Presentation providing an overview of the recent milestones and next steps for getting Critical Outcome's p53-dependent cancer treatment, COTI-2, into clinical trials. This presentation was first given by Dr. Wayne Danter at Critical Outcome Technologies' annual shareholders meeting on October 21, 2014.
Critical Outcome Technologies Inc. is listed on the Toronto Venture Exchange under the trading symbol COT.
💎VVIP Kolkata Call Girls Parganas🩱7001035870🩱Independent Girl ( Ac Rooms Avai...
Pathway to the clinic and beyond
1. Pathway to the clinic … and beyond
Study design
October 2014
TSX-V: TMG
2. 2
2
Potential breakthrough treatment
Effective against many common cancers with a p53 gene mutation
> 50% of all human cancers have a p53 mutation (eg. ~ 95% of serous ovarian cancers)
COTI-2 overview
4. 4
Granted by the FDA for the treatment of ovarian cancer
Potentially qualifies us for:
Assistance in study design
Expedited drug development
Development grants & fee reductions
7-year exclusive marketing period
Orphan Drug Designation
5. 5
Very favourable cost structure
COTI contribution ~ USD 1.25 million
Remainder provided by MD Anderson
Dr. Mills and his team are very familiar with COTI-2’s mechanism of action (“MOA”)
MD Anderson has the state-of-the-art facilities, technical capabilities & expertise to execute a high quality single site study
MD Anderson LOI for Phase 1
6. 6
6
Independently confirmed COTI-2’s novel p53 dependent MOA
Confirmed COTI-2’s selective & potent anti-cancer activity
Identified effective dosage 60% lower than in prior animal experiments
MD Anderson experiments
7. 7
6th U.S. patent announced October 3, 2014
1st Japanese patent provides additional licensing opportunities in Japanese & other Asian markets
1st Canadian patent announced October 15, 2014
Patents pending in major international markets
Additional patents
8. Next steps
IND filing
First patient enrolment
Phase 1 completion
Out-license vs Phase 2
9. 9
Planning IND submission to FDA as soon as possible
Chemistry manufacturing issues resolved
30 day stability testing in progress
Possible delays due to upcoming holiday season
Targeting early December 2014 or first week of January 2015
IND filing
10. 10
Earliest first patient enrolment in February/March 2015
Depends on MDACC, State of Texas and U.S. Federal approval
According to MDACC many patients are available and waiting
First patient enrollment
11. 11
40 women with gynecological cancers
Enriched with ovarian cancer patients
No chemo/radiation for at least 28 days prior to starting
Follow for up to 6 months of treatment
Expected to take 18 months to complete
Interim data at ~ 6 months into the study
Phase 1 completion
12. 12
Positive Phase 1 results create important options:
Out-license
Validates scientific platform and commercial strategy
May not realize maximum shareholder/asset value
Phase 2
Moon shot project at MDACC possible
Maximizes asset value
Out-license vs Phase 2
13. 13
13
U.S. ovarian indication
~ 190k patients - ~ 96% have a p53 mutation
If COTI-2 has meaningful affect on 50% of these ~ 91,200 patients
If drug cost to patient is USD 10K per year = USD 912M or ~ CAD 1B
At a 10% annual royalty = CAD 100M
__________________
Many other indications with p53 mutations are being explored including combination therapy
COTI-2 revenue potential
15. 15
Therapy Library /Compound
Target
CHEMSAS
Lead Selection
Synthesis
Preclinical
Phase 1
Oncology
COTI-2
AML
Colon
Small Cell Lung Cancer Library
COTI-219
COTI-4
COTI-58
6 other leads
Plus projects for MRSA, Multiple sclerosis, Alzheimer’s, and HIV Integrase Inhibitors
Drugs in our pipeline
16. 16
Three existing R&D collaborations expected to bring in milestone payments beginning in 2015
Western University
Delmar Chemicals
Major Pharma Co.
Pursuing additional collaboration opportunities
R&D collaborations
17. 17
17
CHEMFirm – Small molecule profiling & investment due diligence tool
Drug library profiling – Based on customer identified criteria
Drug repurposing – Finding new purposes for drugs coming off patent
Other CHEMSAS applications
18. 18
18
Programmable computer simulation of human cancer cell signaling
Better personalized treatment decisions based on genetic profile of one’s cancer
Personalized cancer gene profiling projected to be ~ USD 35B market by 2018*
* Markets and Markets (2013)
Other applications: ROSALIND
19. 19
1
2
3
COTI-2 in the clinic in 2015
COTI-2 = significant revenue potential
Pipeline of other revenue opportunities
Reaching a tipping point
20. 20
When used anywhere in this presentation, whether oral or written, the words expects, believes, anticipates, estimates and similar expressions are intended to identify forward- looking statements. Forward-looking statements may include statements addressing future financial and operating results of Critical Outcome Technologies Inc. (COTI).
COTI bases these forward-looking statements on its current expectations about future events. Such statements are subject to risks and uncertainties including, but not limited to, the successful implementation of COTI’s strategic plans, the acceptance of new products, the obsolescence of existing products, the resolution of potential patent issues, competition, changes in economic conditions, and other risks described in COTI’s public documents such as press releases and filings with the Toronto Stock Exchange and the Ontario Securities Commission.
All forward-looking statements are qualified in their entirety by the cautionary statements included in this document and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by forward-looking statements contained in this presentation. These forward-looking statements speak only as of the date of this presentation.
Disclaimer