Amarex Receives Study May Proceed Response from U.S. FDA for an ALS Product
Germantown, MD, USA (September 03, 2020) – Amarex Clinical Research, LLC, an NSF International company working closely with client CORESTEM and the U.S. FDA, achieved removal of a clinical hold on Corestem’s product Lenzumestrocel (Korean brand name NEURONATA-R inj.), a stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS). The clinical hold was related to manufacturing information, a common issue with stem cell products. Corestem’s first trial under this U.S. IND will be a Phase III study, having already completed their Phase II studies in Korea. Amarex will also file a Regenerative Medicine Advanced Therapy (RMAT) application to the U.S. FDA on behalf of Corestem; if approved, the RMAT will provide additional access to the FDA on an ongoing basis.
Dr. Kazem Kazempour, President & CEO, stated, “This is an exciting product which already has conditional approval in Korea based on the Phase II data. The U.S. IND will help Corestem support their goal to make the drug available to patients around the world.”
The Phase III study is scheduled to initiate in 2020.
CORESTEM is a global biotechnology company that has maintained growth, momentum, and stability through effective R&D in the field of stem cell therapy since it was established in 2003. The focus has been on R&D in stem cell therapeutics for neurodegenerative disorders and autoimmune diseases. CORESTEM’s lead product is NEURONATA-R inj., a stem cell therapy for ALS (aka. Lou Gehrig's disease), a rare incurable disease, hoping to deliver the first curative ALS treatment in the world. In addition to the stem cell therapeutic for ALS, Corestem has a growing pipeline of treatments for incurable diseases such as lupus, multiple system atrophy, Cerebella ataxia and osteoarthritis. Corestem plans to expand international collaboration with other cutting-edge stem cell researchers to increase a positive world impact as a leader in the fields of Neurological Disorder and Autoimmune Disease with stem cell therapies. Corestem is a market leader in meeting patient expectations beyond national, ethical and economic limitations through ongoing research into intractable diseases.
Lenzumestrocel has been approved for sales in 2014 by MFDS (formerly known as the Korea Food & Drug Administration). In 2019, more than 40 adult patients from the United States had visited Korea for treatment. The cumulative number of patients who visited Korea since 2015 is over 80.
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research. Their combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information visit www.amarexus.com.
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