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MIRAGEN THERAPEUTICS REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
Cobomarsen expansion indication data released; first observations from the ongoing Phase 1 clinical trial on safety and efficacy of cobomarsen in ATLL patients, additional data expected by year end
New cobomarsen Phase 1 data in CTCL released, Phase 2 trial expected to initiate in the fourth quarter
Initiated Phase 2 clinical trial to evaluate remlarsen (also known as MRG-201) in cutaneous fibrosis; data expected in 2019
Initiated Phase 1 clinical trial in collaboration with Servier to evaluate the safety, tolerability and pharmacokinetics of MRG-110
Recently announced collaboration and stock purchase with the Leukemia and Lymphoma Society; provides up to $5 million in funding
$76 million in cash, cash equivalents, and short-term investments as of June 30, 2018
Conference call and webcast today at 4:30 p.m. ET
BOULDER, CO, AUGUST 7, 2018 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today reported second quarter 2018 financial results and provided a corporate update.
This is an exciting time for microRNA-based therapeutics and I am very proud of what our team at miRagen has accomplished, said William S. Marshall, Ph.D., President and Chief Executive Officer of miRagen Therapeutics. We are focused on building a sustainable company with the potential to deliver multiple product candidates for patients in need. During the quarter, we announced progress on each of our three clinical stage product candidates. We were encouraged by the initial efficacy data for cobomarsen in patients with ATLL and pleased to have initiated two new clinical trials during the quarter, including a Phase 2 trial for remlarsen (also known as MRG-201) and our second Phase 1 trial of MRG-110 in collaboration with Servier. During the fourth quarter of this year, we plan to initiate our Phase 2 SOLAR clinical trial for cobomarsen in patients suffering from CTCL. We look forward to providing updates for each of our product candidates through the year and continuing to advance our clinical programs in to later-stage development.
Clinical Development Update
In June, miRagen announced encouraging first observations from the Phase 1 clinical trial on the safety and efficacy of cobomarsen in adult T-cell leukemia/lymphoma (ATLL) patients at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. Two patients with an aggressive form of the disease have shown clinical response to the treatment. This clinical trial is ongoing and miRagen expects to release additional data at the 2018 American Society of Hematology (ASH) Annual Meeting in December.
In June, an update of clinical results from the cobomarsen Phase 1 clinical trial in patients with the mycosis fungoides form of cutaneous T-cell lymphoma (CTCL) was also presented at ASCO. Cobomarsen appeared to demonstrate durable responses measured by skin tumor burden measurements and quality of life improvement, as measured by the Skindex-29 Total Score. Cobomarsen also continued to be generally well tolerated at all dose levels evaluated. miRagen expects to present final data from this trial at ASH in December.
During the fourth quarter of this year, miRagen expects to initiate its global Phase 2 SOLAR clinical trial for cobomarsen in CTCL. In the SOLAR trial, miRagen is planning to evaluate the safety and efficacy of 300 milligrams of cobomarsen given by intravenous infusion in an active control comparison trial versus ZOLINZA (vorinostat), enrolling approximately 65 patients
The following information was filed by Miragen Therapeutics, Inc. (MGEN) on Tuesday, August 7, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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