What role does DAG play towards cancer treatment?
VAL-083 is a novel alkylating agent. It works against cancer cells by interrupting DNA replication causing the tumor cells to die. Research on the drug was originally conducted at the National Cancer Institutes (NCI) in the US during the 'original war on Cancer' in the late 1970s and 1980s. There are more than 40 clinical publications from this original US-based work, supporting activity against multiple tumor types including leukemia, solid tumors such as lung cancer and central nervous system tumors such as glioblastoma multiforme (GBM), which the most common and aggressive form of brain cancer.

Are you planning to take VAL-43 outside China to other markets? If yes, then which markets are you targeting?
Yes we are planning to take VAL-43 outside China. Based on the activity from the previous NCI work, we have initiated new human clinical trials with VAL-083 as a potential treatment for refractory GBM. GBM is the aggressive form of brain cancer that claimed the lives of former Senator Ted Kennedy and former NY Mets star Gary Carter.

New research conducted by DelMar Pharmaceuticals demonstrates that VAL-083 maintains its activity in spite of drug-resistance mechanisms that cause many patients tumors to become resistant to the leading chemotherapy against GBM. We began treating patients whose tumors are resistant to other therapies with VAL-083 under an investigational new drug (IND) application filed with the US FDA. We initiated the study in 2011 and will present initial clinical findings at the Society of NeuroOncology meeting in Washington DC on November 16-17, 2012.

We eventually plan to initiate additional clinical trials in North America, Europe and Asia to evaluate the potential VAL-083 as a treatment against a number of cancers. In China, we will initially be focusing our initial commercial activities on CML and lung cancer, which are the two types of cancer for which VAL-083 is approved in China. We also plan to work toward expanding the approval to include other cancers such as GBM.

What made you choose Guangxi Wuzhou Pharmaceutical as a partner?
Guangxi Wuzhou Pharmaceuticals is the sole license holder from the Chinese State Food and Drug Administration (SFDA) to manufacture VAL-083 for the treatment of lung cancer and leukemia. They have also been the supplier of the drug product for DelMar's clinical trials in the US.