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What is "Mark to Market?"
There's a debate in financial circles over whether banks are unfairly penalized by the requirement that they "mark to market" their holdings. Marketplace Senior Editor Paddy Hirsch explains what that term means.
http://marketplace.publicradio.org/videos/whiteboard/mark_to_market.shtml
What is "Mark to Market?"
There's a debate in financial circles over whether banks are unfairly penalized by the requirement that they "mark to market" their holdings. Marketplace Senior Editor Paddy Hirsch explains what that term means.
http://marketplace.publicradio.org/videos/whiteboard/mark_to_market.shtml
What is "Mark to Market?"
There's a debate in financial circles over whether banks are unfairly penalized by the requirement that they "mark to market" their holdings. Marketplace Senior Editor Paddy Hirsch explains what that term means.
http://marketplace.publicradio.org/videos/whiteboard/mark_to_market.shtml
Bank Saving Plan has Been Drafted
By David Cho
Washington Post Staff Writer
Saturday, January 31, 2009; Page D01
The Obama administration has finished drafting the central elements of its plan to rescue the financial markets and is gathering feedback from regulators and Wall Street executives, sources familiar with the matter said yesterday.
While some details need to be hammered out, the strategy is likely to be laid out publicly in about a week, the sources said.
In finalizing the plan, officials have made a policy decision that could dismay lawmakers. The administration is likely to refrain from imposing tougher restrictions on executive compensation at most firms receiving government aid but instead retain looser requirements initially included in the Treasury's $700 billion rescue program, a source familiar with the deliberations said. Officials are concerned that harsh limits could discourage some firms from asking for aid.
The administration envisions a range of initiatives to jump-start the consumer credit markets, provide aid to struggling homeowners, and motivate banks to increase lending. The plan will also offer banks more capital and buffer them against losses on portfolios of "toxic" assets, backed by failing mortgages and other troubled loans.
MORE: http://www.washingtonpost.com/wp-dyn/content/article/2009/01/30/AR2009013003742.html?hpid=topnews
Bank Saving Plan has Been Drafted
By David Cho
Washington Post Staff Writer
Saturday, January 31, 2009; Page D01
The Obama administration has finished drafting the central elements of its plan to rescue the financial markets and is gathering feedback from regulators and Wall Street executives, sources familiar with the matter said yesterday.
While some details need to be hammered out, the strategy is likely to be laid out publicly in about a week, the sources said.
In finalizing the plan, officials have made a policy decision that could dismay lawmakers. The administration is likely to refrain from imposing tougher restrictions on executive compensation at most firms receiving government aid but instead retain looser requirements initially included in the Treasury's $700 billion rescue program, a source familiar with the deliberations said. Officials are concerned that harsh limits could discourage some firms from asking for aid.
The administration envisions a range of initiatives to jump-start the consumer credit markets, provide aid to struggling homeowners, and motivate banks to increase lending. The plan will also offer banks more capital and buffer them against losses on portfolios of "toxic" assets, backed by failing mortgages and other troubled loans.
MORE: http://www.washingtonpost.com/wp-dyn/content/article/2009/01/30/AR2009013003742.html?hpid=topnews
News! Bank Saving Plan has Been Drafted
By David Cho
Washington Post Staff Writer
Saturday, January 31, 2009; Page D01
The Obama administration has finished drafting the central elements of its plan to rescue the financial markets and is gathering feedback from regulators and Wall Street executives, sources familiar with the matter said yesterday.
While some details need to be hammered out, the strategy is likely to be laid out publicly in about a week, the sources said.
In finalizing the plan, officials have made a policy decision that could dismay lawmakers. The administration is likely to refrain from imposing tougher restrictions on executive compensation at most firms receiving government aid but instead retain looser requirements initially included in the Treasury's $700 billion rescue program, a source familiar with the deliberations said. Officials are concerned that harsh limits could discourage some firms from asking for aid.
The administration envisions a range of initiatives to jump-start the consumer credit markets, provide aid to struggling homeowners, and motivate banks to increase lending. The plan will also offer banks more capital and buffer them against losses on portfolios of "toxic" assets, backed by failing mortgages and other troubled loans.
MORE: http://www.washingtonpost.com/wp-dyn/content/article/2009/01/30/AR2009013003742.html?hpid=topnews
'Bad bank' is best hope for beaten stock market
By Laura Mandaro, MarketWatch
Last Update: 12:01 AM ET Jan 31, 2009
SAN FRANCISCO (MarketWatch) -- Progress creating a government structure to absorb banks' rotten assets could provide some relief next week for the stock market, which otherwise faces a tough lineup of woeful corporate outlooks, plunging auto sales and big job losses.
