Nova Pharmaceutical Corp. said Monday that it has filed a newdrug application seeking FDA approval of Pergamid, a bonemarrow purging agent.
The application is for autologous bone marrow transplants(ABMT) in patients with acute myelogenous leukemia.Pergamid is used outside the body to destroy cancer cells inbone marrow in preparation for ABMT.
Pergamid, which has orphan designation, is a non-biotech drugthat is an activated form of cyclophosphamide, achemotherapeutic agent commonly used to treat leukemias,lymphomas and other cancers.
Use of Pergamid in patients receiving ABMT increases long-term survival by at least 10 percent compared with patientsreceiving ABMT without purging, according to the Baltimorecompany's data.
The FDA filing is based on a retrospective analysis of clinicaldata on 234 AML patients who received ABMT between 1982and 1989. During that period, Pergamid was usedexperimentally in bone marrow transplant centers throughoutthe United States.
Nova is conducting a clinical study in patients with AML. Nodata from that study is included in the FDA submission. Thecompany also is distributing Pergamid under a treatment INDthat allows it to recover its costs.
Nova shares (NASDAQ:NOVX) closed unchanged at $6. Thecompany markets four psychiatric products it acquired fromSmithKline Beecham in 1990 and plans to acquire or licenseadditional products. -- KB
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