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DATA ON NEW TREATMENT FOR VISCERAL LEISHMANIASIS PRESENTED AT THE XIII INTERNATIONAL CONGRESS FOR TROPICAL MEDICINE AND MALARIA

 PATTAYA, Thailand, Nov. 30 ~PRNewswire~ -- A leading British tropical disease specialist presented data on a promising new approach to treating patients infected with visceral leishmaniasis (VL), a frequently fatal parasitic infection endemic in much of the world. The clinical results were presented as part of the keynote address on leishmaniasis at the XIII International Congress for Tropical Medicine and malaria in Pattaya, Thailand, by Dr. Robert N. Davidson of St. Mary's Hospital Medical School, United Kingdom, as well as in a special presentation at the congress about clinical trials of a drug called AmBisome(R), a proprietary liposomal formulation of the drug amphotericin B developed and manufactured by Vestar, Inc. (NASDAQ: VSTR).
 "Our results indicate that AmBisome is entirely safe and non-toxic in visceral leishmaniasis, in contrast to the existing compounds, all of which have frequent and serious adverse effects," commented Davidson. "All of the immunocompetent patients we treated with AmBisome were cured of the infection, and there have been no relapses in this group. Prior to AmBisome treatment, five patients had relapsed a total of nine times, indicating that their infection was drug resistant. These are exciting results and we are, therefore, pursuing the role of AmBisome for both visceral and mucocutaneous forms of this devastating disease."
 Leishmaniasis is a family of parasitic diseases transmitted by the bite of sandflies. The visceral form of the disease is characterized by fever, loss of appetite, wasting, inflammation of the spleen, liver, and lymph nodes, anemia and thrombocytopenia (platelet deficiency). Without treatment, a progressive disease generally develops, and 90 percent of clinical cases of VL will eventually be fatal, particularly when complicated by malaria, pneumonia, tuberculosis, chronic diarrhea, or hemorrhage. VL is associated with a loss of immunity in the human host, during which certain white blood cells -- called macrophages -- become infected with the parasites and the immune system cannot defend the body against invading organisms. Mucosal leishmaniasis can cause death from bacterial infection and respiratory obstruction as the soft tissues erode.
 While VL is a so-called "tropical" disease, it is found also in Europe, particularly in Southern France, Spain, Portugal, and Southern Italy, where infections have been found in increasing numbers of patients being given immunosuppressive drugs for transplants and hematological malignancies, as well as in AIDS patients. There are 400,000 new cases of VL worldwide each year.
 Davidson reported that in the first multi-center trial of 32 VL infected patients, 12 of whom were immunocompromised (including nine with HIV), and five with a drug-resistant strain of the disease, all were cured with either a 10- or 21-day course of AmBisome, and showed no side effects. Four of the immunocompromised patients, originally cleared of parasites, relapsed after three to five months, but subsequently were treated successfully with a second course of the drug. Davidson noted that the immunocompromised patients may require a maintenance regimen of the drug. Patients are currently being enrolled in a second trial conducted by Davidson, in which researchers will assess the value of using even shorter treatment schedules of AmBisome.
 Davidson commented that the safety and efficacy of AmBisome may be directly related to the drug's ability to target macrophage cells. Liposomes have been shown in electron microscopy studies to selectively target, enter and release their drug contents inside macrophage cells, where the parasites reside. Thus AmBisome appears to be delivering a fatal dose of amphotericin B to the parasites inside the diseased cells, without exposing the healthy cells to any harmful impact. In contrast, conventional treatment for leishmaniasis in Kenya, Sudan, and Brazil has a number of side effects and requires relatively long dosing schedules. In addition, some strains of VL have become resistant to these compounds.
 AmBisome is a liposomal formulation of amphotericin B, developed and marketed by California-based pharmaceutical company Vestar, Inc. AmBisome is currently approved in numerous European countries for the treatment of life threatening fungal infections.
 Vestar is supporting the clinical studies of AmBisome for leishmaniasis at St. Mary's Hospital and other participating institutions throughout Europe. The company also has an agreement with the world health organization to conduct trials comparing AmBisome with conventional treatments for leishmaniasis.
 -0- 11~30~92
 ~CONTACT: Michael E. Ross, M.D., executive VP of Vestar, 714-394-4000, or Jeanine Kelly of Feinstein Partners, 617-577-8110, for Vestar~
 (VSTR)


CO: Vestar, Inc. ST: California IN: MTC SU: TM -- NE001 -- 1838 11~30~92 09:20 EST
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Date:Nov 30, 1992
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