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Novacea To Present At 46th Annual American Society of Hematology (ASH) Meeting


10/19/2005 5:12:20 PM

SOUTH SAN FRANCISCO, Calif., Dec. 1 /PRNewswire/ -- Novacea Inc., a privately held biopharmaceutical company, announced today that it will present preclinical study results of its anti-cancer agent, AQ4N (banoxantrone), on December 5 at the 46th Annual American Society for Hematology (ASH) meeting in San Diego. The data indicate that AQ4N has activity against lymphoma and leukemia cell lines and the ability to target lymphatic tissues with minimal systemic toxicity.

"We are encouraged by these findings that suggest the potential benefit of AQ4N in the treatment of lymphoproliferative diseases, in addition to the benefit previously seen in solid tumors," said John Curd, M.D., Novacea's chief medical officer. "Many treatments for lymphoma and leukemia cause complicating side effects, such as myelosuppression and neutropenia. AQ4N is designed to have little or no toxicity until selectively activated in tumor cells, making it an attractive product candidate in the treatment of these diseases. We are making good progress in an ongoing Phase 1 clinical trial of AQ4N and plan to move this promising program forward rapidly."

Novacea currently is studying AQ4N (banoxantrone) in a multiple-dose, Phase 1 clinical trial. The primary objectives of this open-label study are to determine the safety and tolerance of multiple weekly intravenous doses of AQ4N (banoxantrone) given to patients with advanced malignancies (solid tumors or non-Hodgkin's lymphoma), as well as to obtain a maximum tolerated dose to guide subsequent studies.

In December 2003, Novacea licensed the North American rights to develop and commercialize AQ4N (banoxantrone) from United Kingdom-based KuDOS Pharmaceuticals. Interim data from the UK-based Phase 1 dose escalation study of AQ4N (banoxantrone) in combination with radiation in esophageal cancer were presented at the American Society for Clinical Oncology annual meeting in June 2004 and showed the agent to be well tolerated.

The AQ4N (banoxantrone) abstract is listed below and can be viewed at http://www.hematology.org/

Sunday, December 5, 2004, 6:00-7:30 p.m.

Abstract #2498: A Novel N-Oxide Drug, AQ4N, Has In Vitro Activity in Lymphoma and Leukemia Cell Lines and Selectively Targets Lymphocytes and Lymphatic Tissues In Vivo. [Poster Session]

Jeffrey L. Cleland, Alvin Wong, Susan E. Alters, John G. Curd, Robert L. Capizzi, William D. Henner. Nonclinical Development & Clinical Science, Novacea, Inc., S. San Francisco, CA, USA.

About AQ4N (Banoxantrone)

AQ4N (banoxantrone) has demonstrated preclinical activity in both solid tumors and lymphoid malignancies, and represents a new approach to cancer treatment. The drug is designed to be inactive when administered and is selectively converted into its active cytotoxic form, known as AQ4, once it reaches hypoxic tumor cells. This selective activity is thought to produce more targeted tumor effect with reduced potential systemic toxicity. Activity also has been observed in animal lymphoid tissue, suggesting an alternative activation step and the potential for AQ4N to be a treatment for lymphoma and leukemia. AQ4N (banoxantrone) 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 AQ4N (banoxantrone) that has the potential to selectively target lymphoid tissue and lymphocytes could represent a huge advance for patients, by providing a therapy with a more favorable side effect profile.

AQ4N (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 AQ4N (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. KuDOS currently has two drugs in clinical trials: Patrin(TM), which is being developed for the treatment of cancers resistant to alkylating agents, and AQ4N (banoxantrone), which is selectively activated in solid tumors and hematologic malignancies. Research continues on DNA-PK, and mTOR inhibitors, with a candidate compound for ATM and PARP currently in preclinical assessment. Further information on KuDOS can be found on the company's website: http://www.kudospharma.co.uk/ .

About Novacea

Novacea is a privately held biopharmaceutical company focused on building a product portfolio to address the unmet medical needs of people with cancer. The Company currently has two products in clinical development. DN-101, a novel formulation of calcitriol and oral anti-cancer agent, is being evaluated for advanced prostate cancer and advanced non-small cell lung cancer. AQ4N (banoxantrone), a tumor-cell-activated, anti-cancer therapy, has shown preclinical activity in both solid tumors and lymphoid malignancies and is undergoing early-stage clinical testing to determine initial safety and activity in advanced disease. 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 http://www.novacea.com/.

Novacea Inc.

CONTACT: Kristin Nash of WeissComm Partners, +1-415-302-7951, forNovacea



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