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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@edinimage.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.edinimage.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 Supports BHF Grant

Edinburgh Molecular Imaging is proud to support the University of Edinburgh team.
The researchers aim to create new chemicals – known as tracers – to illuminate these unstable plaques in patients. The tracers – which contain small amounts of radioactivity – are injected into the bloodstream and stick to the plaques. This allows their detection on an imaging technique known as positron emission tomography (PET) scanning.

See link below:
http://www.ed.ac.uk/medicine-vet-medicine/news-events/latest-news/ps1-8m-bid-to-beat-heart-disease-targets-unseen-ri?utm_campaign=1814884_SCOPE%20CMVM%20staff%20newsletter%20-%20June%202017%20v2&utm_medium=email&utm_source=College%20of%20Medicine%20and%20Veterinary%20Medicine%2C%20The%20University%20of%20Edinburgh&dm_i=2MP1,12WDG,74YGDT,38Y8Y,1

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EM Imaging in the News

The EM Imaging team hosted Paul Wheelhouse MSP, Minister for Business, Innovation and Energy at our laboratories and offices at Edinburgh Bioquarter. We took the opportunity to explain the value of being based near world leading clinicians who can help us drive our products through clinical trials and to market. We also used this opportunity to campaign for Government and NHS support to drive adoption of our technology within Scotland.

Link to news article http://www.bbc.co.uk/news/uk-scotland-38829002

 

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Biotech Showcase

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Our CEO Ian Wilson will be at the Biotech Showcase on January 9–11 in San Francisco. Contact him through the partnering system to arrange a meeting.

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EM Imaging Win Best Emerging Medtech Company Award

logo        OBN Awards 2016 – Winners Recognised at Industry Leading Event

At the OBN Awards 2016 dinner in Oxford last night,  Edinburgh Molecular Imaging were awarded the Best Emerging Medtech Company Award.

EM Imaging CEO Ian Wilson celebrates wining the Best Emerging Medtech Company Award at OBN 2016.
obn-awards-16-award-eight-best-emerging-medtech-company-winner-edinburgh-molecular-imaging
The Awards, which are in their 8 th year, celebrate the best of UK life sciences – outstanding innovation, fundraisers and achievements – underlining the pre-eminence of the UK sector in the global marketplace.
John Harris, CEO of OBN , said: “We are thrilled with the high quality of nominees this year which made picking just one winner in each category very difficult.   We work hard to keep the awards fresh and have introduced several new categories this year to reflect industry trends. The turn-out and support we’ve received is a true reflection of how buoyant our industry is and I would like to thank our sponsors for helping us make the OBN Awards the success it is today.”
The winners are:
Best Start-up Biotech Company Award Sponsored by Penningtons Manches
Winner: OxStem – for i ts disruptive approach to the field of regenerative medicine
Best Emerging Biotech Company Award Sponsored by Covance
Winner: Mereo BioPharma Group – f or extraordinary progress in the development of products focused on rare and specialty disease areas
Best Established Biotech Company Award Sponsored by Premier Research
Winner: Heptares Therapeutics, for their outstanding acquisitions, impressive product pipeline and industry leading technology
Best Start-up Medtech Company Award Sponsored by JA Kemp
Winner: Precision Ocular, f or making great progress in their strategy to develop novel therapeutics and drug delivery systems to treat retinal disease
Best Emerging Medtech Company Award Sponsored by World Courier
Winner:  Edinburgh Molecular Imaging, for the rapid discovery and clinical development of their optical imaging “SMART Agents”
Best Established Medtech Company Award Sponsored by Arthur J Gallagher
Winner: Oxford Nanopore Technologies, for developing the world’s first and only nanopore DNA sequencer
Best Emerging UK Synthetic Biotech Company Award, Sponsored by SynbiCITE
Winner: Touchlight Genetics, for developing an innovative, in vitro dual enzyme process that produces DNA at commercial scale and quality
Best Implementation of Digital Healthcare Award Sponsored by EY
Winner: Congenica, for its cloud-based technology that supports whole genome analysis from a single DNA test
Best UK Life Sciences Incubator Award Sponsored by James Cowper Kreston
Winner: BioHub at Alderley Park, for running an excellent BioHub that has supported 188 companies and over 600 people resulting in 49 Virtual Companies and 10 Physical Companies
Highest Impact Investor Award Sponsored by N+1 SINGER
Winner: Mercia Technologies, for focusing on the creation, funding and scaling of early stage, innovative technology businesses with high growth, global potential from the UK regions
Best Public-Private Collaboration Award Sponsored by Oxford AHSN
Winner: The Structural Genomics Consortium
Outstanding Achievement Award
Winner: Oxford Nanopore Technologies, for being extremely disruptive in their field and setting an excellent example to the industry
Special Recognition Award
Winner: Neil Woodford CBE, Founding Partner and Head of Investment, Woodford Investment Management

 

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Bio-Europe November 7–9, 2016

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Ian Wilson and Diane Harbison will be attending Bio-Europe in Cologne. We are interested in speaking to potential investors for our Series B funding round or in opportunities for collaboration using our optical imaging agents. If you are interested in meeting them, please request a meeting through the partnering system or come and hear EM Imaging’s presentation in the Next Generation Session on Wednesday, 9th  November at 10.05

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EDINBURGH MOLECULAR IMAGING ARE PART OF A EPSRC FUNDED CONSORTIUM

Edinburgh Molecular Imaging is part of an EPSRC funded consortium, led by Dr Jon Shephard of Heriot-Watt University in collaboration with Professor David Jayne from the University of Leeds to develop a revolutionary new bowel cancer surgery tool that will enable surgeons to carry out operations with far greater precision.

