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MIRAGEN THERAPEUTICS REPORTS THIRD QUARTER 2017 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
|||MRG-106 Phase 1 trial expanded to include additional oncology indications, enrollment commenced|
|||MRG-201 expected to advance into a Phase 2a trial in cutaneous fibrosis in the first half of 2018|
|||MRG-110 on track to complete Investigational New Drug (IND) application/Clinical Trial Application (CTA) enabling studies in the fourth quarter of 2017|
|||Conference call and webcast today at 4:30 p.m. ET|
BOULDER, CO, November 8, 2017 (GLOBE NEWSWIRE) miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development ofRNA-targeted therapies, today announced third quarter 2017 financial results and provided a corporate update.
miRagen made continued progress across its clinical and pre-clinical programs in the third quarter, said miRagen President and Chief Executive Officer William S. Marshall, Ph.D. We are very encouraged by the new MRG-106 clinical data, which showed that 96% of patients treated systemically experienced improvement in total skin disease across all dose levels evaluated. We have expanded the ongoing Phase 1 trial to evaluate MRG-106 in three additional oncology indications, and recently began enrolling subjects. Additionally, we plan to initiate a Phase 2a clinical trial for MRG-201 in the first half of 2018, and advance MRG-110 into clinical development in collaboration with Servier in the first half of 2018.
Business Highlights and Update
|||Reported new interim MRG-106 Phase 1 clinical trial results: In October 2017, miRagen announced new interim results from the systemic administration portion of its ongoing Phase 1 clinical trial evaluating the safety, efficacy and pharmacokinetics of MRG-106 in patients with the mycosis fungoides (MF) form of cutaneous T-cell lymphoma (CTCL). These data were presented at the European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Task Force Meeting. This part of the trial employed a multiple dose-escalation design to evaluate 300 mg, 600 mg or 900 mg subcutaneous or intravenous administrations of MRG-106. Twenty-two of twenty-three patients (96%) treated systemically showed improvement in total skin disease as measured by the maximal change in each patients modified Severity Weighted Assessment Tool (mSWAT) score, which assesses the severity of skin disease over a patients entire body. Nine of thirteen patients treated for more than one month showed a 50% or greater maximal improvement in mSWAT scores with five patients, to date, demonstrating a duration of this improvement for four months or longer. MRG-106 has been generally well-tolerated to date at dose levels ranging from 75 mg to 900 mg.|
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Wednesday, November 8, 2017 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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