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Novacea Begins Phase 1/2 Trial of Anti-Cancer Agent Banoxantrone (AQ4N) In Patients With Lymphoma

10/19/2005 5:13:13 PM

SOUTH SAN FRANCISCO, Calif., April 20 /PRNewswire/ -- Novacea Inc., a privately held biopharmaceutical company, announced today that patient enrollment has begun in the Company's Phase 1/2 open-label, dose-escalation study of banoxantrone, also known as AQ4N, a tissue-targeting cytotoxic prodrug. The planned multi-center study will test banoxantrone in up to 55 patients with B-cell neoplasms, including Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

The primary objectives of this study are to establish the maximum tolerated dose of banoxantrone, determine the agent's pharmacokinetic profile and evaluate its safety and tolerability. In addition, the study will evaluate evidence of anti-tumor activity as measured by overall response rate.

"We are expeditiously moving banoxantrone into the clinic based on preclinical models revealing potent activity in lymphoma and leukemia," said John Curd, M.D., president and chief medical officer of Novacea. "Current treatments for lymphoid malignancies are limited. Even with combination chemotherapy, 15 to 50 percent of patients do not respond to initial treatment. Most patients ultimately relapse and subsequent courses of treatment lead to fewer and shorter remissions. Banoxantrone represents a promising product opportunity for Novacea that leverages our existing expertise in oncology and hematology and fits strategically with our focus on therapies that address unmet needs in cancer."

Banoxantrone is designed to deliver a highly active cytotoxic compound to the site of the tumor while minimizing systemic toxicity. Preclinical data presented at the recent American Association for Cancer Research meeting support the single-agent activity of banoxantrone in solid tumor, lymphoma and leukemia models. Previous studies also demonstrate synergy with radiation and chemotherapy. In addition to the current Phase 1/2 trial, Novacea initiated Phase 1 studies with banoxantrone for the treatment of advanced malignancies, primarily in solid tumors, in 2004.

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.

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.

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.

Banoxantrone was originally discovered by Prof. Laurence Patterson of the School of Pharmacy, at University of London, working in collaboration with the intellectual property and technology commercialization company, BTG. KuDOS acquired a worldwide license for banoxantrone from BTG in March 2001.

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 is undergoing Phase 1/2 clinical testing to determine safety and activity. 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, orinvestor relations, Nina Ferrari of Fleishman-Hillard, +1-415-264-8796, bothfor Novacea

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