US-based biopharmaceutical firm Mirna Therapeutics has enrolled first patient in the hematological malignancy cohort of its ongoing Phase I clinical trial of MRX34, the company’s lead product candidate and first microRNA mimic in human clinical trials in oncology.
The multicentre, open-label Phase I trial of MRX34 started in April 2013 and is currently enrolling patients with unresectable primary liver cancer or solid cancers with liver involvement.
Currently, a separate group of patients with hematological malignancies are being enrolled in the trial.
Hematological malignancies 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.
MD Anderson Cancer Center department of leukemia deputy department chair and principal investigator of the trial Jorge Cortes said: "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."
An interim analysis of safety data from the first 26 patients 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.
According to the company, interim data has showed that maximum tolerated dose had not been reached and additional patients are being enrolled into the trial.
The Phase I clinical trial design includes an initial dose-escalation phase, followed by an expansion phase after the recommended Phase II dose has been identified.
In the liver-based cancer group, which aims to enrol 48 patients, MRX34 is administered intravenously twice a week for three weeks with one week off, during 28-day cycles, until disease progression or intolerance.