Cell Therapeutics vor Tounaround?

habe am 28.02. auf sein Bauchgefühl gehört.
Über 300% sind ja nicht schlecht und die Nachrichten in #48 taugen hoffentlich für noch etwas Luft nach oben.  

 

ich hatte gestern auch gutes Bauchgefühl :-))     bei # 50

CTI Receives the Second Payment of $6.5 million Associated with the Sale of Interest in Zevalin Joint Venture

http://ih.advfn.com/...19580&article=37184437&symbol=N%5ECTIC  

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=36855631

und

http://stockcharts.com/c-sc/...10!uc15!lp5,5][j20444984,y]&r=3555  

Cell Therapeutics, Inc. Announces Single Institutional Investor Purchases $15 Million of Preferred Stock
Date : 04/13/2009 @ 2:54PM
Source : PR Newswire
Stock : (CTIC)
Quote :  0.3452  -0.0348 (-9.16%) @ 3:17PM


Cell Therapeutics, Inc. Announces Single Institutional Investor Purchases $15 Million of Preferred Stock




Company Further Simplifies Its Capital Structure By Completing the Elimination of All Previously Outstanding Preferred Stock

SEATTLE, April 13 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it has agreed to sell up to $20 million of Series 1 Preferred Stock and warrants in a registered offering to a single institutional investor. The investor initially purchased today, for $15 million cash, shares of Series 1 Preferred Stock with a stated value of $15 million and certain associated common stock warrants and has the right to, within 60 days, purchase for an additional $5 million cash additional shares of Series 1 Preferred Stock with a stated value of $5 million with no additional warrants. The Series 1 Preferred Stock is convertible into shares of common stock at a conversion price of $0.30. The investor received 45% warrant coverage on the initial $15 million purchase. The warrants have an exercise price of $0.41 per share, for total potential additional proceeds of approximately $9 million. Approximately three-fifths of the warrants cannot be exercised until after six months from issuance, or 61 days from issuance if the investor does not exercise its option to purchase the additional Series 1 Preferred Stock.

The Series 1 Preferred Stock is non-dividend bearing and has no voting rights except to the extent required by law.

Separately, the Company reacquired the remaining 100 outstanding shares ($100,000 stated value) of its Series A 3% Convertible Preferred Stock in exchange for 288,517 shares of common stock, and the Company has agreed to reacquire the remaining 1,000 outstanding shares ($1,000,000 stated value) of its Series D 7% Preferred Stock in exchange for shares of common stock based on a formula keyed to the volume-weighted average price over a 3-day period following April 13, 2009.

Upon completion of these exchanges, the only preferred stock of the Company outstanding will be the new Series 1 Preferred Stock, thereby relieving the Company of future potential redemptions and restrictive covenants contained in the prior series of Preferred Stock.

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

A shelf registration statement relating to the Series 1 Preferred Stock and warrants issued and to be issued in the offering, and to the underlying common stock, has been filed with the Securities and Exchange Commission and has become effective. A prospectus supplement related to 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 our Series 1 Preferred Stock or warrants or underlying common stock. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

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. The risks and uncertainties include the risk that the investor might not exercise its option to buy additional Series 1 Preferred Stock and/or might not exercise its warrants, the Company's ability to continue to raise additional capital as needed to fund its operations, and other 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 and 8-K. 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: 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: http://www.celltherapeutics.com/investors

DATASOURCE: Cell Therapeutics, Inc.


CONTACT: Media, Dan Eramian, +1-206-272-4343, cell, +1-206-854-1200,

, or Investors, Ed Bell, +1-206-272-4345, or Lindsey Jesch

Logan, +1-206-272-4347, fax, +1-206-272-4434, , all of

Cell Therapeutics, Inc.


Web Site: http://www.celltherapeutics.com/  

Cell Therapeutics Initiating Rolling NDA Submission for Pixantrone

Tuesday April 14, 2009, 1:30 am EDT


SEATTLE, April 14 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it began a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTI expects to complete the submission this quarter and will request priority review which if granted could lead to an approval decision from the FDA in Q4 2009.

"This is a significant milestone for CTI as we move pixantrone closer to addressing a truly significant unmet medical need for relapsed or refractory aggressive NHL patients," said James A. Bianco, M.D., CEO of CTI. "The commercialization of pixantrone will drive shareholder value as a result of the large market potential for this product. We believe that the recent significant investment in CTI by a single institutional investor reflects a growing interest in CTI and in particular in pixantrone by the investment community. With added financial resources, CTI can advance pixantrone through the NDA review process while we continue our progress on strategic business development opportunities and relationships."

CTI 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, progression-free survival (PFS) results from this study 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, p < 0.01, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. 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).

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 (5 vs. 2) with only 1 considered related to the study drug by the investigator. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).

The pixantrone study received Special Protocol Assessment approval from the FDA in 2004, and pixantrone has received fast track designation for this indication. The FDA's fast track programs are intended to expedite the review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The rolling submission process enables companies that have been granted fast track designation to submit sections of the NDA to the FDA as they become available, allowing the review process to begin before the complete dossier has been submitted.  

