Tuesday, 2 September 2008

ERBITUX(R) Phase 3 BMS-099 Lung Cancer Study Secondary Endpoint Update: Overall Survival Results Announced

�ImClone Systems Incorporated (NASDAQ: IMCL) announced overall survival results from BMS CA225-099 (BMS-099), an open-label Phase 3 study of ERBITUX� (cetuximab) in combination with a taxane and carboplatin in the first-line treatment of all histological subtypes of advanced non-small electric cell lung cancer (NSCLC).


These results pertaining to overall survival, a secondary termination, are an update to the antecedently reported results for progression-free survival (PFS), the study's primary endpoint, which were announced in June 2007. The sketch did non meet its primary terminus of PFS, as assessed by an independent radiology review citizens committee (IRRC). Response rate, as assessed by the IRRC, and PFS, as assessed by clinical investigators, were statistically significant and favored the ERBITUX-containing arm.


In this recently completed depth psychology of BMS-099, median overall survival in patients receiving ERBITUX in combination with a taxane and carboplatin was 9.7 months, compared to 8.4 months with chemotherapy alone, with a hazard ratio of 0.89 [95% CI = 0.75-1.05], p=0.17.


The results from this boilers suit survival analysis did not reach statistical significance. BMS-099, a 676-patient study, was not powered to observe an improvement in overall survival with the same degree of statistical preciseness as was the larger 1,125-patient pivotal FLEX (First-line in Lung malignant neoplastic disease with ErbituX) multinational Phase 3 report conducted by Merck KGaA, Darmstadt, Germany. Nonetheless, the BMS-099 survival of the fittest results financial backing those of FLEX, of which boilers suit survival was the primary endpoint.


As recently reported, results from FLEX, demonstrated a statistically significant improvement in overall survival in patients receiving ERBITUX in combination with vinorelbine and cisplatin when compared to chemotherapy (11.3 months vs 10.1 months) with a hazard proportion of 0.871 [95% CI = 0.762-0.996], p=0.044. ImClone and Bristol-Myers Squibb extend to pursue a regulatory filing with the U.S. Food and Drug Administration for the first-line treatment of patients with ripe NSCLC.


"With less than one in five advanced-stage non-small cell lung crab patients presently receiving biologic-based combination therapy in the first-line setting, ImClone is committed to providing new treatment options to address this unmet medical motivation," said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone Systems.


The BMS-099 subject, performed in the U.S. and Canada, was one of several clinical trials intended to assess the potential of ERBITUX in the treatment of ripe NSCLC. Full BMS-099 survey results, including efficacy and safety, testament be submitted to a major medical meeting later on this class.

About Lung Cancer


The American Cancer Society estimates that in the United States, more than 215,000 people will be diagnosed with lung crab in 2008, which accounts for most 15 percent of all cancer diagnoses. Approximately 87 percent of these patients will be diagnosed with NSCLC, with many organism diagnosed with locally in advance or metastatic disease. Lung cancer is the leading cause of cancer-related death in hands and women, with more than than 161,000 deaths expected to occur in 2008 - accounting for about 29 percent of all cancer deaths. In 2008, it is estimated that more Americans testament die from lung crab than titty, prostate, and colorectal cancers combined.

About ERBITUX� (Cetuximab)


ERBITUX (cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal increase factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo brute studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of jail cell growth, elicitation of caspase-mediated cell death, and reduced matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX behind mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. In vitro assays and in vivo animal studies have shown that ERBITUX inhibits the growth and survival of tumor cells that give tongue to the EGFR. No antitumour effects of ERBITUX were observed in human neoplasm xenografts wanting EGFR expression.

