NOVACEA'S PROSTATE CANCER STUDY PUBLISHED IN JCO

Novacea announced the Journal of Clinical Oncology (JCO) has published findings from the large Phase II ASCENT trial of its lead investigational cancer therapy, DN-101 or Asentar. ASCENT was a double-blinded, placebo-controlled, randomized, multicenter trial of DN-101 plus Taxotere (docetaxel) versus placebo plus docetaxel in androgen-independent prostate cancer.

The study shows that DN-101 may help advanced prostate cancer patients live longer while experiencing fewer chemotherapy-associated side effects and cancer complications. Asentar is an investigational new 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).

A significant finding in the ASCENT trial was the impact of Asentar plus Taxotere on the prespecified secondary endpoint of overall survival. Multivariate analyses, including an adjustment for baseline hemoglobin, showed a statistically significant improvement in survival in the Asentar plus Taxotere group over the Taxotere plus placebo group, with a hazard ratio of 0.67. Patients who received the combination of Asentar plus Taxotere had a 49 percent increase in survival versus those patients taking Taxotere plus placebo. Overall prostate-specific antigen responses trended in favor of Asentar and occurred more frequently in subjects receiving the Asentar plus Taxotere combination (63 percent) versus Taxotere plus placebo (52 percent).

The trial also showed that cancer patients taking Asentar also experienced a reduction in blood clots, which affect between 15 and 20 percent of all cancer patients, according to Novacea.

Overall, no increase in serious toxicity was seen with the addition of Asentar to Taxotere, but there were reductions in the frequency of several classes of adverse events observed in the Asentar-treated group. The incidence of any grade 3 or 4 adverse events was 70 percent in Taxotere plus placebo-treated patients and 58 percent in Asentar plus Taxotere-treated patients.