Stable Gene Transfer in Hard-to-Transfect Vertebrate Cells with New Hyperactive Sleeping Beauty Transposase
Referenznummer TO 03-00307
The Challenge
Colorectal (CRC) and Gastric cancer (GC) are among the leading causes of cancer-related death in the world. About 90% of such cancer deaths arise from the metastatic dissemination of primary tumours. Therefore, early detection of tumours and their metastatic potential is critical for improving patient care.
To date, a non-invasive method for diagnosing synchronous metastasis and for discerning the risk of developing metachronous metastasis is not available.
A non-invasive blood-based test for early identification of high risk cancer patients would be of special value due to the high acceptance of this type of diagnostic approach among patients. Additionally, blood-based diagnostics allow easy monitoring of disease progression, therapy efficacy and response.
Technology
The protein product of the gene S1004A has long been known to act as metastasis inducer. High S1004A expression levels correlate with aggressiveness and poor prognosis and/or metastasis in CRC as well as in GC. But all tests so far are done directly in tumour tissues.
The technology provides for the first time the possibility to measure transcript levels of the metastasis-promoting gene S1004A non-invasively. A reliable and simple plasma-based assay via a quantitative RT-PCR has already been established.
Validating data show i.a. that
- plasma S1004A transcripts were increased in CRC (n=375) and GC patients (n=91, P<0.0001) in comparison to tumour-free subjects (n=51).
- plasma levels were increased in all disease stages (P<0.05).
- prospectively analyzed follow-up patients who later metastasized showed higher marker levels than non-metastasized follow-up patients.
- disease-free survival was decreased in high S1004A-expression follow-up CRC patients (P=0.013).
The present invention therefore offers new options to:
- develop S1004A as a biomarker for CRC and GC metastasis at the time of diagnosing the primary tumour
- develop a companion diagnostic marker for accompanying treatment of CRC and GC.
Commercial Opportunity
- In-licensing of IP for developing a diagnostic/prognostic assay based on measuring the marker in body fluids
Patent Situation
A priority claiming US provisional has been filed in November 2009, a PCT application is pending.
Further Reading
A manuscript is under review. Detailed data can be presented under a CDA.
