Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-Initiated Clinical Trial of Ultrahigh-Dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan

Eisai Co., Ltd. today announced that it has initiated preparation on a New Drug Application for ultrahigh-dose mecobalamin (development code: E0302) for amyotrophic lateral sclerosis (ALS) in Japan, based on a favorable clinical results of the JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS: JETALS), an investigator-initiated Phase III trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin (mecobalamin) in early onset ALS patients, published by a research team led by Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University and Professor Yuishin Izumi (Coordinating Investigator), the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences. Eisai submitted an application for an orphan drug designation of this agent to the Ministry of Health, Labour and Welfare (MHLW) in March 2022, and plans to submit a new drug application in fiscal year 2023.

For ultrahigh-dose mecobalamin, Eisai submitted a new drug application as treatment for ALS in May 2015 based on the results of a Phase II/III clinical trial (Study 761) for ALS, but withdrew the application in March 2016 after receiving the opinion about the application package not being sufficient from the Pharmaceuticals and Medical Devices Agency (PMDA).

However, an additional analysis of Study 761 suggested that ultrahigh-dose mecobalamin prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset. In order to re-examine its efficacy and safety in ALS patients within 1 year of onset, JETALS was conducted as an investigator-initiated clinical trial by the research team led by the Tokushima University with the support of the Japan Agency for Medical Research and Development (AMED). The results of the study showed the efficacy, safety, and tolerability of ultrahigh-dose mecobalamin, which have now been published in the peer-reviewed journal JAMA Neurology(New Window). Based on the results of JETALS, in consultation with the Tokushima University, Eisai has decided to newly submit the application for approval of ultrahigh-dose mecobalamin for ALS in Japan.

Eisai considers neurology a therapeutic area of focus and is committed to new drug development in this field in order to fulfill unmet medical needs and further contribute to increasing the benefit for patients and their families.

About Amyotrophic Lateral Sclerosis (ALS)

ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction. As the main cause of death is respiratory failure due to paralysis of the respiratory muscles, without the use of an artificial respirator, death occurs within approximately 3 to 6 years from the onset of the disease. According to the number of patients issued a Certificate of the Recipient of Specified Disease Treatment, there were 10,514 patients with ALS in Japan in 2020. Currently, there is no curative treatment established for ALS, and since there are only limited number of medicines approved in Japan and abroad, this is a disease with significant unmet medical needs.

About Mecobalamin

Mecobalamin (development code: E0302) is approved and marketed as Methycobal, a 500 microgram injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency. Methycobal is also approved as a tablet formulation as well as a fine granule formulation indicated for the treatment of peripheral neuropathies. While the mechanism of action of mecobalamin in ALS is not known, it has been suggested in non-clinical research that mecobalamin may have efficacy through a neuroprotective effect and regeneration of nerve axons. Since the 1990s, clinical research has been carried out on ultrahigh-dose mecobalamin in ALS by a study group on neurodegenerative disease, funded through the Ministry of Health, Labour and Welfare’s Specified Disease Treatment Research Program. Short- and long-term trials of intramuscular injection of mecobalamin at 25 mg and 50 mg per day, which is respectively 50 and 100 times the approved dosage of Methycobal, suggested that ultrahigh-dose mecobalamin could have a clinical effect in ALS.Therefore, Eisai had conducted the Phase II/III clinical trial (Study 761) since 2006 and submitted a new drug application for ultrahigh-dose mecobalamin as treatment for ALS in May 2015 but withdrew the application in March 2016 after the Pharmaceuticals and Medical Devices Agency (PMDA) indicated that additional clinical trials were necessary.

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Canada – Tribunal Initiates Inquiry—Mattresses from China

The Canadian International Trade Tribunal today initiated a preliminary injury inquiry into a complaint by Restwell Mattress Co. Ltd., of Surrey, British Columbia, and the United Steelworkers, of Toronto, Ontario, that they have suffered injury as a result of the dumping and subsidizing of mattresses from the People’s Republic of China. The Tribunal’s inquiry is conducted pursuant to the Special Import Measures Act (SIMA) as a result of the initiation of dumping and subsidizing investigations by the Canada Border Services Agency (CBSA).

Ottawa, Ontario, February 25, 2022—The Canadian International Trade Tribunal today initiated a preliminary injury inquiry into a complaint by Restwell Mattress Co. Ltd., of Surrey, British Columbia, and the United Steelworkers, of Toronto, Ontario, that they have suffered injury as a result of the dumping and subsidizing of mattresses from the People’s Republic of China. The Tribunal’s inquiry is conducted pursuant to the Special Import Measures Act (SIMA) as a result of the initiation of dumping and subsidizing investigations by the Canada Border Services Agency (CBSA).

On April 25, 2022, the Tribunal will determine whether there is a reasonable indication that the alleged dumping and subsidizing have caused injury or retardation, or are threatening to cause injury, as these words are defined in SIMA. If so, the CBSA will continue its investigations and, by May 25, 2022, will make preliminary determinations. If these preliminary determinations indicate that there has been dumping or subsidizing, the CBSA will then continue its investigations and, concurrently, the Tribunal will initiate a final injury inquiry.

