DiaMedica Announces Development Update

MINNEAPOLIS, MINNESOTA--(Marketwired - Jun 5, 2014) - DiaMedica Inc. (TSX-VENTURE:DMA), a clinical stage biopharmaceutical company focused on the treatment of diabetes and its complications, today provided a development update on its lead product candidates, DM199 and DM204. The Company also announced it intends to expand the testing of DM199 in diabetic kidney disease patients while also developing DMDx, a companion diagnostic for kidney disease.

"We believe there is a significant need for more effective therapies for diabetes and diabetic kidney disease, particularly as the prevalence of these diseases rises," explained Mr. Rick Pauls, President and CEO of DiaMedica. "We look forward to further advancing the development of our programs for diabetes while expanding into diabetic kidney disease and other associated diseases with DM199."

DM199 - Type 2 diabetes

DiaMedica's lead product, DM199, is a novel recombinant human tissue kallikrein-1 (rhKLK1) therapy for the treatment of diabetes (type 2 and type 1 diabetes) and its associated complications. To date, DM199 has been administered to more than 80 healthy volunteers and type 2 diabetic patients. DM199 treatment has been generally safe and well tolerated, and the pharmacokinetic profile supports infrequent administration. The Company is currently conducting a 28-day Phase 2 clinical study in 36 type 2 diabetic patients. The primary clinical endpoints are to assess the safety and tolerability of DM199 while also measuring changes in diabetes markers. Twenty-four of the 36 type 2 diabetic patients have completed the Phase 2 study. The study is expected to be fully complete this summer with results to follow in the fall of 2014.

DM199 - Diabetic Kidney Disease

Diabetic kidney disease (DKD) is one of the major complications of diabetes. Currently prescribed therapeutics for DKD only slow the progressive decline in renal function, and there is a major unmet need for novel therapeutics that prevent costly dialysis and/or kidney transplantation. DiaMedica is preparing for upcoming clinical studies that will expand the testing of DM199 to patients with DKD. Published preclinical data suggests that modulation of the kallikrein-kinin system has broad protective effects against the metabolic and vascular abnormalities associated with DKD, and that therapy with human tissue kallikrein-1 improves several parameters of kidney function.

DMDx - Kidney diagnostic

DiaMedica is developing a companion diagnostic assay, DMDx, utilizing the detection of tissue kallikrein-1 as a biomarker in human urine to identify DKD patients who are most likely to respond to a therapy including DM199. The Company anticipates that the identification of target populations based on tissue kallikrein-1 will significantly de-risk clinical DKD drug development. The assay is currently in the development stage, with the near-term goal of analytical validation, followed by longer-term clinical validation. The Company believes that DMDx may fulfill the unmet need for validated clinical biomarkers that can predict the rate of disease progression to end-stage renal disease (kidney failure) in patients with DKD.

DM204 - Type 2 diabetes

DM204 is a novel monoclonal antibody for the treatment of type 2 diabetes and associated complications including hypertension (high blood pressure). DM204 is currently in the preclinical stage of development with plans to move into manufacturing and toxicology testing upon completion of preclinical testing.

For further information, please visit www.diamedica.com

About DiaMedica

DiaMedica 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 product, DM199, is a recombinant human protein known as rhKLK1 that represents a novel approach to treating diabetes and associated complications. DiaMedica is also developing DM204, a preclinical-stage monoclonal antibody, for the treatment of type 2 diabetes.

DiaMedica's common shares are listed on the TSX Venture Exchange in Canada 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, including the intended use of the net proceeds of the Offering, 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 DiaMedica'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. DiaMedica 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, unless required by law. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of the contents of this press release.

DiaMedica Inc.John SavageChief Financial Officer763-270-0603info@diamedica.comDiaMedica Inc.One Carlson Parkway, Suite 124Minneapolis, MNThe Trout Group LLCThomas Hoffmann740 Broadway, 9th FloorNew York, NY 10003646-378-2931thoffman@troutgroup.com

DiaMedica Inc. (TSXV:DMA)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024 DiaMedica Inc. 차트를 더 보려면 여기를 클릭.
DiaMedica Inc. (TSXV:DMA)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024 DiaMedica Inc. 차트를 더 보려면 여기를 클릭.