VANCOUVER, BC and MENLO PARK, CA— DelMar Pharmaceuticals has commenced enrollment in its Phase 2 study of VAL-083 at the University of Texas MD Anderson Cancer Center in Houston, TX.
The Phase 2 study of VAL-083 (dianhydrogalactitol) in patients with MGMT-unmethylated, Avastin (bevacizumab)-naïve recurrent glioblastoma will enroll 48 patients in a single-arm design to determine if treatment with VAL-083 improves overall survival, compared to historical control.
VAL-083 is a “first-in-class,” small-molecule chemotherapeutic that according to the company has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes. DelMar says it has also demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. Further details and information regarding the clinical trial can be found at www.delmarpharma.com.
“This study is a keystone in our strategy to expand the development of VAL-083 to target MGMT-unmethylated GBM, a significant unmet medical need,” said Jeffrey Bacha, chairman and CEO of the company. “We are pleased to launch this important trial in collaboration with the University of Texas MD Anderson Cancer Center, one of the world’s most respected medical centers devoted exclusively to cancer patient care, research, education and prevention.”
Approximately two-thirds of newly diagnosed GBM patients have tumours 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).
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 GBM patients with an unmethylated MGMT promoter.