Investors are hoping for more clarity from Congress and the White House on establishing a good bank/bad bank institution that would buy up the delinquent loans and illiquid securities corroding banks' books.
Traders will also be cued to policymakers' decision on how to spend the second half of last fall's $700 billion Troubled Asset Relief Program, or TARP.
"The market fully understands that the two largest problems we're faced with are the solvency of the banking system and bringing about the end to the real estate crisis," said Robert Siewert, a portfolio manager at Philadelphia-based Glenmede Trust Co., which manages about $17 billion in assets.
"It could start to rally on any sort of indication of putting the banking system on a better footing," he said.
The market could use the good news. The S&P 500 ($SPX) and Dow Jones Industrial Average have lost about 9% this year, adding to last year's double-digit losses.
Any spark of hope from Washington faces a squall of negative reports from corporations around the country.
Some 193 S&P 500 companies, 40% of the entire index, have already reported fourth-quarter results. Another 102, including Dow Jones Industrial Average ($INDU) components Merck Co. (MRK), Kraft Foods, Inc. (KFT) and Walt Disney Co. (DIS), are slated to report next week.
So far, earnings look bad and forecasts look worse.
S&P 500 companies are on track for a 35% earnings decline. Companies are missing earnings' expectations at a rate not seen since the fourth quarter of 1995.
"Most people have thrown away the fourth quarter," said Bill Greiner, chief investment officer for Kansas City, Missouri-based UMB Asset Management, a unit of UMB Financial Corp. that manages $8.5 billion.
"What's more important than the actual earnings is the company guidance," he said.
Along with outlooks, companies like Boeing (BA), Caterpillar (CAT) and Starbucks (SBUX) made shockwaves last week with large-scale layoffs. These added to a gloomy jobs picture that next Friday's jobs report will likely illustrate.
Economists are expecting the economy lost 400,000 to 600,000 jobs in January.
As in past months, the Wednesday release of payroll processor ADP's job forecast, followed by Thursday's jobless claims figures, could roil traders ahead of the Friday Labor Dept. release.
January sales figures from the auto industry and retailers could also tip indexes, even though the theme of plunging auto sales and stingy shoppers is a familiar one.
Analysts and investors are anticipating General Motors Corp. (GM) and Ford Motor Co. (F) sales fell about 40%, Chrysler sales dropped 50% and Toyota Motor Co. (TM) sales lost more than 30%.
Devil's in the bad-bank details
The possibility that policymakers would take a page from the 1980s savings and loan crisis by creating an agency to buy institutions' bad assets sparked a rally in bank shares this week.
After some jaw-jumping intraday rises, the Financial Select Sector SPDR Fund (XLF), which tracks the S&P 500 bank stocks, ended the week 2.8% higher vs. a 0.7% drop for the broader index.
Many agree that the market won't rally until the financial system works through the toxic mortgage and related assets. These prompted the failures last year of Lehman Bros. and Washington Mutual, caused successive writedowns as big banks such as Bank of America Corp. (BAC) and Citigroup, Inc. (C) and sent the industry running hat in hand to the U.S. government - repeatedly knocking down any chance of a stock market rally.
But even if policymakers pull together to form a new version of the 1980s' Resolution Trust Corp., investors say a sustained rally won't necessarily follow.
A lot rides on the details of the structure. If a government "bad bank" buys up bank debts for a steep discount to par value, say at 23 cents on the dollar, those purchases could force struggling institutions to embark on another big round of writedowns and capital raisings. That process could send more down the path to bankruptcy.
But if the government buys the assets at par value, in other words, for far more than they are worth now, the problem passes on to the government and ultimately, the taxpayer.
"I do the idea that this will be such a sizeable pricetag to the taxpayer is certainly something investors are weary of," Siewert said.
And regardless of the details of a proposed bank fix, the market still faces a rocky road. Siewert said his firm continues to underweight equities in favor of more investments in bonds, such as high-yield and municipal securities.
Greiner is shunning financial stocks; carrying higher levels of cash, short-term bonds and gold; and looking for companies with strong dividends.
"As we go through the process of deleveragin the economy, which won't be over in two or three quarters, any business that prospered from an increase use of leverage, that model is over," Greiner said.
Laura Mandaro is a reporter for MarketWatch in San Francisco.
