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发表于 14-9-2009 09:51 AM
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no new ??????? hold so long time liao |
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发表于 14-9-2009 02:29 PM
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什么时侯才有新闻我等到花儿也塮了 ctic and heb |
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发表于 16-9-2009 07:22 PM
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http://www.marketwatch.com/story/18-month-follow-up-data-on-phase-iii-study-of-pixantrone-in-late-stage-relapsed-or-refractory-aggressive-non-hodgkins-lymphoma-continues-to-demonstrate-significant-improvement-in-complete-remission-and-2009-09-16
18 month Follow-up Data on Phase III Study of Pixantrone in Late Stage Relapsed or Refractory, Aggressive Non-Hodgkin's Lymphoma Continues to Demonstrate Significant Improvement in Complete Remission and Progression Free Survival Over Standard Chemotherapy
SEATTLE, Sept 16, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today released updated 18-month follow-up clinical data for its phase III EXTEND (PIX 301) trial of pixantrone (BBR2778) for patients with advanced, relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Responses were evaluated by an Independent Assessment Panel that was blinded to patient assignment.
The table below shows the primary end of treatment data analyses previously reported and the new updated 18 month efficacy data analyses. This data is part of CTI's presentation today at the BioCentury NewsMakers conference at 10:30 AM ET.
End of Treatment 18 Month Follow-Up
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CR/CRu CR/CRu
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Pixantrone 20.0% 25.7%
Control 5.7% 7.1%
P Value 0.021 0.005
ORR ORR
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Pixantrone 37.1% 40.0%
Control 14.3% 14.3%
P Value 0.003 0.001
End of Treatment 18 Month Follow-Up
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Progression Free Progression Free
Survival Survival
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Pixantrone 4.7 months 5.6 months
Control 2.6 months 2.6 months
P Value 0.007 (HR = 0.60) 0.002 (HR = 0.56)
Median Overall Median Overall
Survival Survival
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Pixantrone 8.1 months 10.2 months
Control 6.9 months 6.9 months
P Value 0.54 (HR = 0.88) 0.3 (HR = 0.82)
"We continue to be impressed by the durability of responses in the pixantrone treatment arm which seemed to improve during the study follow up period, compared to the standard chemotherapy recipients - whose responses and duration of response are largely unchanged from the initial assessment period," noted James A. Bianco, M.D., Chief Executive Officer of CTI. "We are also encouraged by the increase in the overall survival estimates, especially among those patients whose histologic diagnosis was verified by independent pathologists where 40% of pixantrone recipients were alive, compared to 27% for standard chemotherapy at the 1 year landmark period. We plan to submit these updated safety and efficacy data to our NDA as part of the 120 Day update."
The FDA typically receives updated clinical study data 120 days following the initial NDA submission.
The most common (incidence greater than or equal to 20%) adverse reactions reported for pixantrone-treated subjects were neutropenia, infection, anemia, leucopenia, thrombocytopenia, asthenia, pyrexia, and cough.
Pixantrone has been accepted for standard review by the Food & Drug Administration (FDA), with fast track status with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
BioCentury's NewsMakers in the Biotech Industry Conference
CTI Presentation: Wednesday, September 16, 2009
10:30 a.m. Eastern /7:30 a.m. Pacific /6:30 p.m. Central European
www.celltherapeutics.com
About the EXTEND (PIX301) Clinical Trial
The EXTEND clinical trial is a phase III single agent trial of pixantrone for patients with relapsed or refractory, aggressive nonHodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial was conducted at 130 sites in 17 countries. 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 (CR) or unconfirmed complete remission (uCR) rate, time to tumor progression, and overall survival. The study was conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) and pixantrone has received fast track designation for this indication. |
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发表于 17-9-2009 08:59 AM
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发表于 19-9-2009 09:58 AM
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Cell Therapeutics, Inc.
1.55 +0.13 (9.15%)
After Hours: 1.55 0.00 (0.00%)
Sep 18, 7:58PM EDT
(CTIC) Cell Therapeutics Releases Encouraging Data for Pixantrone
September 18th, 2009
Yesterday, Cell Therapeutics (CTIC) released encouraging data from the 18-month follow-up clinical trial of pixantrone for the treatment of patients with advanced, relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL).
