Immune Response Corp announced last week that its candidate HIV treatment Remune, formerly known as HIV-1 Immunogen, has been cleared by the US Food and Drug Administration to enter a scheduled 3,000-patient Phase III clinical endpoint trial (Marketletter September 25, 1995).
The clinical trial will begin during March in medical centers throughout the USA. Remune is a gp120-depleted inactivated HIV-1 immunogen devised by polio vaccine pioneer, the late Jonas Salk. It will be given at a dose of 100mcg every three months to patients with CD4 cell counts of 300-550/mm3.
Last year, the Thai Ministry of Public Health gave the go-ahead for a 300-patient study of the immunogen, but Immune Response is still awaiting export approval before this can begin.
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