Cell Therapeutics vor Tounaround?
Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkin's Lymphoma Trial
* Wednesday January 28, 2009, 1:30 am EST
SEATTLE, Jan. 28 /PRNewswire-FirstCall/ -- Cell Therapeutics (CTI) (Nasdaq and MTA: CTIC) announced today preliminary progression-free survival (PFS) results from its pivotal phase III EXTEND (PIX301) trial of pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin's lymphoma (NHL) treated with pixantrone experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, p < 0.01, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. PFS was a prospectively defined secondary endpoint in the study.
"We always believed the effectiveness of pixantrone would translate into a meaningful difference for patients with relapsed aggressive NHL and these dramatic and significant differences in PFS in this tough to treat group of patients provides that evidence," stated James A. Bianco, M.D. Chief Executive Officer of CTI. "Pixantrone is the first agent in this patient population to demonstrate a significant and meaningful PFS advantage. We believe these data will support a priority review designation on our New Drug Application (NDA) once we share them with the Food and Drug Administration (FDA)."
The Company had previously announced that its pivotal phase III (PIX 301) EXTEND trial had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02) with no patients in the standard chemotherapy arm achieving a confirmed complete remission. Additionally, pixantrone treatment also significantly increased the overall response rate (CR/CRu+PR) (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). PFS, CR/CRu and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.
The most common serious toxicities (>5%) seen in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety information is not yet available for the study, however, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee and no serious concerns were raised.
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 enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician. The trial was designed to examine the complete remission or unconfirmed complete remission rate, overall survival and progression-free survival. The study received Special Protocol Assessment approval from the FDA in 2004 and pixantrone has received fast track designation for this indication.
The Company announced on January 27, 2009 that after a pre-NDA communication with the FDA, it expects to begin submission of a rolling NDA and request priority review for pixantrone to treat relapsed aggressive NHL in the first quarter of 2009.
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. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy 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 results of complete safety information, the ability of the company to file a rolling NDA in the first quarter of 2009,a determination by the FDA that the PIX301 trial is insufficient to support an NDA filing and that the FDA would grant priority review, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the Company's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T : 206.272.4347
F : 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors
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10.02.2009 07:31
Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone
SEATTLE, Feb. 10 /PRNewswire-FirstCall/ -- Cell Therapeutics (CTI) (NASDAQ and MTA: CTIC) today announced that they have executed a definitive collaborative agreement with IDIS to manage its investigational drug pixantrone on a named patient basis in Europe. Pixantrone will be supplied by IDIS to healthcare professionals for the treatment of individual patients with relapsing aggressive non-Hodgkin's lymphoma. This program is expected to be initiated by second quarter of 2009.
"Under the named patient program, CTI will be able to provide pixantrone to European patients in need at the prescriber's request while moving it through the approval process in the United States," noted Craig Philips, President of CTI. "With the announcement of preliminary results showing significantly higher rate of complete remission and improvement in progression-free survival for patients receiving pixantrone compared to standard chemotherapeutic agents, we expect to receive a number of requests for pixantrone to treat specific patients."
"Pixantrone is an important new treatment with impressive remission and progression-free survival data," said Dr. Raul Herbrecht of Strasbourg University Hospital in France. "This drug is also important because it meets an unmet medical need for this group of patients. I have been impressed by the good tolerance and efficacy of pixantrone since the first clinical trial we had with this drug in our department. We obtained excellent results in salvage therapy of non-Hodgkin's lymphoma in heavily pretreated patients and several years later some of our patients are still in complete response. These positive results have been confirmed in further studies," Dr Herbrecht added.
The EXTEND clinical trial was 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 enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician.
"We are pleased to be working with Cell Therapeutics to ensure that those patients with non-Hodgkin's Lymphoma who do not respond to current available therapies have access to pixantrone through a named patient program," said Natalie Douglas, CEO, IDIS. "CTI's potentially life-saving medicine can offer these patients renewed hope for remission. We are deeply committed to work in partnership with pharmaceutical and biotechnology companies to give physicians and their patients access to new and innovative medicines through regulated and responsible channels."
CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients. Pixantrone treatment also significantly increased the overall response rate (CR/CRu+PR) with (26/70 (37.1%) for pixantrone arm compared to 10/70 (14.3%) for the control arm, p = 0.003). In January, 2009 CTI announced preliminary results that show patients treated with pixantrone experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, hazard ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. PFS, CR/CRu and ORR were determined by an independent assessment panel that was blinded to the treatment assignments.
The most common serious toxicities (>5%) seen in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety information is not yet available for the study, however, the study was monitored on an ongoing basis by an independent Data Safety Monitoring Committee and no serious concerns were raised.
