VAL-083 is a "first-in-class",small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute ("NCI"), VAL-083 demonstrated safety and efficacy in treating a number of cancers, including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer.
DelMar's business model is to leverage historical data by combining it with modern biological understandings of cancer and drug mechanism in order to address unmet medical needs. This strategy also allows us to generate new intellectual property which is protected through DelMar's patent filings.
- Reduced Risk: Historical evidence of clinical activity
- Reduced Cost: Leverage prior investments
- Reduced Time: Speed up development process with substantial prior data
DelMar is currently studying VAL-083 in a multi-center Phase 1/2 clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). VAL-083 has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.
Our research to date suggests that the unique anti-cancer mechanism of VAL-083 is distinct from platinum-based chemotherapy and much less susceptible to drug resistance mediated by p53.
The p53 gene plays a central role in the protection of the human body from cancer and is responsible for initiating the process of programmed cell death, or apoptosis, which directs a cell to commit suicide if it becomes damaged or cancerous. The p53 pathway is also integral to the activity of many chemotherapy drugs. p53 is frequently mutated in NSCLC and p53 mutations are highly correlated with resistance to chemotherapy and poor patient outcomes in NSCLC.
DelMar believes that these data support the potential of VAL-083 to address significant unmet medical needs in the modern treatment of a range of orphan and major cancer indications.