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Novacea Announces Three Presentations On Anti-Cancer Agent, Banoxantrone (AQ4N), At American Association for Cancer Research Meeting

10/19/2005 5:12:42 PM

SOUTH SAN FRANCISCO, Calif., April 15 /PRNewswire/ -- Novacea Inc., a privately held biopharmaceutical company, announced today that the Company will have three presentations at the 96th annual American Association for Cancer Research (AACR) meeting this week in Anaheim, Calif. The presentations will highlight preclinical data on banoxantrone, also known as AQ4N, a tissue-targeting cytotoxic prodrug.

"The preclinical research being presented at AACR continues to support the single agent activity of banoxantrone, including anti-tumor efficacy in leukemia, lymphoma, colon cancer, and pancreatic cancer models. Banoxantrone exemplifies Novacea's ability to in-license a promising agent with the potential to fill an unmet need in cancer treatment and move rapidly into clinical development," said Brad Goodwin, Novacea's chief executive officer.

Poster Presentations: 1. "The targeted cytotoxic prodrug, AQ4N, has anti-tumor efficacy in L1210, P388 murine leukemia and Namalwa human lymphoma models." Monday, April 18, 8:00 a.m. to noon. Abstract Number: 2408. 2. "The targeted cytotoxic prodrug, AQ4N, has comparable activity to standard of care agents in colon and pancreatic cancer models." Monday, April 18, 8:00 a.m. to noon. Abstract Number: 2411. 3. "The targeted cytotoxic prodrug, AQ4N, persists in the spleen, large intestine, and subcutaneous tumors." Monday, April 18, 8:00 a.m. to noon. Abstract Number: 2410.

In 2004, Novacea initiated a Phase 1 study with banoxantrone for the treatment of advanced malignancies, primarily in solid tumors. Novacea plans to begin a second clinical study of banoxantrone in patients with B-cell neoplasms, including Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in the second quarter of 2005.

In December 2003, Novacea licensed the North American rights to develop and commercialize banoxantrone from UK-based KuDOS Pharmaceuticals. The worldwide collaborative development program between Novacea and KuDOs seeks to demonstrate the utility of banoxantrone as a single agent or in combination therapy for both solid tumors and lymphoid neoplasms. Interim data from a now-completed UK-based Phase 1 dose escalation study of banoxantrone in combination with radiation in esophageal cancer was presented at the American Society for Clinical Oncology annual meeting in June 2004 and showed the agent to be well tolerated. No sensitization of healthy tissues to radiation damage has been observed. The maximum tolerated dose and dose limiting toxicity were not reached with the doses used in this study.

About Banoxantrone

Banoxantrone represents a new approach to cancer treatment, with a unique pharmacology that is thought to minimize systemic toxicity by rapid plasma clearance and tissue distribution of the drug to tumors and the site of disease. Banoxantrone selectively targets lymphoid and hypoxic tumor tissues, with preclinical data demonstrating the killing of hypoxic tumor cells and malignant lymphocytes. Tumor hypoxia is a common mechanism for resistance to chemotherapy and radiation therapy. The agent is activated to a potent cytotoxic, known as AQ4, at the cellular level in hypoxic tumor cells and lymphoid tissues. AQ4 is a potent topoisomerase II inhibitor and DNA intercalator. Many current treatments for lymphoma and leukemia, including chemotherapy and stem cell or bone marrow transplantation, are non-specific and damage normal as well as diseased cells, causing side effects such as nausea and hair loss. An agent like banoxantrone that has the potential to selectively target lymphoid tissue and lymphocytes could represent an advance for patients, by providing a therapy with a more favorable side effect profile.

About KuDOS

KuDOS Pharmaceuticals, a privately held pharmaceutical company, holds a leading position in the discovery and development of small molecule drugs based upon the science of DNA damage sensing, signaling and repair to address unmet medical needs in cancer treatment. Potential applications for drugs that target DNA repair additionally extend to treatment of viral disease, ischemia and immunosuppression. Further information on KuDOS can be found on the company's website: .

About Novacea

Novacea is a privately held biopharmaceutical company focused on the licensing, development and commercialization of novel products to treat cancer. The Company currently has two products in clinical development: DN-101 and banoxantrone (AQ4N). DN-101 is being evaluated in Phase 2 clinical trials for advanced prostate cancer and advanced non-small cell lung cancer. Banoxantrone, a tissue-targeting cytotoxic prodrug, has shown preclinical activity in both solid tumors and lymphoid malignancies and currently is being tested in a Phase 1 clinical trial to determine safety and dosing. The Company plans to expand its product portfolio by in-licensing other compounds that leverage its development expertise in oncology and hematology. For more information, visit

Novacea Inc.

CONTACT: Kristin Nash of WeissComm Partners, +1-415-302-7951; or NinaFerrari, Investor Relations of Fleishman-Hillard, +1-415-264-8796, forWeissComm Partners

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