SALK AIDS VACCINE MAKER IMMUNE RESPONSE TRIES AGAIN
SALK AIDS VACCINE MAKER IMMUNE RESPONSE TRIES AGAIN with an initial public offering of 2.2 mil. shares estimated to bring the firm $16.6 mil. in proceeds, according to the offering, filed March 30 with the Securities and Exchange Commission. The firm in November had postponed an earlier initial offering citing unstable market conditions. The current offering is for fewer shares and at a lower price than the earlier offer of 3 mil. shares at a projected $12 per share. The firm's first product under development is an "AIDS immunotherapeutic," which uses inactivated HIV-1 depleted of its outer envelope to prevent or delay development of AIDS in individuals already exposed to the virus. Sometimes dubbed the "Salk AIDS vaccine" after Nobel Laureate Jonas Salk, MD, the product is based on an approach first suggested by Salk plus the research of immunologist Dennis Carlo, PhD. Salk is on the Immune Response board of directors while Carlo is chief scientific officer and chief operating officer. Immune Response got a publicity boost in March when FDA announced that it gave the go-ahead for the firm to conduct Phase III trials on the AIDS immunotherapeutic. The IND approval, actually granted in November, expanded the firm's clinical research on the product beyond California, where the drug had undergone Phase I/II trials under a waiver from the Food and Drug Branch of the state's Department of Health Services ("The Pink Sheet" Oct. 30, p. 11). The three-year, double-blind, placebo-controlled multicenter trial in 650 subjects is expected to begin by "early 1991," the prospectus says. Eligible subjects will have T4 cell counts below normal, have early clinical signs of AIDS but not yet an AIDS diagnosis, and have been on AZT for at least three months with no signs of intolerance. The patients will continue taking AZT during the trial. In addition, the firm has received approval for an IND supplement to conduct a "one-year, multicenter Phase II/III trial to monitor the clearance of virus in HIV-infected subjects treated with the AIDS immunotherapeutic," the prospectus notes. This study is expected to get underway in May. Involving 100 patients with T4 cell counts close to normal who are not taking AZT, it will evaluate results of earlier immunization. Another recent development is an exclusive licensing agreement with Pasteur Vaccins and Institut Merieux, allowing them to distribute the AIDS immunotherapeutic in Europe, Africa, and Central and South America. Signed in January, the agreement entails payment of $7.5 mil. to Immune Response based on achievement of regulatory milestones and a royalty on sales in licensed areas. It also includes a supply agreement whereby the firms will supply the AIDS vaccine to Immune Response. The AIDS immunotherapeutic vaccine is being developed under a joint venture with Rorer, set up in 1988. Rorer, Immune Response's largest stockholder with a 13.3% stake, will provide $15 mil. to Immune Response, again based on the AIDS vaccine reaching certain regulatory milestones. The prospectus notes that Immune Response anticipates filing an IND for Phase I/II trials for rheumatoid arthritis and multiple sclerosis immunotherapeutics "by as early as late 1990." The firm also has been conducting research to develop an immunotherapeutic for a third autoimmune disease, insulin-dependent diabetes.
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