DiaMedica Letter to Shareholders
19 January 2018 - 12:00AM
DiaMedica Therapeutics Inc. (“
DiaMedica”) (TSX
VENTURE:DMA) (OTCQB:DMCAF), provides corporate update. As we enter
into 2018, we wanted to thank you, our shareholders, for your
continued support. Looking back, 2017 was a momentous year
for DiaMedica as we advanced our deep understanding of DM199, moved
into the second phase of clinical trials and are well positioned
for a very promising 2018. We would like to review our
accomplishments and describe what lies ahead:
- DM199 phase 2 REMEDY stroke study was initiated in the fall of
2017 with patient enrollment anticipated to commence shortly.
- DM199 phase 1B bridging study for acute ischemic stroke dosing
trial with DM199 was completed. – This is an important milestone
which identified a therapeutic dose of DM199 which pharmaceutically
matches the crude form of the protein, known as Kailikang®.
Kailikang® is approved in Asia and has been used to treat
over 400,000 stroke patients. Our bridging study also identified a
subcutaneous dose of DM199 which demonstrated superior
pharmaceutical performance which is anticipated to improve
efficacy, safety and eliminate/reduce the need for daily
in-hospital infusions.
- Dr. Nancy Chang joined our strategic advisory board in April
2017. – Dr. Chang is a prominent Chinese-American who brings more
than 30 years of experience in the biopharmaceutical industry,
successfully developing and commercializing therapeutic and
diagnostic products. She is a co-founder of Tanox, Inc., a
biotechnology company known for the development of Xolaira, the
breakthrough drug which changed the treatment model for
allergy-induced asthma. Dr. Chang served as President and CEO of
Tanox until its acquisition by Genentech for US$919M and has led
development of several products that generate several billion
dollars in annual drug sales.
- Dr. Bruce Campbell of the Royal Melbourne Hospital agreed to
lead our Phase 2 REMEDY Stroke Trial as our Principal Investigator.
– Dr. Campbell is an award-winning neurologist with a pioneering
drive to improve outcomes for stroke patients and a highly regarded
neurologist throughout the world.
- The Australasian Stroke Trials Network (ASTN) announced its
support for our Phase 2 REMEDY stroke study in September 2017. –
ASTN is the key organization that promotes, facilitates and
coordinates stroke clinical trials in Australia and New Zealand.
ASTN endorses clinical trials based on protocol quality and
feasibility, assists with study site identification, facilitates
study logistics and supports patient enrollment efforts.
- We identified chronic kidney disease (CKD) caused by Type 1
diabetes as the primary indication for our first kidney disease
trial. The FDA has scheduled a face-to-face meeting with DiaMedica
in Q1 2018 to discuss our planned CKD trial and the regulatory path
forward. This meeting is intended to provide important confirmation
and/or clarification of the required clinical path for CKD to be
followed by initiation of clinical study.
- Dr. Robert Stanton joined our kidney scientific advisory board
in October 2017. – Dr. Stanton is Chief of the Kidney and
Hypertension Section at Joslin Diabetes Center/Harvard Medical
School and has an extensive and successful history of conducting
research into the abuse, complications and treatment of kidney
disease. Dr. Stanton has published two important KLK1 papers
including in September 2017, the review paper titled “The
kallikrein-kinin system in diabetic kidney disease.” Dr. Stanton is
an important addition to the scientific advisory board and we look
forward to collaborating with him and our other advisors as we
progress further into the clinical evaluation of DM199 for
CKD.
- We published the results of our DM199 Phase 1B acute ischemic
stroke study – the first of what will be several upcoming clinical
papers in peer review journals. The review paper titled “Safety,
tolerability, and pharmacokinetic profile of recombinant human
tissue kallikrein, DM199, after intravenous and subcutaneous
administration in healthy volunteers” has highlighted the lead
compound DM199.
- We attracted US$2.6M capital from a prominent US-China family
office with deep ties to scientific and pharmaceutical community
both in the US and Asian markets. We are working to leverage these
deep ties to further the financial and clinical development of
DiaMedica. We raised an additional ~US$1M in December.
For 2018, DiaMedica is well positioned to make significant
progress in the clinical development of DM199. Phase 2 clinical
development is a critical stage for our Company and, along with our
work to-date, we have significantly “de-risked” our development
approach to treat stroke and kidney patients by restoring KLK1
levels. Early in 2018 we anticipate commencing patient enrollment
in our Phase 2 clinical study for acute ischemic stroke, the REMEDY
trial. Once we complete our upcoming meeting with the U.S. FDA, we
plan to also initiate a Phase 2 clinical study of CKD in Type 1
diabetic patients. Our studies have been designed based on the
extensive use of the crude (porcine and human urine) forms of the
KLK1 protein as currently approved and used in Asia. We also intend
to validate a companion diagnostic test which we have developed to
evaluate patient’s KLK1 levels and potential suitability for
treatment with DM199. In addition, we also plan to publish addition
clinical and white papers to share our science and DM199’s clinical
results with the investment and scientific community and anticipate
additional important corporate developments.
As we look to 2018, we remain, as always, focused on the
complete patient – the whole person – and our mission to help
people lead fuller, richer, more productive lives by restoring KLK1
levels. This is a responsibility we take very seriously and
continues to drive our work.
Once again, we wish to thank all of our shareholders for their
support in 2017 and delighted to have you with us on what should be
an exciting 2018!
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. Follow us on social media –
Twitter, LinkedIn.
For further information, please 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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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.
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