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RESULTS OF COMMUNITY BASED CLINICAL TRIAL OF AIDS DRUGS ANNOUNCED

 NEW YORK, Jan. 22 /PRNewswire/ -- The results of a community-based, open-label, comparative clinical trial of VIDEX (didanosine, ddI) versus ddC (zalcitabine) in patients with severely advanced HIV disease were reported today. The trial, CPCRA 002, was a prospective, randomized comparison of VIDEX versus ddC conducted by the Community Programs for Clinical Research on AIDS (CPCRA) of the National Institute of Allergy and Infectious Disease (NIAID). Bristol-Myers Squibb provided VIDEX for use in the trial.
 Results of the study indicate that the two drugs had similar impact on progression of HIV disease or death when used as salvage therapy after AZT (zidovudine) in HIV infected patients with late stage disease who were intolerant of or who had failed on prolonged AZT therapy. "The advanced nature of disease in this patient group should be considered when interpreting the data and these results should not be extrapolated to a healthier patient population," said Laurie Smaldone, M.D., executive director of HIV/Antiviral Research for Bristol-Myers Squibb Company.
 "The clinical outcome in these patients with advanced HIV disease assigned to VIDEX is similar to what we saw in a comparable patient population in the VIDEX Expanded Access program and in the recently reported European Alpha trial. In all three trials, participants were very sick, had low CD4 counts and suffered from multiple complications of the disease. The results of these studies re-emphasize the urgent need for new drugs to treat patients in the advanced stages of HIV disease," continued Dr. Smaldone.
 The respective rates of adverse events were similar among patients initially randomized to both the VIDEX and ddC arms of CPCRA 002. However, the profiles of specific adverse effects were different for the two drugs. Patients who received ddC were significantly more likely to develop peripheral neuropathy, and stomatitis (painful lesions of the mouth and esophagus) was reported only among patients on ddC. Diarrhea, pancreatitis and abdominal pain were more prevalent in patients enrolled in the VIDEX arm.
 "Again, the side effect profile of VIDEX as demonstrated by CPCRA 002 is similar to that established in the Expanded Access population and the European Alpha study. The results are consistent with what we can expect in patients with low CD4 counts and advanced HIV disease," adds Dr. Smaldone.
 Several large clinical trials of VIDEX have also been conducted by another arm of NIAID called the ACTG, or AIDS Clinical Trial Group. Recently, the clinical efficacy and safety of VIDEX were confirmed in earlier stage AIDS and ARC and asymptomatic patients enrolled in a study called ACTG 116B/117. ACTG 116B/117 was a randomized, double-blind, controlled clinical trial supported by the ACTG. The study was designed to compare two doses of VIDEX (500 mg/day and 750 mg/day) to continuation of AZT (600 mg/day) in patients who had taken AZT for 16 weeks or more.
 ACTG 116B/117 investigators reported that patients who were randomized to VIDEX at 500 mg/day -- which correlates to the currently recommended dose -- had a statistically significant delay in time to first new AIDS defining event or death compared to those randomized to AZT. These results were reported in the Aug. 27, 1992 New England Journal of Medicine and resulted in expanded labeling for the drug. There is a growing worldwide data base that demonstrates the clinical efficacy of VIDEX.
 VIDEX was first cleared for marketing on Oct. 9, 1991 in the U.S. and Canada. The drug was indicated for the treatment of adult and pediatric patients (over six months of age) with advanced HIV infection who have demonstrated intolerance or significant clinical or immunologic deterioration during AZT therapy. On Sept. 23, 1992, a supplemental new drug application amended the VIDEX labeling to include adult patients with advanced HIV infection who have received prolonged prior AZT therapy.
 Upon approval to market VIDEX, Bristol-Myers Squibb implemented a Reimbursement Assistance Program and a Temporary Assistance Program to ensure that individuals with limited financial resources for whom the drug is prescribed can obtain it. The VIDEX Reimbursement HelpLine (1-800-788-0123) is fully staffed from 8 a.m. to 8 p.m., EST, on business days. Physicians and other health care professionals can obtain medical information about VIDEX by calling 1-800-662-7999.
 Bristol-Myers Squibb is a research-based, diversified health care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices.
 -0- 1/22/93
 /CONTACT: Susan J. Yarin, 212-546-5709, or Elizabeth M. Sigler, 212-546-5764, both of Bristol-Myers Squibb/
 (BMY)


CO: Bristol-Myers Squibb ST: New York IN: MTC SU:

TS -- NY042 -- 7923 01/22/93 12:48 EST
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Date:Jan 22, 1993
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