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Executive Summary

IMREG IMMUNOAMPLIFIER INITIAL CANCER CLINICAL STUDIES IN 29 PATIENTS from three Ontario medical centers indicate that the two investigational compounds "appear to be able, under defined dosage, to stimulate the immune system," the New Orleans-based start-up reported in its initial public offering prospectus. Imreg asserted that the two immunoamplifiers "enable the patients to mount an improved response to antigens to which they have been previously exposed." The company added that the Canadian test results "have recently been confirmed by limited trials carried out on eight patients in a London, England hospital." The filing notes that the two immunoamplifiers tested "were shown to augment reactivity to antigens in approximately 61% of the cancer patients tested." Imreg said it believes that this percentage is a significant indication of the potential effectiveness of these immunoamplifiers in regulating the immune system." The firm added that another 40 patients at the Canadian facilities have entered the trial and, to date, no toxic reactions have been observed. In addition, Imreg said that it has carried out limited testing on one of its immunoamplifiers in four patients with AIDS and two other patients "who displayed significant impairment of their cell-mediated immune systems." Noting that all six patients had impaired T4 lymphocyte function, the firm said it "obtaned evidence in each of these cases suggesting partial correction of this immune defect." The company indicated that it is planning on expanding its AIDS clinicals to include "at least two of its immunomodulators" during 1984 in medical centers in the U.S., including the medical center at the University of Southern California. The three-year-old start-up is seeking to develop a group of "immunomodulators" in white blood cells for use in disorders related to the cell-mediated immune system, including cancer, AIDS, infectious diseases, rheumatoid arthritis, and organ transplant rejection, among others. Imreg said it has identified "several" immunomodulators and is "in the advanced stages of purifying four of them." Discussing the firm's technology, the filing notes that "in the last few years, certain of the immunomodulators contained in the cell-mediated immune system have been identified and partially characterized by the company." The filing adds that the compounds are effective "only against antigens to which the patient has been exposed since they enhance or suppress, rather than create, immune reactions." Imreg said that it has laboratory evidence "indicating that two of its immunomodulators stimulate the production of lymphokines." The firm characterizes its immunomodulators as "immunoamplifiers" and "immunosuppressors." The company reported that, on the basis of preliminary results, it believes its immunomodulators "are distinguishable" from research substances with immunealtering capabilities such as interferons, prostaglandins, cortisone, the interleukins, thymosin, monoclonal antibodies, and "transfer factor." However, the filing notes that Imreg's initial patent applications were disallowed by the Patent Office, which asserted that the firm's immunomodulators "are similar to certain other leukocyte extracts." Imreg said that it filed a response to the Patent Office action in November. Imreg said that it presently "intends to purify the immunomodulators and manufacture a sufficient quantity of them to begin large-scale tests in mid to late 1984." The firm added that "no arrangements for large scale testing have been made, although preliminary discussions have taken place with suitable institutions." Imreg raised $9.1 mil., after underwriting discounts and commissions, from its initial offering of 1 mil. shares at $10 per share last January. Imreg said that over $2.6 mil. each will be funneled into research activities, and product and patent development; $2.2 mil. will go toward funding clinical trials; and the remainder will go toward working capital.

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