Mirna Therapeutics, Inc. (Mirna), a clinical-stage biopharmaceutical company pioneering microRNA-based Replacement Therapy to treat cancer, today announced the enrollment of the first patient in the hematological malignancy cohort of its ongoing Phase 1 clinical trial of MRX34, the company's lead product candidate and first microRNA mimic in human clinical trials in oncology.
"We believe microRNA therapeutics hold significant promise in the fight against cancer and we are excited to expand the ongoing clinical study of MRX34 in liver-based cancers, to now also include patients with hematological malignancies," said Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine at MD Anderson Cancer Center and a Principal Investigator of the study.
The multicenter, open-label Phase 1 clinical trial of MRX34 was initiated in April 2013 and is currently enrolling patients with unresectable primary liver cancer or solid cancers with liver involvement. The trial is now enrolling a separate cohort of patients with hematological malignancies, which are cancers that affect blood, bone marrow and lymph nodes and may include non-Hodgkin's lymphoma, acute myelogenous leukemia, acute and chronic lymphocytic leukemia, chronic myelogenous leukemia in accelerated or blast phase, multiple myeloma or myelodysplastic syndrome.
An interim analysis of safety data from the first 26 patients was recently presented at the American Association of Clinical Research (AACR) annual meeting. The interim data showed that the most common adverse events associated with MRX34 in the patients studied have been manageable with standard interventions used by oncologists, with one incident of a dose-limiting toxicity observed. The maximum tolerated dose had not been reached and additional patients are being enrolled into the study.