Xenomics, Inc., and its Subsidiary TrovaGene, Inc., Announce Italian Patent for NPM1 Testing for AML Patients
December 15 2009 - 11:37AM
Business Wire
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 51st 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.
About Xenomics, Inc. and TrovaGene TM,
Inc.
Xenomics Inc. is focused on the development of nucleic acid
based tests using Transrenal DNA (Tr-DNA) or RNA (Tr-RNA) and on
products for personalized medicine to improve patient care. Its
patented technology uses safe and simple urine collection and can
be applied to a broad range of applications, including tumor
detection and monitoring, infectious disease detection, prenatal
testing, tissue transplantation, genetic testing for forensic
identity determination, drug development, and research to counter
bioterrorism.
TrovaGene, Inc. is a wholely owned subsidiary of Xenomics, Inc.
which was formed principally to provide a mechanism to change the
company’s corporate domicile from Florida to Delaware and the
company’s corporate name by statutory merger.
Statements about the company's expectations, applications of its
technology, markets, and other statements that are not historical
facts are "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934 and are based on management's
current beliefs, assumptions, estimates and projections. Actual
results may differ materially from those projected in the
forward-looking statements for various reasons, including risks
associated with product development, government regulation, market
acceptance, dependence on key personnel, obtaining financing and
other factors.