Why is this significant? Before any clinical trial can begin, an IND application has to be filed with the FDA. The application includes the results of preclinical experiments, the drug candidate's chemical structure and how it is understood to work in the body, a comprehensive listing of any side effects and manufacturing information. The FDA reviews the application to make sure people participating in the clinical trials will not be exposed to unreasonable risks.
With this process now complete and the IND status in hand, we can now begin to finalize our plans for our Phase 1 clinical trial, which we expect to commence in the second half of calendar 2015 in partnership with the University of Texas, MD Anderson Cancer Center in Houston.
- Potential breakthrough therapy for many cancers
- Novel p53-dependent mechanism of action
- Orphan Drug status for the treatment of ovarian cancers
- Orally bio-available and effective at low dose
- Low toxicity demonstrated in preclinical experiments