Chemex Pharmaceuticals Inc. said Monday it has completed all studiesof Amlexanox for the treatment of aphthous ulcers, or canker sores,and it expects to file an investigational new drug (IND) application forthe product in August.The Fort Lee, N.J., company expects to have data analyses completedin July from two Phase III safety and efficacy studies that included 952patients at 23 dental schools. Another 130 patients and 225 healthyvolunteers participated in five Phase I safety and pharmocokineticstudies.Chemex is developing the anti-inflammatory agent through a jointventure with Block Drug Co. Inc. of Jersey City, N.J. Under theagreement, Chemex contributed rights to dermatological compoundsand was responsible for research. Block paid a $2 million initial feeand is responsible for manufacturing, marketing and distributing.Chemex will contribute $7 million and Block $10 million of researchand development, and they will share in profits.Development of Amlexanox, an anti-allergic, 5-lipoxygenase inhibitor,was set back about a year when it didn't show statistical significanceagainst placebo in a Phase II study, which was reported in April 1992.Atul Khandwala, Chemex's executive vice president, told BioWorldthat the formulation and treatment regimen were changed for additionalPhase II testing, which included 348 patients and was completed inJanuary 1993. Results of that trial "give us the confidence that PhaseIII data will come out OK."Filing of an IND would be the second for Chemex, which got approvalin September 1992 for its lead compound, Actinex, to treat pre-malignant skin lesions. Block is marketing that product.Chemex estimated that, in 1992, the U.S. market for aphthous ulcerswas $75 million.
-- Jim Shrine
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