Squamous Cell Carcinoma of the Head and Neck (SCCHN)


ERBITUX (cetuximab), in combination with radiation therapy, is indicated for the initial intervention of locally or regionally advanced squamous cell carcinoma of the head and neck. ERBITUX, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

Colorectal Cancer


ERBITUX, as a single agent, is indicated for the treatment of EGFR-expressing metastatic colorectal cancer later failure of both irinotecan- and oxaliplatin-based regimens. ERBITUX, as a single agent, is besides indicated for the treatment of EGFR-expressing metastatic colorectal cancer in patients world Health Organization are intolerant to irinotecan-based regimens. ERBITUX, in combination with irinotecan, is indicated for the treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. The potency of ERBITUX in combining with irinotecan is based on nonsubjective response rates. Currently, no data ar available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX in combination with irinotecan for the discourse of EGFR-expressing metastatic colorectal carcinoma.

Important Safety Information


Grade 3/4 infusion reactions occurred in approximately 3% of patients receiving ERBITUX (cetuximab) in clinical trials, with fateful outcome reported in less than 1 in chiliad. Serious infusion reactions, requiring medical intercession and immediate, permanent discontinuance of ERBITUX, included rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), hypotension, loss of consciousness, and/or cardiac get. Most (90%) of the severe infusion reactions were associated with the commencement infusion of ERBITUX disdain premedication with antihistamines. Caution must be exercised with every ERBITUX infusion, as there were patients wHO experienced their first spartan infusion reaction during by and by infusions. Monitor patients for 1 hour following ERBITUX infusions in a scope with resuscitation equipment and other agents necessary to treat anaphylaxis (eg, adrenalin, corticosteroids, intravenous antihistamines, bronchodilators, and o). Longer observation periods may be needful in patients who require treatment for infusion reactions.


Cardiopulmonary contain and/or sudden death occurred in 4 (2%) of 208 patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUX, as compared to none of 212 patients treated with radiation therapy alone. Fatal events occurred within 1 to 43 days after the last ERBITUX treatment. Carefully regard the use of ERBITUX in combination with radiation therapy in head and neck cancer patients with a story of coronary thrombosis artery disease, congestive bosom failure or arrhythmias in light of these risks. Closely monitor serum electrolytes including blood serum magnesium, potassium, and calcium during and after ERBITUX therapy.


Interstitial lung disease (ILD), which was fatal in unrivalled case, occurred in 4 of 1570 (

In clinical studies of ERBITUX, dermatological toxicities, including acneform efflorescence, skin drying and fissuring, paronychial rubor, infectious sequelae (eg, S. aureus sepsis, abscess formation, cellulitis, blepharitis, cheilitis), and hypertrichosis, occurred in patients receiving ERBITUX therapy. Acneform rash occurred in 76-88% of 3 patients receiving ERBITUX in clinical trials. Severe acneform rash occurred in 1-17% of patients. Acneform rash usually developed inside the start two weeks of therapy and resolved in a majority of the patients after cessation of treatment, although in nearly half, the event continued beyond 28 years. Monitor patients receiving ERBITUX for dermatological toxicities and infectious sequelae. Sun exposure may exacerbate these effects.


The refuge of ERBITUX in combination with radiation therapy and cisplatin has not been established. Death and good cardiotoxicity were observed in a single-arm trial with ERBITUX, actinotherapy therapy, and cisplatin (C mg/m2) in patients with locally ripe squamous prison cell carcinoma of the head and neck. Two of 21 patients died, one as a result of pneumonia and one of an unknown cause. Four patients discontinued treatment due to adverse events. Two of these discontinuations were due to cardiac events.


Hypomagnesemia occurred in 55% (199/365) of patients receiving ERBITUX and was severe (NCI CTC grades 3 & 4) in 6-17%. The onrush of hypomagnesemia and concomitant electrolyte abnormalities occurred years to months after induction of ERBITUX therapy. Monitor patients sporadically for hypomagnesemia, hypocalcemia and hypokalemia, during, and for at least 8 weeks following the completion of, ERBITUX therapy. Replete electrolytes as necessary.


