Thursday 4 September 2008

Cell Genesys Halts VITAL-2 GVAX Trial In Advanced Prostate Cancer

�Cell Genesys, Inc. (Nasdaq:CEGE) announced that it has terminated VITAL-2, the s of two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, which compares GVAX immunotherapy in combination with Taxotere� (docetaxel) to Taxotere asset prednisone in patients with advanced-stage prostate cancer. The Company complete the trial as recommended by its Independent Data Monitoring Committee (IDMC) which, in a routine safety review meeting held this week, observed an instability in deaths between the two handling arms of the study. To date, VITAL-2 enrolled 408 patients. The IDMC based its recommendation on 114 deaths of which 67 occurred in the GVAX plus Taxotere combination treatment arm and 47 deaths occurred in the Taxotere control arm. At this clock time, a specific cause for the asymmetry in deaths has not been identified and the IDMC reported no modern safety issues for GVAX when administered in combination with Taxotere. The Company plans to fully analyze the clinical data from these patients to attempt to empathise the potentiality cause for the higher rate of deaths ascertained in the GVAX immunotherapy plus Taxotere combination arm, including an assessment of potential imbalances between the two arms of the study such as baseline characteristics and prognostic factors, as well as early treatment variables. In light-colored of the IDMC's observation with deference to VITAL-2, the Company has requested that the IDMC perform a antecedently unspecified futility analysis of VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer. The Company expects the results of the VITAL-1 futility analysis in approximately one month.


"Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all active clinical test sites and regulatory agencies that registration of new patients into VITAL-2 has been suspended as has treatment with GVAX immunotherapy for prostate cancer of patients enrolled in the study," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "Notwithstanding this disappointing final result, we would like to acknowledge the courage and commitment of the patients and physicians who have participated in this trial."


Dr. Sherwin continued, "The observation in the VITAL-2 trial is very surprising to us, and we have therefore asked the IDMC to conduct a previously unplanned futility analysis of VITAL-1 in order to determine the overall prospects for our on-going development platform for this product. Moreover, with the cessation of VITAL-2, we expect to make commensurate adjustments to our business operations and we testament provide further details regarding this in the near future. As a reminder, the party ended the second quarter of 2008 with $166 million in cash."

VITAL-2 was a multi-center, randomized, controlled Phase 3 clinical trial designed to measure the guard and efficaciousness of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the purpose of Taxotere chemotherapy and prednisone in hormone-refractory prostate gland cancer (HRPC) patients with metastatic disease who are symptomatic with cancer-related painful sensation. The primary endpoint of the tribulation was an improvement in survival. VITAL-2 was initiated in June 2005 and to escort had enrolled 408 patients at one hundred fifteen clinical trial sites situated in North America and the European Union. VITAL-1, the other Phase 3 clinical test of GVAX immunotherapy for prostate cancer, is designed to compare GVAX genus Cancer immunotherapy as a monotherapy to Taxotere chemotherapy plus prednisone in earlier microscope stage HRPC patients with metastatic disease wHO are symptomless with respect to cancer-related pain. The primary terminus of the trial is an improvement in survival. In 2007, the VITAL-1 trial completed enrollment with 626 patients. In January 2008, Cell Genesys announced that the IDMC had completed a pre-planned meanwhile analysis for VITAL-1 and recommended that the study continue, providing no further information to the company other than the passport to retain the trial.

Conference Call and Webcast


Members of the Cell Genesys management team testament host a conference call today, Wednesday, August 27, 2008, at 8:30 a.m. ET to discuss the IDMC's good word. Investors crataegus oxycantha listen to the webcast of the conference call live on the investor section of the Cell Genesys website, http://www.cellgenesys.com. Alternatively, investors may heed to a replay of the phone by dialing (800) 475-6701 from locations in the U.S. and (320) 365-3844 from outside the U.S. The call in replay and webcast will be available for at least 72 hours following the send for. Please refer to reservation number 958709.

