Earlier this month Novacea, Inc. (NASDAQ: NOVC) announced
that it has prematurely ended its Phase 3 ASCENT-2 clinical trial of Asentar, also known as DN-101. Asentar had been the company’s lead investigational cancer therapy for the treatment of those of us who are androgen-independent (AIP).
The Data Safety Monitoring Board (DSMB) for the clinical study decided to terminate the study
due to an imbalance of deaths between the two treatment arms.
Novacea plans to analyze the clinical data to attempt to understand the cause of the higher death rate in the Asentar plus Taxotere® (docetaxel) treatment group. The study was designed to compare the benefits of weekly Asentar plus Taxotere to the current standard of care. These results are very surprising as the Phase 2 Accent Trials showed great promise.
Asentar is an investigational drug that is an oral, intermittent, high-dose of calcitriol, the most potent natural activator of the calcitriol receptor (also known as the vitamin D receptor.
The primary objective of this study was:
• To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer
The secondary objectives of this study were:
• To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)
• To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)
• A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
Many of us are very disappointed about this turn of events. This just adds to the recent spate of treatment study failures we have had to endure.
Joel T Nowak MA, MSW