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Oxford BioDynamics

Oxford BioDynamics Plc first patient enrolled in ALS biomarker study

Oxford BioDynamics Plc (LON: OBD), a biotechnology company focused on the discovery and development of epigenetic biomarkers based on regulatory genome architecture, for use within the pharmaceutical and biotechnology industry, has noted that Mitsubishi Tanabe Pharma America, Inc. has announced that the first patient has been enrolled in the REFINE-ALS clinical study, designed to identify and measure specific biomarkers and clinical assessments in up to 300 people with amyotrophic lateral sclerosis (ALS) in the United States who have begun treatment on RADICAVA® (edaravone).

As part of the trial, Mitsubishi Tanabe Pharma America, its partners, and trial investigators, will use OBD’s proprietary EpiSwitch™ technology platform to assess the rate of ALS disease progression using highly novel epigenetic biomarkers.

The full text of the announcement from Mitsubishi Tanabe Pharma America, Inc. is as follows:

FIRST PATIENT ENROLLED IN MTPA REFINE-ALS BIOMARKER STUDY

Study is Company’s First Clinical Research in the United States

Mitsubishi Tanabe Pharma America, Inc. (OTC:MTZPY) today announced the first patient has been enrolled in the REFINE-ALS clinical study, designed to identify and measure specific biomarkers and clinical assessments in up to 300 people with amyotrophic lateral sclerosis (ALS) in the United States who have begun treatment on RADICAVA® (edaravone).

“We are honored to be working with so many esteemed collaborators on this novel study and excited to have reached this milestone of enrolling the first patient,”

said Stephen Apple, M.D., Senior Medical Director, Medical Affairs, MTPA.

“This research has great potential to provide a deeper understanding of the biological effects of RADICAVA.”

REFINE-ALS, sponsored by MTPA and led by Massachusetts General Hospital (MGH) Neurological Clinical Research Institute (NCRI), includes approximately 40 sites across the country and will utilize the expertise of multiple specialty laboratories to assess biomarker samples.

The study includes assessments of biomarkers for oxidative stress, inflammation, neuronal and muscle injury. Biomarkers will be measured prior to initiating treatment with RADICAVA, at the start of treatment, and at pre-specified time points throughout the 24-week study period (six cycles of treatment). Interim results are expected in 2020.

“ALS is a multifaceted and complex disease with few treatment options,”

said primary investigator James Berry, M.D., M.P.H., MGH NCRI, Boston.

“We’re proud to be investigating the biological impact of RADICAVA on this disease using a combination of genomic analysis and cutting edge biomarker platforms, potentially enhancing our understanding of the disease and its treatments and improving clinical treatment plans for people with ALS.”

As part of the study, investigators will utilize cutting-edge technology such as Oxford BioDynamics’ proprietary EpiSwitch™, which assesses a novel class of epigenetic biomarkers aimed at understanding the rate of disease progression. Additionally, SomaLogic’s SomaScan® technology will measure the changing levels of approximately 5,000 proteins throughout the body, providing a comprehensive and real-time picture of biologic activity and insights that have the potential to further understanding of a treatment’s effect.

About Mitsubishi Tanabe Pharma America, Inc.

Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. MTPA is dedicated to delivering innovative products that address the unmet medical needs of patients in North America. It was established by MTPC to commercialize approved pharmaceutical products in North America with plans to expand its product line through collaborations with partners.

Oxford BioDynamics Plc is a biotechnology company focused on the discovery and development of epigenetic biomarkers for use within the pharmaceutical and biotechnology industry.

The Company’s award-winning, proprietary technology platform, EpiSwitch™, aims to accelerate the drug discovery and development process, improve the success rate of therapeutic product development and take advantage of the increasing importance of personalised medicine.

In particular, EpiSwitch™ can reduce time to market, failure rates and the costs at every stage of drug discovery. Additionally, the technology provides significant insights into disease mechanisms for drug discovery and product re‐positioning programmes and enables the personalisation of therapeutics for patients in the context of challenging pricing environments where improved clinical outcomes are critical.

In April 2019, Oxford BioDynamics received the Queen’s Award for Enterprise: Innovation. The Queen’s Awards for Enterprise are the most prestigious awards for UK businesses.