Sphinx Pharmaceuticals Inc. announced Monday that it hasstarted Phase II clinical trials on Kynac ointment for treatingeczema.

The double-blind controlled trials, which will be conducted atthree sites, are designed to test the safety and efficacy ofKynac, a protein kinase C inhibitor. It should take about sixmonths to accumulate the 50-60 patients needed for this study,said Clayton Duncan, president and chief executive officer ofthe Durham, N.C., company.

The theory behind using protein kinase C inhibitors such asKynac to treat inflammatory and proliferative skin disorders,such as eczema and psoriasis, is that they interfere with thekey intracellular enzymes that act to regulate cellularprocesses.

Still, because the diseases are biologically and clinically distinct,Sphinx is evaluating them independently. In fact, the companyhas already conducted Phase II clinical trials on the sameointment formulation of Kynac for treating psoriasis, and foundthat although the drug appeared to have a beneficialpharmacological effect on the psoriatic lesions, the effects werenot striking enough to be considered clinically meaningful.

In May the company (NASDAQ:SPHX) suspended those trials tore-evaluate the drug's formulation as well as to determinewhether a more potent PKC inhibitor is needed.

Meanwhile, the new Phase IIs in eczema "allow us theflexibility to test for therapeutic efficacy and pharmacology inquite different disorders in a timely and cost-effectivemanner," Duncan said.

The company now has an opportunity to determine whetherKynac works better in eczema than in psoriasis, or less well, orperhaps not at all, said H. Jeff Leighton, Sphinx's executive vicepresident of research and development.

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