The Chinese government body which approves clinical studies sponsored by foreign companies in that country has given its go signal to Canada’s DelMar Pharmaceuticals to push through with its Phase 2 clinical trial for the firm’s lead product for the treatment of an aggressive form of brain cancer.
DelMar said the Human Genetic Resources Administration of China (HGRAC), has approved the company’s application for a safety and efficacy study of VAL-083 – DelMar’s proposed treatment for newly diagnosed MGMT-unmethylated glioblastoma multiforme (GBM).
GBM is the most common and aggressive primary brain cancer. GBM has an incidence of two to three per 100,000 adults per year and accounts for 52 per cent of all primary brain tumours.
DelMar was required to obtain HGRAC approval because the trial involves analysis of patient’s MGMT status as a biomarker for patient selection and enrollment. Results of the trial will be used to guide the design of global randomized trials.
“Our clinical trials to date have been focused on recurrent GBM for patients whose tumours have recurred following currently approved therapies,” said Jeffrey Bacha, chief executive officer of DelMar. “Obtaining HGRAC approval represents a significant step toward maximizing the potential benefit of VAL-083 in newly diagnosed GBM for patients whose tumours exhibit features, such as high expression of MGMT, which render them resistant to the current standard-of-care chemotherapy.”
Up to 30 newly diagnosed GBM patients whose tumours exhibit high-expression of the DNA-repair enzyme O6-methylguanine methyltransferase (MGMT) will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population.
VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.
MGMT methylation status will be used as a biomarker for patient selection and only patients whose tumours are MGMT-unmethylated will be enrolled.
DelMar hopes to position VAL-083 as a potential replacement for the current standard-of-care (chemoradiation with temozolomide) for the approximately 2/3 of newly diagnosed GBM patients whose tumours feature MGMT-unmethylated GBM.
The trial is expected to open for enrollment in the coming weeks at Sun Yat-sen University Cancer Center (SYUCC) in Guangzhou, China under the direction of Professor Zhong-ping Chen, M.D., Ph.D.
Chen serves as chair of the Department of NeuroSurgery/Neuro-Oncology at SYUCC. He has authored dozens of publications and been involved in numerous international brain tumour trials.
Kun Tuo, a subsidiary of QuintilesIMS, has been retained to monitor and oversee the conduct of the trial.
Funding support for the trial will be provided by Guangxi Wuzhou Pharmaceutical Group Co. Ltd. (Guangxi Wuzhou Pharma), under the terms of DelMar’s collaboration with Guangxi Wuzhou Pharma.
“GBM has been largely left behind in the recent advancements made in the fight against cancer and new therapies improving median survival have been lacking,” said Bacha. “ We strongly believe that VAL-083 represents a potential paradigm shift in the treatment of GBM, particularly for the 2/3 of newly diagnosed GBM patients whose tumours exhibit high expression of MGMT.”
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