Upon completion of these exchanges, the only preferred stock of the Company outstanding will be the new Series 1 Preferred Stock, thereby relieving the Company of future potential redemptions and restrictive covenants contained in the prior series of Preferred Stock.

 

Company Further Simplifies Its Capital Structure By Completing the Elimination of All Previously Outstanding Preferred Stock

 

A Resurgence in Cell Therapeutics  
Written by Mike Havrilla    
Thursday, 02 April 2009 11:26  

....weiterlesen !

http://biomedreports.com/articles/most-popular/...l-therapeutics.html  

Wieder in Cell Therapeutics
Geschrieben von Mike Havrilla
Donnerstag, 02 April 2009 11:26
Da ich profilierte Cell Therapeutics (CTIC) vor zwei Monaten, wie ein Krebs, der Biotech-, aber nicht aus, der Aktienkurs hat sich mehr als vervierfacht von 8 Cent auf 36 Cent im Intraday-Handel heute. CTIC weiter zu reduzieren die Betriebskosten und verkauft seine restlichen Anteile an einem Joint Venture auf den Markt Krebsmedikament Zevalin zu Spectrum Pharma (SPPI) für $ 16,5 im letzten Monat (zusätzlich zu erhalten $ 15M im Dezember letzten Jahres von SPPI für die ersten 50%-Beteiligung).

CTIC reduziert die Betriebskosten im Jahr 2008 um 33% und die Leitlinien, die auch eine Prognose für die operative Kürzung um rund 50% im Laufe des Jahres 2009. Das Unternehmen geht davon aus, dass seine pixantrone NDA Einreichung im 2Q09 mit einer sechsmonatigen vorrangigen Antrag (für eine mögliche Zulassung im Laufe des Jahres 2009), da positive Phase-3-Ergebnisse bei Patienten mit Rückfall, aggressiven Non-Hodgkin-Lymphom.

Im November vergangenen Jahres, pixantrone erreicht primären Endpunkte Wirksamkeit in einer Phase-3-Studie und die neuen Daten eine schnelle Reaktionszeit und günstige Sicherheitsprofil im Vergleich zur Standard-Chemotherapie und Anthrazyklinen (eine Klasse von Krebsmedikamenten, die sich in der chronischen Toxizität wie Herz Schäden, die Grenze ihrer Verwendung).

CTIC hat Vereinbarungen mit Novartis (NVS) für beide pixantrone und Opaxio, die für $ 17,5 Potenzial in pixantrone Meilenstein-Zahlungen ($ 7.5M Lizenzierung Option für NVS + $ 10M Genehmigung Meilenstein für die Zahlung pixantrone) und $ 25 Mio. für eine Opaxio Genehmigung Meilenstein in Europa. Das Unternehmen erwartet, dass es eine Stellungnahme zu dem Antrag auf Genehmigung für das Inverkehrbringen Opaxio in Europa im 2H09.

Im Rahmen ihrer Initiativen Kostensenkung, CTIC wird seine Arbeit Kraft von 194 Beschäftigten zum Jahresende auf 85 in der frühen 2Q09. Der Abbau ist vor allem im Zusammenhang mit der die Pläne des Unternehmens, um seine italienischen Research Center, zusammen mit Mitarbeitern, die mit Zevalin, die übertragen werden SPPI. CTIC erwartet, zur Verringerung der Netto-Betriebskosten von etwa $ 29M, was zu einer monatlichen Höhe von etwa $ 2.1M pro Monat in betrieblichen Aufwendungen in 2H09.

CTIC endete 2008 mit Cash-Äquivalente von ungefähr $ 10,7 und geschlossen, da der Umgang mit SPPI für $ 16,5 auf zusätzliches Kapital. Eine zusätzliche Kapital wird benötigt, in diesem Jahr und CTIC ist, die Möglichkeiten für Partnerschaften, Joint Ventures, Verkauf von Vermögenswerten, Schulden / Eigenkapital-Finanzierungen und / oder Umstrukturierungen zur Erfüllung dieser Anforderungen.

Ende März gab das Unternehmen bekannt, die Ergebnisse einer speziellen Hauptversammlung, welche Genehmigungen für das folgende: die Erhöhung der Zahl der zugelassenen Aktien der Aktien, die Erhöhung der Zahl der Aktien, für die Equity-Incentive-Plan und die Erhöhung der Anzahl von Aktien zur Verfügung für Arbeitnehmer Kauf Pläne. Aktionäre nicht billigen den Vorschlag, wäre es möglich gewesen, den Vorstand auf, ein Reverse-Aktiensplit.

Die vor kurzem wieder in Aktien der CTIC ist bezeichnend für das Unternehmen das Potenzial für wichtige Meilensteine für die Zulassung pixantrone und Opaxio im Laufe des Jahres 2009, die in bis zu $ 42,5 in Meilensteinzahlungen von Novartis. Die Kostensenkungsmaßnahmen und dem Verkauf von Zevalin Joint Venture für die Frequenzverwaltung CTIC die mit der Zeit und Flexibilität zu bewerten, strategische Alternativen für die Finanzierung und die Maximierung des Shareholder Value, da die Gesellschaft erwartet wichtige regulatorische Meilensteine, die voraussichtlich in der zweiten Hälfte dieses Jahres.  

