SOURCE: Novacea, Inc.

November 10, 2006 08:30 ET

Novacea Announces Updated AQ4N Phase 1 Data Presented at EORTC-NCI-AACR Symposium

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- November 10, 2006 -- Novacea, Inc. (NASDAQ: NOVC) today announced that researchers presented updated Phase 1 data of AQ4N (banoxantrone), an investigational drug designed to target the hypoxic regions present in most solid tumors, at the 18th EORTC-NCI-AACR Symposium on November 9, 2006. The conference -- "Molecular Targets and Cancer Therapeutics Symposium" -- is organized by the European Organization for Research and Treatment of Cancer (EORTC) in conjunction with the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR), and is being held in Prague, November 7-10, 2006.

The objective of the Phase 1 study was to assess the maximum tolerated dose (MTD), pharmacokinetics and pharmacodynamics of eight weekly doses of AQ4N in 16 patients with advanced cancers, including renal cell, ovarian and non-small cell lung cancer. The data from this study showed that AQ4N is well tolerated when administered on a weekly schedule with an observed MTD of 768 mg/m2. Furthermore, the MTD achieved in this study exceeded the 200 mg/m2 dose predicted for anti-tumor activity based on previous preclinical studies and a Phase 1 pharmacodynamic study.

"Results of this Phase 1 study are very encouraging and serve as a basis for the initiation of our Phase 1b/2a study in patients with glioblastoma multiforme (GBM), one of the most aggressive brain tumors for which few treatments are available," said John Curd, M.D., president and chief medical officer of Novacea. "Tumors with significant hypoxic regions, such as GBM, have posed a significant challenge to researchers and physicians as these regions limit the effectiveness of radiation and/or chemotherapy to eradicate cancer. With AQ4N, the hope is that hypoxic tumor regions may be exclusively targeted resulting in selective delivery of chemotherapy."

In October, Novacea initiated a Phase1b/2a open-label study of AQ4N, in combination with standard radiotherapy and temozolomide in patients with newly diagnosed GBM. This study is intended to build upon the clinical and preclinical findings to date by evaluating the safety, tolerability and activity of the combination treatment in approximately 60 patients in North America.

About AQ4N

AQ4N is an investigational new drug designed to address the challenge of treating certain cancers with significant hypoxic regions. While many of these tumors are refractory to radiation and/or chemotherapy, AQ4N is an inactive prodrug that is designed to be selectively activated in regions of tumor hypoxia. Upon activation, AQ4N is converted into AQ4, a potent topoisomerase II inhibitor, which binds to DNA thereby blocking the replication of dividing cancer cells and leading to targeted tumor cell elimination.

Novacea acquired North American rights to AQ4N from KuDOS Pharmaceuticals Limited (KuDOS). AQ4N was originally discovered by Professor Laurence Patterson, Ph.D., currently director of the Institute of Cancer Research at the University of Bradford in England, working in collaboration with the intellectual property and technology commercialization company, BTG. KuDOS acquired a worldwide license for AQ4N from BTG in March 2001.

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 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

Note: 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; 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, 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.

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