SOURCE: Novacea

November 01, 2006 08:15 ET

Novacea Initiates Phase 1/2 Trial of AQ4N in Glioblastoma Multiforme

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- November 1, 2006 -- Novacea, Inc. (NASDAQ: NOVC) today announced that it has initiated a multicenter, Phase1b/2a open-label clinical trial of AQ4N (banoxantrone), in combination with radiotherapy and temozolomide, for safety, tolerability and activity in patients with newly diagnosed glioblastoma multiforme (GBM).

The trial consists of two parts. The primary objective of the first part will be to evaluate safety and tolerability of three dose levels (200 mg/m2, 450 mg/m2and 750 mg/m2). The second part will further evaluate safety and tolerability as well as efficacy and the highest safe and tolerated dose of the AQ4N treatment determined in part one. Novacea expects to enroll approximately 60 patients in the trial. For more information on the AQ4N trial, you may visit www.ClinicalTrials.gov.

“Initiating this trial is an important milestone for Novacea and the GBM patient community. For more than 20 years researchers have grappled with the issue of hypoxic (oxygen starved) tumors limiting the effectiveness of radiation and/or chemotherapy. In vitro data indicate that the level of response to radiation and/or chemotherapy in hypoxic tumor cells is one-third that of normally oxygenated cells. By selectively targeting the hypoxic tumor regions, we are hopeful that AQ4N will increase the anti-tumor activity of this regimen compared to the current standard of care,” said Brad Goodwin, chief executive officer of Novacea.

About AQ4N and GBM

Novacea acquired North American rights toAQ4N from KuDOS Pharmaceuticals and is an investigational new drug designed to address the unmet medical needs of certain cancers such as GBM. While many tumors are refractory to radiation and/or chemotherapy, AQ4N is a prodrug that is designed to be activated in regions of tumor hypoxia. Upon activation, AQ4N binds to DNA and functions as a potent topoisomerase II poison thereby blocking the replication of rapidly dividing cancer cells leading to targeted tumor cell killing. Early clinical studies in patients with brain tumors have demonstrated that AQ4N is converted into its toxic form selectively in the hypoxic region of GBM tumors and not in the adjacent normal tissues.

Nearly 1.2 million patients are diagnosed with malignant tumors each year in the United States. The large majority of solid tumors have hypoxic components. According to the American Cancer Society, there were approximately 18,500 new cases and 12,800 deaths from brain and other nervous system tumors in the United States in 2005. GBM is one of the most aggressive and rapidly progressing tumors for which few treatments are available.

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 and is being investigated in combination with radiation and chemotherapy in a Phase 1/2 clinical trial in brain tumors such as glioblastoma multiforme.

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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