Previous Asentar Studies The Asentar™ formulation used in the ASCENT trial was tested by Novacea in a Phase 1 open label, dose escalation study in patients with advanced malignancies to determine the safety, tolerability, pharmacokinetics, and maximum tolerated dose. Single doses up to, including, and beyond the dose used in the ASCENT trial were tolerated. There have been three prior Phase 2 studies looking at the safety and efficacy of calcitriol in patients with prostate cancer. A randomized Phase 2 study conducted at OHSU evaluated 39 pre-surgery prostate cancer patients who were treated weekly with high doses of commercially available calcitriol or placebo over a four-week period. The study confirmed that calcitriol was tolerated in this patient population. In a Phase 2 study 22 prostate cancer patients who had a recurrence as evidenced by a rising prostate specific antigen (PSA) despite definitive local therapy and who had not yet received hormonal therapy for recurrent disease were treated with commercially available calcitriol on a high-dose administration schedule. Patients received calcitriol until a four-fold increase in PSA or other evidence of disease progression was obtained. With a median duration of treatment of 10 months, this therapy was well tolerated. No hypercalcemia or kidney stones were seen. Mild elevations in liver blood tests and mild anemia were the most common toxicities seen. There were no severe toxicities reported related to calcitriol in this study. In an open-label Phase 2 study of androgen-independent prostate cancer patients conducted at OHSU, the combination of weekly high doses of commercially available calcitriol and Taxotere® appeared active as measured by declines in PSA levels and tumor shrinkage. Of the 37 patients who received the combination treatment, 81% had a confirmed PSA reduction of 50% or more as compared to 36%-45% of patients in comparable previous studies of Taxotere alone. The PSA responses in this study were durable, persisting for a longer period of time (11.4 months) compared to patients who received docetaxel alone in other studies (5 months). Toxicity in this study was similar to toxicity seen in patients in other studies who received Taxotere alone. The most common severe toxicities in this study were lowering of the white blood cell counts and elevations in blood glucose. One patient in this study died from a treatment-related pneumonia. Click here to download research abstracts and posters on Asentar.   © 2008 Novacea, Inc.  All rights reserved.