Vion to conduct pivotal phase 2 trial of Cloretazine for leukemia

By Lisa Kerner

Erie, Pa., Jan. 31 - Vion Pharmaceuticals, Inc. said it plans to conduct a pivotal phase 2 trial of its anticancer agent Cloretazine in elderly patients with poor-risk acute myelogenous leukemia (AML).

The trial, Vion CLI-043, is designed to confirm the efficacy and safety of Cloretazine for elderly patients with de novo poor-risk AML, according to a company news release. Elderly de novo poor-risk AML patients are those whose poor-risk AML has not evolved from a prior myelodysplastic syndrome MDS.

Approximately 85 patients will be enrolled in at least 20 sites in North America and Europe. Vion said it plans to begin the study as "soon as practicable."

In October, Vion received a fast track designation from the Food and Drug Administration for Cloretazine in the treatment of elderly patients with poor-risk AML.

"We are excited about launching this pivotal trial and anticipate rapid patient accrual. Together with our previous phase 2 study in an elderly AML population, results from this trial, if successful, will form the clinical basis for a submission to the FDA of a New Drug Application for Cloretazine," Ann Cahill, vice president, clinical development, said in the release.

Vion recently met with the FDA to discuss data from Vion CLI-033, a phase 2 trial in patients with AML and high-risk MDS.

Vion, based in New Haven, Conn., is developing cancer therapeutics.

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