 months in the control arm (HR 0.36[95% CI .25-.51]; p < 0.001).

Subsequent therapy with various modalities including chemotherapy, radiotherapy, immunotherapy, Zevalin and stem cell transplation (ASCT) was given to 63 patients in the Zevalin arm and 108 patients in the control arm, who achieved an overall response rate of 81% and 73%, respectively. The results demonstrate that administration of Zevalin as consolidation therapy does not preclude the use of effective second line therapies.

No previously unreported toxicities were noted and there was no increase in the incidence of secondary malignancies to date in patients treated with Zevalin as compared to control patients.

CTI has submitted a supplemental Biologics License Application (sBLA) to the FDA based on the FIT data obtained through an agreement with Bayer Schering Pharma AG, Germany. The FDA has accepted the application for review and granted a priority review status with a Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 for a decision on the application.

About First-Line Consolidation Therapy

Consolidation therapy is a treatment given after initial induction therapy and is aimed at improving the quality of the patient response by further diminishing the number of cancer cells with the goal of extending the response duration.

About Zevalin®

Zevalin® (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non- Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit http://www.zevalin.com for more information.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.

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. Specifically, the risks and uncertainties that could affect the development of Zevalin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Zevalin in particular including, without limitation, the potential for Zevalin FIT data to be acceptable to the FDA for this expanded indication or any other indication, the determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, and costs of developing, producing and selling Zevalin, and the ability of CTI to continue to raise capital to fund its operations. There is also a risk that even if label expansion of Zevalin is approved, it may not result in a significant market increase for the drug due to the presence of other treatment options, failure to gain market acceptance and other factors. You should also review 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: [e-mail]
http://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: [e-mail]
http://www.CellTherapeutics.com/investors




--------------------------------------------------------------------------------
Source: Cell Therapeutics, Inc.

[Bombenleger]

Three Italian Multicenter Studies Report High (>70%) Rates of Complete Remission (CR) Utilizing Zevalin Radio-Immunotherapy (RIT) in Treatment of Newly Diagnosed or Relapsed or Refractory Non-Hodgkin's Lymphoma
Tuesday December 9, 1:30 am ET


SEATTLE, Dec. 9 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that the results of three Italian multicenter studies utilizing Zevalin® ([90Y]-ibritumomab tiuxetan) were presented at the American Society of Hematology (ASH) 50th Annual Meeting in San Francisco, CA.
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In one presentation, the Italian Cooperative Study Group in a phase II study investigated the use of single dose Zevalin as sole initial treatment in 15 patients with advanced stage (III-IV) follicular NHL. Ninety-three percent (93%) of patients had a response with 73% achieving a complete remission (CR). At a median follow-up of 10 months, 93% of patients are alive, with 71% in continuous CR. No patients required hematopoietic growth factors. Hematologic toxicity was low and quickly reversible; 7 patients developed grade 3 thrombocytopenia and 5 required platelet transfusions.

In a second presentation, investigators from the European Institute of Oncology, Milan treated 13 patients with relapsed or refractory primary gastric NHL including 9 patients with Mucosa Associated Lymphoid Tissue or MALT with a single dose of Zevalin. Ten of 13 patients achieved a CR with all 9 patients (100%) with MALT achieving a CR. Toxicities were mainly hematologic and reversible. After a median follow up of 36 months 9 of 10 CR's (90%) are disease free.

The potential benefits of RIT with Zevalin combined with BEAM conditioning regimen (Z-BEAM) followed by autologous stem cell transplantation (ASCT) for patients who fail to achieve a CR after front line rituximab containing multi- agent chemotherapy for advanced NHL was also presented. The results of the Italian Multicenter Study demonstrated that among 53 patients who failed to achieve CR after CHOP-R, the Z-BEAM followed by ASCT resulted in a 74% CR rate. At a median follow up of 175 days post transplant 40 patients (75%) are alive, 30 patients (57%) in CR. Fourteen patients died, 7 due to treatment related toxicities, and 6 due to progressive disease. The estimated 3 year event free survival (EFS) 64%.

"These three additional studies add to the growing body of clinical trial evidence that radio-immunotherapy with Zevalin produces high, durable rates of complete remission in high risk, relapsed or refractory NHL," noted Jack Singer, M.D. and Chief Medical Officer of CTI. "We believe that the impressive 73% CR rate when given as a single agent in previously untreated patients with follicular NHL is worth pursuing in additional trials as it could potentially provide an alternative to multiagent chemotherapy regimens particularly among elderly or infirm patients. Similarly, the 100% CR rate in MALT is an intriguing finding that could represent an additional registration route as it is an unmet medical need. We believe with these and additional prospective randomized clinical trials Zevalin, Radio-Immunotherapy, may finally assume a role alongside cornerstone treatment regimens for NHL," Dr. Singer added.

