Sioux Falls, South Dakota – The Sanford Project & DiaMedica announced 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.
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DM-99, the first generation DiaMedica drug that has been replaced by the advanced DM-199 was shown to increase insulin producing beta cell proliferation by 1,277% resulting in a 300% increase in pancreas insulin levels and a 68%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.
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.
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
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”.
For more information, please contact:
President & CEO
firstname.lastname@example.org ? ?
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.