The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004 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. Pixantrone is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy 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 IDIS
IDIS is the world leader in the development and implementation of named patient programs and has a proven track record of working in strategic partnership with US-based companies to bring new drugs to Europe for the first time. IDIS supports customers in over 100 countries, supplying more than 400 different medicines per month and responding to more than half a million requests on a named patient basis to medical professionals worldwide. For more information on IDIS please visit our website at http://www.idispharma.com/.
About Cell Therapeutics, Inc. (News)
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 results of complete safety information, the ability of the company to initiate named patient sales by the second quarter of 2009, the failure to receive anticipated number of requests for pixantrone to treat specific patients, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the company's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: media@ctiseattle.com 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: invest@ctiseattle.com http://www.celltherapeutics.com/investors
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12.02.2009 00:02
Cell Therapeutics Updates Shareholders on Trading
SEATTLE, Feb. 11 /PRNewswire-FirstCall/
Cell Therapeutics, Inc. (News) (Nasdaq and MTA: CTIC) announced today that the Borsa Italiana, which is the entity that governs the trading of the Company's common stock on the MTA stock market in Milan, Italy, suddenly suspended trading of the Company's shares in Italy on February 10th. As a result of the suspension of trading by the Borsa Italiana, the security has additionally been halted on the NASDAQ Stock Market pursuant to Marketplace Rule 4120(a)(4) when a security is also registered on a foreign securities exchange and the foreign securities exchange halts trading in such security for regulatory reasons. We have not been advised of any independent basis for NASDAQ's decision to halt trading.
The Company's common stock has traded on the MTA since 2004 and is thus required to comply with the rules and regulations of the Commissione Nazionale per le Societe e la Borsa, or CONSOB, which is the public authority responsible for regulating the Italian securities markets and the Borsa Italiana, which oversees the trading market in Italy. Collectively these agencies regulate companies listed on Italy's public markets. The Company has responded to numerous requests by both the Borsa Italiana and CONSOB to provide additional clarifications about its business operations and financial condition, and the Company has met with CONSOB on several occasions, most recently on February 6th, to answer such questions. As in the past, the Company believes it has complied with CONSOB's requests to issue additional press releases in Italy and if required filed as Form 8-K in the US clarifying the information contained in the Company's SEC filings and press releases and the Company is committed to continuing to do so. The Company is waiting for clarification from the Borsa Italiana and CONSOB as to what additional information or action the Company must take, if any, for the Borsa Italiana to resume trading in Italy. The Company believes that it is currently in compliance with all undertakings for filing and reporting obligations in Italy as agreed with the Borsa Italiana and CONSOB when the shares were accepted for listing in Italy.
The Company is diligently working with the Borsa Italiana, CONSOB and the NASDAQ Stock Market to have one or both markets resume trading in the Company's common stock.
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 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 may not be able satisfy the Italian regulatory authorities requests for information; the Borsa Italiana may choose not to lift the trading halt in Italy; the Company's current extension of time to comply with the NASDAQ listing requirements may not be extended by the NASDAQ Qualification Panel and the Company may be delisted by NASDAQ; 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: media@ctiseattle.com http://www.celltherapeutics.com/press_room Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch T: 206.272.4347 F: 206.272.4434 E: invest@ctiseattle.com http://www.celltherapeutics.com/investors
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Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma
Wednesday February 18, 1:30 am ET
Phase III safety data underscores clinical benefit of pixantrone
SEATTLE, Feb. 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that updated safety and efficacy data from the phase III trial of pixantrone provides further support for a robust clinical benefit for pixantrone when used as single agent therapy in the treatment of multiple relapsed aggressive non-Hodgkin's lymphoma (NHL). On an intent-to-treat analysis, pixantrone recipients who achieved a complete remission did so during the first 2 cycles of therapy, compared to 4 cycles among standard chemotherapy recipients, (1.9 months vs. 3.6 months, pixantrone vs. standard chemotherapy). The duration of response in the patients was similar in the 37% of pixantrone patients who had either a partial or complete response compared to the 14% of comparator patients with a major response. However, the overall progression free survival (PFS) was significantly longer in the pixantrone arm (4.7 months vs. 2.6 months, hazard ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy). Thirty-two percent (32%) of pixantrone patients received all 6 cycles of therapy, with 84% receiving 5 of 6 cycles of treatment. Pixantrone recipients had a low incidence of severe neutropenia complicated by either fever or documented infections, or severe vomiting or diarrhea. Pixantrone patients also experienced a low incidence of hair loss, a very common side effect of other drugs in this class. Overall, the incidence of serious adverse events was similar between pixantrone and the control arm. The pixantrone patients had a higher incidence of leucopenia and neutropenia and numerically more severe cardiac events (4 vs 2) than in the control arm. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).