About Zevalin®

Zevalin® (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non- Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit http://www.zevalin.com for more information.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.

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 about trials conducted by third parties and future potential trials that may conducted by CTI 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 future development of Zevalin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Zevalin in particular including, without limitation, the potential for Zevalin to be proved safe and effective for the treatment of additional indications as noted in these presentations or any other indication, the success of the proposed joint venture for Zevalin with Spectrum Pharmaceuticals, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, the costs of developing, producing and selling Zevalin and CTI's ability to raise additional capital to fund additional clinical trials for Zevalin. You should also review 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: [e-mail]
http://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: [e-mail]
http://www.CellTherapeutics.com/investors




--------------------------------------------------------------------------------
Source: Cell Therapeutics, Inc.

[Pipifax]

Bin heute eingestiegen. Könnte spannend werden.

[VaJo]

Antwort auf Beitrag Nr.: 36.276.916 von Pipifax am 29.12.08 19:30:21

Ja sehr spannend.
Ich warte darauf das CTIC die restlichen 50% von Zevalin an Spectrum Pharmaceuticals verkauft.

Die Chancen das Cell Therapeutics überlebt stehen sehr schlecht.

[Pipifax]

Antwort auf Beitrag Nr.: 36.277.143 von VaJo am 29.12.08 20:02:17

Die Tagesumsätze in letzter Zeit sind auffallend hoch.

[VaJo]

Antwort auf Beitrag Nr.: 36.279.038 von Pipifax am 30.12.08 09:31:19

Die die Zocken wollen zocken. Die Anleger die die Zeichen erkannt haben wollen raus. Darum sind die Umsätze in Mailand hoch.
Der Kurs bei uns ist Makulatur. Wenn Du Pech hast bekommst du deine nie mehr los.

[Pipifax]

Antwort auf Beitrag Nr.: 36.280.550 von VaJo am 30.12.08 12:24:37

Zockeraktie. Absolut. Aber die hohen Umsätze sind schon verblüffend. Ob in Mailand oder Nasdaq. Viele Verkäufer und viele Käufer. Scheinbar scheinen doch einige auf einen plötzlichen Ausbruch zu spekulieren, wie kürzlich bei Angiotech Pharmaceuticals.

[VaJo]

CTIC strampelt ums überleben.

07.01.2009 07:31
Cell Therapeutics Announces Receipt of NASDAQ Panel Decision to Transfer to NASDAQ Capital Market

SEATTLE, Jan. 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (News) (CTI) (Nasdaq and MTA: CTIC) announced today that it has received notification that the NASDAQ Listing Qualifications Panel has granted CTI's request to transfer the listing of its common stock from The NASDAQ Global Market to The NASDAQ Capital Market, which will be effective with the open of trading on Thursday, January 8, 2009. CTI's shares will continue to trade under the ticker symbol CTIC.

CTI's continued listing on The NASDAQ Capital Market is subject to CTI evidencing compliance with all applicable requirements for continued listing on The NASDAQ Capital Market, including the $35 million market value of listed securities requirement or its alternatives, as set forth in NASDAQ Marketplace Rule 4310(c)(3), by February 12, 2009. The Company expects to comply with all applicable requirements for continued listing on The NASDAQ Capital Market by February 12, 2009; however, there can be no assurance that it will be able to do so.

As disclosed on September 6 and October 10, 2008, CTI was previously notified by NASDAQ regarding its non-compliance with the $50 million market value of listed securities requirement for continued listing on The NASDAQ Global Market. In response, CTI appeared before the NASDAQ Listing Qualifications Panel at a hearing at which it requested the transfer of its listing to The NASDAQ Capital Market pursuant to its plan to evidence compliance with the $35 million market value of listed securities requirement for continued listing on that market.

The NASDAQ Capital Market is one of the three market tier designations for NASDAQ-listed stocks and operates in substantially the same manner as The NASDAQ Global Market. Securities listed on The NASDAQ Capital Market must satisfy all applicable qualification requirements for NASDAQ securities, and companies listed on The NASDAQ Capital Market must meet certain financial requirements and adhere to NASDAQ's corporate governance standards.