DiaMedica Therapeutics Announces Ethics Committee Clearance at First Site to Initiate REMEDY Phase 2 Trial for Acute Ischemic...
November 22 2017 - 7:00AM
DiaMedica Therapeutics Inc. (the
“
Company”) (TSX Venture:DMA)
(OTCQB:DMCAF), announced it has received ethics committee approval
to initiate the first clinical site for its Phase 2 REMEDY clinical
trial with DM199 (recombinant human KLK1).
REMEDY is a multi-center, double-blind,
randomized, placebo-controlled Phase 2 clinical trial investigating
DM199 treatment in patients who have suffered a moderate to
moderately severe acute ischemic stroke. The trial is scheduled to
enroll approximately 60 patients with acute ischemic stroke who
will be randomized to receive either DM199 or placebo. The study
drug (DM199 or placebo) will be administered as an intravenous
infusion (within 24 hours of stroke symptom onset) followed by
subcutaneous injections for 21 days. The primary end points will be
safety and tolerability. Secondary endpoints will consist of
monitoring drug exposure, along with multiple tests designed to
investigate DM199’s therapeutic potential including plasma-based
biomarkers and standard functional stroke measures assessed at 90
days post-stroke.
"The Australian Human Research Ethics Committee
approval represents a significant milestone for DiaMedica," stated
Todd Verdoorn, DiaMedica's Chief Scientific Officer. "Ethics
Committee approval is based on DiaMedica’s deep understanding of
DM199’s therapeutic mechanism in acute ischemic stroke and our
substantial body of work showing the safety and tolerability of
DM199. We are looking forward to working with our clinical partner,
The Royal Melbourne Hospital, and the study’s Principal
Investigator, Dr. Bruce Campbell, Head of Hyperacute Stroke in the
Department of Neurology.”
"This clinical trial will build upon our
previous clinical studies and the published efficacy of a human
urine version of the KLK1 protein that has been administered to
over 400,000 stroke patients in Asia," said Rick Pauls, President
and CEO of DiaMedica.
About Acute Ischemic
Stroke
An acute ischemic stroke is characterized by
rapid loss of brain function due to an interruption of blood supply
to the brain due to a blood clot. Affected areas of the brain
become inactive and cells eventually die causing neurological
impairment. Each year over 12 million people worldwide suffer an
acute ischemic stroke and it is the leading cause of death and
disability globally. The only approved U.S. Food and Drug
Administration (“FDA”) or European Medicines Agency (“EMA”) drug
treatment is tPA (Activase®). However, only 5-7% of acute ischemic
stroke patients are actually treated with tPA due to eligibility
and other issues.
About
DM199
DM199 is a recombinant (synthetic) human tissue
kallikrein (“KLK1”) protein to treat neurological and chronic
kidney diseases. KLK1 is a naturally occurring enzyme with a
pivotal role in the kallikrein-kinin system (KKS) that regulates
blood pressure and local blood flow which has important role for
the treatment of diseases including acute ischemic stroke and
chronic kidney disease. DiaMedica has completed five clinical
trials with DM199, including single ascending and multiple
ascending doses, studies in diabetic patients, and a Phase 1b
pharmacokinetic study to confirm dosing strategies. In addition to
a good safety and tolerability profile, DM199 showed the
anticipated activity, lowering blood pressure, over the course of
treatment in multiple clinical studies. DM199 also significantly
increased cerebral blood flow in a preclinical rat study.
In the recently completed Phase Ib
pharmacokinetic study, DiaMedica identified intravenous and
subcutaneous dose levels of DM199 that produces sustained plasma
levels known to be therapeutic in stroke patients. This profile
should allow DM199 to be safely and conveniently administered to
stroke patients during their initial hospitalization and after they
are sent home. The sustained plasma exposure of DM199 should
provide continuous enzyme replacement therapy to optimally benefit
patients and is potentially superior to the urinary form of KLK1,
Kailikang®, a prescription drug approved in China for acute
ischemic stroke.
About DiaMedica Therapeutics
Inc.
DiaMedica Therapeutics is a clinical stage
biopharmaceutical company focused on developing novel treatments
for neurological and kidney diseases. DiaMedica’s shares are listed
on the TSX Venture Exchange under the trading symbol “DMA” and on
the OTCQB under the trading symbol “DMCAF”. For more information,
please visit www.diamedica.com.
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For further
information:Paul Papi Vice President of Business
Development 2 Carlson Parkway, Suite 260 Minneapolis, MN 55447
(617) 899-5941 info@diamedica.com
FORWARD-LOOKING
STATEMENTS
The statements made in this press release that
are not historical facts contain forward-looking information that
involves risk and uncertainties. All statements, other than
statements of historical facts, which address DiaMedica’s
expectations, should be considered forward-looking statements. Such
statements are based on management’s exercise of business judgment
as well as assumptions made by and information currently available
to management. When used in this document, the words “may”, “will”,
“anticipate”, “believe”, “estimate”, “expect”, “intend” and words
of similar import, are intended to identify any forward-looking
statements. You should not place undue reliance on these
forward-looking statements. These statements reflect a current view
of future events and are subject to certain risks and uncertainties
as contained in the DiaMedica’s filings with the Canadian
securities regulators, all of which are available on SEDAR
(www.sedar.com). Should one or
more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results could differ
materially from those anticipated in these forward-looking
statements. DiaMedica undertakes no obligation, and does not intend
to update, revise or otherwise publicly release any revisions to
these forward-looking statements to reflect events or circumstances
after the date hereof, or to reflect the occurrence of any
unanticipated events, unless required by law. Although management
believes that expectations are based on reasonable assumptions, no
assurance can be given that these expectations will
materialize.
Neither the TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of the contents of this press release.
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