London, Ontario (March 30, 2010): Critical Outcome Technologies Inc. (COTI) (TSX Venture: COT) announced positive test results today 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.
"We chose to study this particular model of human breast cancer because it exemplifies an aggressive form of the disease that accounts for about 20% of all breast cancers. Moreover, we wanted to explore recent scientific data indicating that the PI3K/AKT/mTOR pathway is activated in TNBC. We were pleased to see impressive efficacy shown in this study," said Dr. Wayne Danter, President and CSO of COTI. "TNBC responds poorly to commonly used targeted therapies. There are high relapse rates following traditional therapies and as a result there is a clear unmet medical need. Drugs that we have previously studied in combination with COTI-2 like gemcitabine, doxorubicin and various taxols have demonstrated clear evidence of combination benefit and low toxicity in several other models of human cancers. Taken together these results are encouraging and support further evaluation of COTI?]2 in combination with other agents like taxols for the potential effective treatment of triple negative breast cancer," said Dr. Danter.
"We are delighted with these new scientific results which provide evidence to support the commercial development of COTI-2 in breast cancer," said Mr. Michael Cloutier, CEO of COTI. "We look forward to sharing this promising new data with parties who have expressed a licensing interest in COTI-2."
Notice to Readers
Information contained in this press release may contain certain statements which constitute "forwardlooking statements" within the meaning of the Securities Act (Ontario) and applicable securities laws. For example, the statements "supportive evidence for the continued evaluation of COTI-2 for the treatment of breast cancer" and "sharing this new data with parties who have expressed interest in a partnership related to COTI-2" 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.
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, triple negative breast 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 seeking a licensing partner to develop COTI-2. To request a non?]confidential data package or to discuss a partnership concerning COTI-2 please contact Michael Barr, Director of Business Development and Marketing at mbarr@criticaloutcome.com.
About Triple Negative Breast Cancer
According to the World Health Organization breast cancer affects over 1 million people worldwide. Around 20% of all breast cancer patients are 'triple-negative', meaning that they are ER?]negative, PgRnegative and HER-2-negative. Breast cancer is generally diagnosed based upon the presence, or lack of, three receptors known to fuel most breast cancers: estrogen receptors, progesterone receptors and human epidermal growth factor receptor 2. The most successful treatments for breast cancer target these receptors. However, none of these receptors are found in women with triple negative breast cancer. Due to the lack of these receptors, these tumors do not respond well to receptor targeted treatments. Triple negative breast cancer can be particularly aggressive, and more likely to recur than other subtypes of breast cancer.
About Critical Outcome Technologies Inc. (COTI)
COTI is formed around a unique computational platform technology called CHEMSAS, which allows for 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. COTI is focused on preparing COTI-2 for an Investigational New Drug filing in the USA in 2011. Including COTI-2, the company has a significant preclinical pipeline targeting large market opportunities such as: small cell lung and colorectal cancer, adult acute leukemia and other cancers, multiple sclerosis, HIV integrase, and Alzheimer's disease.
For further information, please visit the website at www.criticaloutcome.comor contact:
Michael Barr, Director of Business Development and Marketing mbarr@criticaloutcome.com 519-858-5157
