Dendreon Corporation (NASDAQ: DNDN) has announced that its pivotal Phase 3 IMPACT study of PROVENGE in men with advanced prostate cancer data. While the data is incomplete, Dendreon said that the IMPACT study met its primary endpoint of improving overall survival compared to a placebo control. 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.
PROVENGE is Dendreon’s 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.
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. This was not listed statistically, but we had penciled in a target of about 22% was the endpoint. The safety profile of PROVENGE appeared to be consistent with prior trials.
The 512-patient IMPACT study enrolled men with metastatic androgen-independent prostate cancer, and it was conducted under a Special Protocol Assessment agreement with FDA.
Dendreon said that detailed results from the study will be presented during session at the American Urological Association’s Annual Meeting in Chicago on Tuesday, April 28, 2009. The company also said that the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer.
Shares are currently halted after closing at $7.30 yesterday, but this will resume at 9:00 AM EST. The short interest in this one has been massive, although it has been seeing short covering of late.
Jon C. Ogg