Those interested may access the call with the following information:
Time: 9:00 AM ET/6:00 AM PT
Date: April 14, 2009
Dial-in: 1-877-419-6594 (domestic) or +1-719-325-4855 (international)
Webcast: www.dendreon.com (homepage and investor relations sectionA recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 888-203-1112 or 719-457-0820 for international callers; the conference ID number is 8182435. The replay will be available from 12:00 pm ET on April 14, 2009 until midnight ET on April 16, 2009.
In addition the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.
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Buckle Up: Dendreon Halted as Prostate Cancer Results Coming Tomorrow MorningExceprt from www.xconomy.com
Luke Timmerman 4/13/09
Dendreon’s long-awaited big news is coming tomorrow morning. The Seattle biotech company (NASDAQ: DNDN) said it will hold a conference call before stock trading opens tomorrow morning to discuss the final results of a clinical trial that will show whether its immune-stimulating drug for prostate cancer, Provenge, can help men live longer.
The company’s conference call will start at 9 am Eastern time/6 am Pacific, about a half-hour before trading opens. The company didn’t tip its hand one way or another in its statement today, but it’s important enough that trading was halted in the stock prior to the announcement. Plenty of people are already betting big that Dendreon is going to have positive results from this trial, called Impact, of 500 with terminal prostate cancer. Shares climbed 16 percent today to close at $7.30, on about quadruple the average trading volume.
This announcement will be the culmination of a clinical trial that began six years ago, and may also be the climax to one of the best-known sagas in the biotech industry, as I described in this in-depth recap on April 3. Provenge showed an ability to prolong lives a median time of about 4.5 months in one study of 127 men in 2005, and Dendreon tried to win FDA approval based on that study. But in May 2007, the FDA said that wasn’t enough, and it wanted to see whether the results could be confirmed in the larger trial of 500 men, called Impact, which was already underway. This trial was unable to show a convincing enough survival advantage back in October when a board of clinical trial monitors took an early peek, but the data showed Dendreon was within striking distance of its goals for this final upcoming analysis.
As a reminder, the company needs to show a 22 percent lower risk of death for men on Provenge, compared to those on a placebo. If it clears that bar, the company will whip up its application to the agency as soon as possible. Analysts will remind investors that this drug has $1 billion a year in sales potential, and the stock will likely boom to more than $20 a share if the news is good, says analyst David Miller. If the FDA approves Provenge, it would be Dendreon’s first marketed product. If the trial fails, Dendreon will probably put its promising immune-boosting technology on the back burner and resort to layoffs, Miller says.
It’s time to get on the edge of your seats. Tomorrow will be an early morning for those of us on the West Coast. The dial-in number is 877-419-6594 or you can catch the webcast at www.dendreon.com on the investor relations section.
Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com or call 206-624-2374.
Here's the clinical results press release. There was no discussion of data on the call. CEO Gold says the data is "unambiguous" and "robust" but it won't be discussed until the Dendreon presentation on April 28 at the AUA meeting.
PROVENGE Significantly Prolongs Survival in Men with Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
– Study Meets Primary Endpoint Showing Statistically Significant Improvement in Overall Survival –
– First Active Immunotherapy for Cancer to Prolong Survival –
– Full Data to be Presented at Plenary Session at Upcoming AUA Annual Meeting –
– Company to Host a Conference Call Today at 9:00 AM ET –
SEATTLE, April 14, 2009 - Dendreon Corporation (Nasdaq: DNDN) announced today that the pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of PROVENGE appeared to be consistent with prior trials.
The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer.
Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association's Annual Meeting in Chicago on Tues., Apr. 28 at 2:20 pm CT.
"Survival is the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint of the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE may prolong survival," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We are immensely grateful to our clinical investigators and the more than 1,000 men with advanced prostate cancer who have participated in our studies over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies."
"The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient's own cancer," continued Dr. Gold.
Because the data meet the criteria and specifications outlined in its Special Protocol Assessment (SPA) agreement with the FDA, Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of this year to gain licensure of PROVENGE.
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 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
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