DiaMedica Announces Topline Results From DM-99 Phase IIa Study in Type 2 Diabetes
March 31 2009 - 9:15AM
Marketwired
DiaMedica Inc. (TSX VENTURE: DMA), a drug discovery and development
company focused on novel treatments for Type 2 diabetes today is
pleased to announce results of a proof-of-concept phase IIa trial
for DM-99, the company's third drug in clinical development.
The single dose, placebo controlled, single-blind, crossover
trial studying 40 patients with type 2 diabetes examined the effect
of DM-99 or placebo treatment on plasma glucose and insulin levels
after a meal tolerance test. Those patients receiving oral
anti-diabetes medications used to stabilize glucose levels
continued treatment during the study. During statistical analysis a
sequence effect between period 1 and period 2 was observed in this
crossover study leaving overall results inconclusive. The
underlying cause of this effect is under investigation. Consistent
with standard crossover study design upon detection of a sequence
effect, the statistical analysis plan was predefined to revert to
period 1 results where 20 subjects receiving DM-99 and 20 subjects
receiving placebo were both trial and treatment naive.
The trial was powered to demonstrate a therapeutically
significant effect defined as a p less than 0.2 with an absolute
decrease of at least 10% in glucose and/or insulin. Patients
receiving DM-99 in Period 1 showed a decrease in baseline adjusted
peak blood glucose concentration of 19% (p equals 0.077) versus
those receiving placebo. Patients receiving DM-99 in Period 1
showed a decrease in incremental glucose Area Under the Curve (AUC)
0-240 minutes of 31% (p equals 0.030) versus those receiving
placebo. DM-99 was safe and well tolerated with only one report of
mild nausea that was considered unlikely related to treatment.
"We are encouraged by the result from this exploratory clinical
study along with the results of prior DM-99 pre-clinical data. Our
goal was to see a positive trend indicated by changes in blood
glucose in type 2 diabetes patients after they have consumed a
meal", stated Reggie Bowerman, President & CEO, DiaMedica Inc.
"We believe the results from this proof-of-concept trial support
our continued development of the DM-99 program."
About DiaMedica
DiaMedica is developing novel treatments for type 2 diabetes
based on a newly discovered 'nerve reflex' mechanism for which the
Company has been issued two U.S. patents. DiaMedica completed a
successful phase II trial with its lead product, DM-71, which
demonstrated the ability to reduce HbA1c (blood sugar) levels and
weight in humans. DiaMedica also completed a successful phase II
trial with its second compound, DM-83, designed to measure changes
in insulin and glucose. The success of this clinical trial was
highly significant as DiaMedica believes it validates the novel
'nerve reflex' mechanism that would designate the Company's drugs
as first-in-class. Preclinical results from Vanderbilt University
have shown that DM-99 is able to cause tissue to increase its
uptake of glucose from the blood by over 40% (p less than 0.001)
during the first 60 minutes of treatment. DiaMedica has been
recognized as one of the Top Ten(TM) Life Science companies in
Canada for the past two years by the Ottawa Centre for Research and
Innovation.
Caution Regarding Forward-Looking Information
Certain statements contained in this press release constitute
forward-looking information within the meaning of applicable
Canadian provincial securities legislation (collectively,
"forward-looking statements"). These forward-looking statements
relate to, among other things, our objectives, goals, targets,
strategies, intentions, plans, beliefs, estimates and outlook,
including, without limitation, our anticipated future operating
results, and can, in some cases, be identified by the use of words
such as "believe," "anticipate," "expect," "intend," "plan,"
"will," "may" and other similar expressions. In addition, any
statements that refer to expectations, projections or other
characterizations of future events or circumstances are
forward-looking statements.
These statements reflect management's current beliefs and are
based on information currently available to management. Certain
material factors or assumptions are applied in making
forward-looking statements, and actual results may differ
materially from those expressed or implied in such statements.
Important factors that could cause actual results to differ
materially from these expectations include, among other things:
DiaMedica's early stage of development, lack of product revenues
and history of operating losses, uncertainties related to clinical
trials and product development, rapid technological change,
uncertainties related to forecasts, competition, potential product
liability, additional financing requirements and access to capital,
unproven markets, supply of raw materials, income tax matters,
management of growth, partnerships for development and
commercialization of technology, effects of insurers' willingness
to pay for products, system failures, dependence on key personnel,
foreign currency risk, risks related to regulatory matters and
risks related to intellectual property and other risks detailed
from time to time in DiaMedica's filings with Canadian securities
regulatory authorities, as well as DiaMedica's ability to
anticipate and manage the risks associated with the foregoing.
Additional information about these factors and about the material
factors or assumptions underlying such forward-looking statements
may be found in the body of this news release, as well as under the
heading "Risk Factors" contained in DiaMedica's final long-form
prospectus dated March 12, 2007. DiaMedica cautions that the
foregoing list of important factors that may affect future results
is not exhaustive. When relying on DiaMedica's forward-looking
statements to make decisions with respect to DiaMedica, investors
and others should carefully consider the foregoing factors and
other uncertainties and potential events.
These risks and uncertainties should be considered carefully and
prospective investors should not place undue reliance on the
forward-looking statements. Although the forward-looking statements
contained in this press release are based upon what management
believes to be reasonable assumptions, DiaMedica cannot provide
assurance that actual results will be consistent with these
forward-looking statements. DiaMedica undertakes no obligation to
update or revise any forward-looking statement.
The TSX Venture Exchange does not accept responsibility for the
adequacy or accuracy of this release.
Contacts: DiaMedica Inc. Kevin Richardson, Ph.D. 204.478.5605
204.453.3745 (FAX) krichardson@diamedica.com
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