miRagen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage
biopharmaceutical company focused on the discovery and development
of RNA-targeted therapies, today announced that interim results
from its ongoing Phase 1 clinical trial of MRG-106 will be
presented at the 14th International Conference on Malignant
Lymphoma (ICML) being held June 14-17, 2017 in Lugano, Switzerland.
The company will discuss data from its Phase 1 clinical trial
evaluating the safety, efficacy and pharmacokinetics of MRG-106 in
subjects with the mycosis fungoides (MF) form of cutaneous T-cell
lymphoma (CTCL).
MF is the most common form of CTCL. It generally affects the
skin, often causing rash and sometimes disfiguring skin lesions and
tumors that can progress internally over time.
MRG-106 has been generally well-tolerated to date. Eighteen of
nineteen subjects (95%), independent of administration route,
showed improvement in either the individual lesion or total skin
disease as measured by maximal change in either Composite
Assessment of Index Lesion Severity or modified Severity Weighted
Assessment Tool.
“We are pleased that MRG-106 has been generally well-tolerated
to date with preliminary indications of clinical responses,” said
miRagen President and Chief Executive Officer, William S. Marshall,
Ph.D. “Patients suffering from MF have limited therapeutic options
available, and we look forward to the continued development of
MRG-106 for the potential treatment of MF and, ultimately,
potential additional indications where elevated expression of
microRNA-155 has been implicated in disease.”
Poster Presentation DetailsAbstract
title: Ph 1 Trial Evaluating MRG-106, a microRNA-155
Inhibitor, Administered by Intratumoral, Subcutaneous, or
Intravenous Delivery in Cutaneous T-Cell Lymphoma (CTCL)
Patients
- Session: New Drug Development
- Poster number: 289
- Date: June 15-16, 2017, 12:30 p.m. - 1:00 p.m.
CET
- Location: Marquee Parco Ciani
For additional information, please visit the ICML website:
www.lymphcon.ch
In addition to the presentation of Phase 1 data in Lugano,
miRagen also announced an expanded list of potential clinical
milestones for the coming 18 months.
Dr. Marshall continued, “Including MRG-106, our portfolio of
RNA-targeted therapeutic candidates continues to progress steadily,
potentially expanding certain expected milestones for the second
half of 2017 and next year. We plan to launch additional clinical
studies and produce further data in the coming months and
year.”
Clinical milestones anticipated to be completed in the coming 18
months include:
- MRG-201 (pathologic fibrosis)
- Phase 1 results presentation at a scientific conference (2H
2017)
- Presentation of results from pre-clinical inhalation
feasibility study (2H 2017) and initiation of a Phase 1 trial with
an inhaled formulation (2018)
- MRG-106 (hematological malignancies)
- Interim Phase 1 CTCL data presentation at ASH (Q4
2017)
- Phase 1 trial expansion to include potential second indication
(2H 2017) and potential third indication (1H 2018)
- Initiation of Phase 2 trial in CTCL/Non-Hodgkin’s lymphoma (2H
2018)
- MRG-110 (ischemic disease)
- Completion of Investigational New Drug/Clinical Trial
Application enabling studies (Q4 2017)
- Initiation of Phase 1 in 2018
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’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
microRNA-29, which is found at abnormally low levels in a number of
pathological fibrotic conditions, including cutaneous, 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.miragenrx.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
results of miRagen’s Phase 1 clinical trials 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) 407-4595
alevy@miragenrx.com
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