SEATTLE, April 21 /PRNewswire-FirstCall/ -- Systems Medicine, LLC (SM), a wholly-owned subsidiary of Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC), presented data from a preclinical study, which utilized RNA interference (RNAi) and bioinformatics to identify genetic markers - "contexts of vulnerability" - that enhance the anti-tumor response to the experimental drug candidate brostallicin, at the 2009 American Association for Cancer Research (AACR) annual meeting in Denver, Colorado. "Contexts of vulnerability" refers to the genetic configuration in a patient's tumor that makes it susceptible to a specific drug thus providing the genetic rationale for targeted therapy. The study's objective was to identify molecular determinants of brostallicin's anti-tumor response that could guide clinical development and drug combination studies by incorporating an integrated pharmacogenomics approach. The study was conducted by SM in collaboration with the Translational Genomics Research Institute's Pharmaceutical Genomics Division in Scottsdale, Arizona.

"This study has identified certain patient groups which might be more likely to benefit from therapy with brostallicin and have been invaluable in assisting us in identifying promising clinical development strategies for future development of this novel drug candidate," said Jack Singer, M.D., Chief Medical Officer of CTI. "Ultimately, we believe this approach should shorten the clinical development time and increase the success rate by bringing us closer to being able to offer the right drug to the appropriate patient."

Brostallicin is a small-molecule chemotherapeutic agent with a unique mechanism of action -- it binds to the minor grooves located in the DNA double helix. To identify genes associated with cellular response to brostallicin, a high-throughput RNA interference screen was performed in selected ovarian cancer cell lines. RNA interference is a cellular process that results in the targeted knockdown of specific genes. The current screen assayed the effect of over 7,000 individual gene knockdowns, representing the "druggable" genome, on brostallicin response.

The identified genes, representing unique contexts of vulnerability to brostallicin, converged on cellular concepts relating to DNA repair and chromosome modification. These findings were further extended and confirmed in breast cancer cell lines, wherein the knockdown of specific genes involved in these concepts, mentioned above, resulted in an increased response to brostallicin.

To substantiate the brostallicin response observed in the RNAi studies, drugs that target selected genetic targets were tested for synergistic activity in combination with brostallicin. The outcome of this validation work has identified important contexts and rational drug combinations that will be critical for the clinical development of brostallicin.

To review the poster and see more detailed information about the study, please go to http://www.celltherapeutics.com/investor_updates.

About Brostallicin

Brostallicin, a novel synthetic second-generation DNA minor groove binder, has shown potent cancer killing activity and has demonstrated synergism in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical experimental tumor models. Brostallicin binds covalently to DNA within the DNA minor groove, interfering with DNA division and leading to tumor cell death. More than 200 patients have been treated with brostallicin in single-agent and combination studies. Brostallicin had predictable and predominantly hematologic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma met its pre-defined activity and safety hurdles and resulted in a first-line phase II study that is currently being conducted by the European Organization for Research and Treatment of Cancer (EORTC).

About Systems Medicine (SM)

In July 2007, CTI acquired Systems Medicine, a privately held oncology company, in a stock-for-stock merger. SM applies a systems biology approach to drug development, combining pharmacogenomics and bioinformatics with experienced preclinical, clinical, and regulatory expertise to find and exploit a specific cancer's 'context of vulnerability.' Specifically, SM defines the molecular and genetic alterations (context) that cause cancer cells to be particularly sensitive (vulnerable) to a drug or combination of drugs--the "context of vulnerability."

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.

Sign up for email alerts and get RSS feeds at our Web site, http://www.celltherapeutics.com/news_subscription_service  

 

nach ist das ein klarer Verdoppler noch diese Woche........  

http://ih.advfn.com/...28777&article=37560133&symbol=N%5ECTIC

Pixantrone Now Available in Europe on a Named-Patient Basis
.....  

Im amiland sind bereits jetzt alle aus dem Häuschen. Die haben die ganze Nacht durchgepostet.

Erwartete Eröffnung im yahoo-messageboard für heute 0,70 $

Und es kann schnell über 1 $ laufen, vielleicht noch heute !!!!!

Aber: seht selber und macht Euch schlau.

Auf den Zuuuuuuuuuuuug, der immer schneller rollt...  

aktuell in D
10:54:19  0,530   11000
10:25:12 0,510 10000
10:21:39 0,500 5000
10:08:21 0,500 150  

11:00:44  0,550   1500
11:00:33 0,550 1800
10:58:42 bG  0,545 3746
10:54:19 0,530 11000  

Kaufdruck auch in D enorm

Eure Chance, ich bin drin  

Pixantrone Now Available in Europe on a Named-Patient Basis

Tuesday , May 05, 2009 01:30ET

... (automatisch gekürzt) ...

http://www.knobias.com/...4447a6ae210bebf156e2d2909f5ed37f1acc37c09fd

 

 

 

Augenroll  

das ist eine Rakete ;-)  

hab mir den ganzen Kram ums Unternehmen durchgelesen...liest sich wie der Anfang einer wunderbaren Aktienfreundschaft