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ArticleMedicine Guanlan
US time on November 16, news, Brigham and Women's Hospital (Brigham and Women's Hospital) announced that it will start a phase 1 clinical trial to evaluate a new nasal vaccine in preventing and slowing the progression of Alzheimer's disease (AD) The safety and effectiveness
.
Howard L.
It’s worth mentioning that Tianjing Bio and Enhua Pharmaceuticals have obtained global development, production and commercialization of the immunomodulator Protollin used in the vaccine from Brigham Hospital and Inspirevax (formerly known as “Biodextris”).
Permission
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According to the press release, the immunomodulator used in this new vaccine is Protollin
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Protollin is a new type of immunostimulatory preparation for nervous system diseases.
According to the previous cooperation agreement between Tianjing Bio, Enhua Pharmaceutical, Brigham and Women’s Hospital and Inspirevax (formerly known as “Biodextris”), Brigham and Women’s Hospital will be responsible for the discovery and verification of biomarkers, preclinical Research and clinical trials
.
Tianjing Bio and Enhua Pharmaceuticals will provide financial, technical, registration and business development support for the preclinical research, clinical development and potential commercialization of the Protollin R&D project
What started this time is a single ascending-dose (SAD) phase 1 clinical trial that will recruit 16 subjects
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These subjects were between 60 and 85 years old, and they had early symptoms of AD
According to the press release, the main goal of the phase 1 trial is to determine the safety and tolerability of the nasal vaccine
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In addition, the researchers will measure the effect of nasal Protollin on the immune response of participants, including its effect on white blood cells, by examining cell surface markers, gene mapping and functional analysis
Reference materials:
[1]Brigham and Women's Hospital Launches Clinical Trial of Nasal Vaccine for Alzheimer's Disease.
[3] Tianjing Biopharma announces that Protollin, a new drug under development for the treatment of Alzheimer’s disease, has been approved by the US FDA for phase 1 clinical trials.
(The original text has been deleted)