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"We were impressed to see that 84% of patients received at least 5 cycles of pixantrone therapy with a median total dose of 1,475 mg, despite having had significant prior therapy with doxorubicin, an agent in a similar class with cumulative cardiotoxicity," noted Jack Singer, M.D., Chief Medical Officer at CTI. "The rapid time-to-response data coupled with the relatively low incidence of traditional anthracycline toxicities and a safety profile that compares favorably to standard chemotherapy, positions pixantrone to live up to the promise of providing patients with relapsed aggressive NHL a meaningful clinical benefit."
CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients.
CTI expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to treat relapsed aggressive non- Hodgkin's lymphoma ( NHL) in the first quarter of 2009. If granted priority review a decision on the NDA could occur before the end of 2009.
The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004, and pixantrone has received fast track designation for this indication.
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18.02.2009 15:51
CEP2: WIEDERAUFNAHME/RESTART
DIE FOLGENDE AKTIE WIRD MIT SOFORTIGER WIRKUNG WIEDER IN DEN HANDEL
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THE FOLLOWING SHARE IS RESUMED TRADING WITH IMMEDIATE EFFECT:
INSTRUMENT NAME KUERZEL/SHORTCODE ISIN
Cell Therapeutics CEP2 US1509345039 (News)
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20.02.2009 22:06
Cell Therapeutics Exercises Its Option to Sell Interest in Zevalin Joint Venture to Spectrum Pharmaceuticals for $18 Million
SEATTLE, Feb. 20 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (News) (CTI) (Nasdaq and MTA: CTIC) announced today that it exercised its option to sell its 50% ownership interest in the Zevalin joint venture to Spectrum Pharmaceuticals, (News) Inc. (Spectrum) for $18 million. CTI and Spectrum established a joint venture in December 2008 to develop and commercialize Zevalin. At that time CTI contributed all of the Zevalin related assets to the joint venture and sold to Spectrum a 50% membership interest in the joint venture for $15 million, plus certain milestone payments.
The Company will focus its resources on the approval of pixantrone for relapsed aggressive non-Hodgkin's lymphoma (NHL) and OPAXIO for non-small cell lung and ovarian cancer. CTI estimates that as a result of the sale of the Zevalin interest it will reduce expenses by approximately $15 million annually from activities previously associated with Zevalin while providing CTI with non-dilutive source of operating capital.
"CTI continues to believe in the value of Zevalin as a commercially attractive product and effective form of cancer therapy; however, with the impressive clinical trial results for pixantrone and given the company's need for operating capital, we are compelled to exercise our option and focus our resources on pixantrone," noted James Bianco, MD, CEO of CTI. "CTI has been proud to have provided Zevalin to patients since we acquired it in December, 2007 and having the foresight to bring the first line consolidation for indolent NHL data to the FDA for potential label expansion in the front line consolidation setting. With the progress we made in removing many of the barriers that prevent its more widespread use, we are confident Spectrum will be able to ultimately make Zevalin a commercially attractive product."
At the closing of the sale of CTI's 50% membership interest in the joint venture to Spectrum, CTI will receive $6 million, with the remainder of the $18 million to be paid within 90 days following such closing. The closing of the sale option transaction is contingent upon the satisfaction of certain closing conditions, including the delivery of a legal opinion from counsel to CTI, as specified in the operating agreement for the Zevalin joint venture. CTI believes that it will be in a position to promptly satisfy all of the closing conditions
...
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Cell Therapeutics. Il Pixantrone ad un passo dall’approvazione
giovedì 26 marzo 2009 - 17:55
Il Pixantrone ad un passo dall’approvazione. Secondo indiscrezioni circolate nelle ultime ore già nei prossimi giorni potrebbe essere approvato il Pixantrone, farmaco antitumorale attivo contro il linfoma non hodgkin. Sulla scia delle voci circolate il titolo è arrivato a toccare a Wall Street un rialzo superiore al 200% su forti scambi. Secondo le indicazioni della stessa società la commercializzazione del Pixantrone potrebbe portare entro il 2014 ad un fatturato di 1 miliardo di dollari, anche se a detta degli analisti i numeri potrebbero essere molto più alti. Il colosso Novartis risulta tuttora titolare di un’opzione per negoziare una licenza mondiale in esclusiva per sviluppare e commercializzare il farmaco antitumorale Pixantrone.
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Cell Therapeutics. The Pixantrone to a step from the approval
26 thursdays March 2009 - 17:55
The Pixantrone to a step from the approval. According to indiscretions circulated in the last hours already in the next few days could be approved of the Pixantrone, active antitumor drug against the lymphoma not hodgkin. On the wake of the voices circulated the title it has succeeded in to touch to Wall Street a advanced rise to 200% on strong exchanges. According to the indications of the same society the commercialization of the Pixantrone could carry within 2014 to a turnover of 1 billion of dollars, even if to said of the analysts the numbers they could be very higher. The Novartis colossus still turns out titular of an option in order to negotiate a world-wide licence in exclusive right in order to develop and to commercialize the antitumor drug Pixantrone
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