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Executive Summary

NEWPORT's ISOPRINOSINE SECONF SET OF AIDS RELATED STUDIES will be conducted under a compassionate IND. FDA announced in a May 10 "Talk Paper" that it recently "gave permission to Newport to initiate a compassionate-use protocol to give the drug to any physician for investigational use in patients with" Acquired Immune Deficiency Syndrome (AIDS). FDA said that in November it permitted initiation of an investigational protocol for Newport to test Isoprinosine (inosiplex) in a "limited number of patients with 'persistent generalized lymphadenopathy' and 'AIDS-related complex', syndromes which are believed to progress to AIDS in some cases." Newport said that while it did not have any data on the use of Isoprinosine for AIDS, FDA's approval of the firm's compassionate use protocol was based on the results of a preliminary lymphadenopathy trial at Mt. Sinai Hospital in New York. That trial found a statistically significant increase of immune system cells NK, T-11 and T-4 in Isoprinosine treated patients, the firm said. In announcing approval for compassionate use, FDA emphasized that it has never approved Isoprinosine for general public marketing for any medical purpose. The agency stated that Isoprinosine "is not a cure" for AIDS, but may be of value "as adjunctive therapy for some pre-AIDS or AIDS patients" because it stimulates the immune system. Isoprinosine is the only drug FDA has granted a compassionate IND for use in AIDS. FDA noted that "reports indicate some persons concerned about AIDS are going to Mexico to obtain the drug." The agency stated that "there is no need for anyone interested in obtaining Isoprinosine to leave the country. Any licensed physician who believes that the drug might be helpful for a patient may obtain it by contacting Newport. . .and enrolling their patient in one of Newport's protocols." Newport commented in a May 10 press release that "no final notification regarding the method and approval to initiate compassionate treatment with Isoprinosine for AIDS patients has been received." The firm stated that "discussions are underway with the FDA regarding a protocol to allow compassionate treatment of patients with fully developed AIDS to receive the drug." Newport's clinicals in pre-AIDS patients are currently underway. The firm said it is conducting double-blind placebo controlled studies in nine U.S. centers and one London center, and will possibly enlist patients for an additional two centers. FDA noted that Newport also has an active IND to test Isoprinosine in recurrent herpes virus infections, and has sought FDA's testing or marketing approval for use of the drug for learning and memory enhancement, multiple sclerosis, viral hepatitis, subacute sclerosing panencephalitis, infectious mononucleosis and influenza.

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