INSTITUTE: UiB
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Challenge
Over 250.000 leukemia new cases are diagnosed annually worldwide. Mortality rate and treatment of patients depends on various clinicopathological parameters such as the cytogenetic analysis. In addition to this gold standard method, several predictive biomarkers of survival (prognostic markers) have been proposed to estimate the individual patient’ risk at the diagnosis time. These markers can help clinicians to decide an optimized treatment strategy (e.g. standard chemotherapy vs. stem cell transplantation).
Technology
The invention relates to a detection method of a novel gene – RINF (Retinoid-Inducible Nuclear
Factor) – that predicts survival of some leukemia patients. Our preclinical studies have recently demonstrated the essential role of RINF, in vitro, for the maturation process of both normal and tumoral blood cells. By investigating RINF expression level in blood and bone marrow samples from leukemia patients at diagnostic time, we have now obtained solid evidences that RINF is a strong biomarker of patients’ survival for some leukemia subtypes (retrospective clinical studies).
We have developed a quantitative RT-PCR-based test that offers several technological advantages:
sensitive (RINF is detected in all samples investigated), accurate (low variability between replicates), highly predictive and informative (strong statistics, allow the distinction of a large proportion of patients with high risk), fast (tested locally), easy (less cumbersome than microarray approaches), and relatively low cost (PCR-based).
Commercial Opportunity
Our invention is of interest for clinicians, leukemia patients, researchers and companies that wish to incorporate RINF detection technology into their prognostic or predictive products (microarrays, multiplex PCRs, etc) in the cancer field.
In 2008, about 245.000 individuals in US were affected with some form of leukemia, including those that have reached remission or cure. Global cancer market in 2008 was valued at $47.7bn, an increase of 16.1% over 2007 sales of $41.1bn. It is forecast to return a CAGR of 8.2% within 2008-2014, reaching $76.7bn in 2014.
Geographic sales distribution in cancer market is mainly along the lines of overall pharmaceutical market with US, France, Germany, Italy, Spain and the UK as the major markets. Leukemia prevalence in these countries is expected to grow from 221,700 in 2008 to 228,230 in 2014 . The 7 countries represented 79.5% of sales ($38bn) in 2008, an increase of 14.8% over 2007. US dominated the global cancer market with 2008 sales of $18.7bn and a market share of 39.1%. The 5 major EU markets delivered a stronger sales growth rate of 21.2% within 2007-2008, recording 2008 sales of $14bn.
Development Status
In addition to preclinical studies, the proof of concept of our prognostic biomarker was established in retrospective clinical studies by using 2 different technologies (microarray & quantitative RT-PCR). Our data are now being validated in a larger patient cohort and will be possibly extended to other types of cancers. The technology is offered for licensing and/or co-development.
Patent Situation
PCT/NO09/000214 – Completed national phases:
Japan P11828JP00
USA P11828US00
Norway P11828NO02
EPC P11828EP00