helping patients who are at increased risk for developing colorectal cancer
Colorectal cancer is one of the most common causes of cancer, and proper screening and early detection are keys to preventing the disease. But not all pre-cancerous cells can be seen with standard screening techniques—in particular, those that are “flat” in architecture.
The University of Michigan has developed an innovative fluorescent-labeled peptide screening technique that targets molecules on the surface of abnormal tissues. This results in earlier detection of hard-to-identify pre-cancerous and cancerous lesions in patients.
Significant Need
A higher diagnostic yield may either reduce the need for additional exams or extend the times between exams. Patients would be able to minimize the physical discomfort associated with taking the prep and the inconvenience of undergoing sedation for the procedure.
Competitive Advantage
This advanced imaging may improve detection and prevention of colorectal cancer because it is sensitive to flat lesions and gross polyps and allows doctors to look at molecular targets rather than structural changes. Standard screening techniques have a significant miss rate of hard-to-detect lesions.
Commercialization Path
- Intellectual Property – Patent filed with the United States Patent and Trademark Office
- Commercialization Strategy – Plan is to license Intellectual Property rights
- Regulatory Pathway – Investigational New Drug (IND) and amendment to IND submitted to FDA, PI trial is underway
- Engage Investors – Interest should increase with results of Phase 1 clinical study—MTRAC funds are being used to support the initial clinical trial, which will be complete by mid-2015
- Product Launch Strategy – To be determined by licensee
Milestones
- Obtain FDA and IRB approval for Phase 1B clinical studies to collect fluorescence images
- Collect fluorescence images of colonic dysplasia in n=25 subjects for Phase 1B study
- Quantify fluorescence images and measure target-to-background ratios for dysplasia detection
- Evaluate performance (sensitivity, specificity, predictive value) for detection of colonic dysplasia
- Q316 Update: $500,000 follow-on funding
