Genica Pharmaceuticals Corp., a privately held company focusing ondevelopment of neurological diagnostics, has licensed worldwiderights to a potential eye test for Alzheimer's disease from HarvardUniversity.

Michael Boss, director of research and development for theWorcester, Mass., company, would not disclose financial details ofthe agreement with Harvard in Cambridge, Mass. The university willreceive an equity position in Genica and royalties on sales of the test.

Research describing the potential Alzheimer's diagnostic appeared inFriday's issue of the journal, Science. Harvard scientists said theyfound that Alzheimer's patients were hyper-sensitive to tropicamide,which is an acetycholine receptor antagonist used byophthalmologists to dilate their patients' pupils.

The researchers used a diluted form of the pupil-dilating drug to test58 Alzheimer's patients and control subjects. The diagnosticcorrectly identified 95 percent of the patients with Alzheimer'sdisease.

Boss said his company, founded in 1989, was aware of the Harvardresearchers' work a year ago and began preliminary discussions forlicensing rights. Alzheimer's is considered the most common form ofdementia in older adults.

"We felt we were the best partner to work with Harvard on this testbecause our core program is developing tests for neurologicaldiseases," Boss said. (See BioWorld Today, Aug. 25, 1993, Page 1.)

The Harvard scientists' findings are very preliminary, Bossobserved, but he hopes to have the Alzheimer's test ready for themarket in two years.

Before Genica gets to that stage, Boss added, more work is needed tomake the test easier to use and more patients must be analyzed toassess the diagnostic's effectiveness.

"We still need to determine how well the test can discriminatebetween Alzheimer's and other forms of dementia," Boss said.

He also noted that although tropicamide is a generic product alreadyon the market, the Alzheimer's test will require a new formulation ofthe drug.

Following those steps, Genica then faces clinical trials before gettingFDA approval.

Boss said the Alzheimer's test, which initially would be sold toneurologists, will consist of a pupillometer and a single-doseapplication of the diluted tropicamide. Information from thepupillometer would be relayed to Genica via computer hook-up to beevaluated. n

-- Charles Craig

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