Lung Cancer/Breast Cancer – Annexins

Lung cancer remains the leading cause of cancer death worldwide, accounting for nearly one fifth of all cancer related deaths (WHO statistics). In the US, lung cancer is the second most common cancer in men and is second or third in women, depending on race. It is estimated that 140,000 new cases are diagnosed in the US annually, with 155,000 deaths. More people die of lung cancer than of colon, breast and prostate cancers combined. About 2 of every 3 people diagnosed with lung cancer are older than 65 and less than 3% of all cases are found in people younger than 45.

Global estimates by the NIH, USA, suggest that as many as 25% of all lung cancers worldwide are not attributable to smoking.

Historically in the early stages of lung cancer there are few symptoms and there have been no reliable early diagnostic tests. Patients tend to be diagnosed with advanced disease where surgery is not possible. These patients have poor prognosis with a 90% 5-year death rate. This contrasts with patients for whom surgery is possible where around 50% of patients remain disease free after 5 years. Only 25% of non-small cell lung cancer is diagnosed at an early stage when curative surgical intervention is still possible.

Lung cancers can be divided into two main groups. Non-small cell lung cancer accounts for 80% of cases and has slower progression than small cell lung cancer, which accounts for the remaining 20% of cases. Within non-small cell lung cancer there are further sub-divisions into adenocarcinoma, squamous cell carcinoma and large-cell carcinoma.

Proteome Sciences has studied the protein expression profiles of lung tumours, and identified key markers of disease in tissue and blood as early diagnostics and targets for immunotherapy. Antibodies/autoantibodies have been identified in the blood of patients with lung tumours that specifically react with these marker proteins, even at the earliest stages of disease.

The first blood test for lung cancer was launched at the end of May 2009 in the USA using Proteome Sciences&rquot; annexin autoantibodies. Recent reports in the US media indicate that the test has got off to a good start with 20 sites offering the test in September and this is expected to increase to over 100 sites in the next six months. The lung cancer blood test is expected to launch in the UK and Continental Europe in 2010.

Doctors have been claiming that the test can detect lung cancer three to five years sooner than finding clinical symptoms or through X-ray or CT scans. This is supported by a paper in Journal of Clinical Oncology, November 2008. The test is showing an 80% improvement in specificity over CT scans alone and , by nature of its early utility, survival rates in lung cancer that are notoriously low after late detection at around 15% can show dramatic improvements to 50% to 80% through earlier diagnosis. The test may become as routine as a PSA test for prostate cancer or mammograms for breast cancer and 50 to 70 million people in the US could potentially benefit from having a lung cancer test done on a regular basis.

Differential expressions of the annexin proteins have also been highlighted in recent abstracts and presentations in breast cancer, demonstrating their novel utility and application for early diagnosis, for assessing the suitability of chemotherapy and as a target for therapy (Applied Immunohistochemistry, December 2008; European Journal of Cancer, May 2009; University of North Texas Science Centre, May 2009).

Proteome Sciences biomarker patents cover these uses and non-exclusive licenses are available including annexins for lung cancer diagnosis and for a range of differing applications in breast cancer.

Multiple new avenues and opportunities in diagnostics, prognostics and drug development are opening up as a result of these recent developments. Proteome Sciences, as leaders in the field, can grant licenses to biomarkers and IP in lung and breast cancer and can also provide full biomarker services and rapid assay development through its ISO 9001:2008 accredited facilities for all aspects of drug development.