EMI137

Edinburgh Molecular Imaging Commences Phase II European Cancer Trial

Novel Compound with Potential for Early Detection and to Guide Treatment of Colorectal Cancer

Edinburgh, UK – 19 September 2017: Edinburgh Molecular Imaging (EM Imaging), the clinical phase biotechnology company focused on enabling image-guided therapy, announces it has commenced a pivotal Phase IIb clinical trial with its novel compound, EMI-137, in patients with high suspicion of colorectal cancer (CRC).  EM Imaging is backed by Epidarex Capital together with Scottish Investment Bank and Wren Capital.

Colorectal cancer is the third most common cancer worldwide with approx. 41,000 people diagnosed every year in the UK and over 1.4 million 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.

EMI has developed a novel fluorescent Optical Imaging Agent – EMI-137 – which targets and “lights-up” the cancer cells, helping surgeons to more easily identify and remove suspicious tumours.  EMI-137 targets the cancer marker C-Met, which is overexpressed in CRC cells and cancer precursor cells.

The phase IIb study will be conducted by the Centre for Human Drug Research (CHDR), a world renowned clinical research organization based in Leiden, in close collaboration with the Leiden University Medical Centre and the University Medical Center of Gröningen, The Netherlands.  The Clinical Investigators at these sites are Professor James Hardwick and Dr Wouter Nagengest, who are among Europe’s leading clinicians advancing the diagnosis and treatment of colorectal cancer.

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 objective of the clinical study 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.  Interim results from the trial are expected in Q1 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.

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.

EM Imaging 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.

ENDS

Further information:

Edinburgh Molecular Imaging

Ian Wilson
Tel: +44 131 658 5307
Email: media@emimaging.com
@edinimage  #CRCcure

Centre for Human Drug Research
Josine Vrouwe, MD
Email: jvrouwe@chdr.nl
Tel:  +31 71 751 7163
For patients: www.proefpersoon.nl

About Edinburgh Molecular Imaging

Edinburgh Molecular Imaging (EM Imaging) is a clinical phase biotechnology company focused on enabling image-guided therapy. The Company’s molecular imaging technology, based on Fluorescent Imaging, has the potential to detect disease in real-time during interventional procedures including surgery, providing more accurate treatment while sparing healthy tissue.

EM Imaging discovers and develops small molecules and peptides that, when conjugated with fluorescent dyes, targets diseased tissue – specifically cancerous cells. This will provide the clinician with a clearer view and decision-making tool to benefit the patient.  For more information go to: www.emimaging.com

About Centre for Human Drug Research

The Centre for Human Drug Research (CHDR) is a world renown Clinical Research Organisation in Leiden, The Netherlands with strong academic links which focuses on early drug development. Its mission is to develop compounds, therapeutic or diagnostic in an innovative and highly informative manner to allow early introduction of novel treatment paradigms into the clinic.  ww.chdr.nl

About Epidarex Capital

Epidarex invests in early-stage, high growth life science and health technology companies in under-ventured markets in the US and Europe.  With offices in Bethesda, Maryland and in Edinburgh, Scotland, Epidarex works closely with the management of its portfolio companies to more effectively translate their world-class research to commercial, patient-driven success.

Epidarex’s international management team has a track record of successfully partnering with scientists and entrepreneurs to develop highly innovative products for the global healthcare market. Its global network includes investment professionals, scientists, industry executives, health practitioners, policy experts, regulatory advisors and business development leaders.  More information is available at www.epidarex.com

References

http://www.cancerresearchuk.org/about-cancer/type/bowel-cancer/about/risks/high-risk-groups-for-bowel-cancer

 

 

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Edinburgh Molecular Imaging and Mauna Kea Technologies Announce Clinical Molecular Imaging Collaboration

 

 

 

Edinburgh and Paris, April 6th, 2016 – Edinburgh Molecular Imaging Ltd (EM Imaging) and Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) today announced a clinical research collaboration to study the potential of combining EM Imaging’s in vivo optical imaging agents and Mauna Kea’s confocal laser endomicroscopy platform to diagnose cancer.  The combination of novel molecular imaging agents and advanced visualisation such as endomicroscopy is a promising avenue for advancing personalised cancer diagnosis.

