Dr. Christine Robin, the principal investigator at the Henri-Mondor Hospital (Creteil, France), said: “With all my team, we are glad to have recruited the first patient in MICROCARE.”
Da Volterra announcesfirst patient randomized into MICROCARE trial, a world-first study evaluating DAV132, an innovative protective therapy regulated as a drug in the USA, to preserve the intestinal microbiota from antibiotic disruption in patients undergoing several chemotherapy cycles.
DAV132 will help to prevent infections in cancer patients.
As part of the European COMBACTE-NET program, a public-private partnership co-founded by Innovative Medicines Initiative, Da Volterra, will enroll 900 patients in approximately 80 centers worldwide, newly diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndrome. Hematologic malignancies, including multiple myeloma, lymphoma, and leukemia, originate from the uncontrolled growth of hematopoietic and lymphoid cells and account for about 10 % of all cancers diagnosed in the U.S. each year.
Multiple studies have proven that the gut microbiota is implicated in the genesis and progression of hematological malignancies; thus, gastrointestinal flora protection is a promising approach to improve the efficacy of hematological malignancies therapies, mainly to avoid the severe complications related to those treatments.
As a primary endpoint, MICROCARE will evaluate the occurrence of infections caused by Clostridioides difficile, a significant and life-threatening complication determined by the disruption of the intestinal microbiome.
The diversity of the gut microbiome results in favorable responses to chemotherapy.
MICROCARE will also assess the efficacy of DAV132 in protecting intestinal microbiome diversity, found to be a robust independent predictor of infection during induction chemotherapy.
The overall aim of MICROCARE is to improve the overall survival and quality of life of patients with hematologic malignancies protecting their microbiome, and preventing intestinal colonization with potentially pathogenic bacteria and bloodstream infections.
The clinical network of COMBACTE-NET is committed to a challenging and world’s first clinical study that will show that DAV132 can counteract life-threatening complications and mortality of patients with acute myeloid leukemia or high-risk myelodysplastic syndrome.
“This study is a stepping stone for microbiome-oriented therapies and could pave the way to new treatment options for all patients with cancer,” said Fabien Vitry, M.D., Chief Medical Officer of Da Volterra.