'Bad bank' is best hope for beaten stock market
By Laura Mandaro, MarketWatch
Last Update: 12:01 AM ET Jan 31, 2009
SAN FRANCISCO (MarketWatch) -- Progress creating a government structure to absorb banks' rotten assets could provide some relief next week for the stock market, which otherwise faces a tough lineup of woeful corporate outlooks, plunging auto sales and big job losses.
Investors are hoping for more clarity from Congress and the White House on establishing a good bank/bad bank institution that would buy up the delinquent loans and illiquid securities corroding banks' books.
Traders will also be cued to policymakers' decision on how to spend the second half of last fall's $700 billion Troubled Asset Relief Program, or TARP.
"The market fully understands that the two largest problems we're faced with are the solvency of the banking system and bringing about the end to the real estate crisis," said Robert Siewert, a portfolio manager at Philadelphia-based Glenmede Trust Co., which manages about $17 billion in assets.
"It could start to rally on any sort of indication of putting the banking system on a better footing," he said.
The market could use the good news. The S&P 500 ($SPX) and Dow Jones Industrial Average have lost about 9% this year, adding to last year's double-digit losses.
Any spark of hope from Washington faces a squall of negative reports from corporations around the country.
Some 193 S&P 500 companies, 40% of the entire index, have already reported fourth-quarter results. Another 102, including Dow Jones Industrial Average ($INDU) components Merck Co. (MRK), Kraft Foods, Inc. (KFT) and Walt Disney Co. (DIS), are slated to report next week.
So far, earnings look bad and forecasts look worse.
S&P 500 companies are on track for a 35% earnings decline. Companies are missing earnings' expectations at a rate not seen since the fourth quarter of 1995.
"Most people have thrown away the fourth quarter," said Bill Greiner, chief investment officer for Kansas City, Missouri-based UMB Asset Management, a unit of UMB Financial Corp. that manages $8.5 billion.
"What's more important than the actual earnings is the company guidance," he said.
Along with outlooks, companies like Boeing (BA), Caterpillar (CAT) and Starbucks (SBUX) made shockwaves last week with large-scale layoffs. These added to a gloomy jobs picture that next Friday's jobs report will likely illustrate.
Economists are expecting the economy lost 400,000 to 600,000 jobs in January.
As in past months, the Wednesday release of payroll processor ADP's job forecast, followed by Thursday's jobless claims figures, could roil traders ahead of the Friday Labor Dept. release.
January sales figures from the auto industry and retailers could also tip indexes, even though the theme of plunging auto sales and stingy shoppers is a familiar one.
Analysts and investors are anticipating General Motors Corp. (GM) and Ford Motor Co. (F) sales fell about 40%, Chrysler sales dropped 50% and Toyota Motor Co. (TM) sales lost more than 30%.
Devil's in the bad-bank details
The possibility that policymakers would take a page from the 1980s savings and loan crisis by creating an agency to buy institutions' bad assets sparked a rally in bank shares this week.
After some jaw-jumping intraday rises, the Financial Select Sector SPDR Fund (XLF), which tracks the S&P 500 bank stocks, ended the week 2.8% higher vs. a 0.7% drop for the broader index.
Many agree that the market won't rally until the financial system works through the toxic mortgage and related assets. These prompted the failures last year of Lehman Bros. and Washington Mutual, caused successive writedowns as big banks such as Bank of America Corp. (BAC) and Citigroup, Inc. (C) and sent the industry running hat in hand to the U.S. government - repeatedly knocking down any chance of a stock market rally.
But even if policymakers pull together to form a new version of the 1980s' Resolution Trust Corp., investors say a sustained rally won't necessarily follow.
A lot rides on the details of the structure. If a government "bad bank" buys up bank debts for a steep discount to par value, say at 23 cents on the dollar, those purchases could force struggling institutions to embark on another big round of writedowns and capital raisings. That process could send more down the path to bankruptcy.
But if the government buys the assets at par value, in other words, for far more than they are worth now, the problem passes on to the government and ultimately, the taxpayer.
"I do the idea that this will be such a sizeable pricetag to the taxpayer is certainly something investors are weary of," Siewert said.
And regardless of the details of a proposed bank fix, the market still faces a rocky road. Siewert said his firm continues to underweight equities in favor of more investments in bonds, such as high-yield and municipal securities.
Greiner is shunning financial stocks; carrying higher levels of cash, short-term bonds and gold; and looking for companies with strong dividends.
"As we go through the process of deleveragin the economy, which won't be over in two or three quarters, any business that prospered from an increase use of leverage, that model is over," Greiner said.
