Our latest Investing Matters Podcast episode with QuotedData's Edward Marten has just been released. Listen here.

Less Ads, More Data, More Tools Register for FREE

Pin to quick picksOxford Biodyn Regulatory News (OBD)

Share Price Information for Oxford Biodyn (OBD)

London Stock Exchange
Share Price is delayed by 15 minutes
Get Live Data
Share Price: 9.40
Bid: 9.32
Ask: 9.48
Change: 0.00 (0.00%)
Spread: 0.16 (1.717%)
Open: 0.00
High: 0.00
Low: 0.00
Prev. Close: 9.40
OBD Live PriceLast checked at -

Watchlists are a member only feature

Login to your account

Alerts are a premium feature

Login to your account

First patient enrolled in ALS biomarker study

25 Oct 2019 07:00

RNS Number : 0921R
Oxford BioDynamics PLC
25 October 2019
 

25 October 2019

Oxford BioDynamics Plc

 

("OBD" or the "Company" and, together with its subsidiaries, the "Group")

 

Oxford BioDynamics notes first patient enrolled in ALS biomarker study sponsored by Mitsubishi Tanabe Pharma America

 

Oxford BioDynamics Plc (AIM: 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, is pleased to note 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

 

JERSEY CITY, N.J., October 24, 2019 - Mitsubishi Tanabe Pharma America, Inc. (MTPA) 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. For more information, please visit www.mt-pharma-america.com or follow us on Twitter and Facebook.

 

Overview of Mitsubishi Tanabe Pharma Corporation (MTPC)

Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan's pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company and has the longest history of any listed company in Japan.1 In accordance with the corporate philosophy of "contributing to the healthier lives of people around the world through the creation of pharmaceuticals," the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 2016-2020. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas - autoimmune diseases, diabetes and kidney diseases, central nervous system diseases, and vaccines - Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA and the license holder of RADICAVA. For more information, go to http://www.mt-pharma.co.jp/.

 

About RADICAVA® (edaravone)  

The U.S. Food and Drug Administration approved RADICAVA® (edaravone) on May 5, 2017 as a treatment for amyotrophic lateral sclerosis.2 In a pivotal trial, people given RADICAVA experienced a 33 percent slower rate of decline in the loss of physical function, compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in people with ALS.3,4

 

Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. 

Marketing authorization was granted in Canada in October 2018 and Switzerland in January 2019.

 

IMPORTANT SAFETY INFORMATION 

Before you receive RADICAVA, tell your healthcare provider about all of your medical conditions, including if you:

·; have asthma.

·; are allergic to other medicines.

·; are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby. 

·; are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breast milk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed. 

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.

 

What are the possible side effects of RADICAVA?

·; RADICAVA may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.

·; Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.

·; RADICAVA contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.

·; Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).

·; Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.

 

The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.

 

These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

For more information, including full Prescribing Information and Patient Information, please visit www.RADICAVA.com. 

 

Media inquiries:

Mitsubishi Tanabe Pharma America

Debbie Etchison

908-340-8578

Media_MTPA@mt-pharma-us.com  

 

 

1 Research by TOKYO SHOKO RESEARCH, LTD. 

2 RADICAVA® U.S. Prescribing Information. August 2018.

3 Simon, N. G., Turner, M. R., Vucic, S., Al-Chalabi, A., Shefner, J., Lomen-Hoerth, C., & Kiernan, M. C. (2014). Quantifying Disease Progression in Amyotrophic Lateral Sclerosis. Annals of Neurology, 76(5), 643-657. http://dx.doi.org/10.1002/ana.24273.

4 The Writing Group on behalf of the Edaravone (MCI-186) ALS 19 Study Group (2017). Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurology. 16(7), 505-512.

 

About Oxford BioDynamics Plc

 

Oxford BioDynamics Plc (AIM: OBD) ("Oxford BioDynamics") 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.

 

Oxford BioDynamics is headquartered in the UK, and listed on the London Stock Exchange's AIM under the ticker "OBD". For more information please visit www.oxfordbiodynamics.com.

