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|By PR Newswire
Article Rating:
|December 17, 2012 01:31 AM EST
SEATTLE, Dec. 17, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced the publication of results from a preclinical study of PixuvriTM (pixantrone) in the The Journal of Pharmacology and Experimental Therapeutics providing potential mechanisms for lower cardiotoxicity in patients treated with Pixuvri who received prior doxorubicin therapy. While CHOP-R is considered an effective therapy and is the standard of care in first line treatment of aggressive B-cell non-Hodgkin lymphoma (NHL), exposure to cumulative doses of doxorubicin, an anthracycline contained in this regimen, is associated with increasing the incidence of irreversible, severe, and symptomatic cardiac toxicity. The association with heart damage limits the use of doxorubicin and other anthracyclines beyond first line therapy and in patients with pre-existing cardiac disease.
Pixuvri is a novel anthracenedione that lacks the structural motifs that lead to the formation of reactive oxygen species or long-lived hydroxyl metabolites which are believed to be involved in cardiac damage. Although anthracycline induced cardiotoxicity is complex and multi-factorial, this study provides potential mechanisms by which Pixuvri avoids inducing this serious side effect. The study by Giorgio Minotti, M.D., at the Center for Integrated Research and Drug Sciences, University Campus Bio-Medico, Rome Italy, showed that in a human cardiac tissue model, both untreated and pretreated with doxorubicin, Pixuvri did not form reactive oxygen species or long lived hydroxymetabolites. In doxorubicin pretreated cardiac samples, Pixuvri also inhibited formation of the long-lived hydroxymetabolite of doxorubicin. These results suggest mechanisms for the low incidence of cardiotoxicity seen in clinical trials of Pixuvri in doxorubicin naive or pretreated patients.
"Anthracyclines are an effective therapy in aggressive B-cell NHL patients but their use is limited due to the association with cardiac damage," said Professor Minotti. "Cardiotoxicity complicates the clinical management of patients who relapse after first-line therapy as second or third line non-anthracycline chemotherapeutics might precipitate cardiotoxicity through multiple mechanisms. These data provide a biological rationale for the safety profile of Pixuvri and supports Pixuvri's role in treating multiply relapsed or refractory aggressive B-cell NHL."
The publication by Salvatorelli E., et al., led by Professor Minotti G., titled "The novel anthracenedione, pixantrone, lacks redox activity and inhibits doxorubicinol formation in human myocardium; Insight to explain the cardiac safety of pixantrone in doxorubicin treated patients," is available at http://jpet.aspetjournals.org/content/early/2012/12/03/jpet.112.200568.abstract
About Pixuvri (pixantrone)
Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds, Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.
In May 2012, Pixuvri received conditional marketing authorization in the E.U. as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at www.pixuvri.eu.
CTI is currently accruing patients into a Phase 3 trial comparing Pixuvri and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL.
Pixuvri does not have marketing approval in the United States.
About Conditional Marketing Authorization
Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the E.U. to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.
The European Medicines Agency's (the "EMA") Committee for Medicinal Products for Human Use has accepted PIX306, CTI's ongoing randomized controlled phase III clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.
About Cell Therapeutics, Inc.
CTI (Nasdaq and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit 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 and the market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of Pixuvri include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Pixuvri in particular including, without limitation, the potential failure of Pixuvri to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the U.S. Food and Drug Administration, that CTI may not market and commercialize Pixuvri in the E.U. as planned, that results in future studies may differ,that CTI may not be able to complete the PIX306 clinical trial of Pixuvri-rituximab compared to gemcitabine-rituximab in patients who have relapsed after 1 to 3 prior regimens for aggressive B cell NHL and who are not eligible for autologous stem cell transplant by June 2015 or at all as required by the EMA or have the results of such trial available by June 2015 or at all, that CTI may not be able complete a post-marketing study aimed at confirming the clinical benefit observed in the PIX301 trial, that the conditional marketing authorization for Pixuvri may not be renewed, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials or the total number of patients enrolled, that CTI's average net operating burn rate may increase and CTI's ability to continue to raise capital as needed to fund its operations in general, and, including, without limitation, competitive factors, technological developments, costs of developing, producing, and selling Pixuvri, 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, 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
Monique Greer
[email protected]
Ed Bell
[email protected]
SOURCE Cell Therapeutics, Inc.
