DN-101 (Ascentar) is a high-dose formulation of the active form of vitamin D. Vitamin D, once thought of as only a hormone that regulates calcium metabolism, is now known to be an important growth regulator in many types of tissues, by its action on vitamin D receptors. Activation of vitamin D receptors slows or stops cell division, and promotes differentiation of cells, the process of cells taking on normal functions. In an initial phase II study, addition of DN-101 to standard chemotherapy with docetaxel (Taxotere) and prednisone has been shown to increase response to treatment and prolong disease control in patients with hormone-refractory prostate cancer (HRPC). CORT is conducting a phase III study of standard Taxotere and prednisone therapy with or without Ascentar for the first-line treatment of HRPC. All patients do receive standard therapy.
The risks of chemotherapy for HRPC in this study are fatigue, nausea, vomiting, muscle or bone aches, sensory neuropathy, fever, allergic reaction, or low blood counts. These risks are those of standard treatment. The risk of G-VAX is injection site swelling and discomfort.
For more information on our research studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.
Tags: androgen independent prostate cancer, Ascentar, DN-101, docetaxel, hormone refractory prostate cancer, Prostate Cancer, Taxotere, vitamin D
April 15, 2009 at 5:46 pm |
After reading through this article, I just feel that I really need more information on the topic. Can you suggest some more resources ?
April 15, 2009 at 7:04 pm |
The clinical study of DN-101 the combination of DN-101 with Taxotere (given weekly) was not superior to Taxotere therapy (given every 3 weeks) alone. The DN-101 and taxotere study had inferior survival. The causes of inferior outcomes have not been reported. Whether this is due to inactivity of DN-101 in boosting response to Taxotere, or this was due to the weekly schedule of Taxotere employed in the study (versus every three weeks in the control arm) is unknown. What directions Novacea will take in the further development of this compound have not been made public.