MINNEAPOLIS, MINNESOTA--(Marketwired - Nov. 4, 2015) - DiaMedica Inc. (TSX VENTURE:DMA) (OTCQB:DMCAF) a clinical-stage biotechnology company focused on developing novel protein therapeutics for vascular diseases, including stroke, and metabolic and kidney dysfunction, today provides a corporate development update.
DM199 for Acute Ischemic Stroke
DM199 is positioned to significantly expand the therapeutic treatment window following an acute ischemic stroke from the current standard of care of 3-4.5 hours with tissue plasminogen activator ("tPA"), to up to 48 hours post stroke while also potentially complimenting tPA when administered together. Thereby providing an opportunity to greatly increase the number of patients eligible for treatment to potentially reduce the severity and to improve the functionl outcomes of patients inflicted with strokes.
DM199 is a recombinant form of the killikrein-1 ("KLK1") protein. A urine extracted form of KLK1, trade name Kailikang®, has been approved and is believed to be widely used for the treatment of acute ischemic stroke in China. DiaMedica believes that DM199 offers significant benefits over the urine-sourced product including the removal of any product supply constraints, very low manufacturing costs, reduced risk of endotoxins and a product capable of meeting the regulatory requirements for worldwide use. A subcutaneous formulation of DM199 may also make the treatment much easier to administer compared to intravenous administration.
DiaMedica plans to follow dual development paths for the treatment of acute ischemic stroke with DM199. The first path is a biosimilar strategy taking advantage of the approved Kailikang® product in China, and the second path being an accelerated development program for worldwide markets including the U.S. and Europe. This strategy is designed to produce a potential licensing or partnership deal with an Asian pharmaceutical company and a pivotal phase 2 proof of concept trial in the U.S. and Europe enabling partnering with a major pharmaceutical company.
DiaMedica has completed several safety and toxicology clinical trials with DM199. DM199 has established an excellent safety record with its single ascending and multiple ascending dose trials, and has also established maximum dose limiting tolerability of orthostatic hypotension at the very high dose levels, which is expected and consistent with the mechanism. There was no anti-drug antibody response after 28 days of therapy, and the formulation is free of endotoxin complications.
The Company is preparing the regulatory filing to initiate clinical trials of DM199 with both subcutaneous and intravenous routes of administration and will provide an update when the filing is completed.
"We are excited with the potential of DM199 with its promising mechanism of action and extensive clinical results with the naturally occurring version of KLK1 for the treatment of acute ischemic stoke," said Mr. Pauls, President & CEO of DiaMedica. "Following recent presentations at several forums, we are planning a business development and marketing initiative to Asia to initiate preliminary discussions with pharmaceutical companies in the Asian market."
DM199 for Metabolic and Kidney Diseases
DiaMedica will continue to develop DM199 for the metabolic disease area, with focus on a segment of the patients with kidney dysfunction and patients who suffer from acute kidney injury. DiaMedica is also evaluating DM199 and a follow-on product for a series of orphan drug indication where experts believe the products mechanism may have a major impact on the diseases.
About Acute Ischemic Stroke
Stroke is a major health issue in the U.S. and around the world today. There are 17 million strokes each year, and 1 in 6 males and 1 in 5 females will have a stroke in their lifetime. Most of these strokes, 87%, are what is termed ischemic strokes, a blockage rather than a hemorrhage (bleeding into the brain). The only FDA approved treatment option for acute ischemic stroke is tPA, the clot dissolving agent, trade name Activase®. tPA has proven to be effective when administered within 3-4.5 hours after a stroke, but it is estimated only 5-7% of acute ischemic stroke patients in the U.S. receive tPA because of the limited time window for starting treatment.
The projected total cost of care for stroke patients is forecasted to reach $240 billion in the U.S. by 2030 according to the World Stroke Organization.
DiaMedica is a publicly traded clinical stage biopharmaceutical company focused on developing novel protein therapeutics for vascular diseases, including stroke, and metabolic and kidney dysfunction. DiaMedica's common shares are listed on the TSX-V 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 future plans, product safety, potential regulatory filings and future clinical trials, advancement of DM199 and other products for stroke, metabolic, kidney and other diseases, potential effectiveness of DM199 beyond tPA, combined with tPA or as biosimilar, potential advantages of DM199 over the marketed Chinese product, and potential partnerships. Factors that could cause actual results to differ materially from such forward-looking information include, but are not limited to: uncertainties associated with raising additional capital, its ability to satisfy its current contractual obligations; timing and success of implementing restructuring measures and any future measures; and the additional risk factors described in detail in the Prospectus and DiaMedica's other 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.
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