SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, England, Dec. 11 /PRNewswire/ -- Novacea Inc. and KuDOS Pharmaceuticals announced today that Novacea has licensed from KuDOS the North American rights to develop and commercialize AQ4N, a novel proprietary hypoxic cell-activated agent with broad potential in a variety of cancers.
The agreement grants Novacea an exclusive license to the North American (U.S., Canada and Mexico) development and commercialization rights for AQ4N in all indications in exchange for development milestones and royalty payments. KuDOS will continue to develop AQ4N in Europe and other markets outside North America. The two companies will work together to coordinate worldwide development of a broad range of cancer indications and jointly manufacture the compound. No financial terms of the deal were disclosed.
"The acquisition of rights to this promising clinical-stage product candidate further expands Novacea's portfolio of anti-cancer agents," said Brad Goodwin, Chief Executive Officer of Novacea. "We believe AQ4N has significant potential and we intend to leverage our existing expertise in hematology and oncology to move forward expeditiously with its development for a broad range of potential indications."
"The collaboration with Novacea will prove very effective in bringing additional expertise and resource to bear in the development of this exciting new cancer treatment," said Barrie Ward, Chief Executive Officer of KuDOS Pharmaceuticals. "The collaboration is expected to enhance a route to market approval."
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. AQ4 is a potent topoisomerase II inhibitor and DNA intercalator.
More than two million patients each year are estimated to present with tumors in the U.S. 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.
Preclinical data demonstrate that AQ4N markedly enhances the effects of radiation and chemotherapy when administered in combination with either treatment. Data further suggest anti-tumor activity as a monotherapy. The agent is currently being evaluated in a Phase 1 clinical trial in combination with radiation in esophageal cancer. Sixteen patients have been treated to date and AQ4N has been well tolerated, with no serious drug-related adverse events reported.
AQ4N was originally discovered by Prof. Lawrence Patterson of the School of Pharmacy, at University of London, working in collaboration with BTG International plc (BTG). KuDOS acquired a worldwide license for AQ4N from BTG in March 2001.
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, which targets hypoxic regions of tumors. In addition, the company has a considerable early stage preclinical pipeline resulting from strong links with the academic laboratory of Professor Stephen Jackson of the Wellcome/Cancer Research UK Institute in the University of Cambridge and other academic experts. For more information about KuDOS please visit, http://www.kudospharma.co.uk/.
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 and hematology. The company's first product to enter the clinic is DN-101, an experimental, oral anti-cancer drug containing the most potent active form of Vitamin D, known as calcitriol. DN-101 currently is being studied in combination with Taxotere(R) (docetaxel) in late-stage clinical trials for advanced prostate cancer and non-small cell lung cancer. For more information about the company and its programs, visit its World Wide Web site at http://www.novacea.com/.
CONTACT: Kristin Nash of WeissCom Partners, +1-415-302-7951, firstname.lastname@example.org, for Novacea Inc.; or Barrie Ward, CEO, or RichardOnyett, Commercial Director of KuDOS Pharmaceuticals, +44(0)1223-719719,Ben Atwell or Francetta Carr of Financial Dynamics, +44(0)207-831-3113