Newsgroup: it.economia.borsa
Titolo: CTIC usa

senza osservare il candelone (si fa x dire) intraday al close usa di 
venerd�, l'andamento di oggi ha proseguito perfettamente quello intraday di 
giovedi e venerdi scorsi...
http://finance.yahoo.com/q/ta?s=ctic&t=5d&l=on&z=l&q=c&p=&a=m26-12-9%2Css%2Cfs%2Cr14&c=
-- 
_______________________________________________
"Abbi il coraggio di servirti della tua propria ragione" (I. Kant) 

"LoZioPuparo�" <ZioS...@Tornato.it> ha scritto nel messaggio 
news:SlStm.66581$1s6....@twister2.libero.it...

Pivotal Registration Trial of OPAXIO Maintenance Therapy in First-Line 
Ovarian Cancer Reaches Enrollment Milestone of 600 patients, Cell 
Therapeutics and the Gynecologic Oncology Group Discuss Potential for Early 
Interim Analysis
CTI withdraws European Marketing Authorization Application (MAA) for 
non-inferiority indication in non-small cell lung cancer
  a.. Press Release
  b.. Source: Cell Therapeutics, Inc.
  c.. On Monday September 21, 2009, 8:00 pm ED
  a.. Companies:
    a.. Cell Therapeutics, Inc.
SEATTLE, Sept. 21 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") 
(NASDAQ and MTA: CTIC) announced today that it will re-focus its resources 
on the approval of OPAXIO(TM) for its potential superiority indication in 
maintenance therapy for ovarian cancer. The Gynecologic Oncology Group (GOG) 
is conducting an ongoing phase III trial that evaluates the use of 12 months 
of OPAXIO therapy versus an untreated control arm. To date, 600 patients 
have been enrolled in this trial. CTI has discussed with the GOG, several 
strategies for conducting an interim analysis which could potentially result 
in an earlier registration. In addition, given the encouraging results of 
treatment of advanced esophageal cancer with OPAXIO to be reported at the 
upcoming International Society of Gastrointestinal Oncology Annual Meeting, 
CTI plans on meeting with the Food and Drug Administration (FDA) to discuss 
an additional registration study utilizing OPAXIO as a radiation sensitizer 
in the treatment of advanced esophageal cancer.
CTI has notified the European Medicines Agency (EMEA) of its decision to 
withdraw its Marketing Authorization Application (MAA) for a non-inferiority 
indication in non-small cell lung cancer (NSCLC).
"Given that we have reached a milestone in the ovarian cancer trial 
enrollment coupled with the reservations the Committee for Medicinal 
Products for Human Use (CHMP) expressed about the control arm activity in 
the NSCL cancer study we believe it makes best sense for CTI to focus its 
efforts with OPAXIO on superiority applications like the first-line ovarian 
cancer trial as well as the exciting new potential application as a 
radiation sensitizer," noted Craig W. Philips, President of CTI. "Both of 
these studies would be landmark trials and first in class for this novel 
bioengineered taxane. We look forward to continuing to work with the GOG and 
ultimately the FDA on a registration pathway for OPAXIO."
"We believe focusing on ovarian maintenance, and radiosensitization, not 
only address areas of unmet medical need, but are in the best long term 
strategic interest of CTI. With the FDA review of the NDA for pixantrone in 
relapsed/refractory non-Hodgkin's lymphoma well underway and the phase III 
Ovarian trial of OPAXIO progressing nicely we are pleased with the 
advancement and future potential of these novel treatments," said James A. 
Bianco, M.D., CEO of CTI.
CTI has an existing license and co-development agreement with Novartis for 
OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which also provides Novartis 
with an option to enter into an exclusive worldwide license to develop and 
commercialize pixantrone based upon agreed terms.
About OPAXIO
OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as 
XYOTAX(TM), 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 OPAXIO 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.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to 
developing an integrated portfolio of oncology products aimed at making 
cancer more treatable. For additional information, please visit 
www.CellTherapeutics.com
.
Sign up for email alerts and get RSS feeds at our Web site, 
http://www.CellTherapeutics.com/investors_news.htm
This press release includes forward-looking statements that involve a number 
of risks and uncertainties, the outcome of which could materially and/or 
adversely affect actual future results and the trading price of our 
securities. 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 
OPAXIO in particular, including, without limitation, the potential failure 
of OPAXIO to prove safe and effective in ovarian cancer, esophageal cancer 
or lung cancer as determined by the FDA, the potential that the Gynecologic 
Oncology Group will not perform and early interim analysis on the clinical 
trial for OPAXIO, the potential that there will not be an earlier 
registration of OPAXIO, the potential that there will not be an additional 
registration of OPAXIO, the potential that Novartis will not exercise its 
option, CTI'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 CTI's filings with the Securities and 
Exchange Commission including, without limitation, CTI's most recent filings 
on Forms 10-K, 10-Q and 8-K. 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