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NIH ISOPRINOSINE/VIRAZOLE PRE-AIDS TRIALS

Executive Summary

NIH ISOPRINOSINE/VIRAZOLE PRE-AIDS TRIALS began a week ago at George Washington University Medical Center (GWUMC), Newport Pharmaceuticals announced. The trials on asymptomatic HIV infected patients received NIH and FDA approval last month and are being conducted in conjunction with NIAID, Newport said. Virazole (ribavarin) is manufactured by Viratek, Inc., a subsidiary of ICN. "This trial will assess whether the combination of these two agents exerts beneficial effects against the AIDS virus and whether they merit large scale clinical evaluations," the study's principal investigator, Richard Schulof, MD, PhD, said. The trials involve 20 to 50 asymptomatic HIV infected patients divided into groups that will be treated for three months each with 4g Isoprinosine (inosine pranobex) daily and varying doses of ribavarin, Newport said. "AIDS related conditions will likely be treated with drug combinations, and as we near completion of our Phase III clinical trials with Isoprinosine alone, we are encouraged that the NIH and GWUMC saw fit to study Isoprinosine paired with an antiviral at this time," Newport Senior VP-Scientific Affairs D. Stephen Robbins, MD, noted. Newport is sponsoring ongoing trials in the U.S., England, Australia, Denmark, and Sweden. The trials began in November 1986 and involve 2,300 people. The company anticipates reviewing the results "sometime during the third quarter of 1988," but does not think it will file an NDA for Isoprinosine "any earlier than the fourth quarter of calendar 1988." In April 1987, Newport bought America's Pharmacy, Inc., a Des Moines, Iowa-based mail order prescription dispensary from Caremark for $ 12 mil. ("The Pink Sheet" April 6, 1987, T&G 5-6). Revenues for the mail order business for the eight months ended December 1, 1987 were $ 13.3 mil., However, Newport lost $ 2.5 mil. overall in 1987. Newport indicated that first quarter results will show that America's Pharmacy has become profitable. "If the results [of the NIH/George Washington trials] show strong evidence of the drug's efficacy for pre-AIDS conditions, we plan to submit a [NDA] to the [FDA]," Newport said in its 1987 annual report. "In the event we do not file with the FDA, we will continue to support our foreign licensees and distributors in marketing the drug internationally, and will redirect domestic R&D spending to other business opportunities to meet our goal of overall corporate profitability."
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