SBIR-STTR Award

We will develop AIT-082 for the treatment of dementia due to Alzheimer's disease, stroke or aging. In Phase I, we plan to complete the preclinical studies needed to submit an Investigational New Drug (IND) exemption application to the Food and Drug Administration (FDA). Specifically, we will: (1) determine the preclinical pharmacodynamics/pharmacokinetics of AIT-082, (2) conduct preclinical toxicological testing, and (3) conduct additional preclinical studies on the mechanism of action of AIT-082. The aim of Phase II will be to file an IND application and to establish the clinical safety and efficacy of AIT-082.Awardee's statement of the potential commercial applications of the research:AIT-082 has potential commercial application for the treatment of memory deficiencies associated with Alzheimer's disease, aging, stroke, infection with human immunodeficiency virus (HIV), electroconvulsive shock treatment (ECT) of depression and attention deficit disorder (ADD).National Institute on Aging (NIA)

The long-term objective is to develop a drug for the treatment of memory deficits associated with aging and Alzheimer's disease. Loss of working memory represents the core early symptom of Alzheimer's disease. AIT-082 is a unique purine derivative that specifically enhances working memory in normal animals, restores working memory deficits in aged animals and stimulates neuritogenesis in PC12 cells in a manner similar and additive to the effects of nerve growth factor (NGF). The aims are to (I) establish the psychopharmacological profile and pharmacokinetics of absorption and distribution of AIT-082, (2) evaluate the effect of AIT-082 on age- induced memory deficit in C57BI/6 mice and determine if AIT-082 can prevent the development of these deficits, (3) determine if AIT-082 exerts its NGF-like activity through a guanylate cyclase mediated mechanism or if some other second messenger system is operative, (4) evaluate AIT-082 in a passive avoidance memory model in rats and mice, and (5) determine the activity of AIT-082 in vivo to prevent or reverse the amnestic activity of specific neuro-receptor blocking agents. AIT- 082 can potentially mimic NGF's biological activity by means of a simple organic molecule that passes the blood-brain barrier.Awardee's statement of the potential commercial applications of the research: AIT-082 is a unique purine derivative that has the potential for a cost effective treatment of the memory deficit associated with Alzheimer's disease and aging. AIT-082 mimics the activity of nerve growth factor and has the potential to be of clinical use as an orally active safe agent for the treatment of nerve damage.National Institute on Aging (NIA)