Cell Therapeutics vor Tounaround?
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EMEA Validates Cell Therapeutics, Inc.'s (CTI) Expanded Pixantrone Pediatric Investigation Plan (PIP) / Advances Pixantrone MAA Filing Process in Europe
SEATTLE, Aug. 16 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has received notice that the European Medicines Agency ("EMEA") has validated the expanded Pediatric Investigation Plan ("PIP") that CTI filed in July for pixantrone for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Following the validation, the EMEA Pediatric Committee (the "PDCO") will review and comment or approve the content of pediatric plan. Once the PIP is approved, CTI will submit the Marketing Authorization Application ("MAA") for pixantrone in the E.U. later this year. The pediatric program will study pixantrone in pediatric patients aged 6 months to 18 years with the goal of determining the comparative safety and effectiveness of pixantrone compared to doxorubicin in pediatric lymphoid cancers.
"We are very pleased that the EMEA has validated the expanded PIP for pixantrone, as there is a real need for a less toxic, more effective anthracycline-like treatment option not only in lymphoma, but also possibly in other tumors," said Jack Singer, Chief Medical Officer of CTI. "We look forward to completing the MAA submission, and continuing to pursue our goal of providing pixantrone as a treatment option to the patients who need it most."
CTI submitted the updated, expanded PIP in July 2010 after the PDCO recommended CTI expand the original PIP of September 2009 to include pixantrone's potential, but unproven, clinical benefit to children in reducing long-term cardiotoxicity associated with current curative therapies. The recommendation from the PDCO came following discussions with CTI about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancer.
About Pixantrone
Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines--rather than intercalation with DNA--pixantrone alkylates DNA--forming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone to prevent the binding of iron and perpetuation of superoxide production--both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.
About Cell Therapeutics, Inc.
Stem Cell Therapeutics Corp kündigt Rücktritt eines Board of Director
Calgary, Alberta - (MARKET WIRE ) - 09/15/10 - Stem Cell Therapeutics Corp. (" SCT " oder das "Unternehmen ") (TSX VENTURE: SSS ) gab heute bekannt , dass Scott Tannas wird der Verwaltungsrat im September verlassen 30th, 2010.
Dean Peterson, Chairman SCT sagte : "Wir danken Scott für seine Verdienste um das Unternehmen , und vereinbaren, dass jetzt der richtige Zeitpunkt ist , um die Größe unseres Vorstands zu reduzieren. Wir haben eine " hands - on -Agenda " vor uns , und wir fühlen uns zuversichtlich, dass wir voranschreiten können mit aktuellen etablierten Unternehmen . "
* Positive Stellungnahme von pädiatrischen Komitee der European Medicines Agency ebnet
Weg für Pixuvri Zulassungsantrag Vorlage
* Sagt erwartet die EMA die Entscheidung über die Annahme des PDCO Empfehlungen
später in diesem Quartal
Weitere News im Zusammenhang mit CTIC
* Cell Therapeutics (CTIC) erhält Zulassung für EMA Pixuvri pädiatrischen Prüfkonzept
Weitere News im Zusammenhang mit Corporate News
17. November 2010 07.17 Uhr EST
Cell Therapeutics, Inc. (Nasdaq: CTIC) Gab am Mittwoch, dass es die Genehmigung der Europäischen Arzneimittelagentur erhielt für den Unternehmenserfolg Pixuvri pädiatrischen Prüfkonzept für die Behandlung von malignen lymphatischen und soliden Tumoren bei Kindern im Alter zwischen sechs Monaten und 18 Jahren.
CTI erwartet die EMA zu einer Entscheidung über die Annahme der Vorlage Pixuvri MAA zur Prüfung in diesem Monat machen.
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) (the "Company") today announced that it has entered into a securities purchase agreement (the "Purchase Agreement") to sell, subject to certain closing conditions, up to $25.0 million of shares of its Series 8 Non-Convertible Preferred Stock (the "Series 8 Preferred Stock"), warrants to purchase up to 22,563,177 shares of common stock (the "Warrants") and an additional investment right (the "Additional Investment Right") to purchase up to $25.0 million of shares of its Series 9 Convertible Preferred Stock (the "Series 9 Preferred Stock"), in a registered offering to a single life sciences institutional investor (the "Investor").
SEATTLE, 14. Februar 2011 / PRNewswire / -
Auf Mittwoch 16. Februar, 2011Bei 08.30 Uhr Eastern /14.30 Uhr Central European /05.30 Uhr Pazifik, Mitglieder von Cell Therapeutics, Inc. (CTI) (Nasdaq und MTA: CTIC) wird das Management-Team eine Telefonkonferenz abhalten, um die Gesellschaft für 2010 das vierte Quartal und Jahresende Leistungen und finanziellen Ergebnisse zu diskutieren.
Einwahlnummern
Friday, 11 March 2011 06:57
DALLAS, March 11, 2011 (GLOBE NEWSWIRE) -- MicroStockProfit.com announces an investment report featuring Cell Therapeutics Inc. (Nasdaq:CTIC). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.
The full report is available at: www.microstockprofit.com/lp/CTIC
Cell Therapeutics Inc. (CTIC) engages in the development, acquisition and commercialization of novel treatments for cancer. It focuses on building a biopharmaceutical company with a diversified portfolio of oncology drugs. Its research, development, acquisition and in-licensing activities concentrate on identifying and developing less toxic ways to treat cancer. The Company is focused on developing pixantrone, OPAXIO, brostallicin and bisplantinates. Pixantrone is an anthracycline derivative, for the treatment of non-Hodgkin's lymphoma (NHL), and various other hematologic malignancies, solid tumors and immunological disorders. The Company is developing OPAXIO (paclitaxel poliglumex), a maintenance therapy for women with advanced stage ovarian cancer. Brostallicin is a synthetic Deoxyribonucleic Acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity.
Die läuft jetzt erst los.
riecht alles stark nach der strategie von genta,
wen interessiert schon European Medicines Agency, etwas positives von der fda und
das ding explodiert, siercher ist hier nur, dass man abgezockt wird