The boilers suit incidence of late radiation toxicities (any grade) was higher with ERBITUX in combination with radiation therapy compared with radiation therapy alone. The following sites were unnatural: salivary glands (65%/56%), voice box (52%/36%), subcutaneous tissue (49%/45%), mucous membranes (48%/39%), oesophagus (44%/35%), and skin (42%/33%) in the ERBITUX and radiation versus radiation only arms, severally. The relative incidence of mark 3 or 4 recent radiation toxicities were similar between the radiation therapy alone and the ERBITUX plus radiation therapy coat of arms.


In women of accouchement potential, appropriate contraceptive measures must be used during treatment with ERBITUX and for 6 months next the last dose of ERBITUX. ERBITUX should only be exploited during pregnancy if the potential benefit justifies the potential risk to the fetus.


The most serious adverse reactions associated with ERBITUX across all studies were infusion reactions, cardiopulmonary arrest, dermatological toxicity and radiation dermatitis, sepsis, nephritic failure, interstitial lung disease, and pulmonic embolus.


The most common adverse reactions associated with ERBITUX (incidence greater than or match to 25%) are cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, looseness, and infection.


The nigh frequent inauspicious events seen in patients with carcinomas of the head and neck receiving ERBITUX in combination with radiation therapy (n=208) versus radiation alone (n=212) (incidence greater than or equal to 50%) were acneform rash (87%/10%), radiation dermatitis (86%/90%), weightiness loss (84%/72%), and asthenia (56%/49%). The most common grade 3/4 adverse events (greater than or equal to 10%) included: radiation dermatitis (23%), acneform blizzard (17%), and weight loss (11%).


The most frequent adverse events seen in patients with metastatic colorectal cancer (n=288) in the ERBITUX + best supportive care weapon (incidence greater than or equal to 50%) were fatigue (89%), rash/desquamation (89%), abdominal pain in the neck (59%), and pain-other (51%). The most common grade 3/4 inauspicious events (greater than or equal to 10%) included: fatigue (33%), pain-other (16%), dyspnea (16%), abdominal pain in the neck (14%), infection without neutropenia (13%), rash/desquamation (12%), and other-gastrointestinal (10%).


The nearly frequent inauspicious events seen in patients with metastatic colorectal genus Cancer (n=354) treated with ERBITUX plus irinotecan in clinical trials (incidence greater than or rival to 50%) were acneform rash (88%), asthenia/malaise (73%), diarrhea (72%), and nausea (55%). The most common grade 3/4 adverse events (greater than or rival to 10%) included: diarrhoea (22%), leucopenia (17%), asthenia/malaise (16%), and acneform efflorescence (14%).

About ImClone Systems


ImClone Systems Incorporated is a fully integrated ball-shaped biopharmaceutical company committed to advancing oncology care by developing and commercializing a portfolio of targeted biological treatments intentional to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' headquarters and research operations ar located in New York City, with additional judicature and manufacturing facilities in Branchburg, New Jersey. For more information about ImClone Systems, please visit the Company's web site at http://www.imclone.com.


ERBITUX� is a registered trademark of ImClone Systems Incorporated.


Certain matters discussed in this news release may make up forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the party believes that the expectations reflected in such advanced statements are based upon reasonable assumptions it can 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 differ materially from those jutting. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to take issue materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For innovative statements in this news release, the company claims the protection of the safe harbour for advanced statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any modern statements whether as a result of new information, future events or otherwise.

ImClone Systems


View drug entropy on Erbitux.



More info

Saturday, 23 August 2008

Sony BMG Masterworks Announces New Christmas CD by Kristin Chenoweth

Award Winning Actress and Singer - A Lovely Way To Spend Christmas -
Available October 14, 2008

NEW YORK, Aug. 21 -- On October 14, 2008 Sony BMG
Masterworks will freeing KRISTIN CHENOWETH's new Christmas CD A LOVELY WAY
TO SPEND CHRISTMAS. For her third album, Chenoweth covers a wide range of
Christmas songs from "Christmas Island," popularized by The Andrews Sisters
to Kristin's personal favourite "Come On Ring Those Bells."

