Closing the second tranche of a Series C financing begun two years ago, Novacea Inc. raised more than $25 million - money it will use to launch a Phase III trial with DN-101 to treat advanced prostate cancer.

The South San Francisco-based company completed the first part of the round in January 2004, when it raised $35 million to advance its cancer compounds, including DN-101, through clinical trials. (See BioWorld Today, Jan. 9, 2004.)

The latest financing includes the same investors: Apax Partners, of London; Domain Associates, of Princeton, N.J.; New Enterprise Associates, of Menlo Park, Calif.; ProQuest Investments, also of Princeton; Versant Ventures, also of Menlo Park; and Sofinnova Ventures, of San Francisco.

Founded in 2001, Novacea has raised close to $110 million to date. Company officials could not be reached for comment.

Novacea plans to begin enrolling patients in the Phase III ASCENT-2 trial with DN-101 during the first quarter. It will be conducted at more than 150 clinical sites in the U.S. and Canada, evaluating the drug in combination with Taxotere (docetaxel, Sanofi-Aventis Group) vs. Taxotere in combination with prednisone.

Data from a previous clinical trial, ASCENT (AIPC Study of Calcitriol Enhancing Taxotere) showed that survival for patients treated with DN-101 plus Taxotere was estimated at 24.5 months, as compared to an observed median survival of 16.4 months for patients treated in the placebo plus Taxotere group. Data also showed that the prostate specific antigen (PSA) response occurred more frequently in the DN-101 treated group (58 percent), compared to the control group (49 percent). PSA response at six months was the primary endpoint, which showed a positive trend in favor of DN-101 but did not reach statistical significance. The trial enrolled 250 patients diagnosed with androgen-independent prostate cancer.

DN-101 is administered orally and based on calcitriol, an active form of vitamin D. In preclinical studies, calcitriol has proved to work well with many chemotherapy drugs. The product also is in a Phase I/II trial for non-small-cell lung cancer.

Novacea has a second product set to enter a Phase III trial in 2006: oral vinorelbine, which the company licensed in July from Pierre Fabre Medicament SA, a division of Paris-based bioMerieux Pierre Fabre. (See BioWorld Today, July 26, 2005.)

Sold in most European countries to treat breast and non-small-cell lung cancers, oral vinorelbine was designed to provide a more convenient administration over the intravenous form of the drug, which is a semi-synthetic derivative of a vinca alkaloid. Since its introduction in Europe, it has taken about 25 percent of the vinorelbine I.V.'s market share. Novacea, which holds North American rights, expects to begin Phase III testing this year in patients with breast cancer.

A third clinical product, banoxantrone (AQ4N), is in Phase I and Phase I/II trials for advanced solid tumors, non-Hodgkin's lymphoma and chronic lymphocytic leukemia. AQ4N is a cytotoxin that targets hypoxic regions of tumors. It may be able to more effectively reduce tumors when used in combination with radiotherapy or chemotherapy.

Novacea licensed North American rights to AQ4N in all indications from KuDOS Pharmaceuticals Inc., of Cambridge, UK, in 2003. (See BioWorld Today, Dec. 12, 2003.)