miRagen Therapeutics to Present MRG-201 Data at the Society for Investigative Dermatology Annual Meeting
April 20 2017 - 7:00AM
Miragen Therapeutics, Inc. (Nasdaq:MGEN), a clinical-stage
biopharmaceutical company focused on the discovery and development
of microRNA-targeted therapies, announced today that interim
results from its ongoing Phase 1 clinical study of MRG-201 will be
presented at the Society for Investigative Dermatology (SID) 76th
Annual Meeting being held April 26-29, 2017 in Portland, Oregon.
MRG-201 is designed to mimic the activity of
microRNA miR-29b and decrease the expression of collagen and other
proteins that are involved in fibrous scar formation. Previous
studies by miRagen researchers have indicated that microRNA -29 may
be a powerful regulator of extracellular matrix production, and may
be an attractive therapeutic target for the treatment of cutaneous
and other forms of pathological fibrosis.
“We are pleased to present biomarker focused data on our
anti-fibrosis product candidate, MRG-201, at the 2017 SID Annual
Meeting,” said miRagen President and CEO William S. Marshall, Ph.D.
“The interim molecular and histology results from our ongoing Phase
1 study enhance our belief in the potential of MRG-201 as a
therapeutic candidate for the treatment of pathological
fibrosis.”
Poster Presentation DetailsAbstract
title: Pharmacodynamic activity of a microRNA -29b mimic
(MRG-201) in human skin incisions
- Session: Poster Session I
- Poster number: LB948
- Date: Thursday, April 27, 2017, 10:15 a.m. -
12:15 p.m. PT
- Location: Exhibit Hall A
- Session: Selected ePoster Discussions III
- Poster number: LB948
- Date: Saturday, April 29, 2017, 10:45-11:45
a.m. PT
- Location: Exhibit Hall A Foyer
For additional information, please visit the SID website:
www.sidnet.org
About Miragen Therapeutics, Inc.
Miragen Therapeutics, Inc. is a clinical-stage biopharmaceutical
company discovering and developing proprietary RNA-targeted
therapeutics with a specific focus on microRNAs and their role in
diseases where there is a high unmet medical need. miRagen’s
two lead product candidates, MRG-106 and MRG-201, are currently in
Phase 1 clinical trials. miRagen’s clinical product candidate
for the treatment of certain cancers, MRG-106, is an inhibitor of
microRNA-155, which is found at abnormally high levels in several
blood cancers. miRagen’s clinical product candidate for the
treatment of pathological fibrosis, MRG-201, is a replacement for
miR-29, which is found at abnormally low levels in a number of
pathological fibrotic conditions, including cardiac, renal,
hepatic, and pulmonary fibrosis, as well as systemic
sclerosis. In addition to miRagen’s clinical programs, it is
developing a pipeline of pre-clinical 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, pharmacodynamics and safety of the product
candidate in pre-clinical studies. For more information,
please visit www.miragentherapeutics.com.
Note Regarding Forward-Looking Statements
This press release contains, and the presentation discussed
herein 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 and the presentation
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 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
past results in clinical studies and trials may not be indicative
of future results or the ultimate efficacy of miRagen’s product
candidates, miRagen has incurred losses since its inception, has a
limited operating history on which to assess its business, and
anticipates that it will continue to incur significant losses for
the foreseeable future; miRagen has never generated any revenue
from product sales and may never be profitable; raising additional
capital may cause dilution to miRagen’s stockholders, restrict its
operations or require it to relinquish rights; miRagen may be
unsuccessful in maintaining orphan-drug designation for its product
candidates because even after an orphan drug is approved, the FDA
can subsequently approve a different drug for the same indication
if the FDA concludes that the later drug is clinically superior in
that it is shown to be safer, more effective or makes a major
contribution to patient care; clinical trials are costly, time
consuming and inherently risky, and miRagen may fail to demonstrate
safety and efficacy to the satisfaction of applicable regulatory
authorities; the approach it is taking to discover and develop
novel therapeutics using microRNA is unproven and may never lead to
marketable products; miRagen’s microRNA therapeutic 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; to date, no
microRNA therapeutics have been approved for marketing in the
United States; miRagen may not be able to develop or identify
technology that can effectively deliver MRG-106, MRG-201 or any
other of miRagen’s microRNA-targeted product candidates to the
intended diseased cells or tissues, and any failure in such
delivery technology could adversely affect and delay the
development of MRG-106, MRG-201 and miRagen’s other product
candidates; and miRagen’s product candidates may cause undesirable
side effects or have other properties that could delay or prevent
the regulatory approval, limit the commercial viability of an
approved label, or result in significant negative consequences
following marketing approval, if any.
miRagen has based these forward-looking statements largely on
its current expectations and projections about future events and
trends that it believes may affect its financial condition, results
of operations, business strategy, short-term and long-term business
operations and objectives, and financial needs. These
forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including those described in under
the heading “Risk Factors” in miRagen’s Annual Report on Form 10-K
and any 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 and such presentation 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 these 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.
For information on clinical trials please visit
www.clinicaltrials.gov.
miRagen Investor Contact:
Adam Levy
Chief Business Officer
(720) 407-4595
alevy@miragenrx.com
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