NEW YORK -- Sphinx Pharmaceuticals Inc. is ready to proceedwith Phase II trials of its psoriasis drug, protein kinase Cinhibitor, with treatments scheduled to begin next Monday, thecompany announced on Wednesday.
"In the absence of any adverse news from the FDA onThursday (today), Dr. Gerald Weinstein, head of dermatology atthe University of California School of Medicine in Irvine, willscreen candidate psoriasis patients, and begin treatment nextMonday," said David P. Ward, vice president of clinicaldevelopment at Sphinx (NASDAQ:SPHX) of Durham, N.C.
Ward made the announcement here at the Third AnnualHealthcare Conference of Oppenheimer & Co. Inc. to some 300investment specialists and executives from 111 health carecompanies, half of them biotech.
In September 1991 Sphinx submitted a 19-volumeinvestigational new drug (IND) application to the FDA forpermission to test its protein kinase C inhibitor, trade namedKynac, to treat psoriasis. Under IND rules, if the FDA offers noobjections within 30 days -- that is, by today -- the Phase IItrial may proceed.
Kynac is the first of a new generation of curative drugs thatSphinx is developing, based not on recombinant proteins, buton signals from a cell's lipid membrane that regulate internalcellular behavior, Ward explained.
Psoriasis, like other inflammatory and proliferative skindisorders, involves disturbances in this lipid signaltransduction process, which triggers activation of intracellularenzymes. In psoriasis, the key intracellular enzymatic culprit isprotein kinase C (PKC), which Kynac is designed to inhibit.
Psoriasis affects more than 2.5 million people in the U.S. PhaseI trials of the Kynac-based ointment in the U.S. and the UnitedKingdom found that the topical treatment caused no skinirritation or other adverse side effects.
If the Phase II psoriasis study at U.C. Irvine "shows adequatesafety and efficacy," Ward said, "the next key steps are a 120-patient Phase II trial to select an optimal dose, followed bymuch larger Phase III safety and efficacy trials, and an NDA(new drug application) in the U.S. and product licenseapplications elsewhere."
The PKC-blocking drug -- in a liquid formulation -- will enterPhase I trials against cancer in 1993, Ward said. Sphinx will filean IND for this indication by year's end, he said.
Sphinx's stock fell 25 cents to $7 on Wednesday.
-- David N. Leff Science Editor
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