COT said that in the study, animals were divided into three study groups: Group 1 (Control) animals received vehicle only (no treatment), Group 2 (Pretreatment) animals received oral COTI-2 (200 mg/kg) daily for 5 days prior to tumor implantation and daily for 5 days/week for the duration of the study and Group 3 (Conventional) group received oral COTI-2 daily for 5 days/week once tumors had reached 100-200 cubic mm starting on day 21 and for the remainder of the study.
The results provide strong supportive evidence for the continued evaluation of COTI-2 for the treatment of breast cancer, including HER-2/neu and ER/PR negative disease: The results include: In the Control Group, tumors grew quickly and reached maximum size by day 38 of the study.
In the Pretreatment Group, marked tumor growth inhibition is seen compared to the Control Group at day 38 of the study. In the Conventional Group, significant tumor growth inhibition compared to the Control Group at day 38 of the study (after only 13 doses of COTI-2) is seen. None of the study groups had any evidence of metastatic disease spread using whole body fluorescent imaging.
Tumor growth inhibition in the Pretreatment Group was greater than in the Conventional Group and Treatment with oral COTI-2 as a single agent was well tolerated with no treatment deaths or observable toxicity over the duration of the study.
Wayne Danter, president and CSO of COTI, said: “We chose to study this particular model of human breast cancer because it exemplifies an aggressive form of the disease that accounts for about 20% of all breast cancers. Moreover, we wanted to explore recent scientific data indicating that the PI3K/AKT/mTOR pathway is activated in TNBC. We were pleased to see impressive efficacy shown in this study.
“TNBC responds poorly to commonly used targeted therapies. There are high relapse rates following traditional therapies and as a result there is a clear unmet medical need. Taken together these results are encouraging and support further evaluation of COTI-2 in combination with other agents like taxols for the potential effective treatment of triple negative breast cancer.”
Michael Cloutier, CEO of COTI, said: “We are delighted with these new scientific results which provide evidence to support the commercial development of COTI-2 in breast cancer. We look forward to sharing this promising new data with parties who have expressed a licensing interest in COTI-2.”