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Mirna Therapeutics Announces Presentation of Interim Data from Ongoing Phase I Clinical Trial of MRX34, First-in-Class microRNA-34 mimic, in Patients with Advanced Solid Tumors

AUSTIN, Texas--(BUSINESS WIRE)--Mirna Therapeutics, Inc. (Nasdaq:MIRN), a clinical-stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics, today announced the presentation of interim results from its ongoing Phase 1 clinical trial of MRX34, the Company’s lead therapeutic product candidate.1 The poster presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, reported interim Phase 1 clinical results for MRX34 from 75 patients with advanced solid tumors. MRX34 is a double-stranded “mimic” of the naturally occurring tumor suppressor microRNA (miRNA) miR-34, encapsulated in the SMARTICLES® liposomal delivery formulation.

“We look forward to the expansion phase of this trial in which we expect to enroll more patients with these as well as other cancer types.”

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Interim safety, efficacy and biomarker data from the multicenter, open-label Phase 1 clinical trial in solid tumor patients show that MRX34 has a safety profile manageable with standard interventions or tests used by oncologists, and demonstrate the therapeutic potential of miR-34 replacement therapy. Additionally, dose-dependent effects on miR-34 target genes in patients’ white blood cells have been observed. As of August 13, 2015, two patients with advanced, metastatic Stage IV cancer have achieved clinical responses after treatment with MRX34: one patient with primary liver cancer (hepatocellular carcinoma, HCC) metastatic to the lung, and one patient with acral melanoma, metastatic to lymph nodes, showed more than 30 percent tumor shrinkage (confirmed partial responses).

The findings were presented on Sunday, November 8, in a poster presentation entitled “Safety, tolerability, and clinical activity of MRX34, the first-in-class liposomal miR-34 mimic, in patients with advanced solid tumors” by primary author Muhammad Shaalan Beg, M.D., Assistant Professor, Internal Medicine, University of Texas Southwestern Medical Center.

“These results further confirm our...