DiaMedica Therapeutics Announces Publication of a Paper, “Human Tissue Kallikrein in the Treatment of Acute Ischemic Stroke...
January 22 2019 - 6:45AM
DiaMedica Therapeutics Inc. (NASDAQ:DMAC) announces the publication
of a paper titled “Human Tissue Kallikrein In The Treatment
Of Acute Ischemic Stroke” in the peer reviewed journal, Therapeutic
Advances in Neurological Disorders (“TAND”). The paper summarizes
the mechanistic rationale for using KLK1 to treat patients with
acute ischemic stroke (“AIS”) and summarizes human preclinical and
clinical data supporting the hypothesis that KLK1 treatments may
improve outcomes after AIS.
AIS remains a major cause of death and disability
throughout the world. The treatment strategies currently available
in Western countries for large vessel occlusion involve critical
restoration of blood flow through rapid removal of the offending
blood clot using mechanical or pharmacological means (e.g. tissue
plasma activator or tPA). The paper reviews the prospects for a
novel pharmacological approach to enhance the availability of the
natural protein, tissue kallikrein (“KLK1”), an important regulator
of local blood flow.
KLK1, is a serine protease that plays a critical
role in the regulation of microcirculation, blood pressure and
blood flow. Multiple lines of evidence indicate that KLK1 is
important for a healthy cardiovascular system and that deficits in
KLK1 are associated with cardiovascular and end-organ pathology.
Importantly, KLK1 replenishment therapy is widely used in
Asia where multiple forms are used to treat diseases ranging from
AIS to complications of diabetes (retinopathy and kidney disease).
These diseases involve poor microcirculation or tissue ischemia,
which leads to a hypothesis that directly boosting KLK1 levels will
improve blood flow and protect tissue under ischemic
conditions.
The TAND paper reviews the scientific literature
covering the biochemical role of KLK1 and presents the mechanistic
rationale for using KLK1 as an additional pharmacological treatment
for AIS. In addition to the biochemical mechanism of KLK1, the
review highlights supporting results from human genetics and
preclinical animal models of brain ischemia. It also reviews
published clinical results for treatment of AIS by a form of KLK1
that is isolated from human urine. This form has been approved for
post-infarct treatment of AIS in the People’s Republic of China and
data has been published on clinical trials involving over 4,000
patients. The paper offers a series of testable therapeutic
hypotheses for demonstrating the long-term beneficial effect of
KLK1 treatment in AIS patients and the reasons for this action.
“DiaMedica is committed to providing helpful
information to healthcare professionals and their patients
regarding novel, experimental treatment strategies that may improve
microvascular circulation and stroke. This paper, which reviews the
published information about KLK1 and AIS, further supports the
rationale for our ongoing Phase II REMEDY Clinical Trial.” said
co-author Todd Verdoorn, PhD., Chief Scientific Officer, DiaMedica
Therapeutics.
About DM199
DM199 is a recombinant form of human tissue
kallikrein-1 (“KLK1”). KLK1 is an endogenous serine protease
(protein) produced in the kidneys, pancreas and salivary glands,
which plays a critical role in the regulation of local blood flow
and vasodilation (the widening of blood vessels which decreases
blood pressure) in the body, as well as an important role in
managing inflammation and oxidative stress (an imbalance between
potentially damaging reactive oxygen species, or free radicals, and
antioxidants in your body). KLK1 deficiency may play a role in
multiple vascular and fibrotic diseases such as chronic kidney
disease, retinopathy, stroke, vascular dementia and resistant
hypertension where current treatment options are limited or
ineffective. DiaMedica is the first company to have developed a
pharmacologically active recombinant form of the KLK1 protein. The
KLK1 proteins, produced from porcine (pig) pancreas and human
urine, have been used to treat patients in Japan, China and
Korea.
About REMEDY Phase II AIS
Study
In February 2018, we initiated treatment on the
first patient in our Phase II REMEDY trial assessing the safety,
tolerability and markers of therapeutic efficacy of DM199 in
patients suffering from AIS. Our REMEDY trial is expected to
enroll up to 100 patients to evaluate DM199 in patients with
AIS. The study drug (DM199 or placebo) will be administered
as an intravenous (“IV”) infusion within 24 hours of stroke symptom
onset, followed by SC injections on day 1 and every 3 days for 21
days. The study is designed to measure safety and
tolerability 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. Standard functional stroke measurements include
the Modified Rankin Scale, National Institutes of Health Stroke
Scale, the Barthel Index and C-reactive protein, a measure of
inflammation.
About DiaMedica Therapeutics
Inc.
DiaMedica Therapeutics Inc. is a clinical stage
biopharmaceutical company focused on developing novel treatments
for neurological and kidney diseases. DiaMedica’s common shares are
listed on The Nasdaq Capital Market under the trading symbol
“DMAC.”
For more information, please visit
www.diamedica.com, or follow us on Twitter
(https://twitter.com/diamedica). To be added to the Company’s email
list and receive news directly, please visit
https://ir.diamedica.com/email-alerts.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 and forward-looking information that
are based on the beliefs of management and reflect management’s
current expectations. When used in this press release, the words
“estimate”, “believe”, “anticipate”, “intend”, “expect”, “plan”,
“will,” “may” or “should”, the negative of these words or such
variations thereon or comparable terminology and the use of future
dates are intended to identify forward-looking statements and
information. The forward-looking statements and information in this
press release include statements regarding the expectation that
KLK1 may improve outcomes after AIS. Such statements and
information reflect management’s current view and DiaMedica
undertakes no obligation to update or revise any of these
statements or information. By their nature, forward-looking
statements involve known and unknown risks, uncertainties and other
factors which may cause our actual results, performance or
achievements, or other future events, to be materially different
from any future results, performance or achievements expressed or
implied by such forward-looking statements. Applicable risks and
uncertainties include, among others, DiaMedica’s plans to develop,
obtain regulatory approval for and commercialize its DM199 product
candidate for the treatment of CKD and its expectations regarding
the benefits of DM199; DiaMedica’s ability to conduct successful
clinical testing of DM199 for CKD; the perceived benefits of DM199
over existing treatment options for CKD; ability to obtain required
regulatory approvals of DM199 for CKD; the potential size of the
markets for DM199 and its ability to serve those markets; the
success, cost and timing of planned clinical trials, as well as
reliance on collaboration with third parties to conduct clinical
trials; its ability to obtain funding for its operations, including
funding necessary to complete planned clinical trials and obtain
regulatory approvals for DM199 for CKD, and the risks identified
under the heading “Risk Factors” in DiaMedica’s final prospectus
filed with the U.S. Securities and Exchange Commission (“SEC”)
pursuant to Rule 424(b) promulgated under the U.S. Securities Act
of 1933, as amended, dated December 10, 2018, in connection with
DiaMedica’s Registration Statement on Form S-1, as amended, and
subsequent SEC filings by DiaMedica. The forward-looking
information contained in this press release represents the
expectations of DiaMedica as of the date of this press release and,
accordingly, is subject to change after such date. Readers should
not place undue importance on forward-looking information and
should not rely upon this information as of any other date. While
DiaMedica may elect to, it does not undertake to update this
information at any particular time except as required in accordance
with applicable laws.
IR contact:Paul Papi Vice
President of Business Development DiaMedica Therapeutics Inc. Two
Carlson Parkway, Suite 260 Minneapolis, MN Phone: (617) 899-5941
info@diamedica.com
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