Leukemia Patients Sought for Participation in Worldwide Trial

Two phase III, multicenter clinical trials are seeking patients to participate in studies evaluating PSC 833, an investigational agent,in combating multidrug resistance in patients with acute myelogenous leukemia. The studies, sponsored by Novartis, intend to enroll approximately 650 patients in the United States and in more than 100 sites worldwide.

The American Cancer Society estimates that the number of new cases of acute myelogenous leukemia diagnosed in 1998 in the United States will be 9,400, which represents over 30% of all leukemias.

While patients with acute myelogenous leukemia usually respond initially to chemotherapy, most develop multidrug resistance. Approximately 800,000 cancer patients annually are unable to receive the optimal benefit of chemotherapy because of multidrug resistance, a phenomenon that contributes substantially to morbidity and mortality.

"The announcement that agents that may enhance the effectiveness of chemotherapy are entering larger clinical trials is good news, indeed," said Marshall A. Lichtman MD, executive vice president for research and medical affairs of the Leukemia Society od America. "New approaches to increase the effectiveness of drug treatment for Leukemia and other cancers are needed. That is why it is critical that patients know about such studies, so that--with their physician --they can decide if it is appropriate for them to participate."

Study Protocols

Elderly Patients with Previously Untreated Acute Myelogenous Leukemia--In this phase III study, researchers will evaluate whether PSC 833, when administered in combination with chemotherapy (daunorubicin [Cerubidine] and cytarabine) can either reverse preexisting multidrug resistance or prevent its development in patients whose disease is responsive initially to treatment. As a result of these effects of PSC 833 on multidrug resistance, it is hoped that a greater number of patients will achieve a complete response and that the duration of this response will be prolonged, compared with patients treated with chemotherapy alone.

Study participants will be selected randomly for one of two treatment arms: chemotherapy alone or chemotherapy in conjunction with PSC 833. The study is seeking 420 participants at least 60 years of age who have not been treated previously for acute myelogenous leukemia. The study will compare event-free survival at 2 years.

Patients Resistant to Chemotherapy or Relapsed After First Remission--In this phase III study,researchers will evaluate whether PSC 833, when administered in combination with chemotherapy (cytarabine,mitoxantrone [Novantrone], and etoposide) can help overcome or reversemultidrug resistance and, thus, improve the rate of complete remission in patients who have been resistant to chemotherapy or who have relapsed after remission.

Study participants will be assigned randomly to one of two treatment arms: chemotherapy alone or chemotherapy in conjunction with PSC 833. The study is seeking 250 participants. Complete remission rates will be compared.

Preliminary Results

Ongoing trials are assessing the efficacy of PSC 833 in ovarian cancer, multiple myeloma, non-Hodgkin's lymphoma, renal cell carcinoma, colon cancer, and breast cancer, as well as acute myelogenous leukemia. Preliminary data in acute myelogenous leukemia patients have indicated that PSC 833 is well tolorated and that it may have a positive impact on complete remission rates.

In addition, the National Cancer Institute is sponsoring studies that are evaluating the effect of PSC 833 in overcoming or reversing multidrug resistance in multiple myeloma and acute myeloma and acute myelogous leukemia.

For more information, contact GLoria Stone , Novartis Pharmaceuticals, at (973) 781-5587.