DiaMedica Announces First Patient Enrolled in Bridging Clinical Trial for DM199
MINNEAPOLIS, MINNESOTA -- (Marketwired) -- 10/05/16 -- DiaMedica Inc. (the "Company") (TSX VENTURE:DMA)(OTCQB:DMCAF) announced that the first patient has been dosed in the Phase Ib clinical trial of DM199, a novel recombinant tissue kallikrein ("rKLK1") protein for the development of neurological and kidney diseases.
"Dosing the first patient in the DM199 study represents another important step toward our goal of providing patients and physicians with treatment options for the currently unaddressed complications of stroke and kidney diseases," said Rick Pauls, President and Chief Executive Officer of DiaMedica.
The study will compare multiple doses of intravenous and subcutaneous dosing of DM199 to identify an optimal dose and delivery route for DM199 based on what is already known about urinary tissue kallikrein ("uKLK1"), trade name Kailikang®. Kailikang®, via daily intravenous delivery, has been approved and is believed to be widely used in the People's Republic of China for the treatment of acute ischemic stroke.
DM199 is a recombinant (synthetic) human tissue kallikrien ("rhKLK-1") protein to treat neurological and kidney diseases. DiaMedica has completed four clinical trials with DM199 including single ascending doses, multiple ascending doses, and a pilot study in Type 2 diabetic patients. In addition to a having a good safety and tolerability profile, DM199 showed significant activity on blood pressure over the course of treatment in multiple clinical studies. The dose limiting tolerability was orthostatic hypotension at dose levels greater than those anticipated to be effective for treating disease. These observations are consistent with the DM199 mechanism of action and its effect in pre-clinical studies.
DiaMedica is a publicly-traded clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF".
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. Forward looking statements in this news release include, but are not limited to, the Company's objectives, goals, and future plans; product safety; advancement of DM199 for stroke, neurological and kidney disease; and potential effectiveness or advantages of DM199 over the marketed Chinese product. Factors that could cause actual results to differ materially from such forward-looking information described in detail in the DiaMedica's filings with the Canadian securities regulators, all of which are available on SEDAR (www.sedar.com). 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.
Source: DiaMedica Inc.