Cortex to Begin Phase II Study With CX717

The FDA has accepted Cortex Pharmaceuticals' CX717 investigational new drug application to initiate pilot Phase II clinical trials in the U.S.

CX717 is being developed as a potential treatment for cognitive dysfunction that can arise from a variety of neuropsychiatric conditions including Alzheimer's disease, attention-deficit/hyperactivity disorder (ADHD), and sleep disorders.

The first study of CX717 in the U.S. will be a double-blind, placebo-controlled study using positron emission tomography imaging to determine the response of patients with Alzheimer's disease, as well as healthy elderly volunteers, to CX717. The study will look for changes in regional cerebral blood flow, which is a marker of brain activity. A positive effect with CX717 will build confidence that CX717 may have a therapeutic benefit in patients with Alzheimer's disease.

In a similar study paradigm in primates, CX717 demonstrated specific activity in the prefrontal cortex, hippocampus and visual cortex, which are the key brain regions needed to improve memory, cognition and attention.

The study in Alzheimer's disease will be followed shortly thereafter with an ADHD trial. CX717 is Cortex's exclusive compound and excluded from existing partnerships. These studies, as well as the sleep deprivation study currently underway in the UK, are the key programs to ascertain the efficacy of CX717 and to validate the primate model used to identify potential drug candidates.