THERADIAG Actively Pursuing the Development of a microRNA Theranostics Kit for Rectal Cancer

Regulatory News:

THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in theranostics and in vitro diagnostics, announces the launch of the second phase of its study to identify microRNA biomarkers to predict the response to treatment and metastatic relapse in rectal cancer (miCRA project). Biological validation will be carried out on a broader range of patients, in partnership with the Regional Cancer Institute of Montpellier (ICM).

The first phase of the miCRA project began at the end of 2013 with the screening of potential microRNA candidates, which was followed by a technical validation on an initial cohort of 70. A biostatistical analysis of the data has helped identify modulated and specific microRNA candidates that predict the response to chemo/radiotherapy treatments and metastatic recurrence in rectal cancer.

The aim of the second phase of this study will be to validate, across a broader range of patients, the biological relevance of the identified microRNA candidates in order to establish a robust signature that could be routinely used in a new theranostics test. This second phase is also being carried out in partnership with the ICM.

"Thanks to our partnership with the Cancer Institute of Montpellier (ICM) and to our platform specializing in development applied to microRNAs, we are able to position ourselves on the very large oncology market, on top of our presence on the autoimmune disease market. For the rectal cancer segment, a theranostics kit’s potential world market is estimated at several tens of millions of euros”, comments Michel Finance, CEO of Theradiag.

About rectal cancer
Rectal cancer is the fifth most common cancer in France. Currently, more than 17,000 cases of rectal cancer are diagnosed each year in this country, and this figure is expected to rise to 45,000 new cases annually by 2020. Rectal cancer is also prevalent in Western Europe (United Kingdom, Italy, Spain, Germany), the United States and, more recently, Japan. Indeed, on these 7 major markets, 182,000 new cases of rectal cancer were diagnosed in 2010, 40,000 of them in the United States. Taking into account every stage of the illness, the 5-year survival rate for patients suffering from rectal cancer is approximately 65% (sources: Guide infection de longue durée: Cancer colorectal adénocarcinome, INCa/HAS, 2012 and DataMonitor).

About the miCRA project
In 2013, Theradiag put in place a collaborative research and development program in the field of rectal cancer with the Cancer Institute of Montpellier (ICM) called "miCRA” (circulating microRNAs in locally advanced rectal cancer). The miCRA project was one of the 110 projects to receive a start-up phase award by the French government’s Worldwide Innovation Challenge, which is based on the 7 goals defined by the Innovation 2030 Commission chaired by Mrs Anne Lauvergeon. It receives financing from BpiFrance. The aim of this project is to develop a simple, reliable, fast and non-invasive theranostics solution based on a microRNA signature in patients. The test will allow the early prediction of the response prior to any chemo/radiotherapy and anticipation of metastatic recurrences in rectal cancer.

About ICM
Created in 1923, the Regional Cancer Institute of Montpellier (ICM) is now recognized as of the leading national centers for cancer patient care, as well as the benchmark regional center for cancer patients in the Languedoc Roussillon area (with over 40,000 consultations and 26,000 patients treated per year). The ICM is one of the 18 Cancer Centers (CLCC) of the UNICANCER group, the first hospital group fully dedicated to cancerology with over 900 employees including 105 doctors, 11 research teams and 140 researchers. The ICM is one of 8 research centers in France to have received the Integrated Research Center of Cancer (SIRIC) mark, as well as one of France’s leading CLCCs in terms of clinical, fundamental and translational research.

About Theradiag
Capitalizing on 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 notably markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter theranostics solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is developing new biomarkers based on microRNAs for the diagnosis and monitoring of HIV/AIDS and rectal cancer. Theradiag is thus participating in the development of "customized treatment”, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 60 employees.

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