miRagen Therapeutics, Inc. today announced that data from its ongoing Phase 1 clinical study of MRG-106 in patients with mycosis fungoides will be presented at the 58th Annual Meeting of the American Society of Hematology (ASH). The abstract will be available on the ASH conference web site, http://www.hematology.org.
In the first cohort of the MRG-106 trial, six patients were dosed by direct injection into their tumor. The six patients tolerated the administrations well with only minor redness at the injection site reported for one patent. One patient discontinued the trial due to disease progression, which was considered unrelated to the study drug. Four of the five patients who completed dosing had their Composite Assessment of Index Lesion Severity (CAILS) scores evaluated in the MRG-106 treated lesions. The lesions in these four patients showed a 50% or greater reduction in the baseline CAILS score. The CAILS score measures the size and severity of the lesion.
“We believe our initial clinical experience with MRG-106 is encouraging,” said William S. Marshall, President and Chief Executive Officer of miRagen. “The drug was generally safe and well tolerated with preliminary indications of clinical responses in the first patients studied.”
Poster presentation details are as follows:
Abstract Title: Preliminary Results of a Phase 1 Trial Evaluating MRG-106, a Synthetic microRNA inhibitor (LNA antimiR) of microRNA-155, in Patients with CTCL (Abstract #93903)
Session Number: 624
Session Name: Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I
Session Date: Saturday, December 3, 2016
Presentation Time: 5:30 PM – 7:30 PM
Location: San Diego Convention Center, Hall GH
About miRagen Therapeutics, Inc.
miRagen Therapeutics, Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative microRNA (miRNA)-targeting therapies in disease areas of high unmet medical need. miRagen’s lead product candidate, MRG-106, a synthetic microRNA inhibitor (LNA antimiR) of microRNA-155, is currently being studied in a Phase 1 clinical trial in patients suffering from cutaneous T-cell lymphoma (CTCL) of the mycosis fungoides (MF) sub-type. miRagen is also conducting a Phase 1 clinical trial of MRG-201, its lead anti-fibrosis product candidate and a synthetic microRNA mimic (promiR) to microRNA-29b, in healthy volunteers. miRagen seeks to leverage in-house expertise in miRNA biology, oligonucleotide chemistry, and drug development to evaluate and advance promising technologies and high-potential product candidates for its own pipeline and in conjunction with strategic collaborators.
About MRG-106 and microRNA-155
MRG-106 is an antimiR (inhibitor) of microRNA-155. In hematological malignancy microRNA-155 has key roles in the differentiation, function and proliferation of blood and lymph cells. miRagen believes therapeutic inhibition of microRNA-155 in lymphoma cells may restore normal function and reduce the aberrant cell proliferation that is characteristic of cancerous cells.