AQ4N Well Tolerated in First Phase I Report CAMBRIDGE, England, and SOUTH SAN FRANCISCO, Calif., June 7 /PRNewswire/ -- - KuDOS Pharmaceuticals (KuDOS), a leading private oncology company, and Novacea Inc., a privately-held biopharmaceutical company, today announced the publication of interim results from a Phase I dose escalation study of AQ4N. The results were published in the Proceedings of the 2004 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place from June 5-8 in New Orleans. Novacea has licensed from KuDOS the North American rights to develop and commercialize AQ4N and plans to initiate its clinical development program shortly. KuDOS is developing AQ4N in Europe and other markets outside North America. The aim of this study is to evaluate the safety and tolerability of AQ4N, a hypoxic-cell activated anti-tumor therapy, in patients with advanced esophageal carcinoma receiving palliative radiotherapy. The interim results, in 13 of an expected total of 22 patients, show AQ4N to be well tolerated with a favorable pharmacokinetic profile. No sensitization of healthy tissues to radiation damage has been observed. The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) have not yet been reached with the doses used in this study. Dr. Albert Benghiat, Clinical Director of cancer services at University Hospitals of Leicester and first author of the study, commented, "Many cancer therapies fail due to poor safety but this study indicates that AQ4N has a promising safety profile and should be further explored. The hypoxic fractions of tumors pose a significant challenge to clinicians and AQ4N represents a new approach to facing that challenge." This UK study is being undertaken at Leicester Royal Infirmary, and Churchill Hospital (Oxford), under sponsorship from the intellectual property and technology commercialization company, BTG. Laboratory analyses are done at Bradford University, and Cancer Research UK managed the study. About AQ4N As a first-in-class hypoxic cell-activated anti-tumor therapy, AQ4N represents a new approach to cancer treatment. The drug is considered inactive when administered and is selectively converted into its active cytotoxic form, known as AQ4, once it reaches hypoxic tumor cells (cells that are oxygen starved), reducing potential systemic toxicity. More than two million patients each year are estimated to present with tumors in the US and Europe. The large majority of these tumors have hypoxic components, which are relatively resistant to standard anti-cancer treatment, including radiotherapy and chemotherapy. As a result, a specific agent like AQ4N that can treat the hypoxic fractions should enhance the overall efficiency of cancer cell killing and reduce tumor recurrence. AQ4N was originally discovered by Prof. Lawrence Patterson of the School of Pharmacy, at University of London, working in collaboration with BTG. KuDOS acquired a worldwide license for AQ4N from BTG in March 2001 and entered into a collaborative development agreement with Novacea Inc. in December 2003. About KuDOS Pharmaceuticals KuDOS Pharmaceuticals Limited holds a leading position in the discovery and development of small molecule drugs based upon the science of DNA damage sensing, signalling and repair to address unmet medical needs in cancer treatment. 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, which targets hypoxic regions of tumors. Research continues on DNA-PK, ATM, PARP and mTOR inhibitors, with a candidate compound for PARP currently in preclinical assessment. For more information about KuDOS please visit, http://www.kudospharma.co.uk/. About Novacea Novacea is a privately-held biopharmaceutical company committed to creating a world-class drug development and commercialization organization that addresses significant unmet medical needs in oncology. The company's first product to enter the clinic is DN-101, a novel formulation of calcitriol. The company intends to study DN-101 in multiple cancers in combination with several chemotherapies. Also in Novacea's pipeline is AQ4N, a novel proprietary hypoxic cell-activated agent with broad potential in a variety of cancers. Novacea holds North American development and commercialization rights for AQ4N in all indications. For more information about the company and its programs, visit its World Wide Web site at http://www.novacea.com/. About BTG BTG creates value by investing in intellectual property and technology development, and in early stage ventures. The company realizes value through technology licensing, patent assertion and disposal of equity investments. Through a multi-disciplinary approach, BTG applies intellectual property and commercial expertise, together with specialist skills in science and technology, to create major product opportunities in the health and high-tech sectors. BTG has commercialized important innovations, including alemtuzumab (Campath(R)), the first monoclonal antibody treatment for chronic lymphocytic leukemia and Factor IX blood clotting protein, the first recombinant treatment for Haemophilia B. Further information about BTG can be found at http://www.btgplc.com/. DATASOURCE: KuDOS Pharmaceuticals Limited; Novacea Inc. CONTACT: Cheryl Bishop of KuDOS Pharmaceuticals Limited, +44 (0) 1223 719 719; or Ben Atwell, Francetta Carr, both of Financial Dynamics, +44 (0) 207 831 3113; or Kristin Nash of WeissCom Partners, +1-415-302-7951, for Novacea Inc. Web site: http://www.kudospharma.co.uk/ http://www.novacea.com/ http://www.btgplc.com/

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