DiaMedica Receives Regulatory Clearance for Phase II Human Study of DM-99
05 March 2008 - 1:42AM
Marketwired
WINNIPEG, MANITOBA , a drug discovery and development company
focused on novel treatments for type 2 diabetes is pleased to
announce that it has received regulatory clearance in the European
Union to conduct a Phase II human study with DM-99 in type 2
diabetes patients.
Dr. Karl-Gunnar Hidinger, DiaMedica's President said that the
decision to advance DM-99 into clinical studies was supported by
very encouraging preclinical data, reported on February 11th, from
the Wasserman Laboratory at the Diabetes Research and Training
Center at Vanderbilt University in Nashville, Tennessee. Dr.
Hidinger said that he expects the study to be completed in
2008.
"This will be a double-blind crossover study in 20 diabetic
patients that will measure the change in glucose and insulin levels
after a meal. In this manner the variability between patients is
minimized because each patient crossing over between placebo and
DM-99 treatment in effect serves as its own control" stated Dr.
Hidinger. "The results of this study will give an indication as to
how well DM-99 works at controlling blood glucose levels in a type
2 diabetic population and thus guide us into the next stage of
clinical development".
"DiaMedica is poised for growth as we now have three drug
candidates with enormous market potential in clinical development,"
added Dr. Hidinger. "Our pipeline of clinical stage products has a
tremendous history of safe use in patients to compliment our
growing body of evidence of their efficacy in the significant type
2 diabetes market".
Diabetes is a widespread and rapidly growing disease, affecting
180 million people world wide, with over 90% being diagnosed as
Type 2. According to the American Diabetes Association, the total
annual economic cost of diabetes to the United States in 2007 was
estimated to be $174 billion with over 10% of health care dollars
attributed to it. Most notably, diabetes deaths are projected to
increase by over 80% in middle-upper income countries between 2006
and 2015. Global sales of oral diabetes drugs currently total $6
billion per year and are expected to climb to $11 billion per year
by 2011.
DM-99 is a biological product with a well established safety
profile being studied by DiaMedica for a novel use as a treatment
for Type 2 diabetes. The product has demonstrated the ability to
positively impact glucose metabolism in animal models.
About DiaMedica
DiaMedica is developing novel treatments for various stages of
type 2 diabetes based on evidence that a dysfunctional nerve signal
from the brain to the liver is responsible for 50-65% of total
glucose uptake by muscle. DiaMedica's technology is focused towards
restoring the function of this nerve signal and thus reversing the
progression of the disease. The Company recently completed a
successful phase IIa clinical trial with its lead product DM-71
that demonstrated the ability to reduce HbA1c levels with no
serious adverse advents. DiaMedica has two other drugs in phase II
clinical trials, DM-83 and DM-99, with results expected in each
study 2008.
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. Director,
Investor Relations (204) 478-5605 (204) 453-3745 (FAX) Email:
krichardson@diamedica.com
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