Study is currently enrolling MGMT-unmethylated Avastin (bevacizumab)-naïve recurrent GBM patients at the University of Texas MD Anderson Cancer Center
VANCOUVER, British Columbia and MENLO PARK, Calif., Feb. 13, 2017 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) (“DelMar” and the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today that patient dosing has commenced in a Phase 2 clinical study of its investigational drug VAL-083 (dianhydrogalactitol) for MGMT-unmethylated Avastin® (bevacizumab)-naïve recurrent glioblastoma.
The first patient was dosed by DelMar’s collaborators at the University of Texas MD Anderson Cancer Center in Houston Texas.
“The dosing of the first subject in this VAL-083 trial marks an important milestone in the advancement of our clinical development program targeting MGMT-unmethylated GBM,” said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals.
“The majority of newly diagnosed GBM patients’ tumors are characterized as MGMT-unmethylated, which is directly correlated with resistance to current standard front-line chemoradiation with temozolomide,” added Mr. Bacha. “Our research demonstrates that VAL-083 is active independent of MGMT expression. These data, combined with data from prior clinical trials sponsored by the US National Cancer Institutes that establish VAL-083’s activity against GBM, are the foundation of our belief that VAL-083 may provide a new therapeutic option for GBM patients whose tumors exhibit features making them resistant or unlikely to respond to currently available therapy.”
The Phase 2 trial will test safety, tolerability and clinical efficacy of VAL-083 in 48 adult subjects with MGMT-unmethylated GBM whose tumors have recurred following surgery and standard chemo-radiation with temozolomide. Patients will receive 40 mg/m2 VAL-083 (IV) on days 1, 2, and 3 of a 21-day treatment-cycle, for up to twelve 21-day treatment cycles to determine if treatment with VAL-083 improves overall survival compared to historical controls. Further information regarding the clinical trial can be found on DelMar’s website and at clinicaltrials.gov (clinicaltrials.gov identifier: NCT02717962).
Approximately two-thirds of newly diagnosed GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme, MGMT. Published studies have documented that expression of MGMT is an important factor in predicting the outcome of GBM patients treated with alkylating agents such as temozolomide (TMZ), carmustine (BCNU), and lomustine (CCNU).
Patients whose tumors exhibit a high expression of MGMT have a poor prognosis and significantly shorter progression free survival (PFS) and overall survival (OS) in comparison to patients with a methylated MGMT promoter and low MGMT expression. In a 2011 study of more than 800 newly diagnosed GBM patients, those with tumors carrying the unmethylated MGMT promoter had a median overall survival of 14 months versus 21 months for those with a methylated MGMT promoter. The difference in progression-free survival – the period after treatment during which the cancer does not worsen – was 5.7 and 8.7 months, respectively.
VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.
DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase 3 clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase 2 trial for newly diagnosed MGMT-unmethylated GBM.
DelMar believes that data from its clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available therapies.
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