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walldiver

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walldiver

Re: exwannabe post# 1290

Friday, 10/20/2006 8:23:25 AM

Friday, October 20, 2006 8:23:25 AM

Post# of 12660
Posted by: exwannabe
In reply to: None
Date:10/20/2006 7:18:44 AM
Post #of 1293

Wall - all cause mortality

Does the recent data make you happy?

Non PCA Deaths:

Sip-T 13
Placebo 4

Prostate death stats:

HR 2.04 / P=.002 / CI=95%

----------------------------------------------------------------------------

Posted by: dndn
In reply to: None
Date:10/20/2006 7:43:17 AM
Post #of 1294

http://biz.yahoo.com/prnews/061020/sff012.html?.v=79

---------------------------------------------------------------------------------

Posted by: walldiver
In reply to: read_this_n0w who wrote msg# 1292 Date:10/20/2006 8:16:13 AM
Post #of 1294

Dendreon Announces New Data Analyses Presented at Prostate Cancer Foundation Scientific Retreat
Friday October 20, 7:00 am ET
PROVENGE Significantly Extends Prostate Cancer Specific Survival in Advanced Prostate Cancer


SEATTLE, Oct. 20 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco presented new exploratory analyses of the Phase 3 Study (D9901) that further support the results observed with the Company's investigational active cellular immunotherapy PROVENGE® (sipuleucel-T) in men with advanced androgen- independent (hormone refractory) prostate cancer.

These data were presented at the Prostate Cancer Foundation's 13th Annual Scientific Retreat held Oct. 19-21, 2006 in Scottsdale, Arizona. The Company plans to complete the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) prior to the end of this year to seek approval to market PROVENGE.

The analyses presented by Dr. Small showed:

-- The overall survival benefit does not appear to be due to any imbalances in the treatment arms or the subsequent use and timing of chemotherapy. As published in the July issue of the Journal of Clinical Oncology, the Phase 3 Study (D9901) demonstrated a median overall survival of 25.9 months in the PROVENGE arm compared with 21.4 months in the placebo arm, or a 4.5 month survival difference. For these men, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.71); and

-- An analysis of prostate-cancer-specific survival showed a median survival of 35.2 months for patients randomized to PROVENGE compared to 23.5 months for patients randomized to placebo, a difference of 11.7 months and a 50 percent reduction in prostate cancer-specific mortality (p-value = 0.002; HR = 2.04).

A link to Dr. Small's presentation will be available via Dendreon's web site at www.dendreon.com.

"These and other analyses we have performed further support our BLA filing, which we intend to complete this year," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "We remain focused on the goal of making this active cellular immunotherapy available for the treatment of the many men with advanced prostate cancer who currently have few appealing treatment options available to them."

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

-------------------------------------------------------------------------------

Posted by: read_this_n0w
In reply to: dndn who wrote msg# 1291
Date:10/20/2006 7:55:33 AM
Post #of 1294

And the presentation slides to with that news:


http://investor.dendreon.com/downloads/22568dndn.pdf


-- The overall survival benefit does not appear to be due to any imbalances in the treatment arms or the subsequent use and timing of chemotherapy. As published in the July issue of the Journal of Clinical Oncology, the Phase 3 Study (D9901) demonstrated a median overall survival of 25.9 months in the PROVENGE arm compared with 21.4 months in the placebo arm, or a 4.5 month survival difference. For these men, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.71); and

-- An analysis of prostate-cancer-specific survival showed a median survival of 35.2 months for patients randomized to PROVENGE compared to 23.5 months for patients randomized to placebo, a difference of 11.7 months and a 50 percent reduction in prostate cancer-specific mortality (p-value = 0.002; HR = 2.04).





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