DiaMedica Announces Last Patient in for DM-99 Phase II Clinical Trial
December 23 2008 - 8:00AM
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 in for the phase II proof of
concept clinical trial with DM-99, the Company's third drug
candidate to enter phase II human trials.
The single-blinded clinical trial being conducted in the
European Union will demonstrate DM-99's effectiveness at
controlling blood glucose levels in 40 patients with type 2
diabetes with HbA1c levels over 7.5%, after they have consumed a
standardized meal. Change in insulin and/or blood glucose levels in
time increments over a 4 hour period, post meal consumption, are
the study's primary endpoints. Each patient will be tested for the
effects of treatment with both DM-99 and a placebo, and will
therefore serve as their own control in this cross over study.
Results are expected in early Q1 2009.
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 which is universally
recognized as the gold standard method for measuring insulin
sensitivity. 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 an excellent safety
profile.
"The compelling pre-clinical results suggest that DM-99 may act
as both an insulin sensitizer and hasten the onset of insulin
action", commented Rick Pauls, DiaMedica's President and CEO. "In
addition, we have achieved pre-clinical results demonstrating that
DM-99 behaves synergistically with GLP-1, which may significantly
increase the value of DM-99 as GLP-1 analogs are a promising new
class of drugs for type 2 diabetes".
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 of the disease.
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. Global sales of oral diabetes
drugs total $8 billion today and are expected to climb to $12
billion by 2011.
About DM-99
DM-99 is an oral biologic compound with a well established
safety profile. Pre-clinical results from the Diabetes Research and
Training Center at Vanderbilt University have shown that DM-99 is
able to increase the uptake of glucose from the blood by over 40%
(p less than 0.04) within 60 minutes of administration.
About DiaMedica
DiaMedica is a biopharmaceutical company developing novel
treatments for type 2 diabetes. The Company has completed phase IIa
clinical trials with DM-71, which demonstrated the ability to
reduce HbA1c levels and weight in man and with DM-83, which showed
a reduction in the amount of peak insulin required to process
glucose. DiaMedica's third drug in clinical development, DM-99 will
complete a phase IIa clinical trial in Q1 2009.
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) 918-3868
(204) 453-3745 (FAX) Email: krichardson@diamedica.com Website:
www.diamedica.com
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