Novacea Inc announced that patient enrollment has begun in a Phase 1/2 dose-ranging study of DN-101, the company's investigational lead product candidate, in combination with Taxotere (docetaxel) in patients with advanced non-small cell lung cancer (NSCLC).

DN-101 is an investigational cancer therapy containing high amounts of calcitriol, a naturally occurring hormone and biologically active form of vitamin D. DN-101 is a novel, proprietary formulation of calcitriol that allows for oral, once-weekly administration of the agent that can achieve the high concentrations thought to be needed to produce potent anti-cancer effects. The agent also is being studied for the potential treatment of advanced prostate cancer and myelodysplastic syndromes, a group of blood disorders that can progress to leukemia.

"Lung cancer is by far the leading cause of cancer deaths in the United States, and non-small cell lung cancer accounts for more than 80 percent of cases," said Howard West, director of medical therapeutics for thoracic oncology at Swedish Cancer Institute in Seattle. "Recent work combining calcitriol with chemotherapy, specifically docetaxel, in prostate cancer has shown very encouraging results, and we hope to see similar synergy with docetaxel in lung cancer. The DN-101 formulation is much easier to administer to patients than the currently available form and may represent a significant step forward."

The Phase 1/2 clinical trial is a multi-center, open-label study to determine the maximum-tolerated dose of DN-101 when administered in combination with docetaxel and to evaluate the safety and objective tumor response rate of the combination. Secondary endpoints include disease stabilization rate, duration of tumor response in patients who achieve response, time to disease progression, as well as overall and one-year survival rates. The trial is supported by Novacea in collaboration with Aventis, the manufacturer of Taxotere (docetaxel).