Partnership to initiate phase 1/2a clinical trial for AD dementia vaccine
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A biopharmaceutical company and the Miller School of Medicine at the University of Miami have announced a partnership to conduct a phase 1/2a clinical trial of ALZN002, a treatment for Alzheimer’s-related dementia.
According to a release from Alzamend Neuro, ALZN002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s disease.
“We strongly believe that the ALZN002 patient-specific immunotherapeutic vaccine has the potential of fostering tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms,” Alzamend CEO Stephan Jackman said in the release.
In October, Alzamend announced the addition of healthy adult subjects to its phase 2a multiple ascending dose study of AL001 in patients with dementia related to Alzheimer’s, per the release. The blinded, placebo-controlled trial was initiated in May, and was designed to evaluate safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose.
This addition to the multiple ascending dose study was based upon a recommendation by the FDA after its review and commentary on Alzamend’s pre-investigational new drug briefing package for development of AL001 for bipolar disorder, major depressive disorder and PTSD.
The company additionally stated in the release that it expects to initiate the ALZN002 study during the first quarter of 2023.
“We are pleased to collaborate with Alzamend to advance their mission of finding a cure for neurodegenerative diseases,” Aisha Khan, MSc, MBA, executive director of Laboratory Operations of the Interdisciplinary Stem Cell Institute Cell Processing Facility at the University of Miami Miller School of Medicine, told Healio. “Our cell processing facility will serve as a clinical manufacturing resource and facilitate the translational efforts by seamlessly integrating all aspects of manufacturing and scale up of ALZN002 throughout the clinical trials.”