Mirna Therapeutics, Inc. announced that it has initiated a Phase 1 clinical study of MRX34, the first miRNA to advance into a human clinical trial for cancer. The Phase 1 trial is being conducted in patients with unresectable primary liver cancer or metastatic cancer with liver involvement.
“The initiation of this clinical trial is a landmark event for cancer drug development,” said Paul Lammers, M.D., President and Chief Executive Officer of Mirna Therapeutics. “Scientists at Mirna were among the first to elucidate the promise of tumor suppressor miRNAs as new therapeutic candidates. The preclinical profile of MRX34 across a range of tumors strongly suggests that miRNA-based therapeutics may represent a potent, new class of anticancer drugs working through a mechanism that affects multiple oncogenic pathways simultaneously.”
“Results from this initial clinical trial will be used to evaluate the safety of MRX34, and help us evaluate the potential of this compound for further clinical study,” said Andrew Brenner, M.D., Ph.D., medical oncologist and assistant professor in the School of Medicine at The University of Texas Health Science Center at San Antonio, and principal investigator on the study being conducted at the Cancer Therapy & Research Center at the Health Science Center. “We are excited to be the first to bring this new and innovative therapeutic approach to our patients. We look forward to reviewing the clinical data and to furthering the study of miRNA-based cancer therapeutics.”
The Phase 1 MRX34 study will follow a standard oncology study design, consisting of an initial dose-escalation phase followed by an enrichment phase, and is expected to enroll up to 48 patients in total. MRX34 is a miRNA “mimic” of tumor suppressor miR-34 delivered using a liposomal delivery formulation in-licensed from Marina Biotech.