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Executive Summary

NEWPORT ISOPRINOSINE STUDIES HAVE SHOWN TREND TOWARD DELAY OF "FULL BLOWN AIDS" in patients treated with the drug, the firm told FDA in a recent meeting. "A trend towards a delay in reaching full blown AIDS ]Acquired Immune Deficiency Syndrome[ was claimed in those patients who had taken Isoprinosine for 28 days when the preliminary results of three different studies were combined," an FDA memo of the meeting stated. The agency told Newport that "studies demonstrating decreased numbers of patients progressing from pre-AIDS or a significant time delay in the development of definite AIDS would be viewed as evidence of clinical benefit to patients." The meeting was held at the request of Newport to discuss the firm's research program and NDA plans for the use of Isoprinosine in treating AIDS-related illness. FDA staff present at the meeting included Com. Young, Center for Drugs and Biologics Director Harry Meyer, MD, and Chief Counsel Tom Scarlett. Newport Chairman and President Alvin Glasky reported that in findings to date "early and prolonged effects were claimed on NK cell activity, with lesser delayed effects on T]4[ helper cells and total lymphocyte counts," the memo stated. "No clinical benefit was seen in the AIDS patients, and clinical significance was difficult to document in early or pre-AIDS, since overt symptomatology in many of these patients was lacking." According to the memo, Glasky said "obtaining and maintaining a placebo group was very difficult, especially after 28 days into the study." In May, FDA gave Newport permission to begin a compassionate-use protocol to give the drug to physicians for investigational use AIDS patients. The firm also has a multi-center study underway to test Isoprinosine in pre-AIDS patients. The multicenter study, which began in January, currently has 103 patients enrolled, according to FDA's memo. The memo also noted that Newport "suggested that the agency should consider options to the usual NDA requirements for drugs such as Isoprinosine to be used in treating diseases such as AIDS." According to the memo, "Dr. Young stated that this is already being considered at the departmental level, but will require expert consensus." Newport told "The Pink Sheet" it hopes to file an NDA for Isoprinosine by the end of the calendar year.

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