Laura Mandaro is a reporter for MarketWatch in San Francisco.
Yeah. We've been hearing that from one guy here for weeks. Oh wait.. Was that you? Nevermind. ;)
Anyone know where/when this conference is taking place? Is there a link anywhere?
I see. Please don't take my comments as anything but curiosity in regards to the possible low-balling for the share price. I was simply curious and didn't mean to some across as negative towards anyone's feelings or opinions. Like someone posted, none of knows what will come, but I think that all of us longs are certainly strong in one belief. And that is that GTCB's future looks much brighter than it's past.
I have made lots of money on small cap biopharmas who have gotten FDA approval this past year.
I am used to seeing 150% to 200% price moves the day of the FDA approval, followed by a 50% retracement the following days.
Why can't that happen to GTCB? I see people quoting a $2 FDA approval price and others bashing that as "a dream."
Just wondering why?
CNN Video Regarding Bad Bank plan
http://money.cnn.com/video/
Look for "Caution: 'bad banks' ahead
Jefferies & Co.'s Art Hogan says he supports the plan to create an FDIC-run 'bad bank' to buy troubled assets from 'good banks.'
Video from CNN Regarding Bad Bank plan-- A must see for investors
http://money.cnn.com/video/
Look for "Caution: 'bad banks' ahead
Jefferies & Co.'s Art Hogan says he supports the plan to create an FDIC-run 'bad bank' to buy troubled assets from 'good banks.'
Video from CNN: Regarding Bad Bank plan
http://money.cnn.com/video/
Look for "Caution: 'bad banks' ahead
Jefferies & Co.'s Art Hogan says he supports the plan to create an FDIC-run 'bad bank' to buy troubled assets from 'good banks.'
Apparently, what the Obama group wants to do is use some of the TARP money to leverage an even bigger chunk from the FDIC to get the new "Bad Bank" funded WITHOUT the need from congressional approval.
Pretty smart since the last thing they want to do is waste more time in attacking the problem.
US to unveil menu of bank fixes next week!
WASHINGTON (Reuters) - The Obama administration aims to roll out a menu of options next week to help stabilize the U.S. banking industry, with government aid tailored to individual banks' needs, a source familiar with the administration's thinking told Reuters on Thursday.
The source, who spoke anonymously because the plan is still being finalized, said the options are likely to include a "bad bank" that could soak up mortgage securities and other distressed investments weighing down banks' balance sheets and holding back new lending.
The plan would also include government insurance on a select portfolio of banks' troubled assets to help shield banks from future losses.
A third component would be capital injections by the government in exchange for common shares, rather than the preferred shares and warrants taken so far under the Treasury Department's $700 billion Troubled Asset Relief Program (TARP).
Issuing new shares of common stock to the government would help banks protect their balance sheets, as banks are forced to subtract losses from their common equity.
The White House declined to comment.
The administration hopes to unveil the plan as early as Tuesday or Wednesday, according to the source.
"They're hoping to lay out a menu of options that would provide flexibility and creativity," the source said. The plan would not be a one-size-fits-all approach but would attempt to tailor assistance based on an individual bank's needs.
CNBC reported there were round-the-clock meetings between government officials and senior bank executives over the "bad bank" idea but the talks had hit a snag because consensus could not be reached over how it would work.
The government faces a tough task in trying balance the interests of bankers and taxpayers in setting up a bad bank to soak up the bad assets.
If the government values the assets too high, the taxpayer would be unduly burdened. If they are priced too low, an accounting tsunami would be set off as other banks are forced to write down assets on their own books.
The total cost of the new bank rescue program remained unclear, according to the source.
Sen. Charles Schumer, a New York Democrat, said on Thursday that some experts think creating a "bad bank" to buy toxic assets could require as much as $4 trillion.
READ MORE HERE: http://www.reuters.com/article/topNews/idUSTRE50S75C20090130
Same here. I think today the stock showed me quite a bit. it held and held against the tide all day. And the market was just horrible today. It didn;t actually drop until Obama showed up on TV and started to castigate them. During the last hour of trading. I was like.. WTF!?!
Geez!
I'm with you on CTIC. Their future looks very bright.
BAC is trading in a channel
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=35101563&txt2find=triangle|bac
Seems to be trading within a set pattern:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=35101563&txt2find=triangle|bac
Looks like your chart is right on!
BAC gapping! from $6 close to $7.50 pre-market
http://quotes.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?&pageno=1&selected=BAC&mkttype=PRE
BAC gapping! from $6 close to $7.50 pre-market
http://quotes.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?&pageno=1&selected=BAC&mkttype=PRE
More CTIC News!!!
