SOURCE: Novacea

February 20, 2007 07:30 ET

Novacea's ASCENT Phase 2 Trial Published in the Journal of Clinical Oncology

ASCENT Is the First Placebo-Controlled Randomized Trial to Test Intermittent, Dose Intense Calcitriol, the Natural Agonist of the Vitamin D Receptor, in Late-Stage Prostate Cancer Treatment

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- February 20, 2007 -- Novacea, Inc. (NASDAQ: NOVC) today announced the Journal of Clinical Oncology (JCO) has published findings from the large Phase 2 trial of its lead investigational cancer therapy, DN-101 (Asentar™), entitled ASCENT (AIPC Study of Calcitriol Enhancing Taxotere). ASCENT was a double-blinded, placebo-controlled, randomized, multi-site trial of DN-101 plus docetaxel (Taxotere) vs. placebo plus docetaxel in androgen-independent prostate cancer (AIPC). The JCO publication reports that DN-101 may help advanced prostate cancer patients live longer while experiencing fewer chemotherapy-associated side effects and complications of their cancer. Asentar is an investigational new drug that is an oral, intermittent, high-dose of calcitriol, the most potent natural ligand or activator of the calcitriol receptor (also known as the vitamin D receptor).

"Having the results of the ASCENT trial published in the JCO is a testament to the importance of this clinical research in advanced prostate cancer. We believe the large number of patients (n=250) and the randomized design of the ASCENT Phase 2 trial provide us with valuable data regarding the efficacy and safety observations associated with Asentar treatment. In preparation for this publication, we have continued to conduct sensitivity analyses and remain very impressed with the consistency and robustness of the overall survival and other endpoints. The ASCENT trial results strongly support the ongoing international 900-patient confirmatory Phase 3 trial (ASCENT-2) for which we expect to complete enrollment by the end of 2007. This trial is intended to serve as the main clinical study in the marketing application for Asentar," said John G. Curd, M.D., president and chief medical officer at Novacea.

ASCENT Results

A significant finding in the ASCENT trial was the impact of Asentar plus Taxotere on the pre-specified secondary endpoint of overall survival. Multivariate analyses, including an adjustment for baseline hemoglobin and ECOG performance status, showed a statistically significant improvement in survival in the Asentar plus Taxotere group over the Taxotere plus placebo group, with a hazard ratio of 0.67 (95% Confidence Intervals 0.45-0.97, p < 0.04). Patients who received the combination of Asentar plus Taxotere had a 49 percent increase in survival versus those patients taking Taxotere plus placebo. Overall PSA responses trended in favor of Asentar and occurred more frequently in subjects receiving the Asentar plus Taxotere combination (63 percent) versus Taxotere plus placebo (52 percent).

Another significant outcome observed in the ASCENT trial was that cancer patients taking Asentar also experienced a reduction in blood clots. Blood clots are a serious complication in advanced cancers and affect between 15 and 20 percent of all cancer patients. Overall, no increase in serious toxicity was seen with the addition of Asentar to Taxotere. There were reductions in the frequency of several classes of adverse events observed in the Asentar-treated group. The incidence of any grade 3 or 4 adverse events was 70 percent in Taxotere plus placebo-treated patients and 58 percent in Asentar plus Taxotere-treated patients (p=0.065). Serious adverse events, generally those requiring hospitalization, were observed in 41 percent of Taxotere plus placebo-treated patients and 27 percent of Asentar plus Taxotere-treated patients (p=0.023). The most common adverse events observed with the treatment of Asentar included low-grade elevation of calcium and creatinine in the blood. One case of kidney stones was also reported.

About ASCENT

ASCENT was a double-blinded, placebo-controlled, randomized, multi-site clinical trial to evaluate Asentar in combination with Taxotere for advanced prostate cancer research subjects who are no longer responding to hormonal therapy, a condition known as androgen-independent prostate cancer. Two hundred fifty patients participated in the trial at 48 sites in the United States and Canada. Patients with progressive metastatic AIPC and adequate organ function received weekly docetaxel 36 mg/m2 intravenously for 3 weeks of a 4-week cycle combined with either 45 µg Asentar or placebo taken orally one day prior to docetaxel. The primary endpoint was PSA response within 6 months. Secondary endpoints were overall survival and skeletal morbidity-free survival, as well as safety and tolerability of the trial treatment.

About Novacea

Novacea, Inc. is a biopharmaceutical company focused on in-licensing, developing and commercializing novel cancer therapies. Novacea has two 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, AQ4N, is a hypoxia-activated prodrug and is being investigated in combination with radiation and chemotherapy in a Phase 1/2 clinical trial in brain tumors such as glioblastoma multiforme.

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