The Tribunal is an independent quasi-judicial body that reports to Parliament through the Minister of Finance. It hears cases on dumped and subsidized imports, safeguard complaints, complaints about federal government procurement and appeals of customs and excise tax rulings. When requested by the federal government, the Tribunal also provides advice on other economic, trade and tariff matters.

Any interested person, association or government that wishes to participate in the Tribunal’s inquiry may do so by filing a Form I – Notice of Participation. For more information, visit the Tribunal’s website.

Vesalio Initiates Clinical Study Evaluating Innovative Thrombectomy Technique for Patients with STEMI

 Today, Vesalio announced the start of enrollment in its NATURE study using enVast™, the company’s first thrombectomy system for patients presenting with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention.

NATURE is a randomized, multi-center clinical trial comparing the safety and efficacy of enVast™ as an adjunctive measure to conventional intervention versus the standard of care in STEMI patients with large thrombus burden.

The first patient in the study was enrolled by Professor Marco Valgimigli, Deputy Chief of Cardiology at Cardiocentro Ticino Istituto, in Lugano, Switzerland.

“Our first-in-human case series of 61 STEMI patients with large thrombus burden allowed us to develop a safe and effective thrombectomy technique using the enVast™ stent retriever under continuous aspiration. With the NATURE study, our goal is to assess the comparative effectiveness of this novel technique versus the standard of care. The results could provide a new therapeutic opportunity for patients with large thrombus burden, who still represent a major challenge for procedural success and long-term outcomes,” said Dr. Valgimigli.

Coronary Artery Disease is the number one cause of death globally. Approximately 17 million patients experience myocardial infarction every year, with more than 3 million presenting with a large thrombus burden in STEMI.

“We are excited to diversify the use of our Drop Zone™ technology and venture into this critical indication, where we anticipate making a positive impact on patient outcomes as Vesalio has achieved in stroke intervention,” commented Steve Rybka, Vesalio Chief Executive Officer.

The Vesalio enVast™ coronary thrombectomy system is CE approved.

About Vesalio

Founded in 2013, Vesalio is a privately held medical device company committed to advancing patient care in vascular occlusion by providing physicians superior technology designed to improve clinical outcomes. The company’s proprietary NeVa™ platform was designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removing all types of neurovascular clots from patient anatomy.

For more information, please visit vesalio.com, email info@vesalio.com, or connect with us on LinkedIn or Twitter.

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www.vesalio.com

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Canada – Tribunal Initiates Final Injury Inquiry—Oil Country Tubular Goods from Austria

The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping of oil country tubular goods originating in or exported from the Republic of Austria has caused injury or retardation or is threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that a preliminary determination had been made respecting the dumping of the above-mentioned goods.

Ottawa, Ontario, October 26, 2021—The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping of oil country tubular goods originating in or exported from the Republic of Austria has caused injury or retardation or is threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that a preliminary determination had been made respecting the dumping of the above-mentioned goods.

On February 22, 2022, the Tribunal will determine whether the dumping has caused injury or retardation or is threatening to cause injury to the domestic industry.

The Tribunal is an independent quasi-judicial body that reports to Parliament through the Minister of Finance. It hears cases on dumped and subsidized imports, safeguard complaints, complaints about federal government procurement and appeals of customs and excise tax rulings. When requested by the federal government, the Tribunal also provides advice on other economic, trade and tariff matters.

Any interested person, association or government that wishes to participate in the Tribunal’s inquiry may do so by filing Form I – Notice of Participation. For details on the specific product under inquiry or for more information, visit the Tribunal’s website.

Canada – Tribunal Initiates Final Injury Inquiry—Certain Container Chassis from China

The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping and subsidizing of certain container chassis originating in or exported from People’s Republic of China have caused injury or retardation or are threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that preliminary determinations had been made respecting the dumping and subsidizing of the above-mentioned goods.

Ottawa, Ontario, October 22, 2021—The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping and subsidizing of certain container chassis originating in or exported from People’s Republic of China have caused injury or retardation or are threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that preliminary determinations had been made respecting the dumping and subsidizing of the above-mentioned goods.

On February 18, 2022, the Tribunal will determine whether the dumping and subsidizing have caused injury or retardation or are threatening to cause injury to the domestic industry.

The Tribunal is an independent quasi-judicial body that reports to Parliament through the Minister of Finance. It hears cases on dumped and subsidized imports, safeguard complaints, complaints about federal government procurement and appeals of customs and excise tax rulings. When requested by the federal government, the Tribunal also provides advice on other economic, trade and tariff matters.

Any interested person, association or government that wishes to participate in the Tribunal’s inquiry may do so by filing a Form I – Notice of Participation. For details on the specific products under inquiry or for more information, visit the Tribunal’s website.