US drugmaker Novacea says that the February 20 edition of the Journal of Clinical Oncology contains data from a Phase II trial of its lead investigational cancer therapy, Asentar (DN-101). The double-blinded, placebo-controlled, randomized, multicenter, ASCENT trial assessed DN-101 plus Sanofi-Aventis' Taxotere (docetaxel) versus placebo plus Taxotere in androgen-independent prostate cancer (AIPC).
According to the firm, the JCO paper reports that Asentar may help advanced prostate cancer patients live longer while experiencing fewer chemotherapy-associated side effects and complications. The agent is an investigational new drug that is an oral, intermittent, high-dose of calcitriol, the most potent natural ligand or activator of the calcitriol receptor, also known as the vitamin D receptor.
John Curd, Novacea's chief medical officer, said: "we believe the large number of patients (n=250) and the randomized design of the ASCENT trial provide us with valuable data regarding the efficacy and safety observations associated with Asentar treatment. In preparation for this publication, we have continued to conduct sensitivity analyses and remain very impressed with the consistency and robustness of the overall survival and other endpoints."
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