Newport Pharmaceuticals International Inc. said Tuesday that it has asked the U.S. Food and Drug Administration to approve Isoprinosine, the company’s only drug, as an immune-boosting retardant to AIDS.
The filing is the first the government has received for a drug that could be used to thwart the onslaught of acquired immune deficiency syndrome, or AIDS, in patients already exposed to the deadly disease.
However, an FDA spokeswoman said the agency has reviewed Isoprinosine many times in the last 15 years for maladies ranging from mononucleosis to hepatitis and has never approved it for sale in the United States.
“This drug has been investigated for all different types of diseases that it has not proved effective against,” she said. “It’s considered a drug in search of a disease.”
A Newport Pharmaceuticals spokeswoman said the company has given the FDA results from three separate studies involving 157 AIDS-exposed homosexual men. The studies were conducted at nine different medical centers throughout the country. About half of the test group received doses of Isoprinosine, while the remainder received sugar pills. During the six-month test, AIDS developed in six placebo patients but in only three Isoprinosine recipients.
“It’s not much of a difference, but it is a decrease,” said Alvin Glasky, Newport Pharmaceuticals’ chief executive.
Although Isoprinosine cannot be sold legally in the United States, it is sold in Mexico, where thousands of AIDS victims and AIDS-exposed persons have traveled in recent months to buy the drug.
As a result of the increasing border traffic, the FDA in May allowed Newport Pharmaceuticals to make Isoprinosine available to AIDS victims on a regulated “compassionate care” basis. The FDA action, its first involving a potential treatment for AIDS, was viewed more as providing a last-ditch opportunity for AIDS victims than a full-scale cure for the disease.
“Why not take a chance?” FDA spokesman Don McLearn said at the time. “We know there isn’t anything harmful about the drug. The question is whether it’s good for anything.”
Isoprinosine, developed in 1970, boosts the body’s immune system, or its ability to fend off infection and disease. It is licensed for sale in 80 countries either as an immune booster or to treat viruses.
Under the “compassionate care” program, Isoprinosine has been given to fewer than 100 AIDS victims under their physicians’ care in the last three months. The company’s spokeswoman said results of the program are not expected to be completed for another six to 12 months.