New England Journal of Medicine Publishes Pivotal Data.
AmBisome Shows Proven Benefits Over Traditional
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 AmBisome(R) (liposomal amphotericin B), a product manufactured by NeXstar Pharmaceuticals Inc. (NASDAQ: NXTR) and co-marketed by Fujisawa Healthcare, 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 twenty 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, D.C. "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 randomized, double-blind, multi-center clinical trial, conducted by the (NIAID) Mycoses Study Group with lead investigator Thomas J. 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 Center 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:
o 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
o 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).
"In its conventional form, amphotericin B can cause debilitating side effects which can adversely impact the quality of patient treatment," said Michael E. Hart, chairman of the executive management committee and CFO of NeXstar Pharmaceuticals. "By encasing amphotericin B in our patented liposomes (microscopic bubbles of fat used for drug delivery within the body), we have improved the side effect profile of the drug while at the same time maintaining its effectiveness."
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, we show that 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).
Currently approved in 38 countries around the world, AmBisome has been cleared for an expanded label, including empiric treatment of FUO, in five additional countries. Applications for expanded labeling in approximately 11 more countries have been submitted and await review.
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 v. 44 percent), fewer chills/rigors (18 percent v. 54 percent); and fewer cardio-respiratory events (13.1 percent v. 45.6 percent). In addition, patients receiving AmBisome experienced significantly less (p<0.001) nephrotoxicity (19 percent v. 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.
NeXstar Pharmaceuticals Inc. is an integrated biopharmaceutical company engaged in the discovery, development, manufacture and commercialization of products to treat serious and life-threatening illnesses. The company currently markets two drugs in the United States and around the world, AmBisome and DaunoXome. Based in Boulder, Colo., NeXstar Pharmaceuticals maintains additional research, development and manufacturing facilities in San Dimas, Calif., and marketing subsidiaries worldwide. This month, Gilead Sciences, Inc. (Nasdaq: GILD) and NeXstar Pharmaceuticals announced a definitive agreement whereby Gilead will acquire NeXstar in an all-stock, tax-free pooling-of-interests transaction. The deal is expected to be completed later this year.
Fujisawa Healthcare Inc., headquartered in Deerfield, Ill., is a manufacturer of proprietary pharmaceutical products and a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical, founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its operations not only in Japan but on a global scale, particularly in North America, Europe and Asia. Additional information on Fujisawa Healthcare Inc. can be found at www.fujisawa.com.
This press release contains forward-looking statements that involve risks and uncertainties, and actual events or results may differ materially. While these statements reflect NeXstar Pharmaceuticals' best current judgment, they are subject to risks and uncertainties that could cause actual results to vary from current projections. These risk factors are identified in NeXstar Pharmaceuticals' reports to the Securities and Exchange Commission filed on Forms 10-K and 10-Q, and in other SEC filings.
Note: This release can be obtained from our Internet homepage at
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|Date:||Mar 11, 1999|
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