REPEAT: The Sanford Project & DiaMedica Announce Successful Type 1 Diabetes NOD Mouse Study with DM-199
12 May 2011 - 5:10AM
Marketwired
The Sanford Project & DiaMedica (TSX VENTURE: DMA) today
announce the successful completion of a study involving DM-199 in
preventing the onset of Type 1 diabetes in the non-obese diabetic
(NOD) mouse model. With these latest results, DiaMedica's DM-199
program has now demonstrated efficacy in three critical areas of
Type 1 diabetes treatment consisting of immune therapy, beta cell
therapy, and glucose control.
Immune Therapy
DM-199 administration to NOD mice, the gold standard animal
model for Type 1 diabetes, appeared to prevent the autoimmune
attack and thereby the destruction of insulin-producing beta cells
in the pancreas which causes Type 1 diabetes. Under the direction
of Dr. Alexei Savinov, Associate Scientist at The Sanford Project,
DM-199 showed a significant dose-dependent and dose-frequency
dependent delay in the onset of Type 1 diabetes over the 18-week
course of treatment (beginning at 6 weeks of age). The Sanford
Project and DiaMedica intend to publish the results of this study
together in a peer-reviewed publication.
"The results of this study are extremely exciting and suggest
that DM-199 has the potential to become a very promising treatment
for Type 1 diabetics," said Dr. Alexei Savinov.
"Modulating the auto-immune response and stimulating beta cell
regeneration are key strategies in developing novel therapies and
cures for type 1 diabetes " stated Dr. Paul Burn, the Broin Chair
& Director of The Sanford Project and Professor, Department of
Pediatrics at the Sanford School of Medicine, previously Senior
Vice President of Research & Development at the Juvenile
Diabetes Research Foundation, Global Head of Metabolic Diseases at
Hoffman-La Roche, Director of Research at Bayer Pharmaceutical, and
former Director of Endocrinology at Eli Lilly. "DM-199 has now
demonstrated its benefits in mouse models of type 1 diabetes.
Clinical trials exploring the potential of DM-199 in human settings
are the logical next step. We look forward to continue working with
DiaMedica towards this goal."
In addition to its immuno-modulating activity in NOD mice,
DiaMedica has tested DM-199 in other animal models and demonstrated
it also possess beta cell proliferative activity as well as
improved glucose control.
Beta Cell Therapy
DM-99, the first generation DiaMedica drug that has been
replaced by the advanced DM-199 was shown to increase insulin
producing beta cell proliferation by 1,277% resulting in a 300%
increase in pancreas insulin levels and a 68% (p=0.05) reduction in
fasting blood sugar after three weeks of treatment compared to
untreated animals. In the previously reported study, animals were
injected with streptozotocin, a naturally occurring compound known
to be toxic to beta cells, in order to mimic Type 1 diabetes with
an insult to the beta cells.
Beta cell therapy aims to restore the body's ability to make
insulin by proliferating new insulin producing beta cells in the
pancreas.
Glucose Control
DM-199 improved whole body glucose uptake in a previously
reported hyperinsulinemic euglycemic clamp model. Animals treated
with a single dose of DM-199 had up to 160% increase in maximal
glucose infusion rate.
Human Data
In a Phase II human proof-of-concept study with the first
generation of DM-199, DM-99, diabetics demonstrated an ability to
process 31-48% more glucose following a meal compared to patients
not on treatment.
Glucose control is the ability to maintain normal blood glucose
levels (euglycemia) and prevent high blood sugar (hyperglycemia)
thereby reducing the risk of complications from diabetes when blood
glucose is not properly controlled.
"We are very pleased with the results from the collaboration
with The Sanford Project," stated Rick Pauls, President and Chief
Executive Officer of DiaMedica. "These current NOD mouse results
are pivotal as they confirm that DM-199 addresses the main concerns
of Type 1 diabetes. We look forward to moving ahead with DM-199 and
our ongoing collaboration with The Sanford Project."
About The Sanford Project
The Sanford Project is one of the four initiatives made possible
through Denny Sanford's transformational gift to Sanford Health in
2007. From its inception, The Sanford Project was "designed for
results." Sanford Health will combine clinical components of
patient care and science into one of the most promising and
fast-moving fields of research; regenerative medicine. Their goal
is to research and cure Type 1 diabetes, all in pursuit of a
healthy future for our children. For further information please
visit www.sanfordproject.org
About DiaMedica
DiaMedica is a biopharmaceutical company that develops novel
therapeutic products designed to improve the lives of people with
Type 1 diabetes, Type 2 diabetes and other large, medically unmet
diseases. DiaMedica's lead product candidate, DM-199, has been
shown to protect and proliferate beta cells and significantly
improve glucose metabolism in pre-clinical models.
The Company is listed on the TSX Venture Exchange under the
trading symbol "DMA".
FORWARD-LOOKING STATEMENTS
The statements made in this press release that are not
historical facts contain forward-looking information that involves
risk and uncertainties. All statements, other than statements of
historical facts, which address DiaMedica's expectations, should be
considered forward-looking statements. Such statements are based on
management's exercise of business judgment as well as assumptions
made by and information currently available to management. When
used in this document, the words "may", "will", "anticipate",
"believe", "estimate", "expect", "intend" and words of similar
import, are intended to identify any forward-looking statements.
You should not place undue reliance on these forward-looking
statements. These statements reflect a current view of future
events and are subject to certain risks and uncertainties as
contained in the Corporation's filings with Canadian securities
regulatory authorities. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results could differ materially from those
anticipated in these forward-looking statements. The Corporation
undertakes no obligation, and does not intend, to update, revise or
otherwise publicly release any revisions to these forward-looking
statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of any unanticipated events.
Although management believes that expectations are based on
reasonable assumptions, no assurance can be given that these
expectations will materialize.
Contacts: Sanford Health Media Stacy Jones Strategy Manager
605-328-7056 Stacy.jones@sanfordhealth.org DiaMedica Inc. Rick
Pauls President & CEO 204.477.7590 rpauls@diamedica.com
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