Melbourne, Australia - 7 November 2016 - Dimerix Limited (ASX: DXB), a clinical-stage biotechnology company committed to discovering and developing new therapeutic treatments identified using its proprietary screening assay, today announced the appointment of Kathy Harrison, current General Manager of Dimerix Biosciences Pty Ltd (operating subsidiary of Dimerix Limited), to the role of Chief Executive Officer of Dimerix Limited.
Dimerix Chairman James Williams said, “We are delighted to appoint Kathy to this expanded role. In addition to driving key strategic outcomes from the recent-preIND meeting with the FDA and patent prosecution, Kathy has done a tremendous job establishing our phase II clinical program targeting chronic kidney disease, which is recruiting to schedule and on track to report final phase IIa data in the second half of 2017.”
“The Board looks forward to working with Kathy as we continue to deliver on our milestones. We believe Kathy has the international industry knowledge, expertise and leadership skills to take this business forward.”
Kathy has more than 20 years experience in a number of senior roles within the Australian biotechnology industry and listed companies with a focus on strategic commercial development of company intellectual property assets.
She has also worked for nine years in private practice as a patent and trade mark attorney gaining a wealth of experience in the legal framework underscoring commercialisation of new technologies.
Kathy holds a Master of Science from Manchester University (UK), a Certificate in Governance from the Governance Institute of Australia and is a Registered Patent and Trade Mark Attorney in Australia and Fellow of the Institute of Patent and Trade Mark Attorneys.
The material terms of Kathy’s contract are:
Dimerix Bioscience Pty Ltd
Dimerix Limited’s wholly owned subsidiary Dimerix Bioscience Pty Ltd is a clinical-stage pharmaceutical company committed to discovering and developing new therapeutic models identified using its proprietary assay, termed Receptor-Heteromer Investigation Technology (Receptor-HIT). This assay enables the identification of pairs of receptors that function in a joint manner (interact) when ligands, small molecule drugs, peptides or antibodies, bind to them. The Receptor-HIT technology was used to identify DMX-200 and an internal drug development program, initially for the treatment of a subset of patients with chronic kidney disease. In addition to its own therapeutic programs, the company also earns revenue by providing this technology to global pharmaceutical firms. For more information see www.dimerix.com
DMX-200 combines two existing drugs, irbesartan and ropagermanium. Irbesartan is an off-patent angiotensin II type I receptor blocker indicated for the treatment of hypertension and nephropathy in Type II diabetic patients. Propagermanium (PPG) is a chemokine receptor (CCR2) blocker, which has been used for the treatment of Hepatitis B in Japan and is available in the USA for its anti-inflammatory properties. DMX-200 has been shown to improve the outcome of chronic kidney disease by reducing proteinuria by more than 50 per cent in animal models.1
The DMX-200 Phase II Trial
The trial is a single arm, open label study in adult patients with chronic kidney disease (with proteinuria). The primary end points are the incidence and severity of adverse events and the clinically significant changes in the safety profile of participants. The secondary end points are obtained from statistical analysis of biomarker data at each time point including change from baseline, and the proportion of responders defined as those participants achieving normalisation of proteinuria (proteinuria within normal limits) or those participants achieving a 50 per cent reduction in proteinuria.
The trial has two parts. Part A is a dose escalation trial recruiting up to 30 patients. All patients recruited to the trial will be on stable irbesartan therapy, and will be treated with propagermanium dosed orally three times per day. Each patient will commence on 30mg PPG/day and the dose increased each 28 days to a maximum of 240mg/day, or until proteinuria is absent or reduced to a level the clinician considers acceptable. The Company expects to complete Part A in mid 2017.
Part B is an expansion study, in which up to 30 patients will be given the optimal dose identified from Part A.
Chronic Kidney Disease
Chronic kidney disease can result from diabetes, high blood pressure and diseases that cause inflammation specifically in the kidneys. Proteinuria is the most common manifestation of the disease. As the disease progresses it can lead to end-stage renal disease (ESRD) where the kidneys fail. The only treatment for ESRD is a kidney transplant or regular blood-cleansing treatments called dialysis. More than 26 million people suffer from the disease in the United States.
1Functional interaction between angiotensin II receptor type 1 and chemokine (C-C motif) receptor 2 with implications for chronic kidney disease. Ayoub MA, Zhang Y, Kelly RS, See HB, Johnstone EK, McCall EA, Williams JH, Kelly DJ, Pfleger KD. PLoS One. 2015 Mar 25;10(3):e0119803. doi: 10.1371/journal.pone.0119803.
Issued for and on behalf of Dimerix.
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