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IMREG-I "MAY BE EFFICACIOUS" BUT NEEDS FURTHER CONTROLLED STUDIES, FDA's

Executive Summary

IMREG-I "MAY BE EFFICACIOUS" BUT NEEDS FURTHER CONTROLLED STUDIES, FDA's Vaccines & Related Biological Products Advisory Committee agreed at its April 7 meeting. Summarizing the committee review, Chairman Floyd Denny, MD, University of North Carolina School of Medicine, said: "I think it is the clear consensus of the committee that there is the feeling that there may be some effect for this drug." In November, the committee meet to review Imreg's Treatment IND submission for Imreg-1 and deferred any recommendations until it had an opportunity to review FDA's analysis and the firm's response ("The Pink Sheet" Nov. 21, pp. 304). The committee did not specifically consider whether a Treatment IND should be granted, but rather focused on the issue of whether the biological agent appears to be effective on the basis of FDA's and the firm's conflicting analyses of the trial data. According to FDA's analysis of the data, only seven of the patients in the trial (three of 93 on Imreg and four of 48 on placebo) met the criteria of progressing to AIDS, yielding a p value of 0.13 or 0.15. Imreg believes that an additional number of the patients receiving placebo progressed to AIDS, yielding statistically significant p values. FDA's and Imreg's differing opinions about the patients progressing to AIDS were also articulated at the November meeting. The different views hinged primarily on the definition of symptoms that would be characterized as AIDS. The firm supported its view of clinical endpoints and the resulting efficacy values with experts at the meeting. Paul Levy, professor of epidemiology from the University of Illinois at Chicago, for example, presented a statistical analysis looking at best and worst case analyses of the data. According to his analysis, if all 15 AIDS cases the firm believes were seen in the study were included, Imreg was superior to placebo with a p value of 0.002. If the three cases of peripheral neuropathy, which FDA particularly objected to, were not included, the p value went to 0.011. The seven evaluable AIDS patients identified by FDA yielded a 0.186 p value in his analysis. The statistician also presented data contradicting FDA's contention that the trial was biased toward Imreg patients. Although the committee made no recommendations as to Imreg's Treatment IND request, a few members pointed out that the data seem to meet FDA's criteria of reasonable evidence that the drug may work. However, the same committee members pointed to the difficulties in approving a Treatment IND at this stage. For example, committee member Robert Couch, MD, Baylor College of Medicine, commented: "I think this product is still in the category of needing a good definitive controlled study . . . and I have some concern about . . . getting that kind of information once a Treatment IND had been granted." Committee member Lawrence Gelb, MD, V.A. Medical Center, St. Louis, pointed out that the Treatment IND regs also have requirements on "standards of potency and consistency," citing those as areas he has "problems with." After hearing the committee's assessment on efficacy, Imreg Chairman Arthur Gottlieb said he felt the committee's conclusions do not preclude the granting of a Treatment IND. If a controlled trial is necessary prior to Treatment IND approval, he said, "we would like to obtain permission for cost recovery . . . because there is no way that we can do another trial given the financial situation that we have." In an April 7 statement released during the meeting, Imreg announced that it has a "concluded a definitive financing arrangement with Evergreen Investments Limited Partnership, a group of prominent physicians, scientists and businessman" for $ 2.6 mil. in financing in return for stock warrants and a share of future revenues from Imreg-I.
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