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PILOT STUDY SUGGESTS SAFETY AND EFFECTIVENESS OF 566 A NEW INVESTIGATIONAL PCP THERAPY

 PILOT STUDY SUGGESTS SAFETY AND EFFECTIVENESS OF 566
 A NEW INVESTIGATIONAL PCP THERAPY
 RESEARCH TRIANGLE PARK, N.C., Nov. 28 /PRNewswire/ -- A new investigational antiparasitic drug may have promise as an effective and well-tolerated therapy for Pneumocystis carinii pneumonia (PCP) in AIDS patients, according to a preliminary clinical study published in the Nov. 28 issue of the New England Journal of Medicine.
 The article discusses results of a small open-label trial of the Burroughs Wellcome Co. oral medication 566. The trial involved 34 patients at five locations.
 PCP is the most common and frequently the first opportunistic infection to develop in people with advanced human immunodeficiency virus (HIV) disease. It affects more than 80 percent of people with AIDS and is one of the leading causes of death among people with AIDS.
 Study Results
 "566C80 had a high degree of efficacy and was well-tolerated," according to the study authors. All 34 patients survived their episode of acute pneumonia and 27 responded to 566. These preliminary data suggest that treatment of patients with mild to moderate PCP with 566 compares favorably with the standard therapies, trimethoprim/sulfamethoxazole (TMP/SMX) and pentamidine.
 Four patients discontinued 566 therapy because of side effects, which consisted of fever in 2 patients and rash in 2 patients. In 5 patients, 566 was discontinued because of lack of response and they were treated with another PCP therapy. Of 12 patients known to be intolerant of the standard PCP therapy TMP/SMX, 10 tolerated 566.
 The current standard therapies for PCP are intravenous pentamidine and oral or intravenous TMP/SMX. Both of these drugs are associated with side effects which can prevent 30-60 percent of patients from tolerating treatment.
 The authors said the possible appeal of 566 is enhanced by its broad antimicrobial efficacy in animal and in vitro models, novel mechanism of action, and favorable pharmacokinetic characteristics. The study was conducted by Burroughs Wellcome Co. and the National Institutes of Health.
 Other Results Prompt Expanded Access
 Based upon the encouraging results in this trial, Burroughs Wellcome initiated the largest controlled trial of the treatment of PCP to date. That Phase II/III trial compared 566 to TMP/SMX and involved more than 400 patients at 39 sites throughout the United States, Canada and Europe. Patients were enrolled between August 1990 and August 1991.
 Data are still being analyzed, but the overall outcome for individuals treated with 566 was roughly comparable to that seen with TMP/SMX. Fewer patients had to discontinue therapy because of side effects, while more 566 patients discontinued therapy because of a somewhat lower therapeutic response.
 The preliminary data analysis from this Phase II/III study was submitted to the FDA to support an application for a Treatment IND. This Treatment IND, which was authorized earlier this month, provides 566 free of charge to patients with mild to moderate PCP who are intolerant of TMP/SMX or other sulfonamide containing medications.
 The Treatment IND mechanism makes potentially lifesaving medications more widely available prior to formal marketing approval for patients who do not have satisfactory alternative therapies.
 To date, more than 30 patients have received 566 through the Treatment IND and more than 200 physicians have registered.
 Physicians may call 800-755-2020 to inquire about Treatment IND registration and eligibility.
 Study Locations
 Collaborators in the study included Judith Falloon, M.D., Joseph Kovacs, M.D., Donna O'Neill, R.N., Michael Polls, M.D., Irwin Feuerstein, M.D., and Henry Masur, M.D., Warren G. Magnuson Clinical Center; H. Clifford Lane, M.D., and Richard Davey, M.D., National Institute of Allergy and Infectious Diseases; Walter Hughes, M.D., St. Jude Children's Research Hospital, Memphis; Danny Lancaster, M.D., Regional Medical Center, Memphis; Mack Land, M.D., Baptist Memorial Hospital, Memphis; Carmelita Tuazon, M.D., George Washington University Medical Center; Michael Dohn, M.D., University of Cincinnati; Stephen Greenberg, M.D., Baylor College of Medicine; Michael Rogers, Ph.D., and Stephen LaFon, M.S., Burroughs Wellcome Co.
 Burroughs Wellcome Co. is a research-based pharmaceutical company with U.S. headquarters in Research Triangle Park, N.C. The company is a wholly owned subsidiary of The Wellcome Foundation Ltd., of London.
 -0- 11/28/91
 /CONTACT: Kathy S. Bartlett, 919-248-4302, or Sharon Haggerty, 919-248-8611, of Burroughs Wellcome/ CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU:


JT-KW -- NY002 -- 7968 11/28/91 08:05 EST
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Publication:PR Newswire
Date:Nov 28, 1991
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