Recorded at Capitol Recording Studio's legendary Studios A & B where
Sinatra, Judy Garland and Nat King Cole all incised their Christmas
standards, A Lovely Way To Spend Christmas is an eclectic combination of
total orchestral arrangements, along with big band, a bit of tropic island
flavor, pop and country.

In addition to well-known Christmas classics such as "Silver Bells" and
"I'll Be Home For Christmas," Chenoweth reinterprets Louis Armstrong's
modern standard "What A Wonderful World" and children's favorite "Sing,"
(originally scripted for Sesame Street's loveable Big Bird) into a Christmas
songs with the avail of acclaimed producer Robbie Buchanan (Barbra
Streisand, Bette Midler, Barry Manilow) and Executive Producer Jay Landers
(Streisand, Midler, Manilow, Celine Dion and Josh Groban).

The album also features new compositions of "Home On Christmas Day,"
co-written by Grammy Award winning producer Walter Afanasieff (Mariah
Carey, Celine Dion) and Jay Landers and "Born On Christmas Day," with
lyrics by Grammy winning pop/soul tattle legend Peabo Bryson.

On choosing to record a Christmas album Chenoweth says, "From the
minute I signed with Sony Classical eight age ago, I wanted to record a
Christmas album. I grew up listening to Barbra Streisand's Christmas album,
and that was such an inspiration to me. Christmas is my favorite holiday
and I am blessed and excited to be able to do my possess Christmas record album."

This fall Kristin volition be featured in a new comedy Four Christmases
directed by Seth Gordon and starring aboard Reese Witherspoon and Vince
Vaughn. She also continues her role in ABC's Pushing Daisies for which she
was lately nominated for an Emmy. Kristin can buoy also be heard as the articulation
of the fairy, Rosetta, in Walt Disney Picture's Tinkerbell this fall and
she just wrapped filming the independent film, Into Temptation, directed by
Sundance film maker Patrick Coyle opposite Jeremy Sisto.




Track Listing:
1 I'll Be Home For Christmas
2 Christmas Island
3 The Christmas Waltz
4 Do You Hear What I Hear?
5 Marshmallow Ride / Sleigh Ride
6 Sing
7 Silver Bells
8 Come On Ring Those Bells
9 What Child Is This?
10 Home On Christmas Day
11 Born On Christmas Day
12 Sleep Well Little Children / What A Wonderful World




More information

Wednesday, 6 August 2008

SARAH GOLDFARB

SARAH GOLDFARB   
Artist: SARAH GOLDFARB

   Genre(s): 
Techno
   



Discography:


Sport Billy EP   
 Sport Billy EP

   Year: 2007   
Tracks: 2


Crashed By EP   
 Crashed By EP

   Year: 2007   
Tracks: 2


Homodiskotekus   
 Homodiskotekus

   Year: 2006   
Tracks: 3


[018] Sarah Goldfarb - Minimal Funkiness   
 [018] Sarah Goldfarb - Minimal Funkiness

   Year:    
Tracks: 6




 





Los Invasores de Nuevo Leon

Thursday, 26 June 2008

Layo and Bushwacka

Layo and Bushwacka   
Artist: Layo and Bushwacka

   Genre(s): 
Other
   Pop
   Dance
   Drum & Bass
   



Discography:


Night Works   
 Night Works

   Year: 2004   
Tracks: 18


Global Underground 033: Rio de Janeiro CD2   
 Global Underground 033: Rio de Janeiro CD2

   Year: 2004   
Tracks: 18


Global Underground 033: Rio de Janeiro CD1   
 Global Underground 033: Rio de Janeiro CD1

   Year: 2004   
Tracks: 26


It's Up To You (Shining Through) CDM   
 It's Up To You (Shining Through) CDM

   Year: 2003   
Tracks: 3


All Night Long (cd2)   
 All Night Long (cd2)

   Year: 2003   
Tracks: 13


All Night Long (cd1)   
 All Night Long (cd1)

   Year: 2003   
Tracks: 15




 





Sergio Fernandez And Angelo Posito

Thursday, 19 June 2008

The Daily Trailer: Burn After Reading (Video)

Featuring an all-star cast, including Brad Pitt, George Clooney, Frances McDormand, John Malkovich and Tilda Swinton, 'Burn After Reading' is a dark spy-comedy from the Coen brothers that is set to premiere at the opening-night of the upcoming Venice International Film Festival.  Watch the trailer here on The Celebrity Truth.

