Cell Therapeutics Initiates Process to Obtain Marketing Approval for Pixantrone in Europe
SEATTLE, July 29 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it was notified by the European Medicines Agency ("EMEA") that pixantrone
is eligible to be submitted for a Marketing Authorization Application ("MAA") through...
Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Completed NDA submission could lead to marketing approval in Q4-2009
SEATTLE, June 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has completed the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administratio...
Cell Therapeutics Reports 76% Decrease in First Quarter 2009 Net Loss Attributable to Common Shareholders; Completion of Pixantrone NDA Submission on Track for Second Quarter 2009 Pixantrone
Named-Patient Program Initiated in Europe
SEATTLE, May 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reported recent accomplishments and financial results for the quarter ended March 31, 2009.
"Our focus for the first half of 2009 was to in...
Cell Therapeutics Initiating Rolling NDA Submission for Pixantrone
CTI to Request Priority Review
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...
European Medicines Agency (EMEA) Approves Cell Therapeutics, Inc.'s September Meeting Request to Discuss OPAXIO(TM) Marketing Authorization Application
...gulatory schedule as CTI focused on completing the pixantrone
New Drug Application (NDA) submission in June, 200...aceutical industry in general, and with OPAXIO and pixantrone
in particular, including, without limitation, the potential for OPAXIO and pixantrone
to be proved safe and effective the treatment of t...
Cell Therapeutics Announces Preliminary Results of its Fixed Price Exchange Offers for Any and All of its $118.9 Million Convertible Notes Outstanding
...y a more attractive opportunity for biotechnology investors and position us well as we move to complete the submission of our New Drug Application for pixantrone
to treat relapsed and refractory, aggressive non-Hodgkin's lymphoma to the U.S. Food and Drug Administration this month."
The Company expects to ...
Pixantrone Overview in Non-Hodgkin's Lymphoma to be Presented at 2009 Pan Pacific Lymphoma Conference
...ard Van der Jagt, M.D. of Ottawa Hospital will be presenting an overview of pixantrone
clinical studies in non-Hodgkin's lymphoma at the 2009 Pan Pacific Lymphoma... 2009 Pan Pacific Lymphoma Conference
Presentation: Monday, June 22, 2009
Pixantrone Now Available in Europe on a Named-Patient Basis
...s and IDIS Partner to Accelerate Patient Access to pixantrone
SEATTLE, May 5 /PRNewswire-Fi... (CTI) (Nasdaq and MTA: CTIC) today announced that pixantrone
is now available on a named-patient basis in Europe. pixantrone
will be supplied by IDIS to healthcare professiona...
CTI Focuses on Late-Stage Drug Approvals and Commercialization and Cuts Operating Costs: to Close Bresso Research Center
...ging its two late-stage drug candidates OPAXIO and pixantrone
to market as quickly as possible.
The global ...h the Trade Unions in the near future.
(BBR 2778), a DNA intercalating anti-tumor agent t...
Craig W. Philips Takes Helm at CTI
...xpand the market
indication for Zevalin(R), report pixantrone
pivotal trial results, and
potentially file a NDA,...ggressive NHL in
the second half of 2008. Positive pixantrone
data could allow CTI to submit
an application for ...with interim data
results expected in late 2009.
is an investigational agent under development for ...
Pixantrone in Medical Technology
Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th
SEATTLE, June 22 /PRNewswire-FirstCall/ --
Updated follow-up phase III EXTEND (PIX 301) clinical trial data enhances previously reported superior response rates for pixantrone
over comparator including in high risk patient subgroups
Additional Clinical Studies Also Highlighted at Pan ...
Overview of Pixantrone Phase III Clinical Data Presentation at American Society of Clinical Oncology 2009 Annual Meeting Now Available at Clinical Care Options
SEATTLE, June 10 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that a summary of the pixantrone
Phase III clinical data that were presented at American Society of Clinical Oncology (ASCO) 2009 Annual Meeting on June 1, 2009 is now available at Cli...
Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma
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
Cell Therapeutics' Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint
Complete Remission / Unconfirmed Complete Remission Rate 3.5 Fold Higher Compared to Standard Chemotherapy
SEATTLE, Nov. 11 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc.
(CTI) (Nasdaq and MTA: CTIC) announced today that it achieved the primary
efficacy endpoint of its pha...
Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial
Novartis notified of data set closing, Top-line results expected in November
SEATTLE, Nov. 3 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq and MTA: CTIC) announced today that it has closed the data set for
preliminary analysis of the primary e...
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
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
patients with relapsed di...
Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkin's Lymphoma (NHL)
Fast Track-Designated Study Approved Under FDA Special Protocol Assessment Process Could Expand Indication to Indolent NHL
SEATTLE, Sept. 12 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc.
