SOURCE: Novacea

April 17, 2007 08:00 ET

Novacea Presents New Evidence That Its AQ4N Prodrug Candidate Selectively Targets Oxygen-Starved Regions in Tumors

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- April 17, 2007 -- Novacea, Inc. (NASDAQ: NOVC) today announced that the company's product candidate, AQ4N, an investigational anti-cancer prodrug, was shown in a preclinical study to rapidly penetrate the hypoxic or oxygen-starved regions of tumors that are normally difficult to reach with conventional cancer therapies. Additionally, the study showed that when used in combination with mitoxantrone, a chemotherapeutic agent, tumor growth delay in rodent breast cancer models was achieved when compared to either agents used alone. Results from the study conducted at Princess Margaret Hospital at the University of Toronto were presented today at the American Association for Cancer Research (AACR) Annual Meeting in Los Angeles.

"The results of this study further support the hypothesis that AQ4N may be able to target those regions of a solid tumor that are hypoxic," said Dr. Oliver Tredan from the Princess Margaret Hospital at the University of Toronto. "The study demonstrates that mitoxantrone alone has limited drug penetration in the tumor microenvironment. However, when AQ4N is combined with mitoxantrone, AQ4N is able to permeate deeply within all tumor tissue and selectively accumulates in hypoxic tumor cells. These results provide us with new and important information that could prove to be useful in the development of AQ4N."

Novacea also announced that the journal Clinical Cancer Research published data from a pre-clinical study that shows AQ4N significantly delayed tumor growth, progression, and survival in multiple pancreatic tumor models. The paper is entitled "Selective Tumor Targeting by the Hypoxia-Activated Prodrug AQ4N Blocks Tumor Growth and Metastasis in Preclinical Models of Pancreatic Cancer," and appears in the April 2007 issue. These studies provide further proof-of-principle for the use of hypoxia-activated prodrugs as selective targeted agents for the treatment of solid tumors such as pancreatic cancers.

About AQ4N

Novacea is developing AQ4N as a novel, tumor-selective prodrug with applicability to multiple tumor types, both in combination with a number of chemotherapeutic agents and as a monotherapy for hematological malignancies. AQ4N is an inert, oxidized derivative of AQ4, a well-characterized Topoisomerase II inhibitor which exhibits potent cytotoxicity comparable to other marketed Topoisomerase II inhibitors such as Novantrone® (mitoxantrone) and Adriamycin® (doxorubicin). In November 2006, Novacea initiated a multi-center Phase 1b/2a open-label clinical study of AQ4N in combination with radiotherapy and temozolomide in patients who were newly diagnosed with glioblastoma multiforme (GBM).

Novacea licensed 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 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.

Contact Information