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EM Imaging at EIE16

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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.edinimage.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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Edinburgh Molecular imaging Ltd awarded Innovate UK grant to qualify the role of EMI-137 in colorectal cancer lesion detection

Edinburgh Molecular imaging Ltd (EM Imaging) announced today that the company has received a SBRI Stratified Medicine Connecting the UK Infrastructure Phase I grant from the UK’s innovation agency, Innovate UK. The SBRI grant aims to accelerate and increase the development and adoption of innovative diagnostic tools in order to offer better targeted treatment to patients within the UK healthcare system. It also aims to demonstrate the benefits of companies working within the UK ‘enabling infrastructure’, which is made up of specialist organisations that can help companies understand healthcare needs, and design, evaluate and deliver their products and services into the NHS.

 

EM Imaging is partnering with the National Institute for Health Research Colorectal Therapies Healthcare Technology Co-operative (NIHR Colorectal Therapies HTC) and the NIHR Diagnostic Evidence Co-operative Leeds (NIHR DEC Leeds), both based at the Leeds Teaching Hospitals NHS Trust to qualify the potential role of the novel optical imaging agent EMI-137 for the improved detection of colorectal (CRC) lesion during colonoscopy.

 

Phase I of the SBRI project will provide an initial demonstration of the clinical and economic utility of EMI-137, thereby providing key inputs for the design of a potential follow-on Phase II SBRI and future clinical studies to be undertaken by EM imaging.

 

Ian Wilson, CEO of EMI, commented: “EM Imaging are extremely grateful to Innovate UK for their award to formalise the health economic value of EMI-137. The detection of flat, smaller non-polypoid lesion is problematic, which cannot be detected by conventional imaging. EMI-137 potentially addresses this major unmet medical need, by combining targeted molecular probes and advanced imaging technology to improve polyp detection. The whole EM Imaging team is extremely motivated to complete this product’s development and get it into the hands of physicians in order to benefit patients.”

 

Professor David Jayne, Professor of Surgery at the University of Leeds and Clinical Director of the NIHR Colorectal Therapies HTC in Leeds said: “We are delighted to be working closely with EM Imaging on an Innovate UK-funded project to evaluate an exciting new technique for detecting early bowel tumours. EM Imaging’s novel fluorescent molecular probe can help doctors detect more bowel tumours during colonoscopy. This will allow the tumours to be removed before they get to an advanced stage and therefore improve the outlook for the many patients who suffer from this condition.”

 

About EMI-137

GE-137, a water-soluble probe consisting of a 26–amino acid cyclic peptide that binds the human tyrosine kinase c-Met conjugated to a fluorescent cyanine dye. Intravenous administration of GE-137 leads to its accumulation specifically in c-Met–expressing tumours, and it is safe and well tolerated in humans. Fluorescence colonoscopy in patients receiving intravenous GE-137 enabled visualization of all neoplastic polyps that were visible with white light, as well as an additional previously missed polyps that were not visible with white light. The first-in-human pilot study, published in Nature Medicine shows that molecular imaging using an intravenous fluorescent agent specific for c-Met is feasible and safe, and that it may enable the detection of polyps missed by other techniques.

 

About Edinburgh Molecular Imaging

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

 

About NIHR’s Colorectal Therapies Healthcare Technology Co-operative and Diagnostic Evidence Co-operative Leeds

The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. The NIHR is the research arm of the NHS. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).

The National Institute for Health Research has funded four Diagnostic Evidence Co-operatives (DECs) to help generate information on the clinical and cost-effectiveness of in vitro diagnostic devices which are important in helping to improve the way diseases are diagnosed. This will help patients access the most appropriate treatments more quickly and help the NHS make the best use of its resources.

The Academic Unit of Health Economics (AUHE) at the University of Leeds specialises in evaluations of diagnostic tests and works collaboratively with the NIHR DEC Leeds.

 

The NIHR Colorectal Therapies HTC is a national network that provides expertise in biomedical science, clinical application and commercialisation to advance the care of patients with colorectal diseases. Through a structured and collaborative approach the HTC defines clinical areas in need of innovation and develops novel solutions that are progressed to clinical practice.

 
Further information:

 

Edinburgh Molecular Imaging

 

info@edinimage.com

www.edinimage.com

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