Columbia Labs Advantage-S Additional HIV Prevention Trials Unlikely
This article was originally published in The Tan Sheet
Executive Summary
"It will be very difficult to conduct another study" on Advantage-S (nonoxynol-9) and HIV prevention after a Joint U.N. Program on HIV/AIDS trial produced negative results, Columbia Labs Chairman and CEO William Bologna asserted during a June 12 conference call.
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"It will be very difficult to conduct another study" on Advantage-S (nonoxynol-9) and HIV prevention after a Joint U.N. Program on HIV/AIDS trial produced negative results, Columbia Labs Chairman and CEO William Bologna asserted during a June 12 conference call. Interim analyses of the Phase III multi-center, randomized, placebo-controlled, double-blind study of 700 sex workers in South Africa, the Ivory Coast, Benin and Thailand by a drug safety monitoring board revealed a lower occurrence of HIV infection in one of the study arms. Since previous studies suggested Advantage-S is safe and effective, both UNAIDS and Columbia presumed the active group was benefiting, Bologna explained, stating the monitoring board would have halted the study if it believed otherwise. When the study was unblinded, researchers discovered the spermicide arm had the higher incidence of HIV. Both groups, however, showed a lower rate of HIV than non-participants, UNAIDS reported. "We may never know the reason why" the trial failed, said Bologna, speculating the "extreme" sexual behavior of the sex workers or unknown effects of long-term use could have been confounding factors. It remains unknown whether the product could guard against HIV infection, Bologna maintained. UNAIDS completed the five-year study in March and will present a report at the XIII International AIDS Conference in Durban, South Africa on July 12 (1 (Also see "Columbia Labs" - Pink Sheet, 27 Mar, 2000.)). The news will have "no financial impact" on the company, Bologna said. However, following the UNAIDS disclosure, Columbia's stock dropped from $13 on June 9 to $6 on June 13. The stock closed at $5 on June 16. Advantage-S and Miphil are the firm's only remaining OTC products. Columbia sold Replens, Legatrin, Diasorb and Vaporizer in a Bottle to Li'l Drugstore in March (2 (Also see "Columbia Labs" - Pink Sheet, 24 Apr, 2000.)). Several law firms have filed class-action suits on behalf of shareholders in West Palm Beach, Fla. federal court. The suits allege Columbia misled investors by inappropriately expressing confidence that the Advantage-S study would result in positive findings. |