Scottish biotechnology firm Edinburgh Molecular Imaging (EM Imaging) has announced the commencement of a ‘pivotal’ Phase IIb clinical trial in patients with high suspicion of colorectal cancer (CRC). The company focuses on enabling image-guided therapy, and will use its novel compound, EMI-137, in the trials.
EMI-137 is a fluorescent Optical Imaging agent that targets and ‘lights up’ cancer cells, helping surgeons to more easily identify and remove suspicious tumours. EMI-137 targets the cancer marker C-Met, which is overexposed in CRC cells and cancer precursor cells.
Colorectal cancer is globally the third most common cancer with approximately 41,000 people diagnosed every year in the UK, and over 1.4m people worldwide. Imaging with white light colonoscopy is the established method for the diagnosis and prevention of CRC, however, up to a quarter of cancerous and precancerous bowel cancer tumours can be missed using this method.
Ian Wilson, CEO of Edinburgh Molecular Imaging, commented: “The identification of flat, small non-polypoid lesions is a major problem as they cannot be detected by conventional imaging. EMI-137 has the potential to address this major unmet medical need by combining targeted molecular imaging probes and advanced imaging technology to improve polyp detection. Our team is extremely motivated to complete this product’s development and get it into the hands of physicians in order to benefit patients.”
Deborah Alsina MBE, Chief Executive of Bowel Cancer UK, added: “More than 9 out of 10 people will survive bowel cancer if it is detected at an early stage when treatments are more likely to be effective. Optical imaging techniques, using agents like EMI-137, could potentially reduce the number of polyps missed during colonoscopy, therefore significantly improving outcomes for patients.
“This next phase of the research will help us understand whether this method could be introduced routinely in practice and offer real benefits to patients. It is vital that that the UK and Europe continue to invest in studies and clinical trials to keep finding quicker and more effective ways to identify and diagnose patients early when the disease is curable.”
The phase IIb study will be conducted by the Centre for Human Drug Research (CHDR), a world renowned clinical research organisation based in Leiden, in collaboration with the Leiden University Medical Centre and the University Medical Center of Gröningen, The Netherlands.
The objective is to assess the efficacy of EMI-137 in aiding clinicians to detect pathological lesions during colonoscopy. The study will involve up to 200 patients with a high suspicion of CRC, and interim results from the trial are expected in the first quarter of 2018. EM Imaging and CHDR collaborated on the Phase I study of EMI-137, which showed a 25% increase in bowel cancer lesion detection compared to standard colonoscopy. According to EM Imagine, improved polyp detection in this study might lead to further studies in extended target populations and, possibly, in the end to a wider adoption of fluorescence-guided endoscopy.
The firm is also working with doctors and clinical centres in the UK, Europe, US, and Asia to use EMI-137 to detect tumours during surgery. Studies are planned to look at improving cancer detection in a range of cancers including Breast Cancer, Gastric Cancer, Thyroid Cancer, Head & Neck Cancer, Prostate Cancer and Brain Cancer.