DiaMedica Announces Last Patient Out for DM-99 Phase IIa Human Clinical Trial
February 10 2009 - 9:02AM
Marketwired
DiaMedica Inc. (TSX VENTURE: DMA), a drug discovery and clinical
development company focused on a novel approach to treating type 2
diabetes, today announces last patient out in the phase IIa proof
of concept clinical trial of DM-99.
The 40 patient single-blinded clinical trial was conducted in
the European Union. It was designed to demonstrate DM-99's
effectiveness at changing blood glucose levels in patients
diagnosed with type 2 diabetes, after they consumed a standardized
meal. Change in insulin and/or blood glucose levels was the study's
primary endpoint. Each patient was tested for both the effects of
treatment with DM-99 and a placebo, and therefore served as their
own control in this cross over study.
Pre-clinical animal studies on DM-99 were performed by Dr. David
Wasserman, Professor of Molecular Physiology and Biophysics and Ron
Santo Chair in Diabetes at the Diabetes Research and Training
Center at Vanderbilt University in Nashville, Tennessee. The amount
of glucose being metabolized was measured using the
hyperinsulinemic euglycemic clamp model, the gold standard method
for quantifying insulin resistance. Specifically, healthy animals
treated with DM-99 were able to metabolize 41% more glucose than
untreated healthy animals (p less than 0.04) within the first sixty
minutes of the drug being administered. The drug was also shown to
have a very good safety profile.
"We believe that DM-99 may both insulin sensitize and hasten the
onset of insulin action", commented Mr. Reginald Bowerman,
DiaMedica's President and CEO. "We look forward to the outcome of
this phase II trial in light of the compelling pre-clinical
research results."
Diabetes is a widespread and rapidly growing disease, affecting
over 180 million people world wide with over 90% of people with
diabetes being diagnosed with the type 2 form. According to the
World Health Organization, this number is expected to double during
the next 15 years while the American Diabetes Association has
estimated the annual economic cost in 2007 to the United States to
be $174 billion with over 8% of the population having this disease.
Global sales of drugs for type 2 diabetes currently total $8
billion per year and are expected to climb to $12 billion per year
by 2011.
About DM-99
Pre-clinical results from the Diabetes Research and Training
Center at Vanderbilt University have shown that DM-99 is able to
cause tissue to increase the uptake of glucose from the blood by
over 40% (p less than 0.04) within 60 minutes of being injected.
DM-199, a 40x more biologically active version of DM-99, has been
created and will soon undergo pre-clinical testing.
About DiaMedica
DiaMedica is developing novel treatments for type 2 diabetes
based on a discovery that a dysfunctional nerve signal to the liver
is a key factor leading to insulin resistance, the hallmark of type
2 diabetes. The Company has completed a phase II proof of concept
clinical trial with its lead product, DM-71, which demonstrated the
ability to reduce HbA1c (blood sugar) levels and weight in man.
DM-71 will be entering another phase II clinical trial designed to
optimize drug dosage and improve patient compliance. The Company
has also completed a proof of concept phase II clinical trial with
DM-83 that showed a reduction in the amount of peak insulin
required to process glucose. This indicates that DM-83 may prolong
the insulin producing ability of the pancreas. DiaMedica's third
drug, DM-99, is about to complete a phase II proof of concept
clinical trial. DM-199, a 40x more biologically active version of
DM-99, has been created and will soon undergo pre-clinical
testing.
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) Email: krichardson@diamedica.com Website:
www.diamedica.com
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