DiaMedica Completes Phase 1 Clinical Trial and Initiates Phase 2 Clinical Trial of DM199 in Type 2 Diabetic Patients
January 09 2014 - 7:30AM
Marketwired
DiaMedica Completes Phase 1 Clinical Trial and Initiates Phase 2
Clinical Trial of DM199 in Type 2 Diabetic Patients
Highlights
-- Successfully completes Phase 1 clinical studies
-- Initiated dosing of first Type 2 diabetic patients in chronic
Phase 2 study
MINNEAPOLIS, MINNESOTA--(Marketwired - Jan 9, 2014) - DiaMedica
(TSX-VENTURE:DMA), a clinical stage biopharmaceutical company
announced today it has met the primary endpoints of safety and
tolerability from the recently completed 16-day Phase 1 multiple
ascending dose (MAD) of DM199 in healthy volunteers. DiaMedica has
also initiated dosing of the first Type 2 diabetic patients in a
one-month DM199 Phase 2 clinical trial. DM199 is a recombinant
human tissue kallikrein-1 (rhKLK-1) protein and a novel treatment
for diabetes and its complications by targeting the
Kallikrein-Kinin System.
"We are very pleased to have completed our 16 day Phase 1 study
and have the first patients started on treatment in our chronic
Phase 2 clinical program of DM199 in Type 2 diabetic patients,"
stated Rick Pauls, Chairman & CEO for DiaMedica. "DM199 is
based on a naturally occurring protein and has the potential to
treat Type 2 diabetes, control blood pressure and improve kidney
function."
In the recently completed Phase 1 MAD clinical trial of 18
healthy volunteers, DM199 was well-tolerated at all three dose
levels and met the primary endpoints of safety and tolerability.
DM199 also demonstrated a favorable pharmacokinetic profile
supporting the potential for weekly dosing.
Based on the Phase 1 clinical results, DiaMedica has initiated a
Phase 2 clinical study in patients with Type 2 diabetes to evaluate
the safety, tolerability and pharmacokinetics of two dose levels of
DM199 and its effects on diabetes biomarkers including: HOMA2-IR,
fasting glucose and plasma insulin, meal tolerance test, lipids,
HbA1c and other metabolic markers. The one-month, randomized,
double-blinded, placebo-controlled study is expected to enroll 36
patients with Type 2 diabetes. The patients will start with a
one-month wash out of their diabetes mediations and then be
sequestered for the one-month study.
About DiaMedica
DiaMedica Inc. is a publicly traded (TSX-VENTURE:DMA) clinical
stage biopharmaceutical company focused on the discovery and
development of novel therapies to treat diabetes and the
complications associated with diabetes. DiaMedica's lead clinical
stage compound, DM199, is a recombinant human protein known as
rhKLK1 that represents a novel approach to treating diabetes and
associated complications. DiaMedica is also developing a novel
monoclonal antibody, DM204 for the treatment of Type 2 diabetes,
which is in preclinical development.
The Company is listed on the TSX Venture Exchange in Canada
under the trading symbol 'DMA'.
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 Corporation's filings with Canadian securities
regulatory authorities. 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. The Corporation
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.
Although management believes that expectations are based on
reasonable assumptions, no assurance can be given that these
expectations will materialize.
DiaMedica Inc.Rick PaulsChairman &
CEO763-710-4455info@diamedica.comwww.diamedica.com
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