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:
- Oral presentation: Cobomarsen, an emerging
potential treatment for patients with miR-155 elevated cancers
- Date: January 12, 2019
- Presentation Time: 10:25 a.m. PT
- Location: Hilton La Jolla Torrey Pines
- Poster presentation: Results from Phase 1
Trial of Cobomarsen, an Inhibitor of miR-155, in Mycosis Fungoides
(MF)
- Date: Friday, January 11, 2019
- Presentation Time: 6:00 p.m. to 8:00 p.m.
PT
- Location: Hilton La Jolla Torrey Pines
- Poster presentation: Phase 1 Trial of
Cobomarsen, a miR-155 Inhibitor, in HTLV-1 Associated Adult T-cell
Leukemia/Lymphoma
- Date: Friday, January 11, 2019
- Presentation Time: 6:00 p.m. to 8:00 p.m.
PT
- Location: Hilton La Jolla Torrey Pines
For additional information, please visit the T-Cell Lymphoma
Forum website: www.tcellforum.com
About cobomarsenCobomarsen 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 FungoidesMF 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.
About ATLLATLL 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:Adam Levy, Chief
Business Officer(720) 407-4595alevy@miragen.com
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