About GVAX Immunotherapy for Prostate Cancer


GVAX immunotherapy for prostate gland cancer is comprised of two prostate tumor cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine that plays a key function in stimulant the body's immune response, and then irradiated for safety. GVAX immunotherapy for prostate genus Cancer is intentional to be administered through intradermal injections on an outpatient fundament.

About Cell Genesys


Cell Genesys (Nasdaq: CEGE) is focused on the development and commercialisation of novel biological therapies for patients with crab. The company's lead product platform is GVAX� immunotherapy for cancer, which holds the voltage to treat multiple types of cancer including prostate gland cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys continues to confine an equity interest in its former subsidiary, Ceregene, Inc., which is development gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, California, and has manufacturing operations in Hayward, California. For additional information, please

Monday 25 August 2008

FDA Approves Vidaza Label Expansion

�The Aplastic Anemia & MDS International Foundation (AA&MDSIF) is pleased to inform patients that the U.S. Food & Drug Administration (FDA) has expanded the label for VIDAZA (azacitidine) to include data from the AZA-001 trial, which found that Vidaza is the only agent that extends survival in MDS (myelodysplastic syndromes) patients. Vidaza was too shown to delay advance to acuate myelogenous leukemia (AML) in patients with MDS. Roughly 30 per centum of patients diagnosed with MDS will progress to AML.



"We ar very bucked up by the Vidaza data from the AZA-001 trial. This trial showed, for the first time, a drug can extend survival for MDS patients," aforesaid John Huber, Executive Director of the Aplastic Anemia and MDS International Foundation. "We ar excited to see that in this trial Vidaza also decreased the need for blood transfusions."



MDS occur when the bone vegetable marrow stem cells malfunction. This results in the production of overly many defective blood cells and non enough normal cells. Diagnosis is made through blood tests and a bone marrow biopsy. Once diagnosed, treatment and evaluation should occur below the tending of a hematologist or hematologist/oncologist. There are many subtypes of MDS classified according to how the disease manifests itself in the stemma and bone marrow of the patient. Treatments include rip transfusions, growth factors, chemotherapy and bone marrow transplant.






About the Aplastic Anemia and MDS International Foundation




Founded in 1983, the Aplastic Anemia & MDS International Foundation is consecrate to service of process as a resource for patient assist, advocacy, and support. AA&MDSIF provides patients and their families with support, as well as the a la mode medical information. AA&MDSIF as well funds research to receive cures for aplastic genus Anemia, myelodysplastic syndromes (MDS), paroxysmal nocturnal hemogloburina (PNH), and other os marrow loser diseases. Educational and support resources are free to patients and families, the media and the general public at http://www.aamds.org/.



Source: John Huber
Aplastic Anemia & MDS International Foundation




View drug information on Vidaza.



More info

Friday 15 August 2008

Britney Spears Praises Leona Lewis, Rihanna And Duffy

Britney Spears has praised fellow singers Duffy and Leona Lewis, admitting she is a fan of the artists.


During her

Thursday 7 August 2008

Trouble in Paradise for Lindsay & Sam?

It's incessantly tense when you match your significant other's folk � mayhap that's wherefore rumors ar coming out of Miami that there was a spat terminal night betwixt Lindsay Lohan and gallon pal Samantha Ronson.

Witnesses external the Delano Hotel, where the Georgia Rule star� � and almost a dozen of Sam's family � is staying, allege that all was non well 'tween Linds and her incessant companion when they returned home after a nox of dining at The Shore Club's Nobu restaurant.

But if the pair did get into a spat, it wasn't over dinner. Sources inside the eatery while Sam and Lindsay dined say OK! that everything looked fine betwixt them.










