Italian patent issued for NPM1 to test patients with AML

Dec 16 2009

Xenomics, Inc. (Pink Sheets: XNOM), a developer of transrenal molecular diagnostics, announced today that a key Italian patent covering a unique diagnostic application with critical significance for patients with acute myeloid leukemia (AML) has issued. The patent, entitled: “Nucleophosmin protein (NPM1) mutants, corresponding gene sequences and uses thereof”, focuses on the key role of the human protein NPM1 in managing patients with AML. Xenomics holds exclusive rights to the application of NPM1 to AML and has non-exclusively sublicensed its diagnostic applications to offer clinical testing.

Value of NPM1 for the Management of AML will lead to a significant increase in testing

NPM1 has become a valuable monitoring tool for the management of AML, a clinically heterogeneous disease with about 200,000 new cases per year worldwide. The NPM1 marker provides a clinically effective tool for staging and monitoring the state of disease in AML patients. Dr. Brunangelo Falini, one of the inventors of this NPM1 technology, responding to a recent article by Ommen et al. in the journal Blood published Nov 9, 2009, commented “There is increasing evidence of the clinical value of monitoring of MRD (minimal residual disease) in NPM1-mutated AML.” Moreover, the World Health Organization (WHO) guidelines published in 2008 have established the value of NPM1 testing by classifying AML with NPM1 mutations as a provisional entity. And the National Comprehensive Cancer Network (NCCN) has included NPM1 mutation status in its assessment of risk for AML.

“Results from clinical trials begun as far back as 1996 and 1999 are emerging to demonstrate the efficacy of NPM1 testing,” commented Dr. David Robbins, Xenomics’ Vice President of Research and Development. “This is true not only for initial diagnosis and prognosis of AML, but also as a sensitive monitor of minimal residual disease.” Confirmation of the emerging role of NPM1 was recently provided by the number of presentations by independent groups working on NPM1 at the 51^st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, December 5-8, 2009. Results presented in 84 poster and oral sessions at the ASH meeting included not only the significance of testing for new patients, but also monitor efficacy of therapy, indicating a major role for NPM1 testing during clinical trials for new therapies.

Xenomics Licensing of NPM1 Intellectual Property

Xenomics has granted non-exclusive rights to NPM1 as a laboratory service to Laboratory Corporation of America® Holdings (NYSE: LH), InVivoScribe Technologies, and Warnex Medical Laboratories, a division of Warnex Inc. (Toronto: WNX.TO). Xenomics is actively offering licenses to additional laboratories that will expand testing of this new marker for AML.

Xenomics has also signed co-exclusive worldwide rights to Ipsogen SAS (Frankfurt: IPK.F) and Asuragen Diagnostics, a division of Asuragen, Inc., for the incorporation of NPM1 technology into their molecular diagnostic products. Under the terms of this agreement, Asuragen and Ipsogen have begun developing, manufacturing and marketing products for NPM1 mutation detection.