"The development and validation of a bioanalytical method for COTI-2 in human plasma represents another important milestone in the preparation of COTI-2 for its first in human study," said Dr. Wayne Danter, COTI's President and CEO. "This validated detection method is one of our final requirements for the Phase 1 clinical study submission."
Both Health Canada and the United States Food and Drug Administration require a validated detection method for measuring a drug's concentration in human plasma as part of the Phase 1 submission package. Based on the functional detection method used for rodent species to date, the Company has done considerable work in developing the final bioanalytical method including the successful development of a radio-labeled COTI-2 isotope for use as an internal standard. It is anticipated that the development and validation will take approximately six weeks to complete.
COTI-2's specific cellular targeting, low toxicity, and proven efficacy support a potentially dramatic change in the treatment of cancers that over express AKT/AKT2. Over expression of AKT/AKT2 is common in a broad range of human cancers, including ovarian, endometrial, pancreatic, breast, colorectal and lung. The percent of tumors producing excess active AKT/AKT2 ranges from 20% to 100% depending on the cancer type.