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Creating biomarkers to strike disease early
PARIS—Ariana Pharma, which provides decision support tools and services to accelerate the development and optimal use of drugs and biomarker discovery, announced recently that it has entered into a partnership to improve the diagnosis and prognosis of chronic hepatitis (HCV). In this effort, it will be collaborating with Paris-based Beaujon Hospital and the French National Institute of Health and Medical Research (Inserm), as well Bio-Rad France.
Together, the groups will help Ariana to apply its novel technology to the discovery of new biomarkers, under a three-year effort they are calling the Hepachronix project.
Pooling their collective expertise, they will identify, develop and market new tools for the early diagnosis of fibrosis and for the prognosis of resistance to treatment. The project aims to deepen understanding of the processes by which liver fibrosis in HCV patients evolves from an early, mild stage to serious liver diseases such as cirrhosis and hepatoma carcinoma.
Detecting patients at the early stages of fibrosis is critical, the organizations note, in order to treat them as early as possible. However, roughly 40 percent of HCV-infected patients do not respond to standard antiviral treatment, so the Hepachronix project aims to develop additional biomarkers to characterize patient responder status, and to adapt the therapy.
Taking part in the Hepacronix project helps to demonstrate Ariana's commitment to the field of biomarker identification and validation, as well as its leading position in identifying biomarkers and the strength of its Knowledge Extraction and Management (KEM) platform for disease diagnosis.
"Ariana Pharma is looking forward to applying its expertise and KEM technology to the diagnosis and prognosis of hepatitis which chronically affects many hundred million patients worldwide," says Mohammad Afshar, CEO of Ariana Pharma. "The identification and validation of new sets of biomarkers have the potential to improve diagnosis and treatment of these major public health problems."
Ariana Pharma and its partners will share the expected royalties from sales of the eventual in vitro diagnostic reagents that would be marketed by Bio-Rad Laboratories.
Afshar notes that KEM will be used to "complement traditional statistical tools" so that it can help identify signature probes and he adds that it "has the ability to combine genomic and proteomic data with patient characteristics to maximize the probability of an effective test."
The KEM system is able to generate, assess and prioritize hypotheses, handle missing data and optimize multiple objectives, thus enhancing conventional methods of analysis, Ariana notes.
The KEM platform is designed to comprehensively mine data, including data other systems neglect, and helps scientists take simultaneous decisions involving multiple criteria and objectives, Afshar notes, adding that the Paris-based company has established a rapidly growing software business through collaboration and licensing agreements with some of the largest pharmaceutical and biotechnology companies since its founding in 2003.
Inserm's interest in this effort derives from its strong interest in infectious and parasitic diseases, which the organization notes are the second-leading cause of death worldwide, but which strike countries unequally depending on where the latter are located and their level of development. Inserm notes that even in northern countries, after a clear improvement through the 1970s with better hygiene, prevention and antibiotics, new problems have arisen in the last two decades, among them the worldwide spread of HIV and other chronic viral infections such as hepatitis C, prion infections, emerging infections like SARS and pandemic flu, antimicrobial resistance and nosocomial diseases.
The news of all this activity in France follows another recent announcement that Afshar notes is also very significant to Ariana: a collaboration with the U.S. Food and Drug Administration (FDA) . Under that deal, Ariana is providing its KEM Biomarker technology to help enable FDA reviewers to analyze pharmacogenomic data combined with patient characteristics for biomarker signatures submitted through the FDA's Voluntary Exploratory Data Submission (VXDS) program. This collaboration directly relates to the FDA's desire to develop better tools for the analysis of genomic data in the context of the development of personalized medicine.
The collaboration is also intended to help the FDA systematically identify potential genomic "fingerprints" and develop recommendations for the analysis of genomic data prior to submission of biomarker signatures.
"We are looking forward to this collaboration to help the agency systematically analyze 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 Office of Clinical Pharmacology at the FDA's Center for Drug Evaluation and Research.