Newport Pharmaceuticals announced Monday that it is resuming efforts to obtain approval for the sale of Isoprinosine to people infected with the AIDS virus, reversing a decision made a year ago to stop all research and testing on the drug.
The tiny drug company said it intends to pursue more clinical reviews of the 19-year-old drug after what the firm said were promising results of a study in Denmark and Sweden of 866 people carrying the AIDS virus but showing no symptoms of the disease--a status commonly called being HIV positive.
Newport Pharmaceuticals has pumped more than $6 million into Isoprinosine research. The company has been criticized by the Food and Drug Administration for conducting incomplete tests and for improperly promoting Isoprinosine as a treatment for acquired immune deficiency syndrome. The drug has been touted as everything from a memory stimulator to a treatment for herpes.
The Scandinavian human immunodeficiency virus clinical experiments involved six months of drug testing, plus a six-month follow-up. During that period, 19 of the 866 HIV patients contracted the AIDS virus. Of those, 17 were receiving placebos; two were taking Isoprinosine. "Clearly, what that shows is that Isoprinosine is effective in delaying the progression of the disease," said Judith Archbold, Newport's vice president and general counsel.
But a study completed last year for Newport Pharmaceuticals of the drug's efficacy on AIDS patients in the United States and United Kingdom came to an altogether different conclusion: Isoprinosine was proven ineffective.
The FDA told Newport Pharmaceuticals officials that it would not consider an application for approval unless further studies were conducted because of the drug's poor performance to date.