 

For further details please contact:

 

Oxford BioDynamics Plc

Christian Hoyer Millar, CEO

Paul Stockdale, CFO

 

+44 (0)1865 518910

FTI Consulting

Financial Public Relations Adviser

Brett Pollard

Natalie Garland-Collins

+44 (0)20 3727 1000

 

 

 

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
END
 
 
NRALLFFDIFLSFIA
Date   Source Headline
27th Mar 20242:18 pmRNSResult of AGM
14th Mar 20247:00 amRNSResults of Fundraising
13th Mar 20244:45 pmRNSPrimaryBid Offer
13th Mar 20244:40 pmRNSProposed Fundraising
22nd Feb 20242:30 pmRNSAnnual Report & Accounts
17th Jan 20247:00 amRNSPreliminary Results and Notice of AGM
21st Dec 20237:20 amRNSNotice of Results
13th Nov 202310:22 amRNSDirector/PDMR Shareholding
8th Nov 20237:00 amRNSOBD strengths commercial leadership
7th Nov 202312:30 pmRNSHolding(s) in Company
6th Nov 20235:04 pmRNSHolding(s) in Company
3rd Nov 20239:29 amRNSDirector/PDMR Shareholding
23rd Oct 202311:09 amRNSPDMR Dealing / Grant of Share Options
20th Oct 20239:45 amRNSDirector/PDMR Shareholding
18th Oct 20237:00 amRNSBupa UK to cover EpiSwitch® CiRT for customers
6th Oct 20235:44 pmRNSDirector/PDMR Shareholding
3rd Oct 20234:37 pmRNSHolding(s) in Company
3rd Oct 20237:00 amRNSOBD receives reimbursement code for PSE test
26th Sep 20237:00 amRNSOBD launches 94% accurate PSE test in US and UK
7th Sep 202310:18 amRNSHolding(s) in Company
1st Sep 202312:34 pmRNSAmendment: Director/PDMR Shareholding
31st Aug 20234:02 pmRNSHolding(s) in Company
25th Aug 20239:00 amRNSHolding(s) in Company
22nd Aug 20233:58 pmRNSHolding(s) in Company
22nd Aug 20237:00 amRNSHolding(s) in Company
22nd Aug 20237:00 amRNSHolding(s) in Company
18th Aug 202311:44 amRNSResult of General Meeting
8th Aug 20234:00 pmRNSHolding(s) in Company
4th Aug 20237:00 amRNSResults of PrimaryBid Offer
2nd Aug 20237:00 amRNSResult of Placing and Subscription
1st Aug 20234:55 pmRNSPrimaryBid Offer
1st Aug 20234:54 pmRNSProposed Fundraising
30th May 20237:00 amRNSHalf-year Report
16th May 20237:00 amRNSNotice of Interim Results and Investor Webinar
15th May 20237:00 amRNSCiRT expanded validation for ICI immunotherapies
2nd May 20237:00 amRNSUS PACT Award for prognosis test for IOrelated HPD
18th Apr 20237:00 amRNSDirector/PDMR Shareholding
5th Apr 20237:00 amRNSBusiness update for PSE and CiRT tests
30th Mar 20231:04 pmRNSResult of AGM
23rd Mar 20233:19 pmRNSHolding(s) in Company
22nd Mar 20232:22 pmRNSHolding(s) in Company
15th Mar 202311:43 amRNSAIM Rule 17 Schedule 2(g) Update
3rd Mar 20234:33 pmRNSPublication of FY22 Annual Report
23rd Feb 202310:36 amRNSPDMR Dealing
6th Feb 20237:00 amRNSOBD Prostate Screening EpiSwitch Blood Test Update
27th Jan 20232:36 pmRNSDirector/PDMR Shareholding
24th Jan 20237:00 amRNSPreliminary Results and Notice of AGM
21st Dec 20227:00 amRNSNotice of FY22 Results and Investor Webinar
19th Dec 20227:00 amRNSOBD in San Francisco for JPM Healthcare conf 2023
16th Dec 20227:00 amRNSInitial assessment of EpiSwitch assay in ALS trial

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.