MINNEAPOLIS, MINNESOTA -- (Marketwired) -- 06/24/13 -- DiaMedica (TSX VENTURE: DMA), a clinical stage biopharmaceutical company, today provided an update on the ongoing clinical trial program for DM-199, its novel biopharmaceutical in clinical development for the treatment of diabetes and associated complications. The company completed the first portion of its ongoing phase I/II study of DM-199 in healthy volunteers and has now initiated dosing of DM-199 in Type 2 diabetes patients.
"Our development program is on track as we successfully completed acute escalating dosing of DM-199 at multiple levels in healthy volunteers. We are now advancing the program to evaluate the acute effects of escalating doses of DM-199 in patients with Type 2 diabetes," said Dr. Mark Robbins, Vice President of Clinical and Regulatory Affairs at DiaMedica. "Further, preliminary results from the first part of the study in 18 healthy volunteers show that DM-199 was well tolerated and demonstrated a favorable pharmacokinetic profile, supporting potential once weekly dosing."
The randomized, placebo-controlled, double-blinded study has now enrolled Type 2 diabetic patients to evaluate three well-tolerated dose levels based upon data from the first portion in healthy volunteers. This second portion of the study will evaluate acute safety, tolerability and pharmacokinetic properties for the first time in Type 2 diabetic patients, as well as the effect of DM-199 on improving glucose control.
DM-199 is a novel recombinant human protein known as tissue kallikrein-1 (rhKLK-1) and is currently in clinical development as a potential treatment for Type 1 and Type 2 diabetes and associated diabetic complications. DM-199 is believed to restore the body's regulation of four key areas disrupted in diabetes: increasing insulin sensitivity; improving insulin secretion; improving blood flow and immunomodulation. Through this natural physiological mechanism, DM-199 represents a novel approach for improving glucose control and reducing associated complications in diabetic patients.
DiaMedica Inc. is a publicly traded (TSX VENTURE: DMA) clinical stage biopharmaceutical company focused on the discovery and development of novel therapies to treat diabetes and the complications associated with diabetes. DiaMedica's lead clinical stage compound, DM-199, is a recombinant human protein that represents a novel approach to treating Type 1 and Type 2 diabetes. DiaMedica is also developing a novel monoclonal antibody, DM-204 for the treatment of Type 2 diabetes, which is in preclinical development.
The Company is listed on the TSX Venture Exchange in Canada under the trading symbol 'DMA'.
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.
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