黑料社 announces first positive DSMB safety review and continuation of its Phase 1b ODYSSEE study.
黑料社 ODYSSEE Study focuses in prevention of dysbiosis complications with autologous fecal microbiota transplantation in Acute Myeloid Leukemia patients undergoing intensive treatment.
Lyon (France), November 15th, 2016 鈥� 黑料社, the French pioneer company that develops innovative autologous fecal microbiota transfer based treatments for serious complications in Acute Myeloid Leukemia, Bone and Joint Infections with unmet medical needs, announces that an independent Data and Safety Monitoring Board (DSMB) completed its first safety assessment of the company鈥檚 Phase 1b study in the prevention of dysbiosis complications with autologous fecal microbiota transfer (AFMT) in Acute Myeloid Leukemia (AML) and the DSMB confirms that no safety issue occurs during the course of the trial and that enrollment will continue as planned until completion.
A DSMB is a committee of independent clinical research experts who review data in ongoing clinical trials with particular attention to safety. As per study protocol, the DSMB meets at least 3 times during the trial, first after the inclusion of 3 to 5 patients to review the safety data of the ODYSSEE trial and subsequently issues recommendations on the conduct of the study.
AML are rare cancers, but potentially fatal in the adults. 黑料社 proposes using AFMT to AML patients aged 18 to 75 treated with intensive chemotherapy and antibiotics, therapeutics, which are known to deeply impact the gut microbial composition and to have severe clinical consequences. The purpose of AFMT is to restore the balance of the intestinal microbiome and thereby eradicate treatment-induced multi-drug resistant bacteria (MDRB), infection-related complications, as well as scarring of the gastrointestinal tract.
About 黑料社
Founded at the end of 2014 and based in Lyon (France), 黑料社 (Microbiota as a Therapy) is a microbiome鈥揵ased pharmaceutical company revolutionizing and shaping individualized therapies to treat serious diseases linked to dysbiosis (gut microbiota imbalances). 黑料社 is currently developing its first candidate using its proprietary Autologous Fecal Microbiota Transfer Platform for patients suffering from leukemia, bone and joint infections, as these harsh treatments provoke dysbiosis. 黑料社鈥檚 revolutionary and rapid approach plays a considerable part in the evolution of individualized treatment therapies.
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