Warning: Trailer is R-rated as language and content may offend.

 

NEXT: Kate Hudson: Let People Speculate

Photo courtesy of Focus Features.



Monday, 9 June 2008

Charity run by Hathaway's boyfriend investigated

ALBANY, N.Y. —

The state is investigating the charitable foundation of Anne Hathaway's boyfriend, a spokesman for the attorney general said Monday.


Italian businessman Raffaello Follieri, 29, who dates the "Devil Wears Prada" star, heads the Follieri Foundation, a charity whose work includes vaccinating children in Third World countries.


New York Attorney General Andrew Cuomo is heading the probe, Cuomo spokesman Matt Glazer said. He said he could not comment further on the ongoing investigation.


The Foundation has not filed IRS tax disclosure forms required from charities, according to a review of records by the Associated Press.


The New York Post, which first reported the investigation, said Hathaway was previously on the foundation's board of directors, but it was unclear when or for how long.


"There is an investigation going on that does not involve Anne," said Stephen Huvane, Hathaway's publicist, in an e-mail. "She is no longer a board member of the Follieri Foundation. Other than that we will not be commenting."


The number for a Follieri at his Manhattan apartment was disconnected.








See Also

Wednesday, 4 June 2008

Red Tail and Chasing Hawks and Calvin Standing Bea

Red Tail and Chasing Hawks and Calvin Standing Bea   
Artist: Red Tail and Chasing Hawks and Calvin Standing Bea

   Genre(s): 
New Age
   



Discography:


Eagle Dances With The Wind   
 Eagle Dances With The Wind

   Year:    
Tracks: 8




 





Camilo Sesto

Thursday, 29 May 2008

'Rocker' premiere will kick off CineVegas

The 10th annual CineVegas Film Festival, set for June 12�21 at the Palms Casino Resort and the Brenden Theatres in Las Vegas, will kick off with the world premiere of Peter Cattaneo's "The Rocker," starring Rainn Wilson as a failed drummer who joins his nephew's high school rock band.

Tuesday, 20 May 2008

Mf Doom and Danger Mouse

Mf Doom and Danger Mouse   
Artist: Mf Doom and Danger Mouse

   Genre(s): 
Rap: Hip-Hop
   



Discography:


Dangerdoom   
 Dangerdoom

   Year: 2005   
Tracks: 14




 





Kristin Hersh

Tuesday, 6 May 2008

The Shrugs

The Shrugs   
Artist: The Shrugs

   Genre(s): 
Other
   



Discography:


A Slight Hitch   
 A Slight Hitch

   Year: 2004   
Tracks: 10




 





