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DelMar Pharmaceuticals Announces Completion Of $10.5 Million Oversubscribed Offering And Appointment Of Investor Relations Consultant
Date:3/7/2013

ation study designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of VAL-083 in patients with histologically confirmed initial diagnosis of primary WHO Grade IV malignant glioma (GBM), now recurrent.  Patients with prior low-grade glioma or anaplastic glioma are eligible, if histologic assessment demonstrates transformation to GBM.  Patients with secondary brain tumors due to CNS metastases are also eligible for the study.

GBM patients must have been previously treated for GBM with surgery and/or radiation, if appropriate, and must have failed both Bevacizumab (Avastin®) and temozolomide (Temodar®), unless either or both are contra-indicated. 

Response to therapy and disease progression will be evaluated by MRI prior to each treatment cycle.  An initial phase of the study will involve dose escalation cohorts until a maximum tolerated dose (MTD) is established in the context of modern care.  Once the modernized dosing regimen has been established, additional patients will be enrolled at the MTD (or other selected optimum dosing regimen).

DelMar Pharma is conducting the study under the direction of Dr. Howard Burris at the Sarah Cannon Research Institute in Nashville, Tennessee with a second center in Sarasota, Florida.  In November 2012, DelMar presented interim data from the clinical trial at the Society for NeuroOncology Annual Meeting demonstrating that VAL-083 is well tolerated and that some patients having failed prior therapy showed stable disease or tumor regression at doses tested to date.  DelMar is continuing to evaluate VAL-083 to determine an optimal dose for Phase II and registration studies of VAL-083 in patients with GBM.

Please refer to clinicaltrials.gov identifier NCT01478178 for further details on this clinical trial.

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