SOURCE: Novacea

September 26, 2007 09:00 ET

Novacea Initiates Phase 2 Trial of Asentar in Advanced Pancreatic Cancer

SOUTH SAN FRANCISCO, CA--(Marketwire - September 26, 2007) - Novacea, Inc. (NASDAQ: NOVC) today announced that the company has initiated a randomized, placebo-controlled, multicenter Phase 2 trial of Asentar™ (DN-101) in patients with advanced pancreatic adenocarcinoma. Asentar is the company's lead investigational product and is also currently in a Phase 3 clinical trial for the treatment of patients with advanced prostate cancer.

This Phase 2 trial of approximately 132 subjects will evaluate the effect of weekly Asentar combined with weekly gemcitabine plus or minus daily erlotinib (Tarceva®) in the initial treatment of advanced pancreatic adenorcarcinoma. The primary endpoint of the trial is to assess the six-month survival rate, with secondary endpoints of objective response rate, duration of progression-free survival and overall survival. In addition, the trial will assess safety and tolerability. More information about the trial can be retrieved through www.clinicaltrials.gov. The principal investigator of this trial is Mace L. Rothenberg, M.D., Professor of Medicine and Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center in Nashville, TN. Schering-Plough Corporation (NYSE: SGP) will sponsor the trial and Novacea will oversee the execution of the study.

"As part of Novacea's development plans for Asentar, we are pleased to open a trial in an area where there is a need for better treatment alternatives. We believe Asentar has the potential to be developed in multiple tumor types and that through rigorous clinical research, we can demonstrate Asentar's broad potential as a cancer treatment. We are also very fortunate to have Dr. Rothenberg as our principal investigator as he is recognized internationally as an expert on clinical trial design and evaluating new cancer treatments," said John G. Curd, M.D., Novacea's president and chief medical officer.

"Pancreatic cancer is a devastating disease and accounts for more than 30,000 deaths each year in the United States. There is strong consensus that we need to identify new ways to treat this disease. The Vitamin D receptor and signaling pathway represent one such approach. This trial will be the first to test Asentar in patients with advanced pancreatic cancer. This trial will provide us with the first clinical data to determine whether the beneficial effects of adding Asentar to chemotherapy that have been observed in the laboratory translate into clinical benefit for patients with this disease," said Dr. Mace Rothenberg.

About Pancreatic Cancer

According to the Pancreatic Cancer Action Network ("PCAN"), pancreatic cancer is the fourth leading cause of cancer death in the United States. PCAN reports that it is the third leading cause of cancer death among 40-59 year old men. Approximately 37,000 people will be diagnosed with pancreatic cancer this year in the United States and more than 30,000 people will die from it. The number of Americans diagnosed each year with pancreatic cancer continues to rise. In contrast, an investment in early detection has led to a decrease in cancer incidences in many other prevalent cancers. For all stages of pancreatic cancer combined, the five-year survival rate is estimated to be only 5 percent, which is the lowest survival rate of all major cancers. The average life expectancy after diagnosis with metastatic disease is just 3-6 months; 52 percent of pancreatic cancer patients are diagnosed with metastatic disease.

About Asentar

Asentar is also being developed as an oral treatment in combination with Taxotere® (docetaxel) for the treatment of androgen-independent prostate cancer or AIPC. Prostate cancer is the second leading cause of cancer death in men with approximately 232,000 new cases and 30,000 deaths in the U.S. in 2005. AIPC is an advanced disease state of prostate cancer. Based on results of Novacea's completed Phase 2 clinical trial, known as ASCENT, the use of weekly Asentar in combination with weekly Taxotere may provide AIPC patients with an innovative cancer therapy that may prolong survival with the potential in reducing some of the toxicities and complications normally associated with chemotherapy. Novacea is evaluating the benefits of Asentar in a 1,200-patient Phase 3 trial, known as ASCENT-2, which has overall survival as the primary endpoint and compares weekly Asentar plus Taxotere to the current standard of care in the treatment of AIPC.

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, and is the subject of the development and commercialization agreement with Schering-Plough. Novacea's second product candidate, AQ4N, is a hypoxia-activated prodrug that is currently in a Phase 1b/2a clinical trial in glioblastoma multiforme. More information on any of Novacea's trials can be found at www.ClinicalTrials.gov.

Except for the historical information contained herein, the matters set forth in this press release, including statements as to financial guidance, 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; success or failure of our present and future collaboration agreements; commercialization of products; developments relating to our licensing and collaboration agreements; 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 Quarterly Report on Form 10-Q or Annual Report on Form 10-K, 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.

Novacea is a registered trademark of Novacea, Inc., and Asentar is a trademark of Novacea, Inc. All other trademarks are property of their respective owners.

Contact Information

  • Novacea Contact:

    Paul Laland
    Vice President, Corporate Communications
    Tel: 650-228-1811
    E-mail: Email Contact