SPMS Patient First To Be Treated With Antibody Given via Nasal Spray
04-01-2021, 09:45 PM
SPMS Patient First To Be Treated With Antibody Given via Nasal Spray
For a first time, an immune-modulating antibody will be given via nasal administration to treat a person with Only registered and activated users can see links., Click Here To Register... (Only registered and activated users can see links., Click Here To Register...).
The U.S. Food and Drug Administration (FDA) approved a request to use the antibody — a fully human anti-CD3 monoclonal antibody called foralumab — under an Individual Patient Expanded Access Program, the therapy’s developer, Only registered and activated users can see links., Click Here To Register..., announced in a Only registered and activated users can see links., Click Here To Register....
Treatment is expected to begin by late June, and last for six months.
Foralumab binds to the CD3 receptor on immune T-cells to calm the immune response. This approach could potentially treat a wide range of autoimmune and inflammatory diseases, including progressive forms of MS.
Initially developed to be delivered orally, Foralumab was reformulated for nasal delivery by Howard Weiner, MD, director of the Multiple Sclerosis Program at the Brigham and Women’s Hospital (BWH) in Boston.
“Nasal anti-CD3 is an exciting, novel approach that has the ability to provide a safe treatment for a form of MS that has no effective treatment. We are pleased that the FDA has allowed us to treat a patient with SPMS who needs a better treatment option than is currently available,” Weiner said.
The person will be treated and evaluated for safety at BWH, and undergo neurological and imaging tests. Changes in immunological and neurodegenerative markers will also be assessed.
A Only registered and activated users can see links., Click Here To Register..., now complete, tested a nasal spray formulation of foralumab, given at ascending doses of 10, 50, mmand 250 micrograms once daily for five consecutive days to healthy volunteers. Results showed the therapy was well-tolerated, with no treatment-related safety issues reported at any dose. According to the company, biomarker analysis showed significant positive immune effects.
Tiziana also plans to initiate a Phase 2 clinical trial of nasally administered foralumab in progressive MS this year.
“New treatments for progressive MS are urgently needed. Nasal Foralumab could revolutionize treatment for this disabling form of disease,” said Tanuja Chitnis, MD, a professor of neurology at Harvard Medical School and senior neurologist at BWH.
Only registered and activated users can see links., Click Here To Register...
04-01-2021, 09:45 PM
SPMS Patient First To Be Treated With Antibody Given via Nasal Spray
For a first time, an immune-modulating antibody will be given via nasal administration to treat a person with Only registered and activated users can see links., Click Here To Register... (Only registered and activated users can see links., Click Here To Register...).
The U.S. Food and Drug Administration (FDA) approved a request to use the antibody — a fully human anti-CD3 monoclonal antibody called foralumab — under an Individual Patient Expanded Access Program, the therapy’s developer, Only registered and activated users can see links., Click Here To Register..., announced in a Only registered and activated users can see links., Click Here To Register....
Treatment is expected to begin by late June, and last for six months.
Foralumab binds to the CD3 receptor on immune T-cells to calm the immune response. This approach could potentially treat a wide range of autoimmune and inflammatory diseases, including progressive forms of MS.
Initially developed to be delivered orally, Foralumab was reformulated for nasal delivery by Howard Weiner, MD, director of the Multiple Sclerosis Program at the Brigham and Women’s Hospital (BWH) in Boston.
“Nasal anti-CD3 is an exciting, novel approach that has the ability to provide a safe treatment for a form of MS that has no effective treatment. We are pleased that the FDA has allowed us to treat a patient with SPMS who needs a better treatment option than is currently available,” Weiner said.
The person will be treated and evaluated for safety at BWH, and undergo neurological and imaging tests. Changes in immunological and neurodegenerative markers will also be assessed.
A Only registered and activated users can see links., Click Here To Register..., now complete, tested a nasal spray formulation of foralumab, given at ascending doses of 10, 50, mmand 250 micrograms once daily for five consecutive days to healthy volunteers. Results showed the therapy was well-tolerated, with no treatment-related safety issues reported at any dose. According to the company, biomarker analysis showed significant positive immune effects.
Tiziana also plans to initiate a Phase 2 clinical trial of nasally administered foralumab in progressive MS this year.
“New treatments for progressive MS are urgently needed. Nasal Foralumab could revolutionize treatment for this disabling form of disease,” said Tanuja Chitnis, MD, a professor of neurology at Harvard Medical School and senior neurologist at BWH.
Only registered and activated users can see links., Click Here To Register...
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