Aphios Corporation has received a Phase II SBIR grant from the National Institutes of Health (NIH) amounting to $2.4 million over two years. The National Institute on Aging (NIA), part of the NIH, awarded the grant to the Aphios Corporation to develop an "Alzheimer's Disease Therapeutic."
Alzheimer's Disease (AD) is the third leading cause of death in America and among the highest in the industrial world. AD is a devastating age-related neurological disorder that affects more than 4.5 million Americans and more than 10 million people worldwide. Experts estimate that 22 million people around the world and more than 8 million Americans will be afflicted with this disease by 2025.
"Aphios is developing APH-0703, a potent protein kinase C (PKC) modulator that activates the alpha-secretase pathway which can dramatically enhance the generation of soluble amyloid precursor protein (sAPP), diminishing plaques and cognitive deficits associated with Alzheimer's Disease," explains Dr. Trevor P. Castor, President and CEO, Aphios Corporation. "We are developing novel formulations of APH-0703 based on Aphios' proprietary hydrophobic-based formulation and patented SFS-PNS polymer nanospheres technologies. After formulation selection, Aphios will manufacture and characterize the API and final drug product following cGMP guidelines, and conduct preclinical studies in preparation of filing an IND with the FDA to conduct human clinical trials."
Aphios is collaborating with researchers at Louisiana State University Health Sciences Center, Shreveport, LA (LSUHSC) which will conduct in vitro and in vivo efficacy, toxicity and pharmacokinetic studies in triple transgenic AD mice. According to Dr. J. Steven Alexander, LSU's Principal Investigator, APH-0703 is a highly effective alpha-secretase modulator several orders of magnitude more potent than typical modulators. "In dose and time dependent studies APH-0703 showed a very high level of effectiveness in alpha-secretase assays which appears to reflect the powerful activation of PKC-delta and epsilon. An even more impressive finding is that an oral formulation of APH-0703 rapidly reversed cognitive deficits in animal models of AD." Dr. Alexander and study co-investigator Dr. Lisa Schrott hope to identify the most effective, mechanism-based cognitive enhancer formulations of APH-0703. Nanoencapsulated APH-0703 shows even higher activity than the hydrophobic-based APH-0703 formulation in cell assays, and is currently being studied in animal models of AD.
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