More info

Friday 27 June 2008

The Stone Roses

The Stone Roses   
Artist: The Stone Roses

   Genre(s): 
Indie
   Rock: Pop-Rock
   



Discography:


The Very Best Of   
 The Very Best Of

   Year: 2002   
Tracks: 15


The Complete Stone Roses   
 The Complete Stone Roses

   Year: 1995   
Tracks: 21


The Stone Roses   
 The Stone Roses

   Year:    
Tracks: 13




 






Monday 23 June 2008

Coldplay to work with Joy Division filmmaker

Coldplay are set to work with film director Anton Corbijn, who won a Shockwaves NME Award earlier this year for directing 'Control', the biopic about Joy Division singer Ian Curtis.

The band's spokesperson told NME.COM the director and the band will conduct the shoot for forthcoming single 'Viva La Vida', a song from the band's forthcoming album 'Viva La Vida Or Death And All His Friends', on a Dutch beach.

Corbijn previously directed the video promo for the band's 2005 single 'Talk', which you can see by clicking on the videolink below.

Speaking about the collaboration Chris Martin said, "We're trying an experiment with him. It could be a disaster, but it could be OK."

Monday 16 June 2008

Spyro Gyra Featuring Jay Beckenstein

Spyro Gyra Featuring Jay Beckenstein   
Artist: Spyro Gyra Featuring Jay Beckenstein

   Genre(s): 
Jazz
   



Discography:


Fast Forward   
 Fast Forward

   Year: 1990   
Tracks: 10




 





Liv Tyler - The Things They Say 8411

Friday 6 June 2008

Winehouse refused visa for Grammys

Amy Winehouse will not be performing at this year's Grammy Awards because her request for a visa has been turned down by the US Embassy in London, according to her publicist.
The Outside Organization, which counts the troubled retro-soul singer among its clients, said in a statement: "Amy has been progressing well since entering a rehabilitation clinic two weeks ago and although disappointed with the decision has accepted the ruling and will be concentrating on her recovery."
The 24-year-old singer and her acclaimed 'Back to Black' album are nominated in six categories for the Grammy Awards in Los Angeles on Sunday.
Organisers of the music awards are now arranging for the singer to perform via satellite.
Since the album's US release last year, she has cancelled a slew of appearances amid reports of drug use.

Monday 26 May 2008

Madonna Expresses Herself�Through Tears

MadonnaLike any good confection, Madonna wants you to know she may have a Hard Candy exterior, but she's all soft in the center.

During an interview on Thursday's Nightline, the "4...


Friday 23 May 2008

Executive Decision (1996) [Action, Adventure, Thriller]

Executive Decision (1996) [Action, Adventure, Thriller]




Download At once:

Lean totally available downloads and previews.



Plot of land Sum-up:

Terrorists learn all over a 747 bounds from Athens to George Washington D.C., supposedly to effect the release of their leader. Intelligence information expert St. David Cary Grant suspects another reason and convinces the war machine that the 'plane should not be allowed to enter U.S. air space. An violation commission is devised, exploitation a particularly equipped 'plane designed for midair crowd transfers, and Grant finds himself on board the 747 with a squad of military machine anti-terrorists wHO take to defuse a turkey and overmaster the terrorists.


Starring:

Kurt George William Russell | Steven Seagal | Halle Berry | John Leguizamo | Oliver Platt | Joe Morton | B. D. Wong | Len Cariou | Whip Hubley | Andreas Katsulas | Mary Ellen Trainor | Marla Maples | J.T. Walsh | Ingo Neuhaus | William Jesse James Mary Harris Jones |


Directed By:







Sunday 18 May 2008

Alasdair Fraser and Natalie Haas

Alasdair Fraser and Natalie Haas   
Artist: Alasdair Fraser and Natalie Haas

   Genre(s): 
Celtic
   



Discography:


Fire and Grace   
 Fire and Grace

   Year: 2004   
Tracks: 12




 





Michael Douglas to haunt his old Girlfriends

SIRIUS Satellite Radio Extends Exclusive 'Neil Diamond Radio' Channel Due to Popular Demand

SIRIUS Satellite Radio Extends Exclusive 'Neil Diamond Radio' Channel Due to Popular Demand



Neil Diamond to host special broadcast

NEW YORK, May 15 /PRNewswire-FirstCall/ -- SIRIUS Satellite Radio
(Nasdaq: SIRI) will extend, due to fans' requests, Neil Diamond Radio, its
exclusive commercial-free music channel dedicated to Neil Diamond, for an
additional two weeks through the end of May.

