Procysteine, a drug being developed by Free Radical Sciences Inc.,reduced organ failure in patients with Adult Respiratory DistressSyndrome (ARDS) in Phase II trials, researchers reported Sunday atthe annual meeting of the American Lung Association in Boston.The double-blinded, placebo-controlled trial was conducted in 46patients with ARDS at six centers in the U.S. It was designed tomeasure the effect of two agents that replenish glutathione on thefunction of organs, including the lungs. Patients were given eitherProcysteine, N-acetylcysteine, or placebo.The study found that patients treated with Procysteine had fewerorgan dysfunctions, fewer days with organ dysfunctions, and weremore likely to reverse existing organ dysfunction than those in thecontrol groups. The group treated with Procysteine experienced amean of 10 days with organ dysfunction compared with a mean of29 days for untreated patients.Procysteine stimulates the production of glutathione, a smallpeptide that occurs abundantly in the body and may be depleted inpatients with ARDS. Glutathione is a free radical scavenger, ornatural antioxidant, that combats the toxic effects of anoverproduction of free radicals in the body. Free radicals, moleculesthat possess unpaired electrons, usually contain oxygen as one oftheir components. In certain diseases, such as ARDS, there may bean overproduction of free radicals and a resulting elevation inoxidative stress and destruction of tissues.Gary Pace, president of the Cambridge, Mass. company, said hehopes to begin Phase III trials of Procysteine this year. He said 400to 500 patients would be enrolled in 20 centers."There's a cascade of events in ARDS and then there's a trigger forthe inflammatory response of the body. Some therapeuticapproaches are designed to prevent the trigger from being pulled.Our drug works further down the line after the immune reaction ofthe body has already started," Pace said.Pace said the first approach _ a prophylactic one _ requires greatprecision to prevent the organ failure associated with ARDS fromoccurring. "Our drug is administered after ARDS has beendiagnosed. It decreases the necessity for precision. You still have toact quickly but you have a larger window of opportunity," Pacesaid.Pace said the sequence of events in ARDS is that one organ usuallyfails, then there is multiple organ failure, and then death. He saidProcysteine decreased morbidity by reducing the extent of organfailure. "If you decrease morbidity, you decrease the time spent inan intensive care unit and the cost of care too," Pace noted.
-- Philippa Maister
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