MINNEAPOLIS, MINNESOTA--(Marketwire - Jan. 29, 2013) - DiaMedica (TSX VENTURE:DMA) has successfully completed cGMP manufacturing of DM-199 to be utilized in upcoming clinical trials. Additionally, the Company has successfully completed GLP toxicology studies in non-human primates and rat models, and has demonstrated DM-199 to be safe and well-tolerated in repeated high dose administrations.
"Successful cGMP manufacture is a major development milestone for our DM-199 program and we are working on our regulatory package for a Phase I/II clinical trial which includes Type 2 diabetic patients. The trial design will also allow us to enter Phase 2 trials for multiple indications," stated Rick Pauls, Chairman & CEO of DiaMedica. "Achieving a proprietary, commercially viable manufacturing process of DM-199 and a comprehensive patent position including composition of matter, methods of uses and route of delivery should create a significant barrier to entry for any follow-on competitors."
The large-scale proprietary cGMP manufacturing process resulted in a high yield batch of DM-199 to be used in upcoming clinical trials. The GLP preclinical toxicology studies demonstrate DM-199 is safe and well tolerated at doses at least 25 fold higher than the expected human therapeutic dose over 28-days of repeated-dose and cardiovascular safety studies in non-human primates and rats. The daily administration of DM-199 was safe and well tolerated with no serious adverse events or any other tissue toxicity. Furthermore, DM-199 showed no negative cardiovascular treatment-related effects, including heart rate or ECG intervals, which are important safety attributes for any Type 2 diabetes therapy. Based on toxicology results, doses previously reported for chronic Type 2 diabetes pre-clinical studies could be increased by at least four-hundred (400) fold, suggesting a large therapeutic window.
"The pre-clinical GLP toxicology studies have further demonstrated a good safety profile of DM-199," noted Mark Robbins, Vice President of Clinical and Regulatory Affairs. "These results support moving forward into the clinic in the near term to assess safety and tolerability in healthy volunteers and efficacy in Type 2 diabetic patients."
DiaMedica Inc. (TSX VENTURE:DMA) is biotechnology company developing first-in-class treatments for the treatment of diabetes. DiaMedica's lead compound, DM-199, a recombinant human protein for the treatment of both Type 1 and Type 2 diabetes and their complications. The Company is also developing the first therapeutic GPCR agonist monoclonal antibody, DM-204, for the treatment of Type 2 diabetes and cardiovascular disease. DiaMedica's shares trade on the Toronto Stock Exchange Venture (TSX VENTURE:DMA). For more information please visit www.diamedica.com.
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.