Full Press Release Details
MIRAGEN THERAPEUTICS TO PRESENT NEW COBOMARSEN CLINICAL TRIAL DATA FOR ADULT T-CELL LEUKEMIA/LYMPHOMA AND CUTANEOUS T-CELL LYMPHOMA AT THE 11TH ANNUAL T-CELL
BOULDER, CO, December 20, 2018 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage
biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it will present new data from its Phase 1 trial of cobomarsen in HTLV-1 associated adult T-cell leukemia/lymphoma (ATLL) as well as its Phase 1 trial of cobomarsen in patients with mycosis fungoides, the most common form of cutaneous T-cell (CTCL) at the 11th Annual T-Cell Lymphoma Forum, which is being held in La Jolla, CA, from January 10th-12th.
Presentation Details:
For additional information, please visit the T-Cell Lymphoma Forum website: www.tcellforum.com
Cobomarsen is an inhibitor of microRNA-155. In CTCL, as well as certain other blood cancers, microRNA-155 is present at abnormally high levels and may play a role in the proliferation of blood and lymph
cells. miRagen believes therapeutic inhibition of microRNA-155 may reduce aberrant cell proliferation and tumor growth characteristics of certain types of cancer. The Company is currently evaluating cobomarsen
in three oncology indications within the current Phase 1 trial, including adult T-cell leukemia/lymphoma (ATLL), diffuse large B-cell lymphoma (DLBCL) and chronic
lymphocytic leukemia (CLL).
The Company s global Phase 2 SOLAR trial for cobomarsen in patients diagnosed with cutaneous T-cell lymphoma (CTCL) is in the startup phase with the first 4 clinical sites in the United States open for enrollment with initial dosing expected by early 2019. The SOLAR trial will evaluate the safety and
efficacy of cobomarsen given by intravenous infusion in an active control comparison trial versus ZOLINZA (vorinostat). Based on discussions with the U.S. Food and Drug Administration, miRagen believes the results from the SOLAR trial could allow
the Company to apply for accelerated approval in the United States.
About Mycosis Fungoides
MF is a slow growing form of cancer, and is the most common form of CTCL. Symptoms of MF include rash, tumors, skin lesions and itchy skin. In about
10 percent of cases, the disease can progress to lymph nodes and internal organs. In the U.S., the prevalence of MF is estimated to be around 16,000-20,000 cases, with 3,000 new diagnoses each year.
ATLL is a blood cell malignancy that develops in patients after prolonged infection with the virus, HTLV1. Literature suggests that the infection with HTLV1 as
well as the subsequent malignancies may be associated with elevation in the expression of microRNA-155, the target of cobomarsen. The disease presents in multiple forms, but the most lethal include the acute
leukemic form and the lymphomatous version. Although the disease is rare, these two manifestations lack good treatment options, and once the diagnosis is made, average life expectancy is approximately 4 months for the acute leukemic form and
approximately 10 months for the lymphomatous variety.
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 has three clinical stage product candidates, cobomarsen (MRG-106), remlarsen (MRG-201), and MRG-110. miRagen s clinical product candidate for the treatment of certain cancers,
cobomarsen, is an inhibitor of microRNA-155, which is found at abnormally high levels in malignant cells of several blood cancers, as well as certain cells involved in inflammation. miRagen s clinical
product candidate for the treatment of pathological fibrosis, remlarsen, is a replacement for microRNA-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including
cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as systemic sclerosis. MRG-110, an inhibitor of microRNA-92, is being developed under a
license and collaboration agreement with Servier for the treatment of heart failure and other ischemic disease. In addition to these programs, miRagen is developing a pipeline of preclinical product candidates. The goal of miRagen s
translational medicine strategy is to progress rapidly to first-in-human studies once it has established the pharmacokinetics, pharmacodynamic, safety and
manufacturability of the product candidate in preclinical studies. For more information, please visit www.miragen.com.
For information on clinical
trials please visit www.clinicaltrials.gov.
Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the
Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, including statements regarding miRagen s strategy, future operations, future financial position, future
revenue, projected expenses, prospects, plans and objectives of management or the expected features of or potential indications for miRagen s product candidates are forward-looking statements. The words believe, may,
will, estimate, continue, anticipate, intend, plan, expect, predict, potential, opportunity, goals, or
should, and similar expressions are intended to identify forward-looking statements. Such statements are based on management s current expectations and involve risks and uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements as a result of many factors, including, without limitation: that miRagen has incurred losses since its inception, and anticipates that it will continue to incur significant losses for
the foreseeable future; future financing activities may cause miRagen to restrict its operations or require it to relinquish rights; miRagen may fail to demonstrate safety and efficacy of its product candidates; miRagen s product candidates are
unproven and may never lead to marketable products; miRagen s product candidates are based on a relatively novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval,
if at all; miRagen s product candidates may cause undesirable side effects or have other properties that could delay or prevent the regulatory approval; and the results of miRagen s clinical trials to date are not sufficient to show safety
and efficacy of miRagen s product candidates and may not be indicative of future clinical trial results.
miRagen has based these forward-looking
statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the heading Risk
Factors in miRagen s Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. Moreover, miRagen operates in a very competitive and rapidly
changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause
actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this press release may not occur and actual
results could differ materially
and adversely from those anticipated or implied in the forward-looking statements. miRagen undertakes no obligation to revise or publicly release the results of any revision to such
forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this
cautionary statement.
Investor/Media Contact:
Levy, Chief Business Officer