�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
Thursday, 4 September 2008
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
"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.
�
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Friday, 27 June 2008
The Stone Roses
Artist: The Stone Roses
Genre(s):
Indie
Rock: Pop-Rock
Discography:
The Very Best Of
Year: 2002
Tracks: 15
The Complete Stone Roses
Year: 1995
Tracks: 21
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."
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
Artist: Spyro Gyra Featuring Jay Beckenstein
Genre(s):
Jazz
Discography:
Fast Forward
Year: 1990
Tracks: 10
Liv Tyler - The Things They Say 8411
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