Global Phase 3 Study Of IMC-1121B In Metastatic Breast Cancer Commences

�ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the starting time patient has been treated in a global Phase 3 clinical trial of IMC-1121B, its anti-vascular endothelial growth factor receptor-2 (VEGFR-2) IgG1 monoclonal antibody antibody, in women with metastatic chest cancer.


"Since the growth of breast cancer is dependent on VEGFR-2 activation, IMC-1121B presents a singular opportunity to optimize this therapeutic approach as IMC-1121B uniquely binds to the VEGFR-2 receptor itself, thereby blocking many VEGF ligands from energizing it," aforesaid Eric K. Rowinsky, M.D., Executive Vice President and Chief Medical Officer of ImClone. "Unlike bevacizumab that targets only a single ligand, and unlike small molecule drugs that target many unrelated receptors, IMC-1121B specifically targets only VEGFR-2. This clinical trial will help us understand whether this approach produces greater activity with fewer side effects."


In April 2008, ImClone announced the validation of an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for this trial. The SPA is a written agreement between the trial's shop and the FDA regarding the conception and size of the Phase 3 trial to be used in generating the basal clinical data necessary to support approval of an efficacy claim in conjunction with the submission of a newfangled drug application (NDA) or biologics licensing application (BLA).


Pursuant to the SPA, this Phase 3 trial is a randomized, double blind, placebo-controlled tribulation of IMC-1121B plus docetaxel in women with unresectable locally-recurrent or metastatic breast cancer world Health Organization have non received prior chemotherapy in the locally-recurrent or metastatic setting. The trial, which is beingness conducted under the auspices of the Cancer International Research Group, doing business as Translational Research in Oncology (TRIO), is expected to enter approximately 1,100 patients who will be randomized (2:1) to receive either IMC-1121B plus docetaxel or placebo plus docetaxel. The primary endpoint of the trial is progression-free survival. The trial volition be conducted at more than two hundred sites passim the world.


"This trial of IMC-1121B highlights the efforts of TRIO to bring promising new therapies to women with white meat cancer, which remains the most oftentimes diagnosed crab among women today," aforementioned John Mackey, M.D., FRCPC, Professor of Oncology at the University of Alberta, and Principal Investigator of the study. "Our efforts also certify TRIO's commitment to transforming our understanding of genus Cancer biology into clinical trials by testing compounds, like IMC-1121B, across the spectrum of human cancer."


IMC-1121B is a fully human IgG1 monoclonal antibody intentional to bandage to the extracellular domain of a function of VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from cover to and activating the receptor. This action blocks a sign pathway key to new blood vessel formation in growing tumors, which has been shown to crave tumors of their nutrient supply and result in significant neoplasm growth suppression in preclinical models. In 2007, ImClone completed registration into two Phase 1 studies of IMC-1121B, which demonstrated favorable safety and pharmacokinetic profiles, as advantageously as documentary antitumor activity as a single agent in several patients with refractory solid cancers when administered either weekly or every deuce or terzetto weeks. In addition to this Phase 3 study of IMC-1121B in women with breast cancer, disease-directed studies of IMC-1121B in patients with advanced melanoma, renal and liver cancers have begun to recruit patients, and additional Phase 2 and 3 evaluations are in various stages of developing.

About TRIO


TRIO, which was created as an international inquiry network in oncology in 1997, is an donnish global network of investigators capable of rapid accumulation to clinical trials. TRIO arose verboten of the need to address the increasing number of new anticancer drugs and targeted therapies in development. TRIO has selected dedicated investigators from all around the world to participate in pivotal trials of fresh cancer agents in breast cancer and many other disease settings. TRIO has been highly successful in maintaining a strong and enthusiastic network by offering innovative and exciting science, and more than recently, translational research. TRIO consists of an operations infrastructure that uses comprehensive pharmaceutical diligence standards. By combining these two strategies, that of increasing patient access through global investigator sites and that of applying effective, well-established clinical trial military operation systems, TRIO has since become accepted for its high quality data and rapid accrual rates. TRIO has also been highly successful at captivating the interests of patients and investigators throughout the public, in contribution, due to the incorporation of high school quality and exciting skill into its clinical evaluations. TRIO was incorporated as a Canadian not for profit entity in 1999.

