SOURCE: Novacea, Inc.

September 20, 2006 14:02 ET

British Journal of Haematology Publishes Thrombosis Findings From ASCENT Trial

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- September 20, 2006 -- Novacea, Inc. (NASDAQ: NOVC) today announced that the on-line version of the British Journal of Haematology (http://www.blackwell-synergy.com/toc/bjh/0/0) has published data from the AIPC Study of Calcitriol Enhancing Taxotere (ASCENT) clinical trial of the company's investigational cancer therapy, Asentar™ (DN-101). The publication, entitled "High-Dose Calcitriol May Reduce Thrombosis in Cancer Patients," reports the first clinical observation supporting the hypothesis that calcitriol, the most potent natural metabolite of vitamin D for stimulating the vitamin D receptor (VDR), may play an important role to alter the expression and activity of a number of proteins important for coagulation.

While the full results from ASCENT are awaiting peer-review publication, this data set provides an exploratory analysis from a large randomized placebo-controlled Phase 2/3 trial in patients with advanced prostate cancer. The results are consistent with observations from previous laboratory investigations demonstrating that elevated concentrations of calcitriol (the active ingredient in Asentar) may produce anti-coagulant and anti-thrombotic effects in humans.

Safety analyses from the ASCENT trial demonstrated a 33 percent decrease in serious adverse events in patients randomly assigned to treatment with 45 µg Asentar plus weekly docetaxel (Taxotere®) 36 mg/m2 as compared to patients assigned to treatment with weekly placebo plus docetaxel. To further understand these safety results, the investigators performed an analysis that compared the incidence of thrombosis between the two treatment groups. Thrombosis was defined using composite endpoints for thromboembolic events including deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident, and arterial thrombosis.

Of the 13 thrombotic events observed in the 250 patients enrolled in this study, two occurred in Asentar patients and 11 occurred in the placebo-treated patients (p=0.01). This difference remained significant after adjustment for prior history of thrombosis, atrial fibrillation, and use of anti-thrombotic agents in the two patient groups. Both venous and arterial thromboses were less frequent in Asentar treated patients.

"We believe these findings are important because thrombosis is a frequent and significant complication that affects 15 to 20 percent of cancer patients. The biological rationale found in literature and the clinical observations in the ASCENT study suggest that high-dose calcitriol may reduce thrombotic events commonly seen in advanced prostate cancer patients. We intend to prospectively examine and confirm these findings in our ongoing ASCENT-2 Phase 3 trial," said John G. Curd, M.D., president and chief medical officer at Novacea.

About ASCENT-2 Trial

The ASCENT-2 Phase 3 clinical trial will build on the results observed in the first ASCENT trial by evaluating the potential benefits of Asentar as compared to the currently approved regimen of docetaxel. Approximately 900 patients will be enrolled in this trial at multiple centers in various countries, including the United States, Canada and Germany.

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 Asentar, which currently is in a Phase 3 clinical trial for androgen-independent prostate cancer, or AIPC. Novacea's second product 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.

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