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DelMar Pharmaceuticals Presents Interim Phase 1/2 Clinical Data for VAL-083 in Glioblastoma at Society for Neuro-Oncology Annual Meeting
Date:11/22/2013

ion of mandated safety observation period with Cohort 4 (10mg/m2). 

- Pharmacokinetic analysis demonstrates a dose-dependent plasma exposure. 

The poster entitled "Phase I/II study of VAL-083 in patients with recurrent malignant glioma or progressive-secondary brain tumor," will be presented today from 7 p.m. to 9 p.m.

In August, DelMar received notice of allowance from the U.S. Food and Drug Administration (FDA) that will enable the company to alter the dose-escalation of its ongoing Phase 1/2 of VAL-083 in refractory glioblastoma multiforme (GBM) patients.  After an extensive safety review of patients treated to date, the FDA allowed the revised dosing regimen detailed in the following chart, which enables the trial to reach higher doses and complete the dose-escalation portion of the clinical trial more quickly.  The revised dosing scheme also permits dosing above 30mg/m2 if VAL-083 is safe and well tolerated at that dose.  Dose Escalation
Scheme (mg/m2)Patients
Treated Status OriginalRevised1.51.53

Completed – No DLT3.03.04*

Completed – No DLT5.05.010*

Completed – No DLT10.010.03

No DLT**15.020.020.03

(planned)

Enrollment scheduled Dec

201325.030.030.03

(planned)

To be initiated subject to

no DLT in 20mg/m2 dose*Cohorts 2 and 3 were expanded to allow for patient demand

and to gather additional data on CNS metastases patients.

 

** Observation period for final patient in this cohort ongoing"From previous controlled clinical trials sponsored by the U.S. National Cancer Institute (NCI), we have seen promising safety and efficacy data for VAL-083 in glioblastoma," said Mr. Bacha.  "With our accelerated dose escalation plan compared to the NCI's dosing sche
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SOURCE DelMar Pharmaceuticals, Inc.
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