About ImClone Systems


ImClone Systems Incorporated is a fully integrated global biopharmaceutical company committed to forward oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical inevitably of patients with a variety of cancers. The Company's research and development programs include growth agent blockers and angiogenesis inhibitors. ImClone Systems' headquarters and research operations are placed in New York City, with extra administration and manufacturing facilities in Branchburg, New Jersey. For more than information nigh ImClone Systems, please visit the Company's web site at hypertext transfer protocol://www.imclone.com.


Certain matters discussed in this news sacking may name forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such advanced statements are based upon reasonable assumptions it buttocks give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to dissent materially from those presently expected. Many of these factors ar beyond the company's ability to control or foretell. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this word release crapper be constitute in the company's filings with the Securities and Exchange Commission, particularly those factors identified as "hazard factors" in the Company's most recent annual write up of Form 10-K and in its quarterly reports on Form 10-Q and current reports on Form 8-K. For forward-looking statements in this news sack, the fellowship claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement whatever forward-looking statements whether as a upshot of unexampled information, future events or otherwise.

ImClone Systems


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Liam Gallagher attacks Radiohead and Coldplay

He english hawthorn protest that he and his comrade are "deuce totally unlike people and the sooner people realize that the less we can go on approximately it", merely Liam Gallagher and his brother Noel have at least ane thing in common: they both love f***ing asterisks. In an expletive ridden interview with the Times this weekend, the Oasis frontman laid into an array of targets, including Wayne Rooney and "modern bands", as well as calling fans of Coldplay and Radiohead "boring and ugly".

When asked whether his newfound love of "running, not jogging" was proof that he is mellowing with age, Gallagher mused: "Yeah, I've mellowed, but not in the sense of liking Radiohead or Coldplay ..." He went on to reason, "I don't hatred them, I don't like they had accidents. I think their fans are boring and ugly and don't look like they're having a good fourth dimension". Gallagher went on to compare modern bands to "Topman music".

His issue with Wayne Rooney is that he represents the genial of modern footballer wHO thinks aught of "disbursement 100 grand on f***ing Rolexes". He also says he'd make to be "well and truly f***ing desperate" to imitate the Manchester United striker's decision to sell his marriage photographs to OK magazine.

The 35-year-old singer was more upbeat about embracing a fitter lifestyle, which includes linear ten miles in an hour and a half, and has cut down on liquor and "the other stuff" because it wrecks his ability to sing by rights. In typically trenchant fashion, he claims this is because when his voice is spoiled "it's a bit punter than Pete Doherty's".

The lengthy interview does show up that Gallagher's lifestyle has mellowed at least. The piece covers Gallagher's land retreat in the conservative Oxfordshire town of Henley-on-Thames - "This lady walked past, she said, 'You're the coolest person I've seen in Henley since George Harrison.'" - and that he doesn't see why his son Gene shouldn't go to secret school as much as "some banker's son". The interview ends with Gallagher departing to take his son to the cinema, or as he puts it: "I'm off to f****** 'ave it with Kung Fu Panda."

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Richard O'Brien

   
Artist: Richard O'Brien

   Genre(s): 
Rock
   

---

Discography:


   
 The Rocky Horror Picture Show (1975 Film)

   Year: 1989   
Tracks: 16

---

 





Clipz

Sylver

   
Artist: Sylver

   Genre(s): 
Electronic
   Trance
   Pop
   Dance
   

---

Discography:


   
 Crossroads

   Year: 2006   
Tracks: 12


   
 Nighttime Calls

   Year: 2004   
Tracks: 14


   
 Love is an Angel__Incl Groove Coverage Remix

   Year: 2004   
Tracks: 4


   
 Love Is An Angel incl Dj Wout mix

   Year: 2004   
Tracks: 3


   
 Livin' My Life-Wild Horses (Promo)

   Year: 2004   
Tracks: 4


   
 Why Worry (Vinyl)

   Year: 2003   
Tracks: 3


   
 Why Worry (Promo)

   Year: 2003   
Tracks: 7


   
 Why Worry (100 Copies Limited Edition Vinyl)

