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DelMar Pharmaceuticals Gives Quarterly Shareholder Update
Date:11/11/2013

I/II dose-escalation trial designed to assess the safety and preliminary efficacy of our lead product candidate, VAL-083, for the treatment of GBM.  

The results reported to date have shown promising drug activity and we believe that VAL-083 represents a potential new treatment option for brain tumor patients who have failed or are unlikely to benefit from today's standard of care.  More than half of patients fail the currently approved treatments.

The goal of our current clinical trial is to establish the optimal VAL-083 dosing regimen for both safety and efficacy in a U.S.-based GBM patient population. This dose would then be advanced into a Phase III GBM registration study, which we expect to commence in mid-2014 . During the past quarter, the U.S. Food and Drug Administration (FDA) undertook a detailed safety review of the Phase I/II trial and allowed us to accelerate our dose escalation program.  While this modification is unlikely to shorten the trial due to the length of our discussions with the FDA throughout this review, we should realize significant cost savings as fewer patients will be exposed to sub-optimal doses within the escalation study. We will present additional data from the ongoing Phase I/II trial during the Society for NeuroOncology (SNO) Annual Meeting on Friday November 22, 2013. 

We Are Strengthening Our Intellectual Property Portfolio
We have filed a broad portfolio of new patent applications to protect our intellectual property. Our patent applications claim compositions and methods related to the use of VAL-083 and related compounds as well as methods of synthesis and quality controls for the manufacturing process of VAL-083. In addition to our patent portfolio, VAL-083 has been granted Orphan Drug protection for the treatment of glioma, including GBM, in both the U.S. and Europe.  The orphan drug designation provides VAL-0
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