Cortex Pharmaceuticals is launching a Phase I safety trial in Berlinwith its lead compound, Ampalex, for treatment as a memoryenhancer in Alzheimer's patients.Alan Steigrod, president and CEO of the Irvine, Calif.-basedcompany, told BioWorld the study is the company's first clinicaltrial and a "giant step" forward for Cortex's attempts to test a newconcept for up-modulating a region of the brain.Ampalex is a small molecule compound based on Cortex'sAmpakine technology and is designed to enhance the function ofbrain proteins, called Ampa receptors, which are involved in cellcommunication, learning and memory. Steigrod said the treatmentis the first to target those receptors to improve memory.In preclinical studies, whose results were released earlier this year,rats treated with Ampakine compounds learned to discriminateodors faster and could remember a maze longer than untreated rats.The compounds are based on discoveries of Cortex's co-founder,Gary Lynch, of the University of California at Irvine. Afterpublishing the findings, Lynch provided other scientists withsamples of the compound to conduct analyses of their own.One of those researchers was Ursula Staubli, of New YorkUniversity, who presented results of her behavioral tests at a ColdSpring Harbor symposium last week."This is the first drug specifically designed to target this receptor,"Staubli told BioWorld."In animals, it worked," she added. "The question now is will itwork in humans."Steigrod said the double-blind, placebo-controlled trial in Berlinwill involve 48 healthy volunteers and last about six weeks. If thestudies prove the drug is safe, he said the company will proceed toPhase II trials.Memory involves biochemical processes in which sensoryinformation is transmitted by electrical impulses between nervecells in the brain. The pulses are relayed across synapses byneurotransmitters acting on receptors, one of which is the Ampareceptor.Ampalex, Steigrod said, is designed to keep the receptor openlonger, increasing transmissions between synapses."The drug targets the specific receptors where memory is encodedand doesn't hit the rest of the brain," he said.In Alzheimer's patients, Steigrod said, the drug would not affect theprogression of the disease, but in theory should help the patientsfunction better. Another possible application, he added, is forpatients who suffer loss of memory from small strokes.Cortex's stock (NASDAQ:CORX) closed Friday at $1, up 9 cents. n

-- Charles Craig

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