 

In a first study, EM Imaging will supply EMI-137, a safe and well-tolerated clinical grade investigational molecular optical imaging agent to two investigational sites to perform clinical efficacy studies in pancreatic and lung cancers. The Edinburgh Royal Infirmary will evaluate suspected lung cancer patients while Groningen Medical Centre will study EMI-137 in early stage pancreatic cancer. Both centres will image EMI-137 in real time at the cellular level using endomicroscopy with Cellvizio.

 

Intravenous administration of EMI-137 leads to its selective accumulation in c-Met–expressing tumours, which can then be detected optically via fluorescent markers that are attached to the molecular imaging agent. c-Met is a receptor tyrosine kinase, whose over-expression is known to be associated with tumour growth and correlates with a poor clinical prognosis in many cancer types.

 

“We have been at the forefront of image-guided surgery with novel molecular markers and advanced imaging modalities for several years. With Cellvizio and EMI-137, we will now enable for the first time highly specific real-time imaging at the cellular level in solid tumors” said Prof Go Van Dam, Professor of Surgical Oncology, and Dr Wouter Nagengast  from the Optical Molecular Imaging Group (OMIG) at the University Medical Center Groningen (UMCG). “This combination of molecular markers, targeted macroscopic image-guided surgery/endoscopy and endomicroscopy represents a significant clinical milestone that we are about to embark upon.”

 

“Lung Cancer is the biggest cancer killer in the world and any methodologies that could allow us to improve diagnosis, treatment monitoring and surgical resection are urgently required” said Dr Kev Dhaliwal, Senior Lecturer in Pulmonary Molecular Imaging at the University of Edinburgh and Consultant Pulmonologist at the Royal Infirmary of Edinburgh. “, We will evaluate the potential impact of Cellivizo and EMI-137 in our patients working alongside surgeons and pulmonologists at the University of Edinburgh”.

 

In a second project, it is planned that EM Imaging will provide EMI-200, a neutrophil targeting optical molecular imaging agent developed for topical administration in the lung. The presence of neutrophils in the lung is correlated to an inflammatory response and as such is clinically useful in the acute care setting to improve diagnosis of critically ill patients. Studies will be performed under an investigator-sponsored eIND (Emergency Investigational New Drug) at Cleveland Clinic in acute care patients. In this study, the Cellvizio platform will also be used to image neutrophil activity in real-time at the cellular level.

 

“Early detection and verification of disease at the point of care continues to be a major challenge to patient care and management” said Ian Wilson, CEO of EM Imaging. “This collaboration potentially addresses these major unmet medical needs by combining targeted molecular agents with the most advanced imaging technology available to improve disease detection and guide intervention. We look forward to pioneering this approach with Mauna Kea and our clinical partners.”

 

“Combining our unique endomicroscopy platform with highly-specific molecular markers from EM Imaging is another key milestone in our development strategy to bring in vivo examination to a level never reached by existing standards. We are delighted to partner with EM Imaging and  leading clinical institutions such as the UMCG, Cleveland Clinic and Edinburgh  with the common goal to revolutionize the way cancer patients are diagnosed.” said Sacha Loiseau, Ph.D., CEO and founder of Mauna Kea Technologies, ”We continue to deliver on our ambitious roadmap and look forward to the first in-human clinical results of this cutting-edge endeavour.”

 

About Edinburgh Molecular Imaging (www.emimaging.com)

EM Imaging is a diagnostic company, with a comprehensive R&D portfolio, focused on the development and commercialisation of optical molecular imaging agents. The EM Imaging team is made up of industry and academic experts in the field of imaging, chemistry, clinical development, regulatory affairs and commercialisation of in vivo diagnostic imaging products.

 

 

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company focused on eliminating diagnostic and treatment uncertainties thanks to direct visualization at the cellular level. The Company’s flagship product, Cellvizio, has received clearance to sell for a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, visit www.maunakeatech.com.

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