   Year: 2003   
Tracks: 5


   
 Shallow Water-Confused (Vinyl)

   Year: 2003   
Tracks: 4


   
 Livin' My Life

   Year: 2003   
Tracks: 4


   
 Little Things

   Year: 2003   
Tracks: 11


   
 In Your Eyes - Skin

   Year: 2002   
Tracks: 3


   
 Forgiven

   Year: 2001   
Tracks: 5


   
 Forever In Love

   Year: 2001   
Tracks: 5


   
 Changes

   Year: 2001   
Tracks: 10


   
 Turn The Tide (inc Rui Da Silva mix)-VLS

   Year: 2000   
Tracks: 2


   
 Remix

   Year:    
Tracks: 7


   
 Chances CD 1

   Year:    
Tracks: 13

---

Belgian electronica duet Sylver (at one time known as Liquid ft. Sylvie) emerged in 2000. Their debut single, called "Turn the Tide," climbed to the teetotum of the official local club/dance graph shortly after its release. Producer Regi Penxten and DJ/keyboardist Wout van Dessel (natural 1974) were joined by singer Silvy De Bie (natural 1981) to gather an electronica-oriented act and join the Europop scenery. After the vast success of their first undivided, "Skin" followed in January and "Forever In Love" in April 2001. Sylver's album Chances featured their pip songs and remixes.

Cinema workers in 'popcorn' strike

Cinema workers fighting for better working conditions are asking movie-goers to boycott treats in what they are calling a "popcorn strike".

Unite Union members have asked cinema patrons not to buy food from confectionary stands until the SkyCity Cinema chain amends its pay rates and offers secure hours of work for employees.

Further industrial action is planned for tonight when workers at SkyCity's WestCity Shopping Town cinema in Henderson, Auckland, plan to walk off the job at 6pm and picket outside.

National director Mike Treen said the industrial action would begin at the Henderson cinema but would follow throughout the country.

Mr Treen said members were asking for an hourly rate of $12.20, moving up to $13.10 after two years service, but SkyCity had offered no more than the legal minimum wage for the majority of the workers.

"If the offer was accepted cinema workers would be paid significantly less than those in the fast-food industry who are also represented by our union," Mr Treen said.

Another aspect of the contract members hope to change with the popcorn strike is their hours of employment.

"[SkyCity] won't guarantee even one shift a week for staff, so there's no guaranteed hours from week to week," Mr Treen said.

SkyCity Cinemas chief operating officer Joanne Watt said the cinema chain was very disappointed Unite Union was advocating strike action.

"We have very good relationships with our employees. Our work is attractive to students and we are a very flexible employer offering many additional hours available during their holiday times and flexibility around study and exam leave."

Ms Watt said SkyCity was already comfortably in line with pay rates for the industry.

SkyCity is the largest cinema operator in New Zealand with 19 cinemas throughout the country.

-NZPA





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�Gift Horse� for Makatsch

Tossell takes on top teutonic talent

Related Content Complete Cannes coverage

CANNES -- Berlin-based Egoli Tossell has lined up a cast of A-list German characters actors for its $15 million biopic of 1960s filmstar and chanteuse Hildegard Knef, "The Gift Horse," including Johanna Gastdorf ("Sophie Scholl"), Christian Berkel ("Downfall"), Michael Gwisdek ("Good Bye Lenin!"), Henry Hubschen ("Go For Zucker") and Monica Bleibtreu ("Four Minutes").


Heike Makatsch ("Love Actually") will star as the enigmatic singer/actress who rose to German and then international fame, appearing in such films as "The Snows of Kilimanjaro" alongside Gregory Peck and Ava Gardner.


Kai Wessel will direct from a script by Maria von Heland with "The Lives Of Others" cinematographer Hagen Bogdanski behind the camera.


Shooting is set to start in Germany next month. Warner Bros. will release "The Gift Horse" in Germany in 2009. Beta Cinema is selling the title internationally, presenting it to buyers for the first time here in Cannes.


Egoli Tossell is in production on its Leo Tolstoy biopic "The Last Station," starring Helen Mirren, Christopher Plummer, Paul Giamatti and Anne-Marie Duff, which Warner has also picked up for German release.

