Bone Metastasis – Breast and Prostate cancer
About one million new cases of breast and prostate cancer are diagnosed each year (GLOBOCAN 2008). Metastases are secondary malignant growths that develop through interactions between tumor cells and normal tissue in vital organs. It is responsible for 90% of deaths in cancer patients with solid tumors.
Bone is one of the most common locations for metastasis. It is characterized by severe pain and disabling bone damage that causes a drastic reduction in the patient's quality of life. It is the only type of metastasis that can be controlled, but not cured, by specific drugs. Treatment is only given once the metastasis has been identified, which is often too late. Identifying bone metastasis at an early stage is crucial to improving the patient's quality of life.
Current preventive treatment for bone metastasis is expensive and comes with undesirable side effects. With only 15-20% of cancer patients likely to develop metastasis, identifying these patients at an early stage is crucial, as indiscriminate administration of medications is not a viable option.
Thousands of high-risk patients have been involved in clinical trials for preventative bone metastasis drugs. The somewhat inconclusive results of these trials have not yet influenced routine clinical practice. This highlights an urgent medical need for an early stage diagnostic test that more selectively identifies high-risk bone metastasis in breast cancer and other primary tumors
Predictive Biomarker - OSTEOMET
Inbiomotion has discovered a single biomarker to predict the risk of bone metastasis relapse in breast cancer and primary tumors. The biomarker, OSTEOMET, is independent of any other clinical/pathological parameters for metastasis. It has been extensively studied in retrospective breast cancer patients (>900), demonstrating that it can identify patients with the highest risk of tumor metastasis specific to the bone.
OSTEOMET is currently being tested in several solid tumors, including breast and prostate. It has been evaluated using various analytical platforms (FISH, IHC, gene expression). Its ability to predict the patient's response to therapies for prevention or alleviation of bone metastasis is also being evaluated.
The OSTEOMET biomarker could be the first companion diagnostic used in treatment strategies for bone metastasis prevention. Because OSTEOMET has the ability to select patients at a higher risk of bone metastasis, it can also support the validation of preventive drugs and increase the efficiency and probable success rate of phase III drug trials.
- One single gene/protein level in stage I, II and III primary tumor biopsies that can predict bone metastasis at the first site of relapse
- Proprietary bone metastasis biomarker is independent of any known clinicalpathological parameter known for metastasis prediction
- Univariate statistical analysis significantly associated the biomarker with bone metastasis
- Multivariate statistical analysis confirmed the clinical significance of independence of our biomarker from any other clinical-pathological parameter currently applied in the standard of care
- Biomarker has a causal role in cancer to bone metastasis. Loss-and-gain-offunction experiments in experimental mouse models of metastasis suggest a driver role in bone metastasis processes
- Various platforms (IHC, mRNA and FISH) have been used for validation (n>900). An NPV (negative predictive value) > 95% has been observed using the different platforms