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miRagen Announces Results of Meeting With FDA Regarding the Design of Pivotal Trial for Cobomarsen in ATLL
BOULDER, Colo., Aug. 20, 2020 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"BOULDER, Colo., Aug. 20, 2020 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary RNA-targeted therapies with a specific focus on microRNAs, today announced that the company held a Type C meeting with the FDA Office of Oncologic Diseases on August 11, 2020 to discuss miRagen’s future clinical development plans for cobomarsen for the potential treatment of Adult T-Cell Leukemia/Lymphoma (ATLL).\n “We received clear guidance from the FDA on a potential path to registration in this ultra rare indication based upon a small randomized controlled trial with a primary endpoint of progression free survival that is appropriate for a maintenance therapy. With additional cobomarsen data from the ongoing Phase 2 SOLAR trial in Cutaneous T-cell lymphoma (CTCL) patients expected before the end of the year, we will be able to determine next steps for this program, which may include seeking a partner for the late-stage development and potential commercialization of cobomarsen in miR-155 elevated cancers including CTCL and ATLL” said William S. Marshall, Ph.D., miRagen’s President and Chief Executive Officer. MicroRNA-155 overexpression has been shown to be a poor prognostic indicator in a variety of hematological malignancies and solid tumors. Cobomarsen is an inhibitor of miR-155 that has demonstrated initial safety and efficacy data in a phase 1 clinical trial in which patients with CTCL, ATLL, DLBCL and CLL patients were treated. miRagen believes that the now defined regulatory pathway for potential approval of cobomarsen for both CTCL and ATLL is an important incremental step in its broader strategy to evaluate cobomarsen as a potential treatment for a variety of miR-155 elevated blood cancers. Cobomarsen has received orphan drug designation in the United States for the treatment of T-cell lymphomas, such as CTCL and ATLL. This designation can provide development and commercial incentives for designated compounds and medicines, including market exclusivity. About miRagen Therapeutics, Inc. Miragen Therapeutics, Inc. is a clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapies with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. miRagen ...