Interneuron Inc. is starting a late-stage clinical trial of adietary supplement for Parkinson's disease patients. It plans tostart marketing the product next year.
The supplement aims to keep Parkinson's disease patientswell-nourished while ensuring that the one medication proveneffective in controlling their tremors and muscular rigidity, L-dopa, reaches their brains. Those two objectives -- nourishmentand the delivery of L-dopa (levodopa) -- are often in conflict inParkinson's disease because the intake of proteins andcarbohydrates can cause too little or too much of the drug tocross the body's blood-brain barrier.
As a result, many Parkinson's patients are instructed by theirphysicians to adhere to low-protein diets while on themedication.
Interneuron (NASDAQ:IPIC) of Lexington, Mass., is taking thesupplement, called IP 201, into a double-blind, placebo-controlled clinical trial involving about 120 patients todemonstrate that it can supply well-balanced nutrition whileallowing more L-dopa to reach the brain. The trial will measurethe patients' motor functions.
If successful, the supplement could potentially delay aParkinson's patient's need for nursing care, said Charles J.Casamento, Interneuron's president and chief executive officer.The product was developed by company co-founder RichardWurtman, a neuroscience professor at the MassachusettsInstitute of Technology.
Elan Corp. paid $400,000 for an option, effective through Oct.22, to license the supplement on which it would pay royaltieson sales. Although Interneuron's marketing partner will pricethe supplement, Casamento said it will be reasonable -- lessthan the cost of a restaurant meal and likely to be less than$1,000 per year.
As a medical food product, IP 201 is not expected to requireFDA marketing approval. --Ray Potter
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