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news.Novacea has published data from a phase I study of the company's lead investigational cancer therapy, Asentar, proving it was safe and well tolerated.
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The study was conducted at Oregon Health and Science University and Roswell Park Cancer Institute.
Asentar is a new, high dose oral formulation of calcitriol, the most potent natural metabolite of vitamin D, presently being investigated in a phase III clinical study as a potential treatment for men with advanced prostate cancer.
“The use of calcitriol as a treatment for cancer has been considered by many for over 20 years, however, previous clinical studies evaluating daily administration of low doses were essentially all limited by the development of life-threatening hypercalcemia, an excessive amount of calcium in the blood,” said John Curd, president of Novacea. “With Asentar, we believe that dose intense administration of calcitriol can be safely achieved in cancer patients.”
“Novacea is presently investigating Asentar in combination with Taxotere in men with advanced prostate cancer to determine if this combination can improve patient survival as well as the safety profile of docetaxel,” added Dr Curd.
In the trial the most frequent adverse events were fatigue, hypercalcemia and nausea.