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Replies to post #206451 on Anavex Life Sciences Corp (AVXL)
Name: GRF6019
Therapy Type: Other
Target Type: Inflammation (timeline), Other (timeline), Unknown
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2)
Company: Alkahest, Inc., Grifols Biologicals Inc.
BACKGROUND
GRF6019 is a proprietary plasma fraction of about 400 proteins, developed by Alkahest and manufactured by Grifols. It represents a second-generation product of earlier clinical research infusing young adult plasma to treat age-related neurodegenerative disease (see Young Plasma). This treatment approach grows out of mouse parabiosis studies indicating a rejuvenating effect of young blood on the aging brain (e.g. Nov 2009 news; May 2014 conference news). The rationale behind GRF6019 is that the components of young blood that counteract inflammatory and other age-related degenerative processes in the brain can be enriched and delivered as a plasma-derived product that does not require matching of donor and recipient blood types.
FINDINGS
In April 2018, Alkahest started a Phase 2 trial in 40 people with clinical diagnoses of probable AD; biomarkers to confirm underlying molecular pathology were not required. The study will compare a course of five daily intravenous infusions in week one, and again in week 13, of two different doses of GRF6019 and placebo, primarily on safety measures. Secondary outcomes include six-month change on some widely used cognitive and clinical batteries—MMSE, ADASCog11, CDR-SOB, ADCS-ADL, ADCS Clinical Global Impression of Change, NPI Questionnaire—as well as on some individual tests, e.g., the Grooved Pegboard and Category Fluency tests. The trial is set to run at six U.S. sites, and to finish up in November 2019.
In February 2018, Alkahest received a grant from the Michael J Fox Foundation to support its development of GRF6019 for Parkinson's disease.
For all clinical trials of GRF6016, see clinicaltrials.gov.
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