Winnipeg, MB, March 22, 2012
-DM-199 & DM-204 were both selected on December 1, 2011 as Windhover's "2011 Top 10 Cardiovascular/ Metabolic Projects to Watch"
-Appointing of Mr. Edward Rady as Senior Consultant, Licensing & Partnering
-Started preliminary discussions with major pharmaceutical companies
DiaMedica Inc. (TSX-V: DMA), a biopharmaceutical company focused on the development of novel therapeutic compounds for diabetes, today provides a summary and an update on the development programs for DM-199 and DM-204 and announces the appointment of Mr. Edward Rady as Senior Consultant, Licensing & Partnering.
DM-199 Type 1 diabetes - is a novel recombinant protein which has been found to target the three main aspects of Type 1 diabetes by increasing regulatory T cells, reducing insulitis and improving glucose control in in vivo studies, specifically:
-Halts autoimmune attack - significant dose dependent delay in onset of diabetes in NOD mice leading to a 12x increase in C-peptide (a primary clinical endpoint) to 5-6 nM
-Proliferates beta cells - 1,277% increase in insulin producing beta cells, restoration of blood insulin to near normal levels
-Improves glucose control - 291% increase in peak glucose infusion rate in a hyperinsulinemic euglycemic clamp model and a 1.6% improvement in HbA1C (measure of blood glucose levels) in a ZDF rat model
-Human clinical trial - proof of concept - in a Phase 2a clinical trial with first generation DM-99, glucose levels were lowered by up to 48% after a meal
DiaMedica has submitted its pre-Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in preparation for an upcoming clinical trial with DM-199. The Company has also recently filed additional patents on DM-199 composition of matter and its uses, and developed a proprietary, high-yield manufacturing process for the recombinant protein.
DM-204 Type 2 diabetes - is a novel G-protein coupled receptor agonist monoclonal antibody (mAb) for the treatment of Type 2 diabetes including the complications of hypertension and high cholesterol. In pre-clinical in vivo studies, DM-204 has significantly ameliorated diabetes and associated complications:
-Glucose control - 2.6% improvement in HbA1c (measure of blood glucose levels)
-High blood pressure - 25 mm/Hg improvement
-High cholesterol - 24% improvement
Administration of DM-204 was well tolerated and significantly outperformed marketed Type 2 diabetes drugs sitagliptin (Januvia(R)) and exenatide (Byetta(R)) in our study. The humanized mAb surprisingly demonstrated improved binding affinity of up to two orders of magnitude. Furthermore, DM-204 may be administered infrequently based on the long half-life of its human IgG2 isotype. The Company has also filed comprehensive composition of matter and use patents.
Follow-on Projects: DiaMedica is pursuing a number of longer-term diabetes related projects to expand its pipeline, while its primary focus remains on the development of DM-199 & DM-204.
Mr. Edward Rady joined DiaMedica as Senior Consultant, Licensing & Partnering to drive the partnering/acquisition process for DiaMedica's products. Mr. Rady has nearly 40 years of wide-ranging pharmaceutical industry experience, beginning at Abbott Laboratories in commercial and product management and culminating as the global CEO of Publicis Healthcare.
"After reviewing the programs in detail, I am very excited to be given the opportunity to help the DiaMedica team move into the next phase of product development, commercialization and partnering," stated Mr. Rady. "The novel mechanisms of the two lead products may have the potential to make a significant contribution to the future management of diabetes and be highly attractive to pharmaceutical partners."
"We are delighted that Ed has joined DiaMedica at a critical time to help navigate discussions with pharmaceutical companies while we continue to move the development of our programs forward," said Mr. Rick Pauls, Chairman & CEO of DiaMedica.
DiaMedica is a biopharmaceutical company focused on discovery and development of novel therapeutic compounds for diabetes and other major, medically-unmet diseases.
The company is listed on the TSX Venture Exchange under the trading symbol 'DMA'.
For more information, please contact:
President & CEO
Caution Regarding Forward-Looking Information 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 Company'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 Company 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.
Copyright (c) 2012 Thenewswire.ca - All rights reserved.