(Logo: http://www.newscom.com/cgi-bin/prnh/19991118/NYTH125 )

To celebrate the channel's extended two-week run, Neil Diamond will
guest host his own show on Neil Diamond Radio, personally selecting music
by recording artists playing unique renditions of songs he wrote, such as
UB40's reggae version of "Red, Red Wine" and Frank Sinatra singing "Sweet
Caroline." Diamond will also share stories behind his new album, Home
Before Dark, for SIRIUS listeners.

"Neil Diamond Hosts On Neil Diamond Radio" will air on SIRIUS channel
3, Friday, May 16th at 5 pm and 9 pm. Encore broadcasts will air Saturday,
May 17th at 9 am, 12 noon and 3 pm and Sunday, May 18th at 1 pm, 4 pm and 7
pm (all times Eastern).

Neil Diamond Radio will continue to feature non-stop Neil Diamond
music, interviews and stories from a career spanning four decades,
including his new Rick Rubin-produced album, Home Before Dark, which
debuted this week at No. 1 on the Billboard 200.

Neil Diamond Radio launched on May 2, 2008 offering non-stop Neil
Diamond music. In addition to his own SIRIUS channel and new album release,
Diamond will also return to concert stages this summer for a 37-city North
American tour starting in July. For tour dates and more information about
Diamond's new album, Home Before Dark, go to http://www.neildiamond.com .

Neil Diamond Radio continues SIRIUS' tradition of creating exclusive
limited run artist-branded channels dedicated to iconic musicians. SIRIUS
has previously offered limited run channels such as Rolling Stones Radio, E
Street Radio, JAY-Z Nation, Duran Duran's Red Carpet Radio and Radio
R.E.M., among many others.

For more information on SIRIUS, please visit http://www.sirius.com .

About SIRIUS

SIRIUS, "The Best Radio on Radio," delivers more than 130 channels of
the best programming in all of radio. SIRIUS is the original and only home
of 100% commercial free music channels in satellite radio, offering 69
music channels. SIRIUS also delivers 65 channels of sports, news, talk,
entertainment, traffic, weather and data. SIRIUS is the Official Satellite
Radio Partner of the NFL, NASCAR, NBA, and broadcasts live play-by-play
games of the NFL, NBA, as well as live NASCAR races. All SIRIUS programming
is available for a monthly subscription fee of only $12.95.

SIRIUS Internet Radio (SIR) is an Internet-only version of the SIRIUS
radio service, without the use of a radio, for the monthly subscription fee
of $12.95. SIR delivers more than 80 channels of talk, entertainment,
sports, and 100% commercial free music.

SIRIUS Backseat TV (TM) is the first ever live in-vehicle rear seat
entertainment featuring three channels of children's programming, including
Nickelodeon, Disney Channel and Cartoon Network, for the subscription fee
of $6.99 plus applicable audio subscription fee.

SIRIUS products for the car, truck, home, RV and boat are available at
shop.sirius.com and in more than 20,000 retail locations, including Best
Buy, Circuit City, Crutchfield, Target, Wal-Mart, Sam's Club and
RadioShack.

As of December 31, 2007, SIRIUS radios were available as a factory and
dealer-installed option in 116 vehicle models and as a dealer
only-installed option in 37 vehicle models.

SIRIUS has agreements with Aston Martin, Audi, Bentley, BMW, Chrysler,
Dodge, Ford, Jaguar, Jeep, Kia, Land Rover, Lincoln, Maybach, Mazda,
Mercedes-Benz, Mercury, MINI, Mitsubishi, Rolls-Royce, Volvo, and
Volkswagen to offer SIRIUS radios as factory or dealer-installed equipment
in their vehicles. SIRIUS has relationships with Toyota and Scion to offer
SIRIUS radios as dealer-installed equipment, and a relationship with Subaru
to offer SIRIUS radios as factory or dealer-installed equipment. SIRIUS
radios are also offered to renters of Hertz vehicles at airport locations
nationwide.

