Mirna Therapeutics Halts Phase 1 Clinical Study of MRX34
September 20 2016 - 4:05PM
Business Wire
Management to host conference call and webcast
today at 5 p.m. Eastern
Mirna Therapeutics, Inc. (Nasdaq:MIRN), a clinical stage
biopharmaceutical company, today announced its decision to close
the ongoing Phase 1 study of MRX34, its investigational microRNA
therapy for multiple cancers. The Company voluntarily halted
enrollment and dosing in the clinical study following multiple
immune-related severe adverse events (SAE) observed in patients
dosed with MRX34 over the course of the trial.
“Patient safety is the primary objective of our MRX34 Phase 1
clinical trial,” said President and CEO Paul Lammers, M.D., M.Sc.
“We made the difficult decision to close the study after a fifth,
immune-related serious adverse event was recently reported by one
of our clinical sites. This patient experienced severe (Grade 4)
cytokine release syndrome and is undergoing treatment. We have
notified the U.S. FDA and the Korean FDA of our decision and are in
the process of closing the trial.”
Mirna also announced that it will not be initiating a
translational medicine study of MRX34 in melanoma patients, planned
to begin later this year. The Company will be further analyzing its
full preclinical and clinical data set, and will discuss with its
advisors, as well as the FDA, possible future development of MRX34
and will provide updates when appropriate.
Conference Call Details
To access the call, participants should dial 877-407-9079 (U.S.
& Canada) or 201-493-6746 (international) at least 10
minutes prior to the start of the call. The call will be webcast
live and may be accessed from the Events &
Presentations section of the Company's website. An
archived version of the webcast will be available for replay
following the event.
About Mirna Therapeutics, Inc.
Mirna is a clinical stage biopharmaceutical company developing
microRNA-based oncology therapeutics and is the first to bring a
synthetic microRNA mimic into clinical development for the
treatment of cancer. Mirna's lead product candidate, MRX34, a mimic
of naturally occurring microRNA-34 (miR-34), has been studied in a
Phase 1 clinical trial which included patients with primary liver
cancer, advanced solid tumors and hematological malignancies.
miR-34 is one of the most widely published microRNAs and is
considered a key regulator of multiple oncogenes across key
oncogenic pathways, with the capacity to regulate more than 30
different oncogenes and repress immune checkpoint signaling
molecules, including PD-L1. The Company was founded in 2007 and is
located in Austin, Texas.
For more information, visit www.mirnarx.com.
Forward-Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Mirna, they are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including statements regarding possible future MRX34 development.
Such forward-looking statements involve substantial risks and
uncertainties that could cause our clinical development program,
future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others, the
uncertainties inherent in the clinical drug development process,
including the outcomes of clinical trials, the regulatory approval
process, our substantial dependence on MRX34, our commercialization
plans and efforts and other matters that could affect the
availability or commercial potential of our product candidates and
the risk that our product candidates may cause undesirable side
effects or have other properties that could delay or prevent their
regulatory approval. We undertake no obligation to update or revise
any forward-looking statements. For a further description of the
risks and uncertainties that could cause actual results to differ
from those expressed in these forward-looking statements, as well
as risks relating to our business in general, see our Annual Report
on Form 10-K filed with the U.S. Securities and Exchange Commission
(SEC) on March 30, 2016 and our Quarterly Report on Form 10-Q,
filed with the SEC on August 15, 2016.
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version on businesswire.com: http://www.businesswire.com/news/home/20160920006814/en/
InvestorsThe Trout GroupPete Rahmer,
646-378-2973prahmer@troutgroup.comorMediaBMC
CommunicationsAmy Bonanno,
646-513-3117abonanno@bmccommunications.com
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