Novacea Initiates Pivotal Phase 3 Clinical Study of DN-101 in Men With Advanced Prostate Cancer
April 12, 2006 -- Novacea, Inc. today announced the initiation of ASCENT-2, its pivotal Phase 3 clinical study evaluating the combination of the Company's novel oral anti-cancer agent, DN-101, and Taxotere® (docetaxel) in men with prostate cancer for whom hormonal therapy is no longer working, also known as androgen-independent prostate cancer (AIPC).
This randomized, controlled, multi-national study is seeking to enroll approximately 900 patients at over 125 medical centers in the United States, Europe, and Canada. Patients, or physicians interested in referring a qualified patient, can now go to www.ASCENT-2.com, which was launched today to facilitate trial awareness and enrollment.
"Results from the 250-patient Phase 2 ASCENT clinical study showed that DN-101 appeared to improve survival while reducing some of the serious side effects of chemotherapy," said Howard Scher, M.D., Chairman of the ASCENT-2 study and Chief of the Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center. "The ASCENT-2 Phase 3 trial is designed to determine if this regimen can improve outcomes for patients with advanced prostate cancer."
DN-101 is Novacea's proprietary oral, dose-intense formulation of calcitriol and the most potent ligand for the vitamin D receptor (VDR). DN-101 works by binding to VDR, which subsequently triggers cellular pathways that may stop cancer cell growth, leading to cancer cell death. DN-101 results in higher therapeutic blood levels than those achieved with previous forms of calcitriol. DN-101 can safely deliver high, pharmacologically effective peak blood concentrations of calcitriol without inducing clinically significant hypercalcemia.
ASCENT-2 Study Details
The ASCENT-2 (AIPC Study of Calcitriol ENhancing Taxotere) trial is designed to evaluate DN-101 in combination with Taxotere versus the currently approved regimen of Taxotere for prostate cancer (i.e. docetaxel 75 mg/m²Q3W; prednisone 5 mg bid dosed every three weeks). Study participants randomized to the investigational arm will receive 45 µg of DN-101 on day one and a 36 mg/m² IV of Taxotere on day two repeated weekly for three of four weeks. The primary endpoint of the study is survival. Skeletal-related events and reduction of thromboembolic events such as deep vein thrombosis will be measured as secondary endpoints.
In addition to Dr. Scher, the study's co-chairs are Ronald De Wit, M.D. of Erasmus University, Rotterdam, The Netherlands; and Kim Chi, M.D. of Vancouver Cancer Centre, Vancouver, British Columbia, Canada.
About Prostate Cancer
The American Cancer Society estimates that one in six American men will develop prostate cancer during his lifetime. If detected early, however, treatment can be highly effective. Until recently, late-stage treatment options have been extremely limited, including palliative radiotherapy and, in some patients, palliative chemotherapy. In May 2004, the U.S. Food and Drug Administration approved Taxotere for the treatment of patients with advanced, metastatic prostate cancer on the basis of improved survival over the previously approved palliative chemotherapy regimen.
About Novacea
Novacea, Inc. is a privately held biopharmaceutical company focused on in-licensing, developing and commercializing novel therapies for the treatment of cancer. Novacea's in-licensed product development programs include three clinical-stage oncology product candidates. The Company has one product candidate, DN-101, which is in a Phase 3 clinical trial for prostate cancer and a second product candidate, vinorelbine oral, which is expected to enter into a registration program during the second half of 2006 for the treatment of breast cancer. Novacea's third product candidate, AQ4N, is expected to advance into a Phase 1/2 clinical trial in the second half of 2006 for the treatment of glioblastoma multiforme. For more information, visit www.novacea.com.
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