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Season 1, Episode 13 The One with the Boobies
First Aired: January 20, 1995
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Guest Cast
Fisher Stevens Roger
Robert Costanzo Robert Costanzo Joey Sr.
Brenda Vaccaro Brenda Vaccaro Gloria
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subset: commoncrawl


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Public Forum:
While knocking on doors and visiting businesses all over the village of Brown Deer, I have gained an appreciation of many diverse points of views and suggestions for our village's future. Residents are excited about the news that Walmart has purchased the vacant Lowe's site on Brown Deer Road. More than 75 jobs will be created, grocery shopping choices will improve and the vitality of Brown Deer Road will be enhanced. The Walmart will help the village property tax base long term with a guaranteed $11 million assessed minimum value which may offset residential property taxes.
Beaver Creek: Residents want owner-occupied units there with current zoning. I agree with this stance.
Taxes: Many residents and businesses voiced their frustration to me about our high taxes and low assessed values. Attracting new businesses to Brown Deer could offset future residential taxes. A Dunkin' Donuts on Green Bay Avenue is coming in the spring, which is a positive step. The vacant gas station on Brown Deer Road could be re-developed into a coffee shop, bank branch and/or physical therapy clinic. On taxes, I agree that elected trustees must carefully review public budgets just as your family must budget every day.
Police and fire services: I am in favor of maintaining excellent police, fire and paramedic services. Our police and fire personnel deserve our thanks. I am open to ideas that maximize efficiency, promote public safety and make sense in the long term.
By spending your money at village businesses, you help stabilize our village property tax base which helps everyone.
I believe in the people of Brown Deer, our families, our diversity, and a better Brown Deer for you. I ask for your vote Feb. 18 or by absentee in advance of Election Day. (Absentee's available through Feb. 14.)
Bruce Thomas
Brown Deer
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Afrocentrism and Multiculturalism destroying America
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Typical eugenicist Swede. If your dumb ass was really as smart as you claim it to be, citing IQ tests (lol), then you would consider some cultural facts, such as
Blacks tend not to give a shit about grammar, unlike whites
Similarly, many blacks just don't give a fuck. ie. when faced with some white dude with glasses presented a test, they're like "aight whateva". Unlike whities they don't place much value on such irrelevant stupidities from which a human being can supposedly be ranked and his/her intelligence sequestered and analyzed. they prefer to live real life, not dwell in intellectual fantasies about a eugenicist's wet dream of utopia where morons (ie. anyone who does something differently) don't exist. yeahh, an IQ test will help you in that direction. lmao
Oh but, shit, you took an IQ test that took two full days to complete... nvm me then.
You only make vague grand-sounding claims as to your intelligence but the substance of your argument shows that you're a fucking idiot who prides himself on highly ethnocentric methods of testing that are themselves created to make people like you feel like your retarded ideologies are grounded in fact and "intelligence".
I am neither black nor white so don't throw that in my face k?
Anonymous Coward 25180110
Intelligence isn't the only thing that makes us human, but it's actually pretty important. It's true most of the population can sit comfortably in a centrally heated/air conditioned room and rage on the internet over how some people have the
to be smarter than them, but the fact remains - without those smarter than average, there would be no central heating, no air conditioning, and no internet. It takes intelligence to invent stuff. It also takes intelligence to organize stuff, and to keep stuff chugging along.
The masses possessing average intelligence are free to partake of the fruits of the work of the vastly more intelligent, but a little respect wouldn't hurt. Perhaps even some gratitude would be in order?
Your post literally reeks of hate towards anyone smarter than you. It is immature, and only shows your own poor self image.
It is possible you are actually too dumb to realize how much in your life you owe to more intelligent people than yourself. That's the tragic irony of it all - the dumb are too dumb to realize how dumb they are.
Anonymous Coward 300884
Well, clearly, at this point I must ascertain that your mental barrier is the idea that the ideal society is a white(skin and collar color) slave society.