Wednesday, January 28, 2009 1:31 AM
From:
"StockAlerts@scottrade.com" <StockAlerts@scottrade.com>
View contact details
Scottrade.com
This email is compliments of Scottrade.com
News for 'CTIC' - (Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkin's Lymphoma Trial)
SEATTLE, Jan 28, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics
(CTI) (Nasdaq and MTA: CTIC) announced today preliminary progression-free
survival (PFS) results from its pivotal phase III EXTEND (PIX301) trial of
pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin's
lymphoma (NHL) 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. PFS
was a prospectively defined secondary endpoint in the study.
"We always believed the effectiveness of pixantrone would translate into a
meaningful difference for patients with relapsed aggressive NHL and these
dramatic and significant differences in PFS in this tough to treat group of
patients provides that evidence," stated James A. Bianco, M.D. Chief Executive
Officer of CTI. "Pixantrone is the first agent in this patient population to
demonstrate a significant and meaningful PFS advantage. We believe these data
will support a priority review designation on our New Drug Application (NDA)
once we share them with the Food and Drug Administration (FDA)."
The Company had 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,
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). PFS, CR/CRu and ORR were determined by an independent
assessment panel that was blinded to the treatment assignments.
The most common serious toxicities (>5%) seen in previous trials of pixantrone
include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety
information is not yet available for the study, however, the study was monitored
on an ongoing basis by an independent Data Safety Monitoring Committee and no
serious concerns were raised.
The EXTEND clinical trial is a phase III single-agent trial of pixantrone for
patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or
more prior therapies and who were sensitive to treatment with anthracyclines.
The trial enrolled 140 patients and 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 or unconfirmed complete remission rate, overall
survival and progression-free survival. The study received Special Protocol
Assessment approval from the FDA in 2004 and pixantrone has received fast track
designation for this indication.
The Company announced on January 27, 2009 that after a pre-NDA communication
with the FDA, it expects to begin submission of a rolling NDA and request
priority review for pixantrone to treat relapsed aggressive NHL in the first
quarter of 2009.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents, was discovered by our scientists in Bresso, Italy.
Pixantrone is a novel DNA major groove binder that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents. Anthracyclines have been shown to be very active clinically
in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For
these diseases, anthracycline-containing chemotherapy regimens are effective in
first-line (initial) treatment. However, they may cause cumulative heart damage
that limits lifetime dosage and does not allow for retreatment. Pixantrone has
been designed to reduce the potential for heart damage compared to currently
available anthracyclines or anthracenediones without a loss in anti-tumor or
immunomodulatory activities.
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
http://www.celltherapeutics.com.
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. 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 pixantrone in particular including, without limitation, the
results of complete safety information, the ability of the company to file a
rolling NDA in the first quarter of 2009,a determination by the FDA that the
PIX301 trial is insufficient to support an NDA filing and that the FDA would
grant priority review, the potential failure of pixantrone to prove safe and
effective for treatment of relapsed aggressive NHL as determined by the FDA, the
Company'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 the Company's filings with the Securities and Exchange Commission
including, without limitation, the Company's most recent filings on Forms 10-K,
8-K, and 10-Q. 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.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
www.CellTherapeutics.com/press_room
More CTIC News-- Gonna rocket!
Wednesday, January 28, 2009 1:31 AM
From:
"StockAlerts@scottrade.com" <StockAlerts@scottrade.com>
View contact details
Scottrade.com
This email is compliments of Scottrade.com
News for 'CTIC' - (Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkin's Lymphoma Trial)
SEATTLE, Jan 28, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics
(CTI) (Nasdaq and MTA: CTIC) announced today preliminary progression-free
survival (PFS) results from its pivotal phase III EXTEND (PIX301) trial of
pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin's
lymphoma (NHL) 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. PFS
was a prospectively defined secondary endpoint in the study.
"We always believed the effectiveness of pixantrone would translate into a
meaningful difference for patients with relapsed aggressive NHL and these
dramatic and significant differences in PFS in this tough to treat group of
patients provides that evidence," stated James A. Bianco, M.D. Chief Executive
Officer of CTI. "Pixantrone is the first agent in this patient population to
demonstrate a significant and meaningful PFS advantage. We believe these data
will support a priority review designation on our New Drug Application (NDA)
once we share them with the Food and Drug Administration (FDA)."
The Company had 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,
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). PFS, CR/CRu and ORR were determined by an independent
assessment panel that was blinded to the treatment assignments.
