GRENOBLE, France, Jan. 22, 2015 /PRNewswire/ -- ImmunID, an immune molecular diagnostics company, announced today the enrolment of the first five patients in its PREDICT-ID Melanoma study to assess the predictive value of immune profiles for response to Ipilimumab®, an immunomodulatory agent.
One month after receiving authorization from the French regulatory bodies for the PREDICT-ID study, ImmunID is delighted to announce that the first two clinical centers, in Lyon and Angers, have recruited five metastatic melanoma patients. These two hospitals will be shortly followed by six additional renowned French centers.
Professor Stephane Dalle, a Dermato-Oncologist in the Department of Dermatology of the Hospices Civils de Lyon (France), commented: "Despite recent progress in the management of relapsing melanoma thanks to the new immune-checkpoint blocking agents, there is a major need for a better stratification of patients. Immune monitoring with ImmunTraCkeR® may help us answer the critical question of who will respond to Ipilimumab®, and I am very pleased to see that patient recruitment in the PREDICT-ID trial is going very fast."
Dr David Liens, ImmunID's Chief Medical Officer, explained: "ImmunID is committed to help in the management of cancer immunotherapies. We already have data generated with ImmunTraCkeR® for immunotherapy monitoring and prediction of side effects, with proven level 1b evidence according the ASCO guidelines. Preliminary data on the utility of ImmunTraCkeR® to predict response to Ipilimumab® in metastatic melanoma patients were generated in collaboration with the Memorial Sloan Kettering Cancer Center in New York. With PREDICT-ID, we want to validate these data in a larger patient population, in partnership with oncologists from leading French clinical centers".
Bernhard Sixt, ImmunID's Chairman and Chief Executive Officer, added: "The fast launch of the PREDICT-ID study is promising and makes us confident to achieve our goal to rapidly recruit 200 patients. We see it as indicator that ImmunTraCkeR® addresses a high unmet clinical need in the management of melanoma therapies."
Melanoma is a major public health problem worldwide with an incidence of 191 000 patients in More Developed Regions, and doubling every 10 years (GLOBOCAN 2012, iarc). According to the American Cancer Society, about 76,100 new melanomas have been diagnosed in the US in 2014 close to 10,000 people are expected to die from this disease each year. Melanoma has a very poor prognosis once it becomes metastatic.
About the ImmunTraCkeR® test:
ImmunID has developed the immune molecular diagnostics test ImmunTraCkeR®, which evaluates patient immune competence based on combinatorial T cell diversity. ImmunTraCkeR® is a unique CE-marked diagnostic test, which approaches the disease from the patient immune system's perspective. It is therefore patient-specific, unlike most molecular diagnostics tests, which are either drug- or disease-specific. ImmunTraCkeR® provides information on the patient immune profile, using it as a biomarker for clinical benefit or for risk in patients under immunotherapies. As a new immune companion diagnostic test, ImmunTraCkeR® should answer the urgent medical need for efficient patient stratification tools in melanoma and other solid cancers.
ImmunID has been a pioneer in the immune molecular diagnostic field since 2005. Its two clinical products ImmunTraCkeR® and ImmunIG® evaluate patient immune competence based on T and B cell repertoire diversity, respectively. The company is establishing ImmunTraCkeR® as the general immune companion diagnostic for all immunotherapies and setting the general immune molecular diagnostics standard globally. ImmunID collaborates with leading clinical research centers and biopharmaceutical companies worldwide to further validate ImmunTraCkeR® as an immune companion diagnostic test for new immunotherapies and to widen clinical utility of its products. The company is ISO9001 certified and runs an ISO13485 accredited production and R&D facility in the MINATEC high-tech campus in Grenoble, France. In addition, ImmunID has applied for CAP accreditation / CLIA certification of its central lab to be able to provide ImmunTraCkeR® routinely to clinical patients in the United States.
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