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GLAXO PROVIDING 3TC FREE OF CHARGE TO AIDS PATIENTS

Executive Summary

GLAXO PROVIDING 3TC FREE OF CHARGE TO AIDS PATIENTS who are intolerant or refractory to approved therapies under an open-label protocol. Glaxo is developing the nucleoside analog, which it licensed from the Canadian company BioChem Pharma. Glaxo received FDA approval on Nov. 1 to provide 3TC to adults and children who are at least three years old, have CD4 cell counts of less than 300, are refractory or intolerant to approved therapies and do not qualify for the ongoing clinical trials. Pregnant women can also receive the drug. In October, Glaxo received approval to distribute 3TC to a similar patient population in Canada. Open-label protocols are pending approval in European countries. Distribution of 3TC will be handled by Kern McNeill International, a contract research organization in New Jersey, Glaxo said. Kern McNeill will ship 3TC to physicians by two-day Federal Express. Glaxo and BioChem were unable to provide an estimate of how many patients would be eligible to got 3TC. Glaxo said it will send letters about the open-label protocol to its own investigators and to American Federation for AIDS Research clinical trial sites. The information will be listed in AmFAR's directory and the National Institutes of Health AIDS clinical trials phone line. The letter also will be sent to AIDS patients' organizations and newsletters. The letter provides a phone number (1-800-248-9757) for physician requests. 3TC is in Phase II/III trials of 500 AIDS patients in North America and 320 patients in Europe. The trials involve four treatment arms: 3TC v. AZT (Burroughs Wellcome's Retrovir); 3TC v. AZT and ddC (Roche's Hivid); 3TC v. 3TC and AZT; and 3TC and AZT v. AZT, ddC and 3TC. In the trials to date, 3TC is well tolerated, with almost no side effects and has resulted in some patients showing improvements in weight and energy, Biochem said. BioChem expects data from these trials to be available in the spring and projects that an NDA will be filed next autumn. The same compound, but referred to as lamivudine, is in late Phase II trials in the U.S., Canada and Europe in hepatitis B patients ("The Pink Sheet" July 12, T&G-3). Results from early Phase II trials will be presented by study investigator Lorne Tyrrell, MD/PhD, University of Alberta, Nov. 6 at a meeting of the American Association for the Study of Liver Diseases in Chicago. The Phase 11 trials enrolled 75 patients with chronic hepatitis B infection who were randomized to receive placebo or lamivudine (5, 20, 100, 300 or 600 mg/day) for one month. Patients were followed for two months. A total of 62 patients completed treatment. "Lamivudine at 100 mg/day or higher resulted in >/= 98% reduction in hepatitis B virus DNA during treatment," study presentation materials say. "One patient became and has remained HBeAg negative through follow-up [and] no patients became HBsAg negative." BioChem expects that clinical trials of lamivudine in hepatitis B will begin by year-end in Japan, Hong Kong and Taiwan. Phase III trials in North America and Europe may begin in mid- 1994. Over 200 patients have been on lamivudine for at least two years and no patients have experienced serious adverse events like those seen with Lilly's fialuridine (FIAU), BioChem said. Lilly stopped hepatitis B trials of its nucleoside analog in June because of cases of liver damage.
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