“The receipt of the Orphan Drug Designation for COTI‐2 significantly enhanced the already positive profile of our lead cancer drug candidate. We believe that COTI‐2, with its p53‐dependent mechanism of action, will have a major impact on ovarian cancer, which is the fifth most common cancer in women, and the most lethal women’s cancer."
- Dr. Wayne Danter, President and CEO.
Other first quarter highlights related to the development of COTI-2 included:
- Completing the two‐species toxicity studies for COTI‐2 successfully in support of a filing for a Phase 1 clinical trial;
- Completing additional and definitive testing confirming COTI‐2’s p53‐dependent mechanism of action at dosages 60% lower than previously used in similar experiments that potentially translates into better efficacy and even better safety for the upcoming Phase 1 study;
- Completing a private placement, which enabled us to move forward with the preparation of our investigational new drug filing for COTI‐2 with the FDA.