Together,the groups will help Ariana to apply its novel technology to the discovery ofnew biomarkers, under a three-year effort they are calling the Hepachronixproject.
Pooling their collective expertise, they will identify, develop andmarket new tools for the early diagnosis of fibrosis and for the prognosis ofresistance to treatment. The project aims to deepen understanding of theprocesses by which liver fibrosis in HCV patients evolves from an early, mildstage to serious liver diseases such as cirrhosis and hepatoma carcinoma.
Detectingpatients at the early stages of fibrosis is critical, the organizations note,in order to treat them as early as possible. However, roughly 40 percent ofHCV-infected patients do not respond to standard antiviral treatment, so theHepachronix project aims to develop additional biomarkers to characterizepatient responder status, and to adapt the therapy.
Takingpart in the Hepacronix project helps to demonstrate Ariana's commitment to thefield of biomarker identification and validation, as well as its leadingposition in identifying biomarkers and the strength of its Knowledge Extractionand Management (KEM) platform for disease diagnosis.
"ArianaPharma is looking forward to applying its expertise and KEM technology to thediagnosis and prognosis of hepatitis which chronically affects many hundredmillion patients worldwide," says Mohammad Afshar, CEO of Ariana Pharma. "Theidentification and validation of new sets of biomarkers have the potential toimprove diagnosis and treatment of these major public health problems."
ArianaPharma and its partners will share the expected royalties from sales of theeventual in vitro diagnostic reagents that would be marketed by Bio-RadLaboratories.
Afsharnotes that KEM will be used to "complement traditional statistical tools" sothat it can help identify signature probes and he adds that it "has the abilityto combine genomic and proteomic data with patient characteristics to maximizethe probability of an effective test."
TheKEM system is able to generate, assess and prioritize hypotheses, handlemissing data and optimize multiple objectives, thus enhancing conventionalmethods of analysis, Ariana notes.
TheKEM platform is designed to comprehensively mine data, including data othersystems neglect, and helps scientists take simultaneous decisions involvingmultiple criteria and objectives, Afshar notes, adding that the Paris-basedcompany has established a rapidly growing software business throughcollaboration and licensing agreements with some of the largest pharmaceuticaland biotechnology companies since its founding in 2003.
Inserm'sinterest in this effort derives from its strong interest in infectious andparasitic diseases, which the organization notes are the second-leading causeof death worldwide, but which strike countries unequally dependingon where the latter are located and their level of development. Inserm notesthat even in northern countries, after a clear improvement through the 1970swith better hygiene, prevention and antibiotics, new problems have arisen inthe last two decades, among them the worldwide spread of HIV and other chronicviral infections such as hepatitis C, prion infections, emerging infectionslike SARS and pandemic flu, antimicrobial resistance and nosocomial diseases.
Thenews of all this activity in France follows another recent announcement thatAfshar notes is also very significant to Ariana: a collaboration with the U.S.Food and Drug Administration (FDA). Under that deal, Ariana is providing itsKEM Biomarker technology to help enable FDA reviewers to analyzepharmacogenomic data combined with patient characteristics for biomarkersignatures submitted through the FDA's Voluntary Exploratory Data Submission(VXDS) program. This collaboration directly relates to the FDA's desire todevelop better tools for the analysis of genomic data in the context of thedevelopment of personalized medicine.
Thecollaboration is also intended to help the FDA systematically identifypotential genomic "fingerprints" and develop recommendations for the analysisof genomic data prior to submission of biomarker signatures.
"Weare looking forward to this collaboration to help the agency systematicallyanalyze all equivalent signatures combining both genomic and phenotypical date,this increasing chances of selecting the best biomarker signature," says Dr.Federico Goodsaid, associate director for operations in genomics for the Officeof Clinical Pharmacology at the FDA's Center for Drug Evaluation and Research.
