Chemex Pharmaceuticals Inc. announced Wednesday that it hascompleted additional Phase II clinical trials on Amlexanox, fortreating canker sores (aphthous ulcers).
Chemex (NASDAQ:CHMX) announced last April that it wouldneed to run these additional Phase IIs because the placebo inthe original Phase II was statistically as effective as Amlexanoxwhen it was used alone. This necessitated the extra studies todetermine Amlexanox's optimum concentration and treatmentregimen.
The drug is being developed by a joint venture between theFort Lee, N.J., company and Block Drug Co. of Jersey City.
Based on its initial review of the Phase II results on 348patients, Chemex "has determined that Amlexanox remains aviable product candidate and will request a meeting with FDAto review the Phase II results and to present plans for PhaseIII studies."
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