(CTI) (Nasdaq: CTIC ; MTAX) today announced the launch of its phase III
clinical trial, know...
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...
Publication on Pixantrone Preclinical Studies Demonstrates Reduced
Cardiotoxicity Compared to Equiactive Doses of Doxorubicin and
Interim results in a randomized phase II/III clinical trial
anticipated later this year
SEATTLE, June 26, 2007 /PRNewswire-FirstCall/ -- Cell
Therapeutics, Inc. (CTI) announced the publication of preclinical
studies, which demonstrate that treatment with pixantrone
2778) resulted in minimal o...
Cell Therapeutics, Inc. Management to Discuss Today's Announcement
of Interim Pixantrone Study Results
SEATTLE, July 11, 2007 /PRNewswire-FirstCall/ -- On Wednesday,
July 11, 2007, at 1:30 p.m. Pacific/4:30 p.m. Eastern/10:30 p.m.
Central European Time members of Cell Therapeutics, Inc.'s (CTI)
management team will host a conference call to discuss today's
announcement of the interim results of its...
Pixantrone in Biological Technology
Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval
SEATTLE, Aug. 6 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today reported recent achievements and financial results for the second quarter and six months ended June 30, 2009.
"The second quarter of 2009 was a transforming quarter for the Co...
Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial
Updated Safety data presented at BIO International Convention in Atlanta
ATLANTA, May 19 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) released updated safety data today from its pixantrone
phase III 301 EXTEND trial demonstrating the effectiveness of pixantr...
Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009
SEATTLE, Jan. 14 /PRNewswire-FirstCall/ -- In meetings held in association
with the JP Morgan Healthcare Conference in San Francisco, Cell Therapeutics,
Inc. (CTI) (Nasdaq and MTA: CTIC) reviewed 2009 targeted milestones and 2008
accomplishments. CTI is seeking to obtain two new drug approvals...
Discussions With FDA on Pixantrone EXTEND (PIX301) Trial Provide Path for NDA Submission
Significant Difference in Primary Endpoint Could be Acceptable With Fewer Patients Than Originally Planned
SEATTLE, Sept. 6 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc.
(CTI) (Nasdaq: CTIC ) (MTAX: CTIC) announced today that following
discussions with the U.S. Food and ...
Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
...esults of CTI's EXTEND (PIX 301) clinical trial of pixantrone
(the "PIX 301 EXTEND trial") in relapsed or refrac...l. "These results represent a breakthrough in that pixantrone
could extend our ability to use a highly active an...sease) trial was a phase III single-agent trial of pixantrone
for patients with relapsed or refractory, aggressi...
CTI Receives the Second Payment of $6.5 million Associated with the Sale of Interest in Zevalin Joint Venture
...at could affect the ongoing development of the Company's products such as pixantrone
and OPAXIO include risks associated with preclinical and clinical develop...onal capital to continue to fund its operations, the potential failure of pixantrone
to prove safe and effective for treatment of relapsed aggressive NHL as det...
Cell Therapeutics Satisfies NASDAQ Listing Requirements to Continue to Trade on NASDAQ Capital Market
...our submission of a New Drug Application (NDA) for pixantrone
for aggressive relapse non-Hodgkin's lymphoma in t...ity to submit an NDA in the first half of 2009 for pixantrone
and gain approval in 2009, the potential failure of pixantrone
to prove safe and effective for treatment of non-H...
Cell Therapeutics, Inc. Reports Outcome of Special Meeting of Shareholders
...D., CEO of CTI. "With excellent phase III data for pixantrone
for aggressive relapsed non-Hodgkin's lymphoma we ...uncertainties that could affect the development of pixantrone
include risks associated with preclinical and clin...the biopharmaceutical industry in general and with pixantrone
in particular, including, without limitation, our ...
Cell Therapeutics Presents Corporate Highlights at Invest Northwest Conference
...h 18th . Mr. Philips' highlights focused on CTI's pixantrone
program for treatment of aggressive relapsed non-H... CTI based on third-party market research that, if pixantrone
were approved in late 2009 by the FDA in the US, a...ositive results from the phase III EXTEND trial of pixantrone
in aggressive relapsed NHL for which it met the tr...
Cell Therapeutics, Inc. (CTI) Reports 2008 Fourth Quarter and Year End Financial Results
...ximately 50% in 2009
CTI expects to complete pixantrone
NDA submission in Q2 2009
SEATTLE, March 16 ... Met primary endpoint in the Phase III study of pixantrone
in relapsed, aggressive non-Hodgkin's lymphoma with patients treated with pixantrone
achieving a high rate of confirmed and unconfirmed...