Subject to the FDA granting the IND application, the Company intends to initiate a Phase 1 clinical trial of an oral formulation of COTI-2 in patients with gynecological cancers (cervical, endometrial and ovarian) at the University of Texas MD Anderson Cancer Center in Houston. Extensive preclinical studies have demonstrated COTI-2's ability to restore mutant p53 function and thus induce cancer cell death in cancers with many common p53 mutations. In the upcoming clinical trial, the Company intends to determine primarily the safety of COTI-2, as well as obtain some indications of efficacy, the maximum tolerated-dose and pharmacokinetics in treating gynecological cancers containing p53 mutations in patients who have failed the current first line therapies used in these types of cancers.
"The filing of this IND application is a critical step forward in moving our lead oncology asset into the clinic. With a novel mechanism of action, orphan drug status for ovarian cancer, and a strong clinical development partner in MD Anderson, we believe that COTI-2 is well positioned for a Phase 1 clinical trial in gynecological cancers. Most ovarian cancers have at least one p53 mutation and COTI-2 may represent a potential breakthrough therapy for patients with these mutations. We look forward to working with the FDA in anticipation of their granting the IND application in the near future and commencing our clinical trial for the benefit of women with gynecological cancers who have failed standard therapies."
- Dr. Wayne Danter, CEO