DiaMedica Cleared to Initiate Its Second Phase II Clinical Trial of DM-71 in Patients With Type 2 Diabetes
January 15 2009 - 9:20AM
Marketwired
DiaMedica Inc. (TSX VENTURE: DMA), a drug discovery and clinical
development company focused on a novel approach to treating type 2
diabetes, today announced that it has received a No Objection
Letter from Health Canada to initiate the second planned Phase II
clinical trial investigating DM-71 in patients with type 2
diabetes. In the first Phase II trial, DM-71 showed statistically
significant declines in HbA1c, fructosamine and weight with an
excellent safety profile in humans.
This second trial is a randomized, cross-over, open-label study
to test the effect of DM-71 on two metabolic markers, glucose and
insulin, in a meal tolerance test and will enroll approximately 40
patients in Canada who have been diagnosed with type 2 diabetes.
The entire study is expected to take approximately 16 weeks from
enrollment of entry of first subject until last subject out
following which data on the two primary endpoints will be
reported.
"This trial is in follow-up to the positive phase II study that
demonstrated the ability of DM-71 to reduce HbA1c levels in
humans," stated Dr. Wayne Lautt, co-founder of DiaMedica. "A single
dose of Bethanechol and NAC was taken together one hour prior to a
meal in the previous phase II proof-of-concept study. The upcoming
phase II trial will include multiple doses and measure the efficacy
of DM-71 when taken with a meal."
"Preclinical data has shown that DM-71 works equally well,
whether taken one hour or just before a meal. This trial is
designed to confirm our preclinical findings in a human population,
allowing us the opportunity to improve compliance and optimizing
dosing in upcoming pivotal trials with the expectation of improving
efficacy." stated Rick Pauls, President and CEO of DiaMedica.
Diabetes is a widespread and rapidly growing disease, affecting
over 180 million people world wide. Over 90% of people with
diabetes are 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-71
DM-71 is an oral combination of Bethanechol and N-Acetylcysteine
(NAC). Bethanechol is a muscarinic agonist which is structurally
and pharmacologically related to the endogenous cholinergic
agonist, acetylcholine. It acts on the parasympathetic nervous
system and has been used for over 60 years as a treatment of acute
postoperative and postpartum non-obstructive urinary retention. NAC
is a readily available over the counter naturally occurring
metabolite of the amino acid L-cysteine. It is converted in the
body into metabolites capable of stimulating glutathione synthesis,
promoting detoxification and acting directly as free radical
scavengers. It was introduced over 50 years ago as a mucolytic
agent for chronic pulmonary diseases and has been used extensively
to treat acetaminophen (aspirin) poisoning. Loss of insulin
sensitivity is the hallmark of type 2 diabetes. Preclinical studies
have shown that NAC has no effect at restoring insulin sensitivity
while Bethanechol is able to restore it to about 40% of control
levels. However, when used in combination, these two compounds have
a unique synergistic effect that restores insulin sensitivity to
90% of control levels. DiaMedica has been issued two US patents for
DM-71, due to its novel mechanism of action, which may designate
this drug as first-in-class. Results from a phase IIa
proof-of-concept trial revealed that DM-71 is effective at reducing
HbA1c by 0.55% over 12 weeks in patients whose diabetes was
considered moderate to severe (greater than 8.0% HbA1c). The entire
population had statistically significant weight loss over this 12
the same week period (3 pounds; p=0.0005) with a 10-fold decrease
in fructosamine levels when compared to placebo. This decrease in
fructosamine suggests that a longer treatment period should produce
a greater decrease in HbA1c.
About DiaMedica
DiaMedica is developing novel treatments for type 2 diabetes
based on a newly discovered 'nerve reflex' mechanism for which the
Company has been issued two U.S. patents. DiaMedica completed a
successful phase II trial with its lead product, DM-71, which
demonstrated the ability to reduce HbA1c (blood sugar) levels and
weight in humans. DiaMedica also completed a successful phase II
trial with its second compound, DM-83, designed to measure changes
in insulin and glucose. The success of this clinical trial was
highly significant as DiaMedica believes it validates the novel
'nerve reflex' mechanism that would designate the Company's drugs
as first-in-class. The Company's third drug in clinical
development, DM-99, will complete a phase II trial in Q1 2009.
Preclinical results from Vanderbilt University have shown that
DM-99 is able to cause tissue to increase its uptake of sugar from
the blood by over 40% (p less than 0.001) during the first 60
minutes of treatment. DM-199, a 40x more biologically active
version of DM-99, has been created with the expectation that it
will be developed into a once-a-week injection. DiaMedica has been
recognized as one of the Top Ten(TM) Life Science companies in
Canada for the past two years by the Ottawa Centre for Research and
Innovation.
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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