A leading Texas biotechnology company, Mirna Therapeutics, Inc. has announced the initiation of Phase 1 clinical trials of MRX34 in patients with unresectable primary liver cancer or metastatic cancer with liver involvement.
The Texas based company, Mirna Therapeutics Inc. is known for its pioneering work in the development of microRNA (miRNA) replacement therapies for the management and treatment of complicated cancers. The phase 1 study of MRX34 will be the first human clinical trial for cancer utulziing miRNA technology.
Chief Executive Officer and President of Mirna Therapeutics, Paul Lammers MD suggested:
“The initiation of this clinical trial is a landmark event for cancer drug development. 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.”
Goals of Phase 1 clinical trials of MRX34:
The principal investigator of the study, Andrew Brenner, M.D., Ph.D, who is also medical oncologist and assistant professor in the School of Medicine at The University of Texas Health Science Center in San Antonio, briefed that the initial results and recommendations from the clinical trial will be used for the determination of safety of MRX34 and future potential for study. This study will be conducted at the Cancer Therapy & Research Center at the Health Science Center. Dr. Brenner commented:
“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.”
A standard oncology study design will be followed for the phase 1 clinical trials of MRX34. This includes an initial phase of dose-escalation in 48 selective patients with unresectable primary liver cancer or metastatic cancer with liver involvement, followed by an enrichment period.
About MRX34 and miRNAs:
MRX34 utilizes liposomal delivery formulation and mimics the properties of tumor suppressor miR-34. The company filed its first Investigational New Drug Application for MRX34 with U.S. Food and Drug Administration in the first quarter of 2013. miRNA are small 25 to 30 base nucleotide sequences that can significantly alter the expression of certain genes with the help of its interaction with messenger RNAs. These nucleotides are coded in the human genome to regulate the gene expression.
Over 1,500 miRNAs are encoded in human genome to regulate the expression of approximately 30% of all genes by acting as master-switch via multiple cellular processes. Abnormalities in the expression of miRNAs play a significant role in the pathogenesis of many cancers, and it is believed that replacement of down regulated miRNAs in cancer cells may play a role in management and control of carcinogenesis.
About Mirna Therapeutics:
The Austin based company was founded in 2007 and has emerged as one of the most renowned biotechnology institutions in Texas, focusing mainly on the development of interventional and innovative cancer therapies utilizing miRNA therapeutics, developed by its scientists and scientists from all over the world. Currently, the portfolio of company contains over 300 miRNAs in various stages of development. miRNAs that mainly deals with oncology includes miR-34 and let-7 (key tumor suppressors) that has been shown to block the growth of tumor in various pre-clinical animal studies
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