DiaMedica Announces Last Patient Out for DM-83 Phase II Human Clinical Trial
May 26 2008 - 9:04AM
Marketwired
WINNIPEG, MANITOBA , a drug discovery and development company
focused on novel treatments for Type 2 diabetes, today announces
last patient out in the phase II proof of concept clinical trial of
DM-83.
Mr. Rick Pauls, DiaMedica's President and CEO, said that the
study will evaluate DM-83s effectiveness at controlling blood sugar
levels in type 2 diabetics after consuming a meal. The twenty
patient trial will measure both changes in insulin and glucose as
the study's primary endpoints with final results to be analyzed and
released by early Q3.
"Patients will compare the effects of DM-83 to a placebo in this
cross over study" stated Mr. Pauls. "In this regard, each
individual will serve as their own control and therefore we will
have a better idea as to how well DM-83 is able to manage a Type 2
diabetic's blood sugar and insulin levels in the post prandial
state."
The inability to use insulin produced by the pancreas is a
significant problem for people who suffer from Type 2 diabetes.
This is demonstrated by the fact that many Type 2 diabetics have
high levels of both glucose and insulin circulating in their
bloodstream. DiaMedica believes that restoring insulin sensitivity
and allowing the body to use its own naturally produced insulin is
the key to combating this illness. Preclinical animal studies have
demonstrated that DM-83 is able to restore insulin sensitivity to
near prediabetic levels and has been shown to be very safe.
Diabetes is a widespread and rapidly growing disease, affecting
over 180 million people world wide with over 90% of the diabetics
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 million. Global sales of oral diabetes drugs total $6
billion and are expected to double within the next three years.
About DM-83
DM-83 has demonstrated the ability to restore insulin
sensitivity in a type 2 diabetes animal model. The product is a
novel combination of two known compounds with well established
safety profiles that are used to treat other unrelated human
conditions, one of which is used to improve cardiovascular
conditions. Neither compound is able to restore insulin sensitivity
on its own while combining the two results in a synergistic effect
that restores insulin sensitivity to prediabetic levels.
About DiaMedica
DiaMedica is developing novel treatments for various stages of
type 2 diabetes. The Company recently completed a successful phase
IIa clinical trial with its lead product DM-71 which demonstrated
the ability to reduce HbA1c levels and weight in man. The Company
has two other drugs in its clinical pipeline, DM-83 and DM-99. The
Company believes that a dysfunctional parasympathetic nerve signal
to the liver is a key factor in the development of type 2
diabetes.
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
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