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Executive Summary

SCHERING INTRON STUDIES FOR COMMON COLD INDICATION INCLUDE DATA on over 3,000 patients, according to the company. Schering said it has just completed one Intron (alpha-2 interferon) study for prophylaxis of the common cold involving about 200 families and is considering additional studies for the spring and fall of 1986. The most recent published data on Schering's alpha-2 interferon appears in the Jan. 9 issue of the New England Journal of Medicine. The data, which have been added to Schering's biological license application for the common cold indication, consists of a U.S. study involving 60 families and an Australian study involving 46 families. Both randomized, placebo-controlled, double-blind studies were conducted to determine whether intranasal alpha-2 interferon could prevent respiratory illness in healthy contacts of ill family members. In the U.S. study, conducted by Frederick Hayden, MD, et al, University of Virginia, healthy participants self-administered interferon (5X10 IU) or placebo spray once daily for seven days within 48 hours of the onset of illness in a family member. "Respiratory illness developed during the eight-day period, starting with the second day of spraying, in 52 of 222 persons in the placebo group as compared with 32 of 226 in the interferon group (P = 0.02; efficacy, 39%)," Hayden, et al, reported. Among persons exposed to laboratory-documented rhinovirus colds, "illness developed in two of 27 interferon recipients as compared with 12 of 34 placebo recipients (P = 0.02; efficacy, 79%)," the investigators said. Further, "interferon recipients who were contacts of family members with rhinovirus colds had a 79% reduction in both illness occurrence and laboratory-documented rhinovirus colds." Similar results were reported by the Australian investigators Robert Douglas, MD, et al, University of Adelaide. In that study, 120 adult members of 46 Australian families used 325 courses of intranasal alpha-2 interferon during a six-month period. They applied the drug for seven days when respiratory symptoms developed in another family member. "By comparison with the control group of 109 members of 49 families who used 319 seven-day courses of placebo spray, the users of alpha-2 interferon experienced 33% fewer days with nasal symptoms and 41% fewer episodes of 'definite' respiratory illness," the investigators concluded. Hayden, et al, noted that "the most common symptom associated with spray use was the appearance of blood in nasal mucus, which tended to occur more often during the use of interferon (4.7%) than of placebo (1.8%) (P = 0.16)." Douglas, et al, also reported that "minor nasal bleeding or blood tinging of the nasal mucus was mentioned by the sprayer in 8 of 330 placebo courses and 27 of 345 alpha-2 interferon courses (P = 0.001)." The investigators added that "other nasal symptoms, including stuffiness and irritation attributed by the user to medication, were comparable in the two groups (eight placebo v. seven alpha-2 interferon)." In an editorial published in the same issue of the New England Journal of Medicine, R. Gordon Douglas, Jr., MD, New York Hospital-Cornell Medical Center, commented that the two studies show "that daily prophylactic administration of a large dose of interferon is useful in preventing common colds in situations in which the frequency of colds is sufficient to outweigh the 10% risk of minor nasal bleeding." However, he adds that "unfortunately, almost all the effect was in rhinovirus infections, and no effect was observed in colds having other etiologic agents. Although rhinovirus colds were prevented with efficacies of 78% and 79%, only 39% and 41% of all colds were prevented." In addition to the common cold indication, Schering also has biological license applications pending for use of alpha-2 interferon in the treatment of multiple myeloma, malignant melanoma, Kaposi's sarcoma, hairy cell leukemia and venereal warts. Roche also has applications pending for its alpha interferon for cancer indications.

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