March 12, 2008
Dendreon (DNDN) is one again in the news. At first, it appears that there is a faster track that the FDA is allowing when it comes to the trials for Provenge. If you read the news item it is really nothing significant, yet it is may be a hint that the FDA is softening and may allow for study results to be moved up a year.
None of the informations appears to change any of the results we have seen thus far. It simply allows for the removal of the results within the test-group that show a false-positive return. In other words – the results that are meaningless are being removed from the test group. This should be a common practice, so any excitement created by inferring more from the news should be contained.
Shares are up in pre-market today on this announcement by 15% or so.
This particular topic will be in focus during our upcoming podcast conversation with Mike Huchman, CNBC’s health correspondent.
March 12, 2008 7:42 AM EDT Dendreon Corporation (Nasdaq: DNDN) said the FDA has agreed to an amended Special Protocol Assessment for the Phase 3 IMPACT clinical trial of PROVENGE. In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application for licensure of PROVENGE. The amended SPA accelerates the expected timing of the final IMPACT results by approximately one year while maintaining comparable powering of the study’s interim and final results. By increasing the number of events and decreasing the alpha (false positive error) spending function for the interim analysis, the Company is able to reduce the number of events for the final analysis (from 360 to 304) and still maintain a comparable statistical power for both the interim and final analyses. Interim results are still expected in the second half of 2008; however, final results are now expected in the second half of 2009 rather than 2010.
In another spin, there are news reports that read: “U.S. health regulators approved its amended trial design of the late stage study of its Provenge cancer vaccine, accelerating the expected timing of the final study results by about one year.”
The fact that the first few words read : U.S. health regulators approved is a magnificent spin, so don’t get caught in this trap. We need to see a real result and change to the FDA position, which is not contained in this news item. While it may show some level of advancement, it may be a good idea to watch for further results.
Disclosure: Horowitz & Company clients are LONG DNDN as of publish date..
February 14, 2008
It is one day after the House Energy and Commerce Committee sent a declination letter to the four Congressmen that had been requesting a further review of the questionable FDA ruling for Dendreon’s (DNDN) Provenge, the company’s groundbreaking Prostate cancer drug. Now, a news release shows another beneficial study result that should have the FDA looking even more ridiculous.
According to the HSE Committee, represented by Chairman John Dingell (D-MI) writes, “An investigative hearing prior to an agency’s final decision runs the risk of interfering with the normal regulatory process.” (CLICK FOR LETTER)
The news looks promising. But realize, so did the last report, and the one before that as well.
SEATTLE and SAN FRANCISCO, Feb 14, 2008 /PRNewswire-FirstCall via COMTEX/ — Researchers from Dendreon Corporation (Nasdaq: DNDN) today presented data demonstrating the correlation of a measure of the cumulative potency of PROVENGE (sipuleucel-T), an investigational active cellular immunotherapy for hormone-refractory prostate cancer, with overall survival. This the first time that an association between higher potency of an active immune therapy and increased patient survival has been reported. The correlation appeared to be independent of other important baseline prognostic factors.
The abstract (#21), “Cell Number and CD54 Expression in Sipuleucel-T correlate with Survival in Metastatic Androgen Independent Prostate Cancer,” is being presented at the American Society of Clinical Oncology’s 2008 Genitourinary Symposium in San Francisco.
In two Phase 3 trials, D9901 and D9902A, researchers evaluated cumulative product release parameters of PROVENGE, including CD54 upregulation (a measure of product potency defined as the increase of CD54 molecules expressed on antigen Presenting Cells [APC] after incubation with the PROVENGE Antigen Delivery Cassette(TM)) and the number of total nucleated cells (TNCs) among patients treated with sipuleucel-T (n=146). CD54 is a costimulatory molecule which serves as a marker for APCs. Its expression is increased when APCs become activated and this upregulation of CD54 serves as a potency release
assay for PROVENGE.
Results showed that PROVENGE patients experienced improved survival if they received more cells across the three doses of PROVENGE (higher cumulative TNC count (p=0.019)) or higher cumulative CD54 upregulation values (p=0.009). The effect on survival for TNCs appeared to reflect in part the patients’ baseline prognostic factors. However, the CD54 upregulation ratio appeared to be an independent predictor of survival in patients who received PROVENGE, as the correlation remained strong even after adjusting for baseline prognostic factors (p=0.022).
“We have been able to show a correlation between patient survival and a measure of the cumulative potency of PROVENGE; such a correlation between product potency and clinical outcome has not been previously demonstrated with an active immunotherapy,” said Mark Frohlich, MD, chief medical officer of Dendreon. “These data provide further evidence that sipuleucel-T is actively engaging the immune system in a clinically meaningful way that prolongs
Disclosure: Horowitz & Company Clients are LONG DNDN