It is obvious to me that you do not believe in any sort of "conspiracy" theories that attempt to identify the real dynamics of our globalized world. Consequently you point to the bourgeois European white lifestyle, marvel at its technological achievements and the like, and determine that it is their culture and race that is supreme. Everyone needs to work towards achieveing such intelligence (enter the ethnocentrism). Yet you fail to realize the reliance on black/brown slave labor. These races represent and manifest the outward physical manifestation of slavery. The white race represents the subtle one, disguised in self-indulgent, unquestioning belief in a dream and its trickle of benefits.
But there's really no point discussing this stuff with you since you're an ardent believer in (lol) the IQ test and everything it stands for.
Why don't you go have fun lobbying for the forced genetic modification (spelled extermination) of black people in your Nazi country? I'm sure you'd receive a sizeable following. Your country has done much worse.
Eugenics represents the negative side of the essence of your particular country's archtypical dream of societal and physical perfection. Why not recognize this energy guiding your countrymen and gain a glimpse into true intelligence that allows you to see how a person's personality is constructed based on soul age and incarnations and their manifestations as experiences, repression of emotions, tendencies and fears?
Think it about faggot. No, calling you names doesn't make me unintelligible, see? It's just fun :)
Anonymous Coward 25180110
Effective, too. :)
It's not "white bourgeois society" that invented just about everything we use. It's specific white people. An Arabian did give us algebra, that very fundamental tool of mathematics. Calculus came from Leibniz and/or Newton. Newtonian physics came from, well, Newton, who used the writings of those before him like Galileo and Copernicus. It was extended to relativity by various white physicists including Einstein. It was extended to quantum physics by various white physicists including von Heisenberg and (my favorite) Boehm.
William Shockley invented the transistor. He was famously a racist.
Linux was started and project-managed by Linus Torvalds, helped by lots of sharp programmers from various places but never, to my recollection, Africa. I'm just free-associating here, thinking of something and who is responsible for it.
Pick anything, anything at all, and try to find a black who has made a fundamental contribution to it.
Anonymous Coward 23597994
Well, no shit, Africans had nothing to do with Linux. IT penetration is tiny in Africa, good luck finding programmers there lucky enough to have free time to do volunteer work on an open-source OS. WTF man you clearly didn't absorb my initial reply to the Swede. Neither do you possess the ability to logically analyze such fundamental cultural and historical differences, something you point out as central to your own argument.
Again, do you really think Africans in Africa give two shits about such inventions? They are of the earth, that is their energy. They respect it, unlike (unevolved slave-minded) whites and most have no desire to lead sedentary lifestyles doing programming work lol, contrary to what the MSM may dictate to you about all the beautiful schools being built and how Africans for once look forward to a good future based on mimicking white society.
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Posts by Rich of Observationz
Speaker: A Disorderly Brexit, in reply to
FPP prevents any of it.
Only three parties have ever been in government in the UK during the nearly 400 years since they stopped being an absolute monarchy: Tories/Conservatives, Whigs/Liberals and Labour. The Liberal => Labour transition occurred in the late 19th and early 20th century as working class man and women gradually gained the right to vote and thus led to the growth of the Labour party.
The hurdle to be jumped for a new party to gain office 9or even opposition/influence) is huge, The SDPs best result was 23 MPs (on 25% of votes) and the LibDems was 54 MPs on 23% of the vote (due to a higher concentration of votes in winnable seats).
In a sensible political system, the rump PLP (made up of Blairites, Brownites, careerists and those who don't really care if the government bombs foreigners and throws people out of jobs so long as they use the correct language around their chosen identity group) would accept the loss of Labour, found their own party and contest the next election.
(Alternatively Momentum would morph into a Podemos/Syriza type party and contest the election).
That is broadly what would happen in NZ if a party's parliamentary and grassroots support became irretrievably alienated (in the case of the Greens, it would self correct as the list gets reset each election by the membership).
However, the UK's voter-chosen FPP system means that parties are forever, so that option will be vigorously resisted.
(UK) Labour won in 1974 though. Not because they were particularly united (the Healey supporters were widely at odds with the Bennites) or because the mass of the UK population were particularly in love with them - they won because of a crisis.
