SOURCE: Novacea

October 30, 2007 09:00 ET

Novacea Provides Update on Ascent-2 Protocol Amendment

SOUTH SAN FRANCISCO, CA--(Marketwire - October 30, 2007) - Novacea, Inc. (NASDAQ: NOVC) announced today that representatives from the company and Schering-Plough (NYSE: SGP) are finalizing the ASCENT-2 protocol with the U.S. Food and Drug Administration (FDA). ASCENT-2 is a Phase 3 clinical trial of Asentar™ (DN-101) for the treatment of patients with androgen independent prostate cancer or AIPC. The study is comparing the benefits of weekly Asentar plus Taxotere® (docetaxel) to the current standard of care in the treatment of AIPC.

As Novacea reported in August of 2007, the Joint Development Committee of Novacea and Schering-Plough submitted to the FDA a protocol amendment for the companies' ASCENT-2 Phase 3 clinical trial of Asentar in AIPC. Pending completion of the formal amendment process, the new ASCENT-2 protocol will include the following:

-- The sample size will increase from 900 to 1,200 subjects and the statistical power will increase from 85 percent to 90 percent.

-- The primary efficacy endpoint is overall survival (OS); OS is defined as the time from the date of randomization to the date of death from any cause. The study has two secondary efficacy endpoints: Skeletal-Related Event Free Survival and PSA Response, defined as a reduction from baseline in PSA, or prostate-specific antigen, of at least 50 percent that is maintained for at least three weeks. The original ASCENT-2 protocol did include thromboembolic (TE) events as a secondary endpoint, however, TE events will now be a primary safety endpoint.

-- The protocol will empower the Data Safety Monitoring Board (DSMB) to review an interim analysis, however, the data from this interim analysis will not be unblinded to either Novacea or Schering-Plough. Due to the high statistical threshold, it is unlikely the trial will be stopped early based on the interim analysis and due to a favorable result in the weekly Asentar plus Taxotere arm.



"We are very pleased with our FDA meeting and appreciate their constructive feedback on the regulatory requirements for Asentar. We continue to see strong enrollment trends and recently passed 900 patients, nearly three months ahead of schedule based on the original sample size for ASCENT-2. Since the top-line analysis is driven by survival events, it is difficult to predict exact timing of top-line data. However with the assumption that the median overall survival in the control arm of ASCENT-2 is 18.9 months (based on the Taxotere registration trial in 2004), we estimate having top-line data before the end 2009," said John P. Walker, Novacea's chief executive officer. "Based on the feedback from the FDA, Schering-Plough and we believe the amendment was the right decision and that it should increase the likelihood of detecting a meaningful difference between the treatment regimens being tested."

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 a Phase 2 trial for advanced pancreatic cancer. Asentar is part of a development and commercialization agreement with Schering-Plough Corporation. Novacea's second product candidate, AQ4N, is a hypoxia-activated prodrug that is currently in a Phase 1b/2a clinical trial in glioblastoma multiforme and a Phase 2 trial for refractory acute lymphoblastic leukemia (ALL). 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