London, Ontario (January 20, 2010): Critical Outcome Technologies Inc. (COTI) (TSX Venture: COT)announced more positive results today from animal experiments carried out at a prominent Canadian cancer research facility. This new series of experiments adds to the impressive data package for COTI-2, demonstrating efficacy both as a single agent and in combination with current first line therapies, as well as low toxicity in several different animal models of human cancers.
This most recent study was designed to determine first, the effectiveness of oral COTI-2 as a single agent, second, the effectiveness of COTI-2 in combination with Abraxane, a standard first line therapy for advanced pancreatic cancer, and third, the toxicity of chronically administered oral COTI-2 as a single agent and in combination with Abraxane in an animal model of human pancreatic cancer (PANC-1). The following results provide strong evidence for the continued development of COTI-2 in combination with conventional single agent therapy for the treatment of pancreatic cancer:
- COTI-2 is effective as a single agent in an animal model of human pancreatic cancer.
- COTI-2 plus Abraxane was significantly more effective than Abraxane as a single agent and this result was observed by day 28 of the study.
- The combination treatment group receiving COTI-2 plus Abraxane responded earlier than the Abraxane alone.
- Complete tumor regressions were observed more frequently in the combination treatment groups than with single agent Abraxane.
- At the conclusion of the study mean tumor volumes in the Abraxane only treated animals were trending higher while mean tumor volumes in the combination treatment group were trending lower.
- Chronic oral treatment with COTI-2 as a single agent or in combination with Abraxane was well tolerated with no treatment deaths or observable toxicity over the duration of the study.
"In 2010 pancreatic cancer remains the most lethal cancer and effective oral treatments with low toxicity are urgently needed. The results of this second set of experiments confirm that chronically administered oral COTI-2 is a well tolerated effective single agent and there is enhanced efficacy in combination with Abraxane in an animal model of human pancreatic cancer," said Dr. Wayne Danter, President and CSO of COTI. "These results extend previous findings for oral COTI-2 alone and in combination with gemcitabine in pancreatic cancer. We continue to add to the impressive data set for COTI-2, showing effectiveness and low toxicity, particularly in combination with first and second line agents, against multiple cancers."
COTI will present this new data to prospective partners at BioPartnering North America taking place January 24-26, 2010 in Vancouver, Canada. "We are once again delighted with these new experimental results providing further evidence supporting the commercial potential of oral COTI-2 in pancreatic cancer," said Mr. Michael Cloutier, CEO of COTI. "This new data will stimulate further discussions as we continue to evaluate our options pertaining to a licensing arrangement for COTI-2."
About COTI-2
COTI-2 is a novel small molecule that acts by inhibition of Akt/PKB (Protein kinase B) phosphorylation that leads to caspase-9 activation in cancer cells resulting in apoptosis or programmed cell death. COTI-2 is easily synthesized and has good in vitro and in vivo efficacy against multiple cancers including small cell lung, non-small cell lung, colon, brain, ovarian, endometrial and pancreatic cancers. COTI-2 test results show it to be highly effective as a single agent therapy and as a combination therapy in a number of animal models of human cancers. COTI-2 differs from other cancer treatments in that other treatments involve the killing of all growing and dividing cells in the body resulting in significant toxic side effects while COTI-2 appears to target and destroy cancer cells only and has demonstrated low toxicity in normal human cells compared to human cancer cells. The combined scientific evidence indicates that COTI-2 is an ideal agent for combination therapy with current standard agents for a number of cancers. COTI is currently evaluating partners to share in the risk/reward of development via a licensing agreement for COTI-2. To request a non-confidential data package or discuss a partnership concerning COTI-2 please contact Michael Barr, Director of Business Development and Marketing at mbarr@criticaloutcome.com.
About Pancreatic Cancer
According to the World Health Organization (WHO) pancreatic cancer is the 13th most common cancer worldwide. WHO states that over 232,000 new cases of pancreatic cancer are diagnosed each year across the world. According to the National Cancer Institute of the United States (USA) an estimated 42,470 individuals will be diagnosed with pancreatic cancer in 2009 in the USA and 35,240 will die from this cancer. Incidence and mortality rates have remained steady for the last 30 years, indicating a great need for better, more efficacious treatments. The reasons for poor survival include the insidious and aggressive nature of the tumors, late diagnosis, low rates of resection and the lack of effective therapies.
According to WHO, there is currently no early diagnostic test or population based screening procedure for pancreatic cancer. Due to the lack of diagnostics, even better treatments will be necessary to overcome pancreatic cancer in later disease stages.
About Critical Outcome Technologies Inc. (COTI)
COTI is formed around a unique computational platform technology called CHEMSAS®, which allows for the accelerated identification and optimization of targeted small molecules potentially effective in the treatment of human diseases for which current therapy is either lacking or ineffective. Currently COTI is focused on preparing COTI-2 for an Investigational New Drug filing in the USA in 2010. In addition to COTI-2, COTI has a number of active preclinical programs in small cell lung cancer, multiple sclerosis, HIV, acute myelogenous leukemia, colorectal cancer and Alzheimer's disease.
For further information, please visit the website at www.criticaloutcome.com or contact:
Michael Barr, Director of Business Development and Marketing 519-858-5157