DM-99 Shown to Improve Glucose Metabolism in Pre-Clinical Study, DiaMedica Seeking Regulatory Clearance for Phase II Human Trial
12 February 2008 - 1:54AM
Marketwired
WINNIPEG, MANITOBA , a clinical stage biotechnology company
developing novel treatments for various stages of type 2 diabetes,
is pleased to announce positive pre-clinical data for DM-99, its
third clinical drug candidate. Results demonstrated, with
statistical significance, greater glucose metabolism in normal
animals treated with DM-99 when compared to untreated animals.
The study was conducted in the Wasserman Laboratory at the
Diabetes Research and Training Center at Vanderbilt University in
Nashville, Tennessee. In the study, the amount of glucose being
metabolized was measured using the well established
hyperinsulinemic euglycemic clamp model. Specifically, animals
treated with DM-99 were able to use 41% more glucose than an
untreated animal (p less than 0.04) during the first sixty minutes
of the study.
"The study results suggest that DM-99 may hasten the onset of
insulin action. It is particularly significant that it does so at a
physiologically relevant insulin level, similar to concentrations
observed after a meal or after a therapeutic dose in diabetics",
commented Dr. David Wasserman, Professor and Ron Santo Chair,
Department of Molecular Physiology and Biophysics, Vanderbilt
University. "This is an important proof of principle supporting the
value of DM-99 in the treatment of diabetes."
"The treated animals displayed increased glucose utilization
when compared to control animals. These interesting results clearly
show that DM-99 is having a positive impact on glucose metabolism,
a desirable effect for diabetic patients", stated Dr. Alan
Cherrington, Professor and Turner Chair in Diabetes Research,
Department of Molecular Physiology and Biophysics, Vanderbilt
University and Past-President of the American Diabetes Association.
"Further study of DM-99 is encouraged."
"Based upon the collective results of our pre-clinical studies,
we have already initiated the regulatory clearance process for a
Phase II human study with DM-99 and expect to receive feedback in
the near term," stated Dr. Karl-Gunnar Hidinger, President of
DiaMedica Inc. "We plan to test DM-99 as a stand-alone therapy in a
meal-tolerance model. Past studies with DM-99 have demonstrated its
ability to improve the activity of GLP-1, and we believe its
performance with GLP-1, and alone, will serve to make the eventual
product even more marketable."
Diabetes is a widespread and rapidly growing disease, affecting
177 million people world wide. Over 90% of diabetics are of the
Type 2 form. Global sales of oral diabetes drugs total $6 billion
today and are expected to climb to $11 billion by 2011.
About DM-99
DM-99 has demonstrated the ability to positively impact glucose
metabolism in a type 2 diabetes animal model. The product is a
novel use of an existing product, with a well established safety
profile, used to treat an unrelated human condition.
About DiaMedica
DiaMedica is developing novel treatments for various stages of
type 2 diabetes. The Company recently completed a phase II clinical
trial with its lead product DM-71 which demonstrated the ability to
reduce HbA1c levels in man. The Company has two other drugs in its
clinical pipeline, DM-83 and DM-99, which are progressing toward
clinical studies.
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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