The most common serious toxicities (>5%) seen in previous trials of pixantrone
include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety
information is not yet available for the study, however, the study was monitored
on an ongoing basis by an independent Data Safety Monitoring Committee and no
serious concerns were raised.
The EXTEND clinical trial is a phase III single-agent trial of pixantrone for
patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or
more prior therapies and who were sensitive to treatment with anthracyclines.
The trial enrolled 140 patients and 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 or unconfirmed complete remission rate, overall
survival and progression-free survival. The study received Special Protocol
Assessment approval from the FDA in 2004 and pixantrone has received fast track
designation for this indication.
The Company announced on January 27, 2009 that after a pre-NDA communication
with the FDA, it expects to begin submission of a rolling NDA and request
priority review for pixantrone to treat relapsed aggressive NHL in the first
quarter of 2009.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents, was discovered by our scientists in Bresso, Italy.
Pixantrone is a novel DNA major groove binder that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents. Anthracyclines have been shown to be very active clinically
in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For
these diseases, anthracycline-containing chemotherapy regimens are effective in
first-line (initial) treatment. However, they may cause cumulative heart damage
that limits lifetime dosage and does not allow for retreatment. Pixantrone has
been designed to reduce the potential for heart damage compared to currently
available anthracyclines or anthracenediones without a loss in anti-tumor or
immunomodulatory activities.
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
http://www.celltherapeutics.com.
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. 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 pixantrone in particular including, without limitation, the
results of complete safety information, the ability of the company to file a
rolling NDA in the first quarter of 2009,a determination by the FDA that the
PIX301 trial is insufficient to support an NDA filing and that the FDA would
grant priority review, the potential failure of pixantrone to prove safe and
effective for treatment of relapsed aggressive NHL as determined by the FDA, the
Company'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 the Company's filings with the Securities and Exchange Commission
including, without limitation, the Company's most recent filings on Forms 10-K,
8-K, and 10-Q. 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.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
www.CellTherapeutics.com/press_room
CTIC News Pixantrone Increases Progression-Free Survival by ...
Wednesday, January 28, 2009 1:31 AM
From:
"StockAlerts@scottrade.com" <StockAlerts@scottrade.com>
View contact details
Scottrade.com
This email is compliments of Scottrade.com
News for 'CTIC' - (Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkin's Lymphoma Trial)
SEATTLE, Jan 28, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics
(CTI) (Nasdaq and MTA: CTIC) announced today preliminary progression-free
survival (PFS) results from its pivotal phase III EXTEND (PIX301) trial of
pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin's
lymphoma (NHL) 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. PFS
was a prospectively defined secondary endpoint in the study.
"We always believed the effectiveness of pixantrone would translate into a
meaningful difference for patients with relapsed aggressive NHL and these
dramatic and significant differences in PFS in this tough to treat group of
patients provides that evidence," stated James A. Bianco, M.D. Chief Executive
Officer of CTI. "Pixantrone is the first agent in this patient population to
demonstrate a significant and meaningful PFS advantage. We believe these data
will support a priority review designation on our New Drug Application (NDA)
once we share them with the Food and Drug Administration (FDA)."
The Company had 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,
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). PFS, CR/CRu and ORR were determined by an independent
assessment panel that was blinded to the treatment assignments.
The most common serious toxicities (>5%) seen in previous trials of pixantrone
include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety
information is not yet available for the study, however, the study was monitored
on an ongoing basis by an independent Data Safety Monitoring Committee and no
serious concerns were raised.
The EXTEND clinical trial is a phase III single-agent trial of pixantrone for
patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or
more prior therapies and who were sensitive to treatment with anthracyclines.
The trial enrolled 140 patients and 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 or unconfirmed complete remission rate, overall
survival and progression-free survival. The study received Special Protocol
Assessment approval from the FDA in 2004 and pixantrone has received fast track
designation for this indication.
The Company announced on January 27, 2009 that after a pre-NDA communication
with the FDA, it expects to begin submission of a rolling NDA and request
priority review for pixantrone to treat relapsed aggressive NHL in the first
quarter of 2009.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents, was discovered by our scientists in Bresso, Italy.
Pixantrone is a novel DNA major groove binder that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents. Anthracyclines have been shown to be very active clinically
in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For
these diseases, anthracycline-containing chemotherapy regimens are effective in
first-line (initial) treatment. However, they may cause cumulative heart damage
that limits lifetime dosage and does not allow for retreatment. Pixantrone has
been designed to reduce the potential for heart damage compared to currently
available anthracyclines or anthracenediones without a loss in anti-tumor or
immunomodulatory activities.
