Critical Outcome Technologies Provides Updates Regarding its Lead Cancer Drug Candidate, COTI-2
London, Ontario, September 10, 2014 (Newswire.com) - Critical Outcome Technologies ("COTI" or the "Company") (TSX VENTURE:COT)(OTCQB:COTQF) is pleased to announce that it has completed definitive experiments with its lead cancer drug candidate, COTI-2 and that the Company has signed an LOI with MD Anderson regarding the phase 1 development of COTI-2 in gynecological cancers.
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.
"We are looking forward to this partnership with MD Anderson and believe the collaboration will result in COTI-2 one day becoming a breakthrough therapy not only for ovarian cancer patients, but for many patients with other common cancers," said Dr. Wayne Danter, COTI's Chief Executive Officer. "MD Anderson ranks as one of the world's most respected cancer centers focused on patient care, research, education, and prevention. It has the state-of-the-art facilities, technical capabilities and expertise to successfully execute the clinical development of COTI-2. Dr. Mills and his team at MD Anderson have been conducting experiments with COTI-2 for the past 21 months and are now very familiar with its mechanism of action and we believe are in the best position to partner with us as we move the compound forward into clinical trials."
Dr. Wayne Danter, President of Critical Outcome Technologies
"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."
Under the terms of the LOI, the Company and MD Anderson will work together to design and conduct a first in humans (Phase 1) study with oral COTI-2 in up to 40 women with advanced gynecological cancers who have failed conventional therapy. For the purposes of the study, the term “gynecological” cancers refers to cancers of the ovary, endometrium, and cervix. The parties have negotiated a cost structure for the clinical trial that is very favorable to the Company. COTI’s contribution is estimated at approximately $1.25 million USD with the remainder of the costs provided by MD Anderson as in kind monitoring, testing and pharmacy capabilities. The parties anticipate that patient recruitment for the Phase 1 clinical trial will begin in early 2015. The co-principal investigators for the COTI-2 Phase 1 clinical trial will be Dr. Gordon B. Mills, Chairman, Department of Systems Biology, Wiess Distinguished University Chair in Cancer Medicine, Co-Director, Institute for Personalized Cancer Therapy at MD Anderson and Dr. Shannon Westin MD, MPH Assistant Professor, Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson.
Additional details will be communicated when the definitive agreement has been completed.
About The University of Texas MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center is one of the world’s most respected centers devoted exclusively to cancer patient care, research, education, and prevention. The mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public. At MD Anderson, important scientific knowledge gained in the laboratory is rapidly translated to clinical care. Overall, MD Anderson's research program is considered one of the most productive efforts in the world aimed solely at cancer.
About Critical Outcome Technologies Inc.
COTI is a leading-edge bioinformatics 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.
