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NOVA's PERGAMID PURGING AGENT RECEIVES TREATMENT IND

Executive Summary

NOVA's PERGAMID PURGING AGENT RECEIVES TREATMENT IND approval from FDA on June 19. Pergamid (4-hydroperoxycyclophosphamide), a form of the chemotherapeutic agent cyclophosphamide, will be used to treat acute myelogenous leukemia (AML) patients who, in second or later complete remission, are undergoing autologous bone marrow transplantation (ABMT). During the autologous transplant, bone marrow is treated with Pergamid before being reinfused into patients. In a June 20 press release announcing the Treatment IND, Nova noted that patients undergoing ABMT "experience greater than 40% long-term survival, compared with a rate of less than 10% with conventional chemotherapy." The major adverse event seen with Pergamid treatment is a prolongation of the bone marrow's time to engraftment. In trials, Pergamid-treated patients experienced a delay in normalization of bone marrow cell counts of seven to 10 days. The delay in engraftment, according to Nova, did not lead to increased infections or mortality. The data submitted for the Treatment IND filing was collected over 10 years from uncontrolled studies in autologous bone marrow transplant patients. Nova began manufacturing the drug in March 1989. Prior to that, 4-HC was synthesized on a small scale in the laboratories at Johns Hopkins University. Over 1,500 patients worldwide have been treated with the drug, Nova said. The Baltimore-based firm expects to file a rolling NDA for the product beginning in the third or fourth quarter of this year. The filing will be based on data from about 200 patients with AML who are in their second or later complete remission. Data from these patients will be compared to a historical database of AML patients who received conventional chemotherapy without transplantation. Nova is currently compiling another historical control of AML patients who received unpurged autologous transplants. Phase III trials comparing Pergamid-purged to unpurged ABMTs began six months ago but has enrolled only 10 patients thus far. Nova explained that physicians are reluctant to enter patients in a trial in which they may not receive treatment since the prognosis of unpurged patients is poor. Data from the trials, which are designed to last two years, will not be included in the original NDA filing. Pergamid also has been used for purging ABMT patients with non-Hodgkin's lymphoma; however, Nova is not pursuing that indication for initial approval. A June 21 FDA "Talk Paper" notes that "Pergamid is an activated form of a chemotherapeutic agent (cyclophosphamide) commonly used to treat patients with leukemia, lymphoma and other forms of cancer." The company estimates that 14,000 AML and 33,000 non-Hodgkin's lymphoma patients are diagnosed each year. However, only 5,000 bone marrow transplants worldwide are currently performed each year and only 60% of those are autologous. Upon approval, Pergamid, which is an orphan drug, will gain seven years of market exclusivity. ABMTs are expected to increase in number as colony stimulating factor products come on the market. Pergamid already is being studied in conjunction with GM-CSF (Immunex' Leukine and Hoechst- Roussel's Prokine) in two cancer settings outside of leukemia. Nova said that studies are underway with Pergamid in breast cancer, non-Hodgkin's lymphoma and multiple myeloma.
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