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Oral COTI-2 is Effective Against Aggressive Triple Negative Human Breast Cancer

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Critical Outcome Technologies Inc. (COTI) announced positive test results from a series of animal experiments carried out at a prominent Canadian cancer research facility with COTI-2 as a single agent against an aggressive strain of triple negative human breast cancer (TNBC); MDA-MB-231-luc.

The significance of this development is that TNBC is a difficult-to-treat cancer subtype that does not have an approved standard-of-care and does not respond to current hormone-based and targeted therapies. TNBC is a very aggressive cancer, with higher rates of metastases and poorer survival rates than other breast cancer subtypes.

In this particular 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 following 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:

• Control Group:
- Tumors grew quickly and reached maximum size by day 38 of the study.

• Pretreatment Group:
- Marked tumor growth inhibition (78.0%, p<0.001) compared to the Control Group at day 38 of the study.

• Conventional Group:
- Significant tumor growth inhibition (56.8%, p<0.005) compared to the Control Group at day 38 of the study (after only 13 doses of COTI-2).

• 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 significantly greater than in the Conventional Group (78.0% vs. 56.8%, p=0.01).

• 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.