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news.Novacea's investigational product candidate DN-101 has shown an encouraging safety profile and signs of efficacy in a phase I/II clinical trial evaluating the drug in second line treatment of non-small cell lung cancer.
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The primary purposes of this clinical trial were to assess the safety and tolerability of DN-101 in combination with Sanofi-Aventis’ Taxotere (docetaxel) and to evaluate the objective tumor response rate in patients with advanced non-small cell lung cancer who have failed previous therapy with platinum-based chemotherapy. Overall survival was among the clinical trial’s secondary endpoints.
The clinical trial was divided into two DN-101 groups: three-weekly dosing and weekly dosing. In both stages of this trial, DN-101 was well tolerated at all doses.
Among the 61 patients who received the three weekly dosing regimens of DN-101 and docetaxel, the tumor response rate was 6.6% with a median overall survival of 6.9 months.
“Although this is an open label phase I/II trial of DN-101, we continue to be encouraged by the safety profile and the preliminary assessment of drug activity. We believe this trial provides us with the basis for further development of DN-101 in NSCLC,” said Dr John Curd, president and chief medical officer at Novacea.