BioCryst Inc., which three months ago acknowledgedoverstating positive Phase II clinical trial data because ofan analytical error, is back on track with development ofits lead compound for a treatment for cutaneous T-celllymphoma (CTCL) and psoriasis.

John Higgins, BioCryst's vice president of corporatecommunications, said Wednesday the Birmingham, Ala.-based company has launched a Phase III trial of BCX-34for CTCL. The studies will enroll 90 patients at eightU.S. medical centers.

In addition, an expanded Phase II trial of the topicalcream for psoriasis is expected to begin next month.

Higgins said the embarrassing error in analysisdiscovered in June caused minor delays, but the FDA issatisfied with the corrected Phase II results. The problemwas tied to faulty randomization codes that credited to thedrug some of the placebo-treated group's improvementsin two six-week Phase II studies for CTCL and psoriasis.Following the re-analysis, the trials' efficacy data werenot statistically significant as first reported.

BioCryst's stock (NASDAQ:BCRX) dropped 32 percentto $8.75 June 19, 1995, after the error was reported. Thecompany's shares closed Wednesday at $10.50, down$1.38.

BCX-34 is a small molecule compound designed toinhibit purine nucleoside phosphorylase, an enzymelinked to proliferation of T cells.

Although the placebo-controlled Phase II trials of BCX-34 for CTCL were not as encouraging as first believed, asubsequent open-label, six-month study demonstratedfavorable results for 18 of the 24 patients participating.

Higgins said the open-label trials showed that astreatments progressed more patients responded and thosewho were cleared of the disease have remained free ofCTCL. Because of those results, he said, the studies havebeen extended six months.

In the Phase III trials, patients will receive six months oftreatment with either BCX-34 or a placebo. As inprevious studies participants with early stage CTCL willbe enrolled.

CTCL, a potentially deadly cancer, starts with skinlesions and can spread to the lymph nodes and internalorgans. In addition to topical BCX-34, BioCryst isdeveloping an oral form of the drug to treat themetastasized CTCL and T cell leukemia. An estimated5,000 to 10,000 people in the U.S. suffer from CTCL.

In the expanded Phase II trials for psoriasis, 90 patientswill be enrolled for three-month treatments. Higgins saidthe additional Phase II trials were planned prior todiscovery of the analytical error last June. n

-- Charles Craig

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