On January 25, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported the opening of enrollment of a Phase II study of VAL-083 at the University of Texas MD Anderson Cancer Center in Houston, Texas (Press release, DelMar Pharmaceuticals, JAN 25, 2017, View Source [SID1234517555]). Schedule your 30 min Free 1stOncology Demo! DelMar Pharmaceuticals Logo (PRNewsFoto/DelMar Pharmaceuticals, Inc.)
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The Phase II 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. Further information regarding the clinical trial can be found on DelMar’s website and at clinicaltrials.gov (clinicaltrials.gov identifier: NCT02717962).
"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 & CEO of DelMar Pharmaceuticals. "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 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 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 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.
About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes. DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. Further details can be found at View Source
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 III clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase II trial for newly diagnosed GBM patients with an unmethylated MGMT promoter.
"We believe that data from these upcoming 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 chemotherapy," added Mr. Bacha.
"Our data demonstrating that VAL-083’s activity against GBM is independent of MGMT expression combined with VAL-083’s established clinical activity against GBM from published NCI-sponsored clinical studies provides confidence to our hope that VAL-083 will give doctors and their patients a new and unique chemotherapy to address this enormous global unmet medical need."
About Glioblastoma Multiforme (GBM)
GBM is the most common and the most lethal form of glioma. Approximately 15,000 new cases of GBM are expected to be diagnosed in the United States during 2017. GBM progresses quickly and patients deteriorate rapidly. Common symptoms include headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly. The majority of GBM patients do not survive for more than two years following diagnosis, and the median survival in newly diagnosed patients with best available treatments is less than 15 months.