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Coldplay announce UK arena tour

Coldplay have announced full details of a UK tour, set to take place this winter.

The group, who release their fourth album 'Viva La Vida Or Death And All His Friends' on June 12, will play ten arena dates in December.

The tour kicks off with two nights at Birmingham NIA on December 1, before the group end their trip with a two-night stint at London's O2 Arena, beginning on December 14.

The group also made their album's title track available on iTunes on Sunday (May 25), following the earlier release of 'Violet Hill', the vinyl version coming free with NME last month.

Coldplay will perform at:

Birmingham NIA (December 1, 2)
Glasgow SECC (5, 6)
Sheffield Arena (7)
Liverpool Echo Arena (10)
Manchester MEN Arena (11, 12)
London O2 Arena (14, 15)

Tickets go on sale at 9.30am on May 30.

To check the availability of Coldplay tickets and get all the latest listings, go to NME.COM/GIGS now, or call 0871 230 1094.

Joaquin Phoenix recording an album

Following his portrayal of Johnny Cash in the film 'Walk the Line', Joaquin Phoenix is recording an album with Charlatans singer Tim Burgess.
However Billboard.com reports that Phoenix's perfectionism may mean that the record is never released.
Burgess is mixing the album with The Charlatans' manager, Alan McGee.
He said of Phoenix: "Once he learned guitar, he found that he had quite a lot of demons inside himself that he wanted to expel through music."
He continued: "All the tracks that me and Alan worked with him on were brilliant. But I think he just keeps scrapping everything or redoing everything. I'm sad to say that I think it's one of those records that may never come out, to be honest with you."
Burgess added: "It's an ongoing thing. I'm trying to get Alan to force him to put it out at the moment, but I don't know whether it will [get released]."

Producers of 24 working on prequel

The producers of '24' are developing a special two-hour prequel episode for the seventh season of the hit action-drama.
The Hollywood Reporter says that the prequel will bridge the two-year storyline gap between seasons six and seven.
The makers of '24' have begun making deals with the show's stars for the prequel.
The prequel would air on US television in the autumn, with '24' returning to American screens in January.
The seventh season of '24' is set in Washington, with actress Cherry Jones playing the first female US president.

Ozzfest switches to single-day format for 2008

Ozzfest [ tickets ] will return this year in much different form than in the past, with namesake Ozzy Osbourne [ tickets ] and Metallica topping the bill for a one-day only stadium show in Texas.The new, downsized heavy metal festival is set to take place Aug. 9 in Frisco, TX, a suburb of Dallas, at 20,500-seat Pizza Hut Park, home of Major League Soccer's FC Dallas club. In keeping with the event's history, the concert will feature bands playing concurrently on three stages.Other names confirmed by organizers include System of a Down's Serj Tankian, Hellyeah, Jonathan Davis of Korn, Cavalera Conspiracy, Shadows Fall, Apocalyptica and In This Moment. Second stage acts include Sevendust, Devildriver, Kingdom of Sorrow, Soilent Green, Witchcraft and Goatwhore, while the third stage will put the spotlight on local acts, featuring Texas outfits The Sword, Drowning Pool and Rigor Mortis.Tickets for the concert go on sale May 31. For up-to-the-minute details, consult the event's official website."Ozzy just finished an 11-month world tour so I think he deserves a summer off," Osbourne's wife (and Ozzfest's founder), Sharon, said in a press statement about the festival's switch to a one-day format. "We're going to be a stadium destination festival for now--we have gone past doing the sheds every summer. We've given everyone else the blueprint and we have to keep evolving Ozzfest."Osbourne recently completed a major arena trek with Rob Zombie, playing before crowds in 40 cities in North America alone. Last year, Osbourne led a lineup of metal acts on a 24-city trek in his return to a headlining position on the tour he created. In an unprecedented move, organizers gave away more than a half million free tickets to the concerts in an effort to "redefine a concert industry marred by rising ticket prices," according to a press release."Ozzy has great relationships with all of the bands that have played Ozzfest," added Sharon Osbourne. "We're the only real festival for harder edge bands and these artists have been very loyal to us--there is lots of love on this line-up."

