Cell Therapeutics [CTIC] 第3贴。..

@.@MiKeY@.@

Cell Therapeutics (NASDAQ: CTIC]) is getting ready for a critical decision next Wednesday, when a panel of cancer drug experts will advise the FDA on whether to approve pixantrone as a new treatment for relapsed, aggressive forms of non-Hodgkin’s lymphoma.

葉芬

8/2/2010


Cell Therapeutics, Inc. (CTIC) - Next Wednesday, the FDA advisory panel will discuss Pixantrone. Resistance is located at $1.24.

@.@MiKeY@.@

Cell Therapeutics, Inc. (CTI) to Report Fourth Quarter and Year-End 2009 Financial Results on February 11
February 08, 2010: 01:30 AM ET

SEATTLE, Feb. 8 /PRNewswire-FirstCall/ -- On Thursday, February 11, 2010, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of Cell Therapeutics, Inc.'s (CTI) (Nasdaq and MTA: CTIC) management team will host a conference call to discuss the Company's 2009 fourth quarter and year-end achievements and financial results.

@.@MiKeY@.@

Cell Therapeutics - Facing The Big Test

(RTTNews) - The Food and Drug Administration's Oncologic Drugs Advisory Committee is scheduled to review Cell Therapeutics Inc.'s (CTIC: News ) New Drug Application for Pixantrone for the treatment of relapsed and refractory non-Hodgkin's lymphoma on February 10.

The company began a rolling New Drug Application submission for Pixantrone to the FDA in April 2009 and completed the submission in June 2009. The NDA submission was based on a phase III single-agent Pixantrone trial dubbed EXTEND, or PIX 301 in patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines.

The FDA is expected to make a final decision on Pixantrone on April 23.

@.@MiKeY@.@

Cell Therapeutics, Inc. (Public, NASDAQTIC)

Pre-market
Feb 8, 6:07AM EST
    1.00   -0.06(5.66%)

韦一笑

跌很多。。。
Pre-market Real-Time: 0.77  -0.29 (27.36%)

雨后的秋林

Pre-market Real-Time: 0.62 0.44 (41.51%) 9:32AM ET

韦一笑

大家如看。。狂泻?!

葉芬

CTIC

0.639 -0.421 (-39.75%)
Real-time:   9:36AM EST



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http://www.reuters.com/article/idUSTRE6172QS20100208

FDA staff questions Cell Therapeutics drug data

WASHINGTON
Mon Feb 8, 2010 9:20am EST

WASHINGTON (Reuters) - U.S. drug reviewers questioned effectiveness data from Cell Therapeutics Inc for an experimental lymphoma drug and said the medicine carried substantial side effects, according to documents released on Monday.

Health

The Seattle-based biotechnology company is seeking approval to sell pixantrone under the brand name Pixuvri for treating non-Hodgkin's lymphoma that has stopped responding to other treatments.

Food and Drug Administration reviewers, in an analysis prepared for an advisory committee, said issues raised in their review included "the reliability of (efficacy) conclusions" and "substantial hematologic and cardiac toxicity."

They said they would ask the advisory panel at a meeting on Wednesday whether the company had provided enough evidence that pixantrone worked and whether the benefits outweighed risks.

Cell Therapeutics, in a separate summary prepared for the panel, said its data showed pixantrone worked better than comparison drugs with "manageable toxicities."

(Reporting by Lisa Richwine, editing by Gerald E. McCormick)

葉芬

* FEBRUARY 8, 2010, 9:35 A.M. ET

FDA: Limited Clinical Data On Proposed Cancer Drug Pixantrone



   By Jennifer Corbett Dooren
   Of DOW JONES NEWSWIRES


WASHINGTON (Dow Jones)--The Food and Drug Administration said Monday there was limited clinical evidence involving a proposed Cell Therapeutics, Inc. (CTIC) drug that would treat non-Hodgkin's lymphoma.

The agency said the main clinical study involving the drug, pixantrone, was stopped early because doctors had a hard time recruiting patients into the trial. The agency also said that deaths and serious adverse events "were all more common on the pixatrone" portion of the study.

Pixantrone faces a review by an outside panel of medical experts on Wednesday who serve on the FDA's oncologic drugs advisory committee.

The panel is being asked to make a recommendation about whether it thinks the FDA should approve the product.

Specifically, Cell Therapeutics is seeking FDA approval of pixantrone to treat patients with non-Hodgkin's lymphoma whose disease has progressed after treatment with at least two other therapies.

Lymphoma is a type of cancer that originates in white blood cells known as lymphocytes. About 63,000 cases of non-Hodgkins lymphoma are diagnosed each year according to the National Cancer Institute.

One of the main studies of the drug involved 140 patients. Study researchers had planned to enroll 320 patients in the study.

Half of the patients were given pixantrone while the other half were treated with other currently approved drugs. The primary goal of the study looked at the number of patients who achieved a confirmed or complete remission of the cancer. At the end of treatment, 14 patients receiving pixantrone achieved remission compared with four not receiving the drug. A secondary goal looking at whether patients responded to the drug for at least four months showed 25.7% of patients in the pixantrone group achieved a so-called overall response compared with 8.6% of patients who didn't receive the drug.

