Theradiag : Creation of an International HIV/AIDS Scientific Advisory Board

Regulatory News :

THERADIAG (Paris:ALTER) (ISIN : FR0004197747, Ticker: ALTER), a company specializing in theranostics and in vitro diagnostics (IVD), announced today the formation of an international HIV/AIDS Scientific Advisory Board. The Board will advise the Company on the clinical development of a test to characterize HIV tropism based on the identification of a microRNA signature. CE mark for the test is planned for 2015.

« This new immuno-diagnostics approach seems very promising and could lead to a new therapeutic pathway rendering HIV receptor antagonists more efficient » commented Mark Wainberg, M.D, Ph.D, of Montreal’s Jewish Hospital-McGill University, a world class HIV/AIDS researcher and member of the Scientific Advisory Board.

First step towards clinical validation of the HIV cell tropism theranostics kit
The four independent members of the Scientific Advisory Board met in October 2013 to provide clinical guidance to the company in the final development phase and clinical program for its theranostics assay to characterize HIV tropism. An international, multicentric study will be initiated on a large cohort of patients to demonstrate the diagnostics and prognostics values of microRNA signatures linked to HIV tropisms CXCR4 and CCR5.

The goal of this innovative theranostics approach is twofold: improve access to the HIV tropism test while increasing performance; and favor the treatment of AIDS with Maraviroc and future HIV receptor antagonists. "This proof-of-concept clinical program should begin in the coming weeks, in order to obtain a CE mark in 2015” stated Odile Prigneau, the CEO of Prestizia, Theradiag’s subsidiary dedicated to microRNAs.

« We have just met a significant milestone in the development of our microRNA program. Theradiag now receives clinical guidance from HIV/AIDS key opinion leaders. This lends strong clinical validation to our HIV tropism characterization program. We are the first company to use microRNAs to characterize HIV tropism” comments Michel Finance, CEO of Theradiag. He concludes: "There is growing interest by the scientific community and pharmaceutical industry for microRNAs. We observe a strong increase in scientific publications and partnering deals in the field”.

About Theradiag’s HIV/AIDS Scientific Advisory Board
The Scientific Advisory Board provides clinical guidance to the Company on the clinical development of innovative theranostics tests based on microRNAs for academic research and the pharmaceutical industry. It has 4 members:

Vincent Calvez, M.D, Ph.D., Department of Virology, Pitié Salpétrière Hospital in Paris. Professor Calvez heads one of the leading laboratories in HIV-1 research in France and worldwide. He specializes in characterization of antiretroviral resistance.

Diane Descamps, M.D, Ph.D, Virology Department of Bichat-Claude Bernard Hospital and Medical Faculty of Paris-Diderot University in Paris. Professor Descamps specializes in HIV resistance to antiretroviral therapies, with about 200 publications in this topic.

Jacques Reynes, M.D, Ph.D, Infectious and Tropical Disease Department, University Hospital of Montpellier. Professor Reynes was among the first physicians to prescribe Maraviroc in France. His research focuses on new therapeutic pathways in HIV/AIDS treatment, notably receptor antagonists and side effects of antiretroviral treatments.

Mark Wainberg, M.D, Ph.D, Director of the McGill AIDS Center, Quebec Jewish General Hospital. Professor Wainberg is the former President of the International AIDS Society, an honorary fellow of the Royal College of Physicians and Surgeons of Canada and a Chevalier of France’s Légion d’honneur in 2008. He has received numerous awards and honors in recognition for his achievements, including a National Scientist Award for AIDS Research (1990).

About microRNA-based theranostics assays
Theradiag is among the first companies to use microRNAs for the diagnostics and monitoring of AIDS, autoimmune diseases and cancer. Prestizia, Theradiag’s subsidiary dedicated to microRNAs, demonstrated proof-of-concept for the technology, and notably the characterization of specific microRNA linked to HIV cell tropism in 2012. Since the beginning of 2013, Theradiag has launched two other projects using microRNAs to develop theranostics tools in HIV/AIDS and obesity (CaReNa project) and colon cancer.

About Theradiag
Backed by its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus participating in the development of "customized treatment”, which favors the individualization of treatments, the evaluation of their efficiency and the prevention of drug resistance. Theradiag markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter diagnosis solution for patients with autoimmune diseases treated with biotherapies. Theradiag is also developing new diagnostic markers thanks to its microRNA platform, which will allow specific biomarkers to be identified in order to guide therapy and will be first and foremost applied to the treatment of AIDS. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 50 employees.

For more information about Theradiag, please visit our website: www.theradiag.com