It was more of a material crisis than today (thus far) - the miners were on strike, the "coal dependent" electricity supply was cut off half the time and businesses were on a three day week. Labour won the election because they offered to fix this (by giving the miners the money).
If UK Labour could manage to offer a fix for the EU situation (basically, concede acceptance of all EU rules without actual membership in return for market access) then, once businesses start closing in droves, they could win without much in the way of public love.
(The challenge then would be to do what Wilson and Callaghan failed to do and capitalise on this with an Attlee-style program of radical and lasting change).
I guess it depends on whether you think the members of a party should be allowed to decide the leadership and direction of that party, or whether you prefer the model (as in NZ National and the CCP) where control flows from the top down and the members are instructed on what to do and think by the centre.
Brecht had a solution:
the people
Had forfeited the confidence of the government
And could win it back only
By redoubled efforts. Would it not be easier
In that case for the government
To dissolve the people
And elect another?
Die Lösung, 1953 https://en.wikipedia.org/wiki/Die_L%C3%B6sung
On the main topic:
Geoffrey Robertson (QC, incidentally) sez what I was thinking
The UK government can't trigger Article 50 without first getting legislation to repeal the European Communities Act through Commons and Lords.
Crimes of the Corbynites:
- student activists being mildly nasty on Facebook
Crimes of the Blairites
- their leader organising to kidnap people and send them to Libya to be tortured
Obviously, the Corbynites are way worse…
Speaker: A Disorderly Brexit, in reply to
"Both vigorously deny the claims" – it's not unheard of for organs like the Telegraph to just make shit up, you know. And there is an influential minority that conflate Zionism with Judaism and the Jewish race, allowing any criticism of Israel to be treated as anti-semetic.
Corbyn won with three times the votes of the runner up, you know – it's the MPs who are out of line. Do you think Labour should be run as a self-perpetuating entity (like the NZ National Party) where the MPs tell the members what to do?
Basically, the UK establishment rely on Labour as their plan B. When the Tories become too toxic, a Blair-style figure can get in and put a new face on the same policies.
Corbyn's destroyed this insurance policy and that's what they're terrified of - an actual left-wing government
Speaker: The Government you Deserve, in reply to
The UK would analyse its census categories by occupation using the NRS system:
https://en.wikipedia.org/wiki/NRS_social_grade. This reflects one aspect of social class but not the caste-like system that pervades England - e.g. a working class FX trader would be in AB, while a posh gardener would be in C2D.
NZ collects the same information, it just presents it differently http://www.stats.govt.nz/datavisualisation/treemap/occupation.html. You could extract the NRS information from summary/meshblock data and I'm sure people do, but not Stats I don't think...
Speaker: The Government you Deserve,
My experience of UK education is that while it was (at the time) functional, it was also a process designed to perpetuate social division and produce an ignorant and unthinking populace.
My year was the first to enjoy comprehensive education, but at least in the south-east, state schools were mostly populated by the lower middle and working classes (joined by those in the middle classes who had parents too idealistic, cheap, or both to send their kids to private school). The middle classes attended a range of schools, ranging from famous public schools down to those whose main function was to keep the more retarded offspring of the gentry out of trouble until they became army officers (boys) or married an army officer (girls).
Despite being nominally comprehensive, a sifting process operated at every stage - pupils were assessed and streamed by ability (and of course pre-selected by social class) at 14 (GCE or GCSE exams, now rebranded as separate papers), 16 (staying of for A levels) and then at university.
The selective university system is the final filtering process in the UK. University courses are ranked by UCAS points, with Oxbridge at the top and places like Luton at the bottom. Unless you are either brilliant or well coached (e.g. went to public school) you won't get to fuck pigs at Oxbridge and will wind up somewhere down the list - and the list very accurately mirrors social class.
So basically, everyone outside a tiny minority (who run the country and write the media) gets failed by the education system. Add to that they way the system rewards conformity (because docile kids allow a school to get good results in the various league tables) and prioritises cramming for exams, it's pretty unsurprising you've got a population of disgruntled failures.


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