miRagen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage
biopharmaceutical company focused on the discovery and development
of RNA-targeted therapies, announced today new interim results from
its ongoing Phase 1 clinical trial evaluating the safety, efficacy
and pharmacokinetics of MRG-106 in patients with the mycosis
fungoides (MF) form of cutaneous T-cell lymphoma (CTCL). The data
is being presented at the European Organisation for Research and
Treatment of Cancer (EORTC) Cutaneous Lymphoma Task Force Meeting
in London, United Kingdom, by Christiane Querfeld, M.D., Ph.D.,
Chief of the Division of Dermatology, and Director, Cutaneous
Lymphoma Program at the City of Hope in Duarte, California.
“We are encouraged by the new MRG-106 Phase 1 data, as we
observed that 96% of patients treated systemically experienced
improvement in total skin disease at all dose levels evaluated,”
said miRagen President and CEO William S. Marshall, Ph.D. “These
findings suggest that MRG-106 has the potential to offer meaningful
benefit to patients with CTCL. We are making what we believe to be
important progress for patients in our MRG-106 Phase 1 clinical
trial, and we were pleased to share these new data with the medical
community.”
The MRG-106 Phase 1 trial consists of two parts. In the first
part, patients were treated with 75 mg injections of MRG-106
directly into a specific lesion. These data, which showed a
decrease in lesion size for all injected lesions, have been
previously presented. The second part employed a multiple
dose-escalation design to evaluate 300 mg, 600 mg or 900 mg
subcutaneous or intravenous administrations of MRG-106. The newest
results to be reported at EORTC include observations from four
additional patients as well as longer term dosing data for existing
patients who have continued on the trial. Interim data from
the second part of the Phase 1 trial are summarized below:
- Twenty-two of twenty-three patients (96%) treated systemically
showed improvement in total skin disease as measured by the maximal
change in each patient’s modified Severity Weighted Assessment Tool
(mSWAT) score, which assesses the severity of skin disease over a
patient’s entire body.
- Nine of thirteen patients treated for more than one month
showed a 50% or greater maximal improvement in mSWAT scores.
- Responses in mSWAT of 50% or greater appeared to be durable for
all patients who continued on therapy. Additionally, to date five
patients maintained a durable response for four months or
longer.
- The magnitude of mSWAT improvements appeared to correlate with
amount of time the patient received MRG-106 treatment.
- In patients who showed improvements, these were observed
regardless of whether the patient was receiving background
medication(s) for CTCL or MRG-106 alone.
- MRG-106 has been generally well-tolerated for all 27 patients
evaluated to date at dose levels ranging from 75 mg to 900 mg.
- Injection site reactions were seen in some patients after
subcutaneous administration and were generally minor and
self-limited.
- Only one patient had a Grade 3 adverse event, worsening of
pruritus (itchy skin) compared to baseline, which was considered
potentially related to MRG-106 administration.
“The new MRG-106 Phase 1 data build upon those presented
throughout the year, and to date has been generally well-tolerated
with preliminary indications of clinical response,” said Paul
Rubin, M.D., miRagen’s Executive Vice President of Research and
Development. “We are encouraged by these results, which we believe
support advancing MRG-106 into controlled clinical trials next
year.”
The interim results announced by miRagen are from an ongoing
Phase 1 trial in patients with documented mycosis fungoides. In
part 1, patients were treated with 75 mg injections of MRG-106
directly into a specific lesion. Part two, of the trial which is
currently enrolling, employs a multiple dose-escalation design to
evaluate 300 mg, 600 mg or 900 mg subcutaneous or intravenous
administrations of MRG-106. Patients were allowed to continue
background medication provided these have remained unchanged for
one month prior to receiving MRG-106. Enrolled
patients receive a one week loading regimen followed by weekly
dosing with 300 to 900 mgs through IV or subcutaneous
administration. Patients are monitored for safety, and for
improvement in skin disease via mSWAT at regular intervals
throughout the trial.
MRG-106 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 the tumor
growth characteristic of certain types of cancer.
miRagen plans to evaluate MRG-106 in additional oncology
indications within the current Phase 1 trial, including adult
T-cell leukemia/lymphoma, diffuse large B-cell lymphoma and chronic
lymphocytic leukemia as in each case the disease process appears to
be related to an increase in miR-155 levels.
Oral Presentation DetailsAbstract
title: Phase 1 trial evaluating MRG-106, a synthetic
inhibitor of microRNA-155, in CTCL patients
- Session: Therapeutics (II)
- Number: 0-44
- Date: Saturday, October 14, 2017, 4:00 p.m. -
5:30 p.m. BST
For additional information, please visit the EORTC Cutaneous
Lymphoma Task Force Meeting website: www.eortclondon2017.org
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
clinical development. 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 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, 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, pulmonary and ocular fibrosis, as well as systemic
sclerosis. miRagen is also developing MRG-110, an inhibitor of
microRNA-92, under a license and collaboration agreement with
Servier. MRG-110 is being developed 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)
407-4595 alevy@miragen.com
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