Printer Friendly

POTENTIAL NEW TREATMENT FOR LEISHMANIASIS TO ENTER HUMAN CLINICAL TRIALS

POTENTIAL NEW TREATMENT FOR LEISHMANIASIS TO ENTER HUMAN CLINICAL TRIALS
 SAN DIMAS, Calif., June 18 /PRNewswire/ -- Clinical trials of a potential new treatment for leishmaniasis -- a so-called "tropical" disease that also affects temperate countries and threatens an estimated 350 million people worldwide -- will begin under an agreement between the World Health Organization (WHO) and Vestar, Inc. (NASDAQ: VSTR), a U.S.-based pharmaceutical company.
 The new treatment is AmBisome(R), Vestar's proprietary liposomal formulation of conventional amphotericin B, a well-known antifungal agent. Vestar will supply free to WHO sufficient quantities of AmBisome for WHO to conduct Phase II trials with approximately 120 patients in Sudan, Kenya and Brazil. Results of these trials are expected in 1993.
 The trials compare AmBisome, which assists the drug's incorporation into the human macrophage cells in which leishmania parasites reside, with conventional treatments for leishmaniasis, which often require daily injections for 10-60 days (depending on the form of the disease), and cause side effects. Preliminary evidence with a small number of patients suggests that the mechanism of action of AmBisome may make it both effective and nontoxic at low doses, so that the kidney damage and fevers sometimes suffered with conventional amphotericin B might be avoided.
 In Sudan and Kenya, the studies will test AmBisome treatment against visceral leishmaniasis, a form of the disease which is fatal unless treated; in Brazil, the drug will be tested against mucocutaneous leishmaniasis, a form which attacks mucous tissues of the mouth and nose and which can lead to deformities like those of untreated leprosy.
 Currently, AmBisome is used for AIDS, cancer and other seriously ill patients who have developed systemic fungal infections. "We are very enthusiastic about this collaboration with WHO, and the potential opportunity to help the millions of people affected with leishmaniasis," said Michael Ross, M.D., Vestar's vice president of medical affairs.
 If AmBisome proves safe and cost effective for this disease it could be used against cases in India that are showing servere resistance to the existing antimony-based treatments for the disease. An estimated 10,000 cases of resistant visceral leishmaniasis are now being reported each year India, mostly in Bihar state in the North, where the disease is spreading rapidly. "We estimate there are some 200,000 new cases of visceral leishmaniasis a year in Bihar alone," said Tore Godal , M.D., director of the United Nations Development Programme/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), which arranged the agreement between WHO and Vestar. The same focus extends also into Bangladesh and Eastern Nepal, and is spreading as people carry the disease into new communities.
 "There is also an appalling problem with the disease in Southern Sudan, where perhaps 40,000 people have died of it, out of a population of 1 million, over the last five years," added Dr. Godal. In the Andean regions of Latin America, approximately one in 20 patients with cutaneous leishmaniasis -- which causes unpleasant large ulcers on the skin -- develop the most severe mucocutaneous forms of the disease.
 Leishmaniasis is caused by a protozoan transmitted by the bite of sandflies. The visceral form of the disease causes debilitation as the parasites spread to the liver, spleen, bone marrow and lymph nodes. Without treatment, if a progressive disease develops, patients die in less than two years, Mucosal leishmaniasis can cause death from bacterial infection and respiratory obstruction as the soft tissues erode.
 Leishmaniasis is found not only in the tropics, but 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. Sandflies can transmit the parasites from dogs to people, and in some areas 10 percent to 20 percent of the dogs carry these parasites.
 Vestar, headquartered in San Dimas, Calif., develops, tests and manufactures and markets pharmaceuticals to treat patients with cancer and serious infections including AIDS. Vestar is marketing AmBisome in Europe to treat systemic fungal infections. DaunoXome(R), a liposomal formulation of the chemotherapeutic agent daunorubicin, is in development as Vestar's second major product, and other injectable and oral compounds for cancer and serious infections are in the company's research pipeline.
 -0- 6/18/92
 /CONTACT: Michael E. Hart of Vestar, Inc., 714-394-4113, or Robert Walgate of the World Health Organization, 41-22-791-3810, or Marcia A. Kean of Feinstein Partners, 617-577-8110, for Vestar/ CO: Vestar; World Health Organization ST: California IN: MTC SU:


SH-TM -- NE002 -- 1401 06/18/92 09:49 EDT
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jun 18, 1992
Words:758
Previous Article:DICK ACOSTA TO RETIRE FROM CHRYSLER
Next Article:NORTHSTAR INDUSTRIES PRESENTS CONCLUSIONS REGARDING PRIVATIZATION OF MINNESOTA WORLD TRADE CENTER
Topics:


Related Articles
DATA ON NEW TREATMENT FOR VISCERAL LEISHMANIASIS PRESENTED AT THE XIII INTERNATIONAL CONGRESS FOR TROPICAL MEDICINE AND MALARIA
VERTEX BEGINS PHASE II CLINICAL TRIAL WITH VX-105 TO TREAT HEMOGLOBIN DISORDERS
IMMTECH ESTABLISHING CONSORTIUM TO TREAT LEISHMANIASIS.
IMMTECH REPORTS NET LOSS FOR 4TH QTR. AND FISCAL 2000.
AEterna Through its Subsidiary Zentaris Signs Partnership with Roche in Brazil for New Treatment of Leishmaniasis, a Devastating Tropical Disease.
AEterna through its subsidiary Zentaris signs partnership with Roche in Brazil for new treatment of leishmaniasis, a devastating tropical disease.
MMV to Fund Clinical Development of Immtech Malarial Drug.
Immtech Reports Fiscal Second Quarter 2004 Results.
AEterna Reports Positive Phase III Trial Results With Impavido(R) (miltefosine).

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters