The FDA has given United Biomedical Inc. (UBI) the go-ahead toinitiate Phase I clinical trials of a drug designed to stimulate the body'simmune system to destroy HIV-infected cells.UBI's drug stimulates cytotoxic or "killer" T lymphocytes (CTL) torecognize and destroy HIV-infected cells. It identifies the regions ofthe virus that are capable of turning on the CTLs stimulating thesekiller lymphocytes to levels the company believes will be effective inkilling the virus."Our treatment is a `cocktail' of lipid-modified peptides designed torespond to the HIV virus in genetically diverse populations throughoutthe world," said Wayne Koff, vice president for vaccine research anddevelopment. "The HIV virus as it appears in India, for example, is notthe same as the HIV virus in Thailand or the United States."Koff said the Phase I trials will be conducted in two groups. One trialwill be done in healthy people who are not infected with HIV. The goalhere will be to see if the drug can stimulate the CTLs to turn on. Thesecond trial will be done in infected people to determine whether thedrug increases CTL activity in HIV-infected cells."By stimulating CTLs to attack the HIV virus, we hope to prolong theperiod between HIV infection and the onset of AIDS indefinitely,"Koff said. "Our goal is to maintain individuals indefinitely in anasymptomatic state. In the initial stages of HIV infection there is a highlevel of immune activity. Then for unknown reasons there's a declinein CTL activity that coincides with the onset of opportunisticinfections. Our goal is to maintain or increase that activity. The T cellswill be turned on and will recognize the infected cell and kill it."UBI is already in Phase I trials of an AIDS vaccine. The trials are beingconducted in the United States, China and Australia. The vaccine isintended to protect uninfected individuals from developing AIDS.UBI's AIDS vaccine research is being supported by BaxterInternational Inc. of Deerfield, Ill. Baxter agreed in 1992 to finance upto $10 million of research and development on the vaccine. At thesame time, Baxter acquired almost 12 percent equity in UBI. Baxterwill gain exclusive distribution rights to the vaccine"To be effective, an AIDS vaccine should be able to recognize anddestroy HIV-infected cells as well as cell-free virus," Koff said. "Theprincipal components are the ability to introduce neutralizingantibodies and to stimulate CTL response. By effectively combiningthis prototype vaccine with a product capable of stimulating HIV-specific CTL, our global AIDS vaccine will fulfill these requirements."Other companies with vaccine candidates include MicroGeneSys Inc.,Bristol-Myers Squibb, Oncogene Science Inc., Immuno-Ag, BiocineCo., Genentech Inc., United Biomedical Inc., Connaught LaboratoriesInc., and Progenics Pharmaceuticals Inc.

-- Philippa Maister

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