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Novacea Announces Preliminary Results of a Phase 1/2 Clinical Trial in Non-Small Cell Lung Cancer

Posted on: Thursday, 8 June 2006, 09:00 CDT

Novacea, Inc. (NASDAQ: NOVC) announced today 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 (NSCLC).

The primary purposes of this clinical trial were to assess the safety and tolerability of DN-101 in combination with Taxotere(R) (docetaxel) and to evaluate the objective tumor response rate in patients with advanced (Stage IIIb or IV) 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 the first stage of the trial, patients received three-weekly DN-101 with three-weekly docetaxel. DN-101 was escalated at four dose levels (from 45 ug up to 180 ug) and was administered orally on Day 1, followed by docetaxel at a dose of 75 mg/m2 body surface area on Day 2. In the second stage of the trial, patients received weekly DN-101 with three-weekly docetaxel. DN-101 doses were escalated at three dose levels, Day 1 (180 ug), Day 8 (45 ug to 180 ug) and Day 15 (45 ug up to180 ug).

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 percent 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. A full analysis from this clinical trial is being prepared and will be presented at upcoming scientific meeting later this year.

"Although this is an open label Phase 1/2 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. In the context of the results observed in our ASCENT Phase II clinical trial of DN-101 in patients with androgen independent prostate cancer (AIPC), there appears to be some parallel trends in safety and drug activity including a potential reduction in adverse events and prolongation of survival," said John Curd, M.D., president and chief medical officer at Novacea.

DN-101 is an investigational form of calcitriol, the biologically active form of Vitamin D. Many forms of human malignancies, including human NSCLC, contain vitamin D receptors (VDRs). In pre-clinical models, vitamin D receptor ligands, such as calcitriol, have been shown to increase the activity of cytotoxic chemotherapy agents in prostate cancer, squamous cell carcinoma and breast carcinomas. Calcitriol and other VDR ligands have a variety of effects on malignant cells, and the mechanisms by which calcitriol synergizes with cytotoxic agents may include inhibition of cell cycle checkpoint function, promotion of apoptosis, or inhibition of angiogenesis.

About Novacea

Novacea, Inc. is a biopharmaceutical company focused on in-licensing, developing and commercializing novel cancer therapies. Novacea has three product candidates in clinical trials, including DN-101, which currently is in a Phase 3 clinical trial for androgen-independent prostate cancer, or AIPC. Novacea's second drug candidate, oral vinorelbine, is expected to enter a registration trial for metastatic breast cancer in the second half of 2006. Novacea's third product candidate, AQ4N, is expected to advance into a Phase 1/2 clinical trial in the second half of 2006 for glioblastoma multiforme in combination with radiation and chemotherapy.

Note: Except for the historical information contained herein, the matters set forth in this press release, including statements as to development, clinical studies, regulatory review and approval, and commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events. You should not put undue reliance on any forward-looking statements. Important factors that could cause actual performance and results to differ materially from the forward-looking statements we make include: early stage of development; the focus, conduct, enrollment and timing of our clinical trials; regulatory review and approval of product candidates; commercialization of products; market acceptance of products; funding requirements; intellectual property protection for our product candidates; competing products and other risks detailed from time to time under the heading "Risk Factors" in our most recent Registration Statement on Form S-1, as amended, and as may be updated from time to time by our future filings under the Securities Exchange Act. If one or more of these risks or uncertainties materialize, or if any underlying assumptions prove incorrect, our actual performance or results may vary materially from any future performance or results expressed or implied by these forward-looking statements. We assume no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws.

 Contact: Paul Laland 650.228.1811 Contact via http://www.marketwire.com/mw/emailprcntct?id=79C026D4DCA870A5  

SOURCE: Novacea, Inc.

Source: MARKET WIRE

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