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| |  AmBisome Shows Proven Benefits Over Traditional Antifungal Therapy BOSTON, MA -- March 11, 1999 -- Research results published today in the New England Journal of Medicine may provide hope for cancer patients at risk of developing severe or life-threatening fungal infections. The data show that NeXstar Pharmaceutical Inc.’s AmBisome(R) (liposomal amphotericin B), is a safer alternative for empiric therapy in patients who are fighting invasive (systemic) fungal infections and emergent fungal infections as compared to conventional amphotericin B, which has been the standard of empiric treatment for these infections over the past 20 years. "Patients with a severely compromised immune system, such as cancer patients receiving chemotherapy and transplant patients, cannot fight disease-causing microbes and are, therefore, at higher risk of developing infection," said Nita Seibel, M.D., associate professor of pediatrics, at the Children's National Medical Center, in Washington, DC. "Fungal infections are particularly troublesome in these patients. However, it is often difficult to isolate the fungal pathogen within a lifesaving time frame. As a result, when symptoms of infection, such as fever, persist, the standard approach has been to treat empirically [treatment based on observation or experience before receiving confirmation of the actual cause]. "The standard of care for suspected fungal infections has been empiric treatment using amphotericin B, yet the side effects of this product can be debilitating. Now, armed with these data, we appear to have a safer and equally effective alternative treatment." These new data are from a randomised, double-blind, multi-centre clinical trial, conducted by the (NIAID) Mycoses Study Group with lead investigator Thomas Walsh, senior investigator, at the National Cancer Institute (NCI), pediatric oncology branch, that compared the liposomal drug, AmBisome, with conventional amphotericin B as empiric therapy for systemic fungal infections. Several leading oncology institutions participated in the study, including the Dana Farber Cancer Institute, the Mayo Clinic, the National Cancer Institute, the H. Lee Moffit Cancer Centre and the University of Pennsylvania Hospital. Nearly 700 patients across the country participated in the study and highlights of the results led to the following conclusions: -- AmBisome is equivalent to amphotericin B in terms of patient survival, when used as empiric antifungal treatment in patients with low white blood cell counts (neutropenia) and with signs of infection, -- AmBisome is associated with fewer adverse events as compared to amphotericin B, specifically in the areas of infusion-related toxicity and nephrotoxicity (impairment in kidney function). Generally considered the standard treatment for systemic fungal infections, the usefulness of conventional amphotericin B has been limited by its potential to cause damage to the kidneys and infusion related reactions. Using NeXstar Pharmaceuticals' proprietary liposomal drug delivery technology, scientists have shown that a powerful product like amphotericin B, can be improved through a novel drug delivery technology using liposomes. By encapsulating amphotericin B in a liposome, this technology has improved the safety of the conventional drug, while maintaining its effectiveness. In August 1997, data from this study provided the basis for AmBisome marketing approval in the United States as therapy for presumed fungal infections in patients with neutropenia who experience a fever of unknown origin (FUO). In addition, AmBisome was cleared for use as salvage (second-line) therapy in confirmed fungal infections and as primary treatment for visceral leishmaniasis (a life- threatening parasitic infection that invades the body). Investigators for this study evaluated two groups of patients. One group received AmBisome and the other received amphotericin B. Infusion bags were masked (blinded) so administrators could not identify which drug was being administered. For each patient who received at least one dose of the study drug (AmBisome), the mean duration of therapy was 10.8 days for AmBisome and 10.3 days for amphotericin B. The survival rate for AmBisome was 93 percent as compared to the amphotericin B survival rate of 90 percent. Considerable differences were observed in the adverse events reported between the two patient groups. Among patients who received AmBisome: there were fewer infusion-related fevers (17 percent versus 44 percent), fewer chills/rigors (18 percent versus 54 percent); and fewer cardio-respiratory events (13.1 percent versus 45.6 percent). In addition, patients receiving AmBisome experienced significantly less nephrotoxicity (19 percent versus 34 percent) than patients receiving amphotericin B. Once rare, systemic fungal infections are becoming increasingly common in hospital settings. It is estimated that there are approximately 100,000 cases of severe fungal infections in the United States each year. Related Links: AmBisome, NeXstar Pharmaceutical Inc.
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