BioCryst preparing to start pivotal trial of anticancer compound Fodosine

By Jennifer Lanning Drey

Eugene, Ore., Sept. 7 - BioCryst Pharmaceuticals, Inc. expects to start a pivotal clinical trial of its lead anticancer compound Fodosine (forodesine hydrochloride) in refractory relapse patients with acute lymphoblastic T-cell leukemia before the end of the year, according to Charles Bugg, chief executive officer of the company.

The compound is being developed under a Special Protocol Assessment, and BioCryst has come to an agreement with the Food and Drug Administration on the final protocol of the pivotal trial, Bugg said during a presentation Thursday at the BioCentury NewsMakers in the Biotech Industry conference.

The pivotal trial will be a single-arm study performed at sites in the United States, Europe and South America. Patients will receive intravenous dosing of the drug for the first six weeks of the trial and will then be switched to a once-daily oral dose, Bugg said.

The clinical endpoint is complete response rate, he said.

BioCryst also hopes to present data from the phase 2 clinical trial of Fodosine for the same indication at the American Society of Hematology meeting in December, Bugg said.

Phase 2 flu study planned

In its influenza program, BioCryst is preparing to complete a phase 1 clinical trial of peramivir, the company's lead influenza neuraminidase inhibitor, in order to begin a worldwide phase 2 clinical trial of the drug during the upcoming flu season, Bugg said.

The phase 1 clinical trial is being conducted in association with the National Institutes of Health.

In preclinical studies, peramivir showed encouraging activity against H5N1 avian influenza, which has led researchers to believe that in the proper formulation, the drug may be effective against that virus, as well as against other life-threatening influenza strains that infect humans.

"The urgency of this program right now is being driven by the concern about a pandemic," Bugg said.

However, the company believes the drug could also have indications in a non-pandemic flu season, he added.

BioCryst is a Birmingham, Ala., biopharmaceutical company focused on the development of small-molecule pharmaceuticals to prevent, treat and control cancer, cardiovascular diseases and viral infections.

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