George Michael makes Paula cry

When the aura is tensed and the heart beats like never before, who can bring the situation back to normalcy? No price for guessing! It has to be George Michael. Yes, George Michael's presence at the grand finale of American idol seemed to give strength to the finalists David Cook and David Archuleta to take both success and failure with grace. The judges of the contest were all over the 17-year-old David Archuleta. But it was the audience who were to choose the American Idol, and they chose David Cook, the matured singer of the contestants. Before the winner of American Idol was announced, the top final 12 contestants sang George Michael's songs "Faith" and "Father Figure". Carrie Underwood, the winner of 2005 American Idol also made her presence felt. Then George Michael himself took the stage and sang the song "Praying For Time". Judge Paula Abdul was in tears on hearing the song.

Jennifer Grey - Grey Feared Dirty Dancing Disaster

Actress JENNIFER GREY was far from happy when she learned PATRICK SWAYZE would be her love interest in cult movie DIRTY DANCING because she hated working with the actor on a previous film.

Grey let it be known to producers that she had not enjoyed making Red Dawn with the movie hunk - and feared she and Swayze would not have the chemistry needed for the 1987 film.

Producer Linda Gottlieb recalls, "When Jennifer heard that Patrick was playing the part she was not a happy camper.

"They had performed together in Red Dawn and I gather that was not a wonderful working relationship.

"They had very different temperaments - Jennifer is a kind of spontaneous girl and she'd be very emotional; she would cry easily. Patrick is the exact opposite."

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Nelly's 'Brass Knuckles' Gets Pegged With A June Release

An official release date for Nelly's  forthcoming solo album titled Brass Knuckles has been announced.

According to Billboard, the set will hit shelves On June 24th and will feature appearances from Ciara, Lil Wayne, Snoop Dogg, Akon and LL Cool J, among others.

As reported earlier, the first single off the set , "Party People",  features an appearances from Fergie of The Black Eyed Peas.  [Listen to Party People]

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Michael Douglas to haunt his old Girlfriends

At the New York junket for his new movie 'The Spiderwick Chronicles', director Mark Waters revealed the cast of his upcoming romantic comedy 'The Ghosts of Girlfriends Past'.
The cast includes Matthew McConaughey, Jennifer Garner and Breckin Meyer, and Waters revealed that Michael Douglas is set to join the line-up.
Speaking about the 'Wall Street' actor's role in the film to Comingsoon.net Waters said: "(He'll be playing) the Marley character, the old ghost who's dead, Uncle Wayne. He's a '70s playboy...and he wears Bob Evans shades."
McConaughey replaced Ben Affleck, who was originally lined up to play the lead role. 
Waters told Comingsoon.net what he thought that McConaughey brought to the table: "There's something great about Matthew. He has an aspect of him that he can get away with murder with women."
He continued: "He's the kind of guy where women are apologising to him when he breaks up with them, because he's so charming. It's always been such a delicious concept of taking a Christmas Carol and making a romantic comedy out of it."
In the film, McConaughey plays a womaniser who attends the wedding of his younger brother (Breckin Meyer) and bride (Lacey Chabert).
There, he's haunted by several old flames, including the bride's best friend (Jennifer Garner).

Whitney Houston - Whitneys Drug Charges Dropped

Drug charges against WHITNEY HOUSTON which rose from a marijuana-related incident in 2000 have reportedly been dropped.

The misdemeanour possession charges had been pending for almost eight years, since it was alleged that police caught the singer carrying marijuana at a Hawaiian airport.

While the fallen singer was not arrested at the time, she was charged with possession after authorities discovered an ounce of marijuana and three rolled joints in her possession before boarding a flight with her then husband, BOBBY BROWN.

WHITNEY had string of hits in the 1980s and 1990,s but became embroiled in a tempestuous relationship with Brown which many believe contributed to her escalating drug use.

HOUSTON finally filed for separation from BROWN in September 2006 following trips to rehab.

The divorce became finalized on April 24th last year, with HOUSTON granted custody of the couple's daughter.

According to TMZ, the pop-star has now been completely cleared of the charges.







21/05/2008 12:02:46

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