LONDON, ONTARIO–(Marketwired – Sept. 10, 2014) – Critical Outcome Technologies Inc. (“COTI” or the “Company”) (TSX VENTURE:COT)(OTCQB:COTQF), the bioinformatics and accelerated drug discovery company, has successfully completed additional and definitive testing confirming COTI-2’s p53-dependent mechanism of action. The additional animal experiments were requested as part of Portage Biotech Inc.’s (“Portage”) due diligence related to the non‐binding letter of intent to form a joint venture previously announced on February 26, 2014.
This series of animal experiments carried out by Dr. Gordon Mills, Chair of Systems Biology at The University of Texas MD Anderson Cancer Center (“MD Anderson”) in Houston, yielded data clearly demonstrating the selective and potent anti-cancer activity of oral COTI-2. In these experiments, tumors of three specific common mutations of p53 and one mutation without the p53 gene present were allowed to grow in mice. Treatment with oral COTI-2 at both 30 mg/kg and 75 mg/kg produced dramatic growth inhibition in tumors with the p53 mutations but had no effect on the tumors without the p53 gene. The treatment was well tolerated by the animals.
“P53 mutations are the most common genetic aberration in ovarian cancer. Unfortunately, p53 mutations have not previously been targetable,” said Dr. Mills. “The marked activity of COTI-2 in ovarian cancer models and specifically in p53 mutant models makes this an exciting opportunity. We are looking forward to testing COTI-2 in clinical trials at MD Anderson.”
“These highly compelling data have important implications, not only for their strong confirmation of COTI-2’s p53-dependent mechanism of action, but also for our upcoming Phase 1 study,” said Dr. Wayne Danter, COTI’s Chief Executive Officer. “The experiments further extend our understanding of how well COTI-2 is likely to work in human cancers with specific p53 mutations. The impressive potent single agent anti-tumor activity at a well-tolerated dose 60% lower than the dose previously used in similar experiments should translate into better efficacy and even better safety for our upcoming Phase 1 study.”
Since announcing the proposed joint venture with Portage, the Company has continued the development of COTI-2. This has included the successful completion of the two-species toxicity studies, obtaining an Orphan Drug Designation for ovarian cancer, and moving closer to the completion of an investigational new drug filing with the United States Food and Drug Administration. As announced on September 8, 2014, the identification and engagement of a clinical partner, MD Anderson, for a Phase 1 study on favourable financial terms has added further value to the asset. With these important developments and the significant added value to the asset, the Company has decided not to pursue the proposed joint venture with Portage. Based upon the positive relationship developed with Portage there may be opportunities for the two companies to work together in the future.
About p53 Gene Mutations
For more information on p53 gene mutations, visit the Company’s blog at: www.criticaloutcomeblog.com/blog-posts.
About Critical Outcome Technologies Inc.
COTI is a leading-edge technology company specializing in accelerating the discovery and development of small molecules – dramatically reducing the time and cost to bring new drugs to market. COTI’s proprietary artificial intelligence system, CHEMSAS®, utilizes a series of predictive computer models to identify compounds with a high probability of being successfully developed from disease specific drug discovery through chemical optimization and preclinical testing. These compounds are targeted for a variety of diseases, particularly those for which current treatments are either lacking or ineffective.
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Notice to Readers
Information contained in this press release may contain certain statements, which constitute “forward- looking statements” within the meaning of the Securities Act (Ontario) and applicable securities laws. For example, the statement “We are looking forward to testing COTI-2 in clinical trials at MD Anderson” and “… important implications, not only for their strong confirmation of COTI-2’s p53-dependent mechanism of action, but also for our upcoming Phase 1 study” and “… should translate into better efficacy and even better safety for our upcoming Phase 1 study” and “… may be opportunities for the two companies to work together in the future” are forward-looking statements. Forward‐looking statements by their nature are not guarantees of future performance and are based upon management’s current expectations, estimates, projections and assumptions. COTI operates in a highly competitive environment that involves significant risks and uncertainties, which could cause actual results to differ materially from those anticipated in these forward‐looking statements. Management of COTI considers the assumptions on which these forward‐looking statements are based to be reasonable, but as a result of the many risk factors, cautions the reader that actual results could differ materially from those expressed or implied in these forward-looking statements. Information in this press release should be considered accurate only as of the date of the release and may be superseded by more recent information disclosed in later press releases, filings with the securities regulatory authorities or otherwise.
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