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MIRAGEN THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
|||Data from Phase 1 clinical trial supports advancing cobomarsen, or MRG-106, into a Phase 2 potentially registrational clinical trial for CTCL (the SOLAR trial)|
|||Completed Phase 1 clinical trial of MRG-201 supports advancement into a Phase 2 trial in cutaneous fibrosis / scarring|
|||miRagen-Servier strategic alliance advances with Servier filing a clinical trial authorization to initiate the first of two Phase 1 clinical trials planned for MRG-110 in 2018|
|||Conference call and webcast today at 4:30 p.m. ET|
BOULDER, CO, March 14, 2018 (GLOBE NEWSWIRE) miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today reported fourth quarter and full year 2017 financial results and provided a corporate update.
2017 was a remarkable year for miRagen, underscored by the clinical success and advancement of our two lead programs, cobomarsen (MRG-106) and MRG-201, and we believe we are well-positioned to make advances in the development of our product candidates in 2018, said miRagen President and Chief Executive Officer William S. Marshall, Ph.D. The cobomarsen Phase 1 results have been encouraging, and we plan to initiate a Phase 2 clinical trial to evaluate cobomarsen in cutaneous T-cell Lymphoma (CTCL) this year. We have designed this trial to allow the possibility of accelerated approval in the United States, subject to the outcome of the trial. In 2018, we expect to initiate four clinical trials, including the Phase 2 SOLAR trial evaluating cobomarsen in CTCL, a Phase 2 trial for MRG-201 in cutaneous fibrosis and two Phase 1 trials in collaboration with Servier for MRG-110 to support development in ischemic diseases. Additionally, in 2018 we expect to report interim data from our Phase 1 trial evaluating cobomarsen in multiple hematological malignancies beyond CTCL.
Business Highlights and Update
|||Data from Phase 1 trial supports advancing cobomarsen (MRG-106) into a Phase 2 potentially registrational trial for CTCL: In February 2018, miRagen announced interim results from its ongoing Phase 1 clinical trial evaluating the safety, efficacy and pharmacokinetics of cobomarsen in patients with the mycosis fungoides form of CTCL. These data showed 26 of 29 evaluable patients, or 90%, with improved modified Severity Weighted Assessment Tool (mSWAT) scores, a measurement of the severity of skin disease. Four of five patients (80%) who were treated with 300 mg IV infusion achieved a 50% or greater mSWAT reduction, which the Company believes represents an important beneficial clinical response. Cobomarsen has been generally well-tolerated to date at the range of doses tested.|
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Wednesday, March 14, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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