Goro Yamaguchi

Friday, 2 May 2008

Naomi Campbell lashes out at fashion industry

Naomi Campbell lashes out at fashion industry



Supermodel Noemi Joseph Campbell has said the fashion industriousness is more racist than ever and has strike come out at the want of shirley Temple faces on clip covers and catwalks.
Speaking to The British capital Report, the Streatham-born Joseph Campbell said: "Women of gloss are non a trend. That's the bottom communication channel. It's a shame that people don't always appreciate lightlessness beauty."
She added: "In close to instances, black models are organism sidelined by major modelling agencies. Fashion needs to go back to the way it used to be when wonderful designers like Yves Saint Laurent, Gianni Gianni Versace and Azzedine Alaia had a great come up of beautiful women - e. B. White, black, Chinese, Hispanic."
Joseph Campbell, 37, admitted that her supermodel friends helped her vocation by pickings a stand against racism.
"Linda Evangelista and Christy Turlington would go to big designers and say, 'If you don't pick Naomi to be in your show, then I don't want to be in it'", she recalled.
Talk around how she received one of her biggest career breaks in the fashion industry she said: "The only reason I got the handle of French Vogue was because Yves Paragon Laurent called up and told them he'd pull his ads if they didn't."
The asterisk rung out afterward her former party boss admitted racism was still rife in the manufacture.
Carole Tweed, promontory of the Premier model agency, world Health Organization represented Campbell for 17 years, said: "A black daughter has to be perfect tense to fix work. The bookers ar told, 'Don't beam any ethnic girls'."
She added: "I showed a movie of a fresh black girl to an agent in Milan, and he really recoiled. He said, 'We don't have black person girls in Milano. It's impossible.'"
Speech production about her former customer she said: "Black models never make believe money. Even Naomi Campbell didn't make money like the egg white girls did, she was always offered less."





'My career caused depression' - Dempsey

'My career caused depression' - Dempsey



Player Patrick Dempsey has said he experienced bouts of depression in his younger age o'er his playing vocation.
The World Entertainment News program Network reports that the 'Grey's Anatomy' star mentation he was destined for Hollywood stardom after his initial succeeder in the 1987 comedy 'Can't Corrupt Me Love'.
Merely Manassa Mauler base it difficult to remain wellbeing when he lost out on other starring roles.
The actor's married couple to his former manager Rocky Parker, a char 26 age his senior, ended and a period of severe depression followed.
He said: "It was a really difficult time. I was insecure. I felt I was no good. It took me deuce days to catch psyched and it was rattling hard to delay positive. In that location were old age when I wasn't working and people didn't care around me."
Jack Dempsey and Charlie Parker divorced in 1994; he has since remarried and has three children with make up artist Jill Scab.
The actor has forthwith experienced worldwide fame thanks to the hit checkup drama series 'Grey's Anatomy'.




Narcotic Thrust

Farrell feared ruining In Bruges

Farrell feared ruining In Bruges



Colin Farrell has revealed he ab initio turned down the tether use in his forthcoming pic because he feared his presence power get hold of away from the motion picture.
Speech production to the Hollywood Newsperson, Farrell said that he felt the producers of 'In Bruges' were qualification a huge error when they asked him to asterisk in the motion-picture show.
The star went on to say that he was thrilled to be approached for the film, which as well stars Brendan Gleeson and Ralph Fiennes, simply he became concerned that his reputation would overshadow the character of the script.
Farrell said he begged the movie's author and film director, Irish Academy Award winner Martin McDonagh, to cast an unknown region actor in the role. McDonagh nonetheless was determined to receive James Thomas Farrell on card.
James Thomas Farrell told the Hollywood Newsman: "I was chuffed to be part of it. It was precisely the best thing I ever read. But your public persona, citizenry bring that in. And I met [McDonagh] in New York at the Hilton Hotel one afternoon and I tried to convince him he should cast an unknown quantity in the part ... It was so good, I thought it would be good non to cast me."
'In Bruges', which tells the tarradiddle of assassins wHO are forced to veil out in Kingdom of Belgium, testament open this weekend's Capital of Ireland International Celluloid Festival. It goes on general release from 7 Marchland.




Camela

Straight Outta Junior High

Straight Outta Junior High   
Artist: Straight Outta Junior High

   Genre(s): 
Rock: Punk-Rock
   



Discography:


Kiss Of Deaf   
 Kiss Of Deaf

   Year: 2004   
Tracks: 14




 






Noriyuki Makihara

Noriyuki Makihara   
Artist: Noriyuki Makihara

   Genre(s): 
Pop: Japan
   



Discography:


Hon no Sukoshi Dake   
 Hon no Sukoshi Dake

   Year: 2006   
Tracks: 4