The FDA said "a higher level of evidence is usually required in trial which discontinue prior to final analysis."

Cell Therapeutics has proposed a brand name of Pixuvri for pixantrone. The FDA has a deadline to make a regulatory decision on the drug of April 23.

kelvin2080

坏消息哦。。。 希望结果是好的。。。 我在想要不要乘低买点？？再看下去。。。。

白面包

坏消息哦。。。 希望结果是好的。。。 我在想要不要乘低买点？？再看下去。。。。
kelvin2080 发表于 8-2-2010 10:49 PM

奉劝楼上的还是不要轻举妄动
我个人已经对ctic死心绝望
常常都有创新低的现象
如果你要short的话，可以试一试
long的话，最好不要抱太大期望

我当作把那十几千丢进大海。。

fifi1985

CTIC ,我第一只美国股，看来要沉了

@.@MiKeY@.@

Cell Therapeutics Shares Fall as FDA Says Lymphoma Drug Has “Substantial” Side Effects
Luke Timmerman 2/8/10

Seattle-based Cell Therapeutics’ experimental drug for non-Hodgkin’s lymphoma was tested in “substantially fewer” patients than planned in a pivotal clinical trial, and the data that it gathered to support its application shows the treatment has “substantial” toxicity to blood cells and the heart, according to an analysis by FDA staff posted online today. The FDA’s statements sent shares of the company down 38 percent at the opening of today’s trading.

Cell Therapeutics (NASDAQ: CTIC), in its own briefing document, said the clinical data to support the drug is “comprehensive” and that it shrank tumors without causing cumulative heart damage like other drugs in its class.

The documents appeared online in advance of the company’s big appearance before an FDA advisory panel. The meeting starts at 8 am Eastern time/5 am Pacific on Wednesday, February 10. That’s when the Oncologic Drugs Advisory Committee, a panel of cancer drug experts that advises the FDA, will gather in a suburban Washington, DC, hotel. While investors often (correctly) focus on the panel vote as an all-important indicator of whether a new drug will be approved, the FDA itself has the ultimate authority, and isn’t required to follow the committee’s advice.

The FDA’s review of pixantrone is vital for the future of Cell Therapeutics. The company, founded in 1991, has a long and controversial history of ups and downs. It currently has no marketed products, and pixantrone represents its only imminent hope of getting a revenue-generating product on the U.S. market. The drug, a modified form of an anthracycline chemotherapy, was shown to completely eliminate tumors in about 20 percent of patients, compared with 5.7 percent on a standard chemotherapy, based on a single pivotal trial. If the treatment is approved, Cell Therapeutics officials estimate the company can tap into a market of about 10,000 U.S. patients each year who are on at least their third round of treatment for aggressive non-Hodgkin’s lymphoma.

The FDA noted in its analysis that Cell Therapeutics planned to enroll 320 patients in its pivotal trial, known as PIX 301 or Extend, but the study was stopped early at an unplanned point because of poor enrollment. The trial ultimately enrolled 140 patients. “A higher level of evidence is usually required” in trials that are stopped short before a final analysis, the FDA staff said.

The FDA report includes details on how many patients died in the PIX-301 study. A total of 12 out of 68 (17.6 percent) who got pixantrone died from an adverse event during the trial, while five out of 67 (7.5 percent) in the comparison group died, the FDA said. A total of 25 out of 68 pixantrone patients dropped out of the study because of adverse events, and 21 of the 67 in the control group quit early, the FDA staff said. Most patients dropped out because of bone marrow suppression or toxicity to the heart, the FDA said.

The FDA is asking the panel to respond to two questions. The first question notes that the pivotal trial was halted early after less than half of the planned number of patients enrolled, and given that, the FDA wants to know if the data is strong enough to support approval. The second question is whether the benefits of the treatment outweigh the risks. We’ll find out what the panel says on Wednesday.

Shares of Cell  Therapeutics fell 41 cents, or 38 percent, to 65 cents at 9:37 am Eastern time today.

@.@MiKeY@.@

回复 33# fifi1985


不会沉啦。。。帮它穿救生衣。。。可以趁它现在跌了再买啊。。。

jochen

omg.....都是 坏消息。。。

怕的人 猛抛。。。。

求神保佑。。。。。bo be bo be.....

SUNNY仔

一觉起来,看到CTIC狂掉..发生什么事啦...?近来都是坏消息....唉..要冬眠了..

葉芬

9/2/2010

Cell Therapeutics, Inc. (CTIC) - Shares of Cell Therapeutics, Inc. tanked on Monday due negative comments out of the FDA. I have been avoiding this stock lately because it could not get back above $1.24. However, CTIC remains high on my watch list.

pink0905

希望今天会好些。
（谁有空闲要不去四马路pray ？）

乐静思

唉 不要BK就好了,就冬眠吧。