Critical Outcome Technologies Inc. (COTI) has announced that it has initiated the final series of toxicity experiments in two animal species for its lead oncology asset, COTI-2.
The data from these experiments are an important part of the toxicity package required by the U.S. Food and Drug Administration (FDA) for a first in human trial.
The completion of the two species toxicity experiments represents the final study of three major risk reduction studies that COTI has announced it would complete in order to make COTI-2 an Investigational New Drug (IND) submission ready compound.
"The initiation of these toxicity experiments is the final part of the IND scientific data package for submission to the FDA and represents another important step in enhancing COTI-2 as a commercially attractive asset," said Dr. Wayne Danter, President and Chief Executive Officer of COTI.
Dr. Danter continued, "We are pleased with the continued development of COTI-2 and are excited to take another step towards an IND filing. The results of these experiments will be critical in moving COTI-2 towards human clinical trials in early to mid 2013 and increasing the value for a licensing transaction."