Click on http://www.sirius.com to listen to SIRIUS live, or to purchase a
SIRIUS radio and subscription.

Any statements that express, or involve discussions as to,
expectations, beliefs, plans, objectives, assumptions, future events or
performance with respect to SIRIUS Satellite Radio Inc. are not historical
facts and may be forward-looking and, accordingly, such statements involve
estimates, assumptions and uncertainties which could cause actual results
to differ materially from those expressed in any forward-looking
statements. Accordingly, any such statements are qualified in their
entirety by reference to the factors discussed in our Annual Report on Form
10-K for the year ended December 31, 2007 filed with the Securities and
Exchange Commission. Among the significant factors that could cause our
actual results to differ materially from those expressed are: our pending
merger with XM Satellite Radio Holdings, Inc. ("XM"), including related
uncertainties and risks and the impact on our business if the merger is not
completed; any events which affect the useful life of our satellites; our
dependence upon third parties, including manufacturers of SIRIUS radios,
retailers, automakers and programming providers; and our competitive
position versus other audio entertainment providers.



P-SIRI

MEDIA CONTACT:

Sal Resendez
SIRIUS
646 313 2405
sresendez@siriusradio.com



See Also




Ethan Hawke to become a father again

New movie deal for wrestling stars

New movie deal for wrestling stars



World Hand-to-hand struggle Amusement has inked a first-look parcel out with 20th Century Fox, which volition give up the movie giant the right to distribute films starring WWE stars.
From 2009, WWE Films plans to press release single new moving-picture show in cinemas and four straight-to-DVD p.a..
The low gear film under the newly care volition be '12 Rounds', which testament star matman Toilet Cena and testament be released in 2009.
Production on '12 Rounds' begins in Fresh Siege of Orleans in March.
WWE wants to make films across wholly genres that volition invoke to a broader audience.





Britney on psychiatric hold for 14 days

Britney on psychiatric hold for 14 days



Britney Spears will stay on in a hospital psychiatric mrs. Humphrey Ward for another 14 years, sources close to the asterisk get revealed.
Spears was to be released from UCLA Medical exam Centre's psychiatric infirmary yesterday just doctors at the ward determined that she should remain, the source reportedly said.
Motor hotel Commissioner Reva Goetz ruled the day after Spears was taken to hospital that her don, James Spears, would be Britney's curator.
On with attorney Andrew Notecase, he is as well conservator of the popstar's multi-million dollar land.
Goetz granted the conservator access to totally Spears' medical exam records, as advantageously as the flop to restrict her visitors and to provide her with around the clock security.
Goetz too issued a restraining edict, keeping SAM Lutfi, the pop singer's friend and sometime managing director, away from her.





Sloth

Sloth   
Artist: Sloth

   Genre(s): 
Rock
   Rap: Hip-Hop
   



Discography:


Dead Generation   
 Dead Generation

   Year: 2003   
Tracks: 11


The Voice of God   
 The Voice of God

   Year: 2000   
Tracks: 7




 






Musical masonry?

Musical masonry?





Ex-Talking Heads presence humankind David Byrne plans to turn a landmark Manhattan building into a giant musical theater instrumental role. The US department of State of Freshly York says Byrne will make a temporary worker instalment called Playing the Building in the Great Hall of the Battery Maritime Construction.Devices will be attached to ceiling beams, plumbing, electrical conduits and other parts of the structure. Sound will be produced through trembling. Officials said the initiation would open in late Whitethorn, along with a newly rider waiting room at the adjacent Whitehall Ferry Terminal.Byrne has forged a solo career as a instrumentalist and visual artist since the freshly wave ring Talking Heads stopped making records in the 1980s.