The original trial compared pixantrone with standard chemotherapy; the results of which were reported last November. The company completed filing its rolling New Drug Application (NDA) in June this year and has been assigned a Prescription Drug User Fee Act (PDUFA) date of Apr 23, 2010.
The follow-up trial conducted over a period of 18 months found improved results for patients on pixantrone compared to the control group. Based on the parameters of complete response (25.7% vs. 7.1% in control group), overall response rate (40% vs. 14.3%) and progression free survival (5.6 months vs. 2.6 months), the pixantrone data were better compared to both the control group and its own original trial data. Cell Therapeutics plans to submit the updated data to the FDA shortly.
Meanwhile, Cell Therapeutics submitted a Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMEA). This is part of the filing process for pixantrone approval in the treatment of children in Europe. It includes the course of action to be undertaken by the company in order to broaden its use for pediatric patients.
Pixantrone, on approval, will have to face tough competition from several established products. One of the top-selling drugs for the treatment of NHL is Rituxan, co-promoted by Biogen Idec (BIIB) and Genentech (a part of Roche) in the US. Biogen recorded sales of $1.13 billion from Rituxan in 2008, an increase of 18% over 2007. Competition is quite tough in this therapeutic area with the presence of Genzyme’s (GENZ) Campath, Millennium’s (a part of Takeda now) Velcade and Cephalon’s (CEPH) Treanda, among others. |
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发表于 20-9-2009 10:20 PM
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Cell Therapeutics, Inc ( CTIC ) Support & Resistance Levels - 9/21/09
Resistance Levels: $1.62, $1.70, $1.85
Support Levels: $1.50, 1.40
Cell Therapeutics, Inc. (CTIC) exploded higher in the final 5 minutes of trading on Friday. The stock is now trading back over the 10 and 50 day moving averages which is bullish. I wouldn't be surprised to see a press release first thing Monday morning as the move on Friday seemed like a news leak.
Support is now located at $1.50 - Resistance is located at $1.62 & $1.70. |
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发表于 23-9-2009 04:12 PM
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起起起起起起起起起起 |
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发表于 23-9-2009 08:21 PM
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发表于 24-9-2009 12:38 AM
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为何CTIC被列入纳斯达的指数股后股价还是跌的呢....??不过,块三多是否是好时机进货呢...?再看多几天吧..可能会把手上的MESA买了后再进回CTIC来拉平衡我手手上高价的CTIC($1.8X5000)... |
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发表于 24-9-2009 01:02 PM
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发表于 24-9-2009 01:03 PM
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发表于 24-9-2009 10:30 PM
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发表于 24-9-2009 10:56 PM
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我在$1.32亏本$0.01卖掉我的2000股。。。。
今年年底再来买回。。。。
很可惜近期已经没有任何的drug on the approval line。。。
只剩明年的pixantrone。。。
现在又pullback application，又present new trial on esophageal，看来反反复的公司先跑微妙。。。
[ 本帖最后由 bennywt 于 24-9-2009 11:07 PM 编辑 ] |
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发表于 24-9-2009 11:09 PM
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原帖由 bennywt 于 24-9-2009 10:56 PM 发表 
我在$1.32亏本$0.01卖掉我的2000股。。。。
今年年底再来买回。。。。
很可惜近期已经没有任何的drug on the approval line。。。
只剩明年的pixantrone。。。
现在又pullback application，又present new trial ...
希望你的决定是对的。。
现在钱被扣住了。。
我的血汗钱呀。。。 |
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发表于 24-9-2009 11:11 PM
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原帖由 白面包 于 24-9-2009 11:09 PM 发表 
希望你的决定是对的。。
现在钱被扣住了。。
我的血汗钱呀。。。
我最好奇的是为什么人家ask for trial design，他就pull back，这里有很大的问题。。。 |
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发表于 25-9-2009 11:04 PM
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不知不觉已经跌到1。24了
不懂还会不会再跌呢？ |
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发表于 26-9-2009 01:21 AM
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1.16 了 。。。。 |
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发表于 26-9-2009 01:27 AM
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发表于 26-9-2009 01:30 AM
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发表于 26-9-2009 01:31 AM
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