Nova Pharmaceutical Corp. said Thursday that it has beengranted treatment investigational new drug (IND) approval bythe Food and Drug Administration for Pergamid, a bone marrowpurging agent for patients with acute myelogenous leukemia(AML).
Pergamid is in Phase III clinical trials. It is a non-biotechgeneric drug that is an activated form of cyclophosphamide, achemotherapeutic agent. The treatment IND approval meansthat the company will be able to recover costs from patientsof drugs administered in clinical trials.
Pergamid is used after bone marrow is removed from patientswith AML in second or later complete remission. The patientsare then given high doses of chemotherapy and radiation, whichkill cancer cells and the remaining marrow.
The previously removed marrow of these patients is thentreated with Pergamid to kill any cancer cells before themarrow is reinfused into the patient.
More than 40 percent of patients who have undergone thistreatment live two years or more, compared with a rate ofless than 10 percent for patients receiving conventionalchemotherapy, Nova says.
Nova of Baltimore received orphan drug designation forPergamid in 1990 and plans to file for marketing approval bythe end of this year. Nova stock (NASDAQ:NOVX) closed at $4.56on Thursday, up 56 cents.
-- Karen Bernstein BioWorld Staff
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