DiaMedica Announces First Enrollment in its PHASE 2 “REMEDY” TRIAL for Acute Ischemic Stroke
22 February 2018 - 11:00PM
DiaMedica Therapeutics Inc.
(“
DiaMedica”) (TSX VENTURE:DMA)
(OTCQB:DMCAF), a clinical stage biopharmaceutical company focused
on improving lives of patients with neurological and kidney
diseases associated with low KLK1 levels, announces the first
patient enrollment in its Phase 2 REMEDY trial assessing the
safety, tolerability and markers of therapeutic efficacy of DM199
(recombinant human KLK1) in patients suffering from acute ischemic
stroke at the Royal Melbourne Hospital, Melbourne Australia.
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 will enroll
approximately 60 patients who will be randomized to receive either
DM199 or placebo. The study drug (DM199 or placebo) is administered
as an intravenous infusion within 24 hours of stroke symptom onset
followed by subcutaneous injections every three days for a period
of three weeks. Primary endpoints include safety and tolerability.
Secondary endpoints consist of the standard functional stroke
scales (NIHSS, Modified Rankin Scale and Barthel Index), the plasma
concentration of DM199 and multiple tests designed to investigate
DM199’s therapeutic potential based upon standard plasma-based
biomarkers, such as inflammation.
The Principal Investigator of the study is Bruce
Campbell, MD, MBBS(Hons) BMedSc PhD, FRACP, a neurologist and Head
of Hyperacute Stroke in the Department of Neurology, Royal
Melbourne Hospital. Dr. Campbell commented, “I look forward to the
outcome of the trial in the potential advancement of treatment
options for patients with ischemic stroke.”
Mr. Rick Pauls, President and CEO of DiaMedica,
stated, “We look forward to working with Dr. Campbell and all site
investigators as we enter the enrollment phase of the REMEDY
trial.” Mr. Pauls further commented, “In addition to the Royal
Melbourne site we expect to have additional centers enrolling
patients in the very near future.”
The design of the REMEDY trial builds upon the
recently completed Phase 1b pharmacokinetic study in which
DiaMedica identified a DM199 dosing strategy that restored
deficient KLK1 levels and demonstrated a pharmacokinetic profile
superior to the Chinese approved Kailikang® product. DiaMedica
estimates that over 50,000 stroke patients annually are prescribed
Kailikang despite its known deficiencies in formulation and the
challenges of its human urine sourcing.
About
KLK1:
DM199 is a recombinant (synthetic) form of human
tissue kallikrein ("KLK1"), a protein currently used to treat
neurological and kidney diseases. Dr. Todd Verdoorn, Chief
Scientific Officer of DiaMedica stated, “DM199 activates molecular
pathways that improve vasodilation, angiogenesis and blood flow.
KLK1 also reduces fibrosis, inflammation and oxidative stress to
protect brain tissue from damage caused by stroke and is expected
to promote faster, more complete recovery of function for stroke
patients.” Dr. Verdoorn further commented, “DM199 represents a
novel, breakthrough treatment strategy for acute ischemic stroke.
Together with an excellent safety profile, the short and long-term
actions of DM199 on blood flow and neuronal health could markedly
enhance recovery and improve the quality of life for patients
suffering from stroke.”
About 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. Currently, the only approved drug treatment in
the United States and Europe is tPA (Activase®). However, only 5-7%
of acute ischemic stroke patients are actually treated with tPA due
to eligibility, its short treatment window and other issues.
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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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 fact, 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.
DiaMedica Therapeutics Inc.
For further information, please contact:Paul
PapiVice President of Business DevelopmentDiaMedica Therapeutics
Inc.Two Carlson Parkway, Suite 260Minneapolis, MNPhone: (617)
899-5941info@diamedica.com
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