Austin-based biopharmaceutical company Mirna Therapeutics announced the recruitment of the initial patients for a phase 1 clinical trial focused on hematological malignancy and on MRX34, the first micro RNA mimic in oncological human trials.
MRX34 is a novel therapy being studied to deliver a simulation of the natural microRNA tumor suppressor, miR-34, which is underexpressed in patients suffering from a large number of cancers. The idea is to encapsulate the miR-34 in Smarticles, a liposomal formulation, and make MRX34 the first microRNA replacement therapy product.
“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,” stated Jorge Cortes, M.D., Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine at MD Anderson Cancer Center and principal investigator of the study.
Initiated in April 2013, the multicenter and open-label trial of MRX34 is starting to enroll patients with unresectable primary liver cancer or solid cancers with liver involvement, as well as a different group of patients with hematological malignancies. The last one includes blood cancer, bone marrow, and lymph nodes, but it may also 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.
The trial is now in a phase of initial dose-escalation and is willing to engage 48 new liver-cancer patients, which it will be administrated intravenously MRX34 twice a week on 28-days cycles of three weeks of treatment and one off. The heme malignancy group will gain 15 more patients that will be treated for five days with MRX34 continuously, and have then two weeks off, during 21-day cycles. The main purpose is to establish the maximum dose tolerated, in order to prepare the phase 2 of the trial, as well as to evaluate safety, tolerance and pharmacokinetic profile of MRX34.
At this point, researchers were able to conclude that the most common adverse events related to MRX34, in the first 26 patients studied, were treated with oncological standard interventions, according to a recent presentation at the American Association of Clinical Research. Scientists from the University of Texas Southwestern recently presented the evaluation of the use of MRX34 and its interim manageable safety profile, at the American Association for Cancer Research Annual Meeting in San Diego.
The clinical trial is funded in part by the Cancer Prevention and Research Institute of Texas (CPRIT).