Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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The NIH grant is largely irrelevant, it is the move into Phase 2 and also the possibility of the FDA granting BTD / accelerated approval in the future that is most important
The grant was $262,180.
New York/London, 4 June 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the Chairman of the Company's Scientific Advisory Board, Dr. Howard Weiner, has received a competitive research grant from the National Institutes of Health (NIH) to investigate nasal anti-CD3 for the treatment of Alzheimer's disease.
The demonstration that nasally administered anti-CD3 ******s disease processes underlying the progression of Alzheimer's disease in animal models, further expands clinical development of nasally administered Foralumab, the only entirely human anti-CD3 monoclonal antibody, for the potential treatment of Alzheimer's and other neurodegerative diseases in humans.
The Company has a worldwide exclusive license for nasal administration of anti-CD3 mAbs for treatment of neurodegenerative diseases, including Alzheimer's disease, from Brigham and Women's Hospital, Harvard Medical School, Boston. To date the Company has successfully completed two phase 1 trials and intends to initiate two phase 2 trials with nasally and orally administered Foralumab shortly for treatment of progressive multiple sclerosis (pro-MS) and Crohn's disease, respectively.
"Nasal administration of Foralumab is a potentially revolutionary approach to treat patients with Alzheimer's disease. Preclinical animal studies have established that nasal administration of anti-CD3 can modulate brain microglia and ameliorate disease in animal models. This is a major scientific advancement that provides the basis to move forward with clinical development of nasally administered Foralumab in Alzheimer's disease," commented Dr. Weiner, who is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital. "Targeting microglia with nasal anti-CD3 is a first-in-class immunotherapeutic approach to treat Alzheimer's disease."
Alzheimer's disease is the most common cause of dementia, which affects millions of people worldwide. It is now recognized that brain microglia have a critical role in Alzheimer's disease. In an unexpected discovery, Dr. Weiner found that nasal anti-CD3 modulates brain microglia in animal models. Treatment with anti-CD3 is known to stimulate T regulatory (Tregs) cells, which have the ability to cross the blood-brain barrier (1) The effect of nasal anti-CD3 in dampening microglial activation led Dr. Weiner's team at the Ann Romney Center for Neurologic Diseases at Brigham and Women's Medical Center to evaluate nasally administered Foralumab for pro-MS (2). In 2019, Dr. Weiner successfully completed a Phase 1 study with nasally administered Foralumab in healthy volunteers in a dose-ranging trial. A subsequent Phase 2 trial in patients with pro-MS will be
https://www.google.com/amp/s/www.proactiveinvestors.co.uk/companies/amp/news/921111
Tiziana Life Sciences PLC (LON:TILS, NASDAQ:TLSA) said the chairman of its scientific advisory board has received a research grant from the National Institutes of Health in the US to investigate the company’s nasal anti-CD3 drug, Foralumab, for the treatment of Alzheimer’s disease.
The NIH award provides third-party validation of the work of Dr Howard Weiner in an area of great unmet medical need.
He believes the nasal administration of Foralumab is a “potentially revolutionary approach” to treat patients with Alzheimer’s.
To date the company has successfully completed two phase I studies on the drug candidate, administered both nasally and orally for the treatment of progressive multiple sclerosis and Crohn’s disease.
It will be hoped this early work will speed up the clinical progress in Alzheimer’s
Etc