The 28-day, two-species toxicity testing is underway and is being conducted by Charles River Laboratories in Montreal, Quebec. The results from this testing will be used to estimate an initial safe starting dose and dose range for human trials and to identify parameters for clinical monitoring for potential adverse effects.
We look forward to successfully completing these tests and then moving forward with our FDA IND filing - expected in the latter half of calendar 2014.
“With the financing announced in early February, we have moved ahead with our two-species 28-day toxicity testing contract,” said Dr. Wayne Danter, President and CEO. “This testing is the final toxicity testing required before we can prepare our investigational new drug filing with the FDA and will determine the safe starting dosage for COTI-2 in human trials.”
This morning we announced our third quarter financial results by way of a news release. In this news release we also announced that our lead cancer drug candidate, COTI-2, had entered the final 28-day, two-species toxicity testing required in order to move forward with an IND filing to the FDA.
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