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Executive Summary

HEM's AMPLIGEN AIDS ANTIVIRAL CLINICALS SET TO RESTART shortly at four to six medical centers, pending approval of the Philadelphia-based firm's IND. The company expects that the Phase II trials will be initiated in September. Ampligen's earlier Phase III trials on patients with AIDS-related complex were terminated in 1988 due to insufficient evidence of efficacy. HEM Research attributed lack of efficacy data to the use of plastic I.V. bags in administration, which, it said, rendered the drug (poly(1)poly(C[sub 12],U) inactive. The firm is now packaging Ampligen in glass vials. The apparent lack of efficacy found in the 300 patients then in the Phase III trials led to the dissolving of a joint venture between HEM and DuPont two years ago ("The Pink Sheet" Aug. 22, 1988, T&G-1). The joint venture to develop Ampligen (a mismatched, double-stranded RNA) was signed in October 1987. Under the contract, DuPont planned to manufacture and market the drug once approved. In May 1987, DuPont had acquired rights to Ampligen and a small equity stake in the R&D firm HEM ("The Pink Sheet" June 1, 1987, T&G-4). The loss of its primary project was a major blow to HEM, but the resolution of a bitter legal battle with DuPont and the anticipated restart of human clinicals for Ampligen signal brighter days for the firm. On July 16, HEM announced that it had reached a settlement with DuPont in which DuPont agreed to drop a lawsuit against the company and pay HEM a $2.7 mil. cash settlement. DuPont also agreed to sell 2.7 mil. shares of HEM stock back to the company. In the lawsuit, filed in April 1989, DuPont had sought more than $30 mil. from HEM, alleging that the company misrepresented data from its original 10-patient Ampligen study. That study, published in the Lancet, was the impetus for the formation of the joint venture. HEM countersued, claiming that DuPont owed it more than $7 mil. for numerous charges, including breach of contract. In the ensuing months, HEM nearly went bankrupt, and its board fired CEO and chief scientist William Carter, who subsequently sued the firm. However, HEM then found a new group of investors, led by Paul Charlap, who is the current chairman and CEO. In addition to the AIDS studies, Ampligan is in Phase II studies for chronic fatigue syndrome, renal cell carcinoma, and hemophilia.

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