New data will be presented on the pharmacology, pharmacokinetics and toxicology of MRX34, a liposomal formulation containing a mimic of the miR-34 tumor suppressor. miR-34 represses the expression of more than 20 oncogenes and inhibits processes required for cancer cell viability, cancer stemness, metastasis, and chemoresistance. The company has previously demonstrated that intravenous administration of the miR-34 mimic can inhibit the growth of pre-existing B-cell lymphoma, liver, lung and prostate cancer (Craig et al., 2012; Wiggins et al., 2010, Trang et al., 2011, Liu et al., 2011).
MRX34 was well tolerated in rodents and non-human primates during IND-enabling studies and did not induce RNAi-mediated toll-like receptor activation or immune response at anticipated therapeutic dose levels. The pharmacokinetic profiles suggest a satisfactory residence time in blood and will be used to determine the recommended human starting dose and treatment regimen in the clinic.
“These data continue to support the safety profile and therapeutic potential of MRX34. We are on track to file an Investigational New Drug application (IND) for MRX34 with the US Food and Drug Administration and initiate clinical testing of this miRNA replacement therapy approach in the first half of this year in patients diagnosed with primary liver cancer or advanced solid cancers with liver involvement,” said Paul Lammers, M.D., President and Chief Executive Officer of Mirna Therapeutics.
This project was funded in part by a Cancer Prevention and Research Institute of Texas (CPRIT) Commercialization grant.