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
http://www.celltherapeutics.com.
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. 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 pixantrone in particular including, without limitation, the
results of complete safety information, the ability of the company to file a
rolling NDA in the first quarter of 2009,a determination by the FDA that the
PIX301 trial is insufficient to support an NDA filing and that the FDA would
grant priority review, the potential failure of pixantrone to prove safe and
effective for treatment of relapsed aggressive NHL as determined by the FDA, the
Company'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 the Company's filings with the Securities and Exchange Commission
including, without limitation, the Company's most recent filings on Forms 10-K,
8-K, and 10-Q. 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.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
www.CellTherapeutics.com/press_room
CTIC News Pixantrone Increases Progression-Free Survival by ...
Wednesday, January 28, 2009 1:31 AM
From:
"StockAlerts@scottrade.com" <StockAlerts@scottrade.com>
View contact details
Scottrade.com
This email is compliments of Scottrade.com
News for 'CTIC' - (Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkin's Lymphoma Trial)
SEATTLE, Jan 28, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics
(CTI) (Nasdaq and MTA: CTIC) announced today preliminary progression-free
survival (PFS) results from its pivotal phase III EXTEND (PIX301) trial of
pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin's
lymphoma (NHL) 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. PFS
was a prospectively defined secondary endpoint in the study.
"We always believed the effectiveness of pixantrone would translate into a
meaningful difference for patients with relapsed aggressive NHL and these
dramatic and significant differences in PFS in this tough to treat group of
patients provides that evidence," stated James A. Bianco, M.D. Chief Executive
Officer of CTI. "Pixantrone is the first agent in this patient population to
demonstrate a significant and meaningful PFS advantage. We believe these data
will support a priority review designation on our New Drug Application (NDA)
once we share them with the Food and Drug Administration (FDA)."
The Company had 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,
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). PFS, CR/CRu and ORR were determined by an independent
assessment panel that was blinded to the treatment assignments.
The most common serious toxicities (>5%) seen in previous trials of pixantrone
include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety
information is not yet available for the study, however, the study was monitored
on an ongoing basis by an independent Data Safety Monitoring Committee and no
serious concerns were raised.
The EXTEND clinical trial is a phase III single-agent trial of pixantrone for
patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or
more prior therapies and who were sensitive to treatment with anthracyclines.
The trial enrolled 140 patients and 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 or unconfirmed complete remission rate, overall
survival and progression-free survival. The study received Special Protocol
Assessment approval from the FDA in 2004 and pixantrone has received fast track
designation for this indication.
The Company announced on January 27, 2009 that after a pre-NDA communication
with the FDA, it expects to begin submission of a rolling NDA and request
priority review for pixantrone to treat relapsed aggressive NHL in the first
quarter of 2009.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents, was discovered by our scientists in Bresso, Italy.
Pixantrone is a novel DNA major groove binder that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents. Anthracyclines have been shown to be very active clinically
in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For
these diseases, anthracycline-containing chemotherapy regimens are effective in
first-line (initial) treatment. However, they may cause cumulative heart damage
that limits lifetime dosage and does not allow for retreatment. Pixantrone has
been designed to reduce the potential for heart damage compared to currently
available anthracyclines or anthracenediones without a loss in anti-tumor or
immunomodulatory activities.
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
http://www.celltherapeutics.com.
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. 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 pixantrone in particular including, without limitation, the
results of complete safety information, the ability of the company to file a
rolling NDA in the first quarter of 2009,a determination by the FDA that the
PIX301 trial is insufficient to support an NDA filing and that the FDA would
grant priority review, the potential failure of pixantrone to prove safe and
effective for treatment of relapsed aggressive NHL as determined by the FDA, the
Company'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 the Company's filings with the Securities and Exchange Commission
including, without limitation, the Company's most recent filings on Forms 10-K,
8-K, and 10-Q. 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.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
www.CellTherapeutics.com/press_room
CTIC News Pixantrone Increases Progression-Free Survival by ...
Wednesday, January 28, 2009 1:31 AM
From:
"StockAlerts@scottrade.com" <StockAlerts@scottrade.com>
View contact details
Scottrade.com
This email is compliments of Scottrade.com
News for 'CTIC' - (Pixantrone Increases Progression-Free Survival by 81% Compared to Standard Chemotherapeutic Agents in Phase III Relapsed Aggressive non-Hodgkin's Lymphoma Trial)
SEATTLE, Jan 28, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics
(CTI) (Nasdaq and MTA: CTIC) announced today preliminary progression-free
survival (PFS) results from its pivotal phase III EXTEND (PIX301) trial of
pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin's
lymphoma (NHL) 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. PFS
was a prospectively defined secondary endpoint in the study.
"We always believed the effectiveness of pixantrone would translate into a
meaningful difference for patients with relapsed aggressive NHL and these
dramatic and significant differences in PFS in this tough to treat group of
patients provides that evidence," stated James A. Bianco, M.D. Chief Executive
Officer of CTI. "Pixantrone is the first agent in this patient population to
demonstrate a significant and meaningful PFS advantage. We believe these data
will support a priority review designation on our New Drug Application (NDA)
once we share them with the Food and Drug Administration (FDA)."
The Company had 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,
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). PFS, CR/CRu and ORR were determined by an independent
assessment panel that was blinded to the treatment assignments.
The most common serious toxicities (>5%) seen in previous trials of pixantrone
include grade 3 and 4 neutropenia and febrile neutropenia. Complete safety
information is not yet available for the study, however, the study was monitored
on an ongoing basis by an independent Data Safety Monitoring Committee and no
serious concerns were raised.
The EXTEND clinical trial is a phase III single-agent trial of pixantrone for
patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or
more prior therapies and who were sensitive to treatment with anthracyclines.
The trial enrolled 140 patients and 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 or unconfirmed complete remission rate, overall
survival and progression-free survival. The study received Special Protocol
Assessment approval from the FDA in 2004 and pixantrone has received fast track
designation for this indication.
The Company announced on January 27, 2009 that after a pre-NDA communication
with the FDA, it expects to begin submission of a rolling NDA and request
priority review for pixantrone to treat relapsed aggressive NHL in the first
quarter of 2009.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents, was discovered by our scientists in Bresso, Italy.
Pixantrone is a novel DNA major groove binder that contains an
aza-anthracenedione molecular structure, differentiating it from anthracycline
chemotherapy agents. Anthracyclines have been shown to be very active clinically
in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For
these diseases, anthracycline-containing chemotherapy regimens are effective in
first-line (initial) treatment. However, they may cause cumulative heart damage
that limits lifetime dosage and does not allow for retreatment. Pixantrone has
been designed to reduce the potential for heart damage compared to currently
available anthracyclines or anthracenediones without a loss in anti-tumor or
immunomodulatory activities.
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
http://www.celltherapeutics.com.
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. 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 pixantrone in particular including, without limitation, the
results of complete safety information, the ability of the company to file a
rolling NDA in the first quarter of 2009,a determination by the FDA that the
PIX301 trial is insufficient to support an NDA filing and that the FDA would
grant priority review, the potential failure of pixantrone to prove safe and
effective for treatment of relapsed aggressive NHL as determined by the FDA, the
Company'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 the Company's filings with the Securities and Exchange Commission
including, without limitation, the Company's most recent filings on Forms 10-K,
8-K, and 10-Q. 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.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
www.CellTherapeutics.com/press_room
No problem.
Go make some $$$$!
Even if they disappoint, they will move!
Plan for Banks' Toxic Debt To Be Unveiled Next Week
From CNBC --
http://www.cnbc.com/id/28879872
BAC and C are up big A/H becaus eof this:
Plan for Banks' Toxic Debt To Be Unveiled Next Week
From CNBC --
http://www.cnbc.com/id/28879872
BAC and C news!
From CNBC --
http://www.cnbc.com/id/28879872
Good pick up on BAC
Plan for Banks' Toxic Debt To Be Unveiled Next Week
From CNBC --
http://www.cnbc.com/id/28879872
Plan for Banks' Toxic Debt To Be Unveiled Next Week
From CNBC --
http://www.cnbc.com/id/28879872
Plan for Banks' Toxic Debt
From CNBC --
http://www.cnbc.com/id/28879872
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Plan for Banks' Toxic Debt
From CNBC --
http://www.cnbc.com/id/28879872
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All banks will move tomorrow! Especially BAC
Plan for Banks' Toxic Debt To Be Unveiled Next Week
From CNBC --
http://www.cnbc.com/id/28879872
Plan for Banks' Toxic Debt To Be Unveiled Next Week
From CNBC --
http://www.cnbc.com/id/28879872
Plan for Banks' Toxic Debt To Be Unveiled Next Week
From CNBC --
http://www.cnbc.com/id/28879872