Novacea: DN-101 well-tolerated at all doses

By Elaine Rigoli

Tampa, Fla., June 8 - Novacea, Inc. released preliminary results from a phase 1/ 2 clinical trial of its investigational product candidate, DN-101 (calcitriol), in second line treatment of non-small cell lung cancer, which showed the drug was well-tolerated at all doses.

DN-101 is an investigational form of calcitriol, the biologically active form of Vitamin D.

The primary purposes of this clinical trial were to assess the safety and tolerability of DN-101 in combination with Taxotere (docetaxel) and to evaluate the objective tumor response rate in patients with advanced (stage 3b or 4) 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, according to a news release.

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.

While only 18 patients were studied in the weekly DN-101 and three-weekly docetaxel regimen, the overall median survival appeared to be longer than what was observed in the three-weekly DN-101 dosing, the release said.

Novacea is a South San Francisco, Calif.-based biopharmaceutical company focused on in-licensing, developing and commercializing cancer therapies.

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