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COTI-2 is a novel small molecule activator of misfolded mutant p53 protein soon to enter multiple Phase 1 clinical trials. Extensive preclinical studies have demonstrated COTI-2's ability to restore mutant p53 function and thus induce cancer cell death in many common p53 mutations. COTI-2 is being developed as an oral treatment for solid tumors; it is easily synthesized and has good in vitro and in vivo efficacy against multiple human cancers including small cell lung, non-small cell lung, colon, brain, ovarian, endometrial, triple negative breast, head and neck, and pancreatic.

Clinical Trials are currently being planned with MD Anderson Cancer Centre in Houston, Texas to evaluate COTI-2 for the treatment of patients with ovarian cancer, and with Western University in London, Canada for the treatment of patients with recurrent head and neck squamous cell cancer. The Company is in the final stages of completing an Investigation New Drug filing with the U.S. Food and Drug Administration and a Clinical Trial Application with Health Canada.

How does a p53 targeted therapy differ from traditional cancer treatments?
Traditional cancer treatments have been largely unfocused in that they indiscriminately kill dividing cells, cancer or otherwise, which often leads to significant toxic side effects in patients. Targeted therapies on the other hand, try to inhibit one or more abnormal proteins that are found in proliferating cancer cells resulting in programmed cell death.

One or more mutations in the p53 gene are found in at least 50% of all human cancers. These mutations begin a sequence of events that leads to loss of control of cell growth and proliferation. Due to its central importance in many human cancers, drugs that restore function to mutated p53 proteins have been described as one of the three holy grails of cancer research.

Targeting specific abnormal proteins found only in cancer cells could be expected to be associated with less toxicity in normal healthy cells.

What would be the impact on cancer patients if COTI-2 proves to be effective in people with p53 mutant tumours?
Given the central role of p53 mutations in human cancers, COTI-2 could represent a breakthrough therapy for many cancer patients if clinical trials confirm its activity in people. If we consider a specific disease such as ovarian cancer, p53 mutations are found in more than 95% of advanced tumors. Preclinical animal experiments with a human ovarian cancer known to have a p53 mutation and be resistant to conventional chemotherapy clearly demonstrated that treatment with COTI-2 as a single agent either completely halted tumor growth or lead to dramatic tumor regression depending on the dose. COTI-2 was associated with no observable toxicity in these experiments.

Unlike nearly every other cancer treatment in existence today, COTI-2 is non-genotoxic. Conventional chemotherapy involves the killing of all growing and dividing cells in the body (cancer or otherwise), which often leads to significant toxic side effects in patients. By contrast, COTI-2 specifically targets and primarily destroys tumor cells and is expected to have reduced toxicity in people.

For more information on COTI-2, p53, and many other COTI related topics, visit our blog.

To request a non-confidential data package please contact Wayne Danter, President and CEO.

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