Nanotherapeutics

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NTC-942 (PRX-3140)

In December 2009, Nanotherapeutics, Inc. acquired PRX-3140 from EPIX Pharmaceuticals, Inc.  PRX-3140, an orally-bioavailable Alzheimer's treatment, is currently in Phase 2 clinical studies. Nanotherapeutics also acquired the U.S. and foreign patent estates covering the clinical program.

Alzheimer's disease is the most common form of dementia, affecting more than five million Americans and over nine million worldwide. The National Institute of Aging estimates that about five percent of the population aged 65-74 and as many as 50% of the US population over 85 have the disease. The global market is projected to grow from $4 billion in 2006 to over $5 billion in 2010. The disease is currently incurable and manifests as progressive memory loss, confusion, and ultimately loss of control of physical and mental functions leading to death. 

PRX-3140 stimulates cognition and memory by selectively activating the 5-HT4 G-protein coupled receptor in the brain to produce and release acetylcholine, a neurotransmitter that plays a role in learning and memory. As Alzheimer's disease progresses, acetylcholine production declines, and brain levels of this critical neurotransmitter decline also. PRX-3140 has the potential to slow the progression of the disease with fewer and less severe side effects than current Alzheimer drugs.

A randomized, double-blind, placebo-controlled Phase 2a clinical trial was completed to assess the effects of PRX-3140 following two weeks of treatment as monotherapy and separately in combination with donepezil (Aricept®) in patients with mild Alzheimer's disease. PRX-3140 appeared to be well tolerated alone and in combination with Aricept® with no serious drug-related adverse events. In October, 2009, the FDA approved a Physician-Sponsored IND and continuation of the fourth six-month open label extension of PRX-3140. 

 

Clinical Development

Currently, no Mild Cognitive Impairment (MCI) drugs or other treatments are specifically approved by the Food and Drug Administration (FDA). However, MCI is an active area of research. Clinical studies are under way to shed more light on the disorder and find treatments that may improve symptoms or prevent or delay progression to dementia.  Doctors sometimes prescribe cholinesterase inhibitors, a type of drug approved for Alzheimer's disease, for people with MCI whose main symptom is memory loss. However, cholinesterase inhibitors aren't recommended for routine treatment of MCI because they don't appear to provide lasting benefit.  Nanotherapeutics believes that the mechanism of action (MOA) of NTC-942 provides a different pathway than other drugs previously used to treat MCI.  Given the selective target population and its MOA, NTC-942 may offer greater potential for successful outcomes.  Nanotherapeutics plans initiation of a Phase 2 trial for MCI late 2015 with completion set in 2016. 

 

References

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Giles F, Rizzieri D, Karp J, et al. Cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients age 60 years or older